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PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus and is qualified in its entirety by the more detailed information and financial statements included elsewhere in this prospectus. It does not contain all of the information that may be important to you and your investment decision. You should carefully read this entire prospectus, including the sections titled “Risk Factors,” “Special Note Regarding Forward-Looking Statements,” “Business,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included elsewhere in this prospectus.

Overview

We are a commercial-stage medical device company redefining stroke recovery for survivors living with life-altering motor impairments. Our Vivistim Paired Vagus Nerve Stimulation (Paired VNS) System is the first and only clinically-validated, FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. Stroke is one of the leading causes of long-term disability in the United States. While advancements in acute stroke care over the past decade have significantly reduced mortality, innovation for chronic stroke recovery has lagged, resulting in a growing number of stroke survivors living with meaningful impairments. Our breakthrough Vivistim Paired VNS System (Vivistim System) addresses this unmet need. The Vivistim System includes an implanted pulse generator and lead that deliver stimulation to the vagus nerve when activated. During treatment (Vivistim Therapy), intentional bursts of stimulation are delivered during functional movement to increase neuroplasticity and durably restore motor function. Clinical data has demonstrated that Vivistim Therapy delivers meaningful improvements in upper limb function, which can help stroke survivors regain critical capabilities and independence and restore quality of life, regardless of the time elapsed since the patient’s stroke. We believe we are setting a new standard of care in chronic stroke recovery, facilitating a new treatment pathway for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. We have experienced rapid growth since our full commercial launch in 2023, and physicians have performed over 1,000 implants, including approximately 700 in 2025.

In the United States, a stroke occurs every 40 seconds and approximately 800,000 strokes occur annually, according to a report published by the American Heart Association (AHA) in 2025. Stroke occurs when blood flow to a region of the brain is suddenly interrupted, either because an artery becomes blocked in the case of an ischemic stroke, or because a weakened blood vessel ruptures in the case of a hemorrhagic stroke. For stroke survivors, the interruption of blood flow to the brain can result in lasting motor, cognitive, visual, and language impairments, including weakness or hemiparesis affecting the extremities. Based on a report published by the AHA in 2025, we estimate that there are currently approximately 10 million stroke survivors in the United States, the majority of whom are living with chronic impairments.

Chronic ischemic stroke is a serious medical condition characterized by physical and cognitive impairments that persist beyond the first three to six months post-stroke. These impairments can materially diminish a patient’s independence and quality of life. According to a report published by the AHA in 2025, ischemic stroke is a leading cause of serious long-term impairment for adults in the United States and has an estimated annual healthcare burden of more than $25 billion.

Chronic stroke recovery presents a significant market opportunity. According to the AHA, approximately 87% of the strokes in the United States are ischemic. This equates to approximately 9 million ischemic stroke survivors in the United States, of which we estimate that more than 4 million are chronic ischemic stroke survivors living with moderate to severe upper extremity impairment. This population falls within the current on-label indication for the Vivistim System. We believe that an initial market opportunity comprises approximately 1 million of those survivors that demonstrate the requisite overall health, cognition and motivation to participate in therapy and have received some amount of post-stroke therapy, which we estimate represents an initial market opportunity of over $30 billion based on the average selling price of the Vivistim System. Vivistim Therapy is effective for recent stroke survivors as well as patients who initiate treatment many years post-stroke. Based on a report published by the AHA in 2025, we estimate that each year approximately 200,000 new stroke survivors in the United States meet our indication for use, with 50,000 of these survivors representative of our initial market opportunity.

There is no standard of care for motor recovery in the chronic stage of stroke. After the initial three- to six-month sub-acute phase post-stroke, patients typically reach a functional plateau with conventional physical rehabilitation and have limited options to continue improving. As a result, we believe that there is a large population of highly motivated stroke survivors who have few proven options.

Our breakthrough Vivistim System is the first and only FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. The Vivistim System facilitates Vivistim Therapy, which has been clinically proven to significantly improve upper limb function and help patients regain critical capabilities and independence. Vivistim Therapy leverages neuroplasticity – the ability of the nervous system to adapt and reorganize its connections – to improve upper limb function in patients with chronic stroke. The Vivistim System includes an implantable device that stimulates the vagus nerve only when intentionally activated, triggering the release of neuromodulators. These neuromodulators create a heightened state of plasticity in the brain, such that neural networks can more readily adapt and reform in response to stimuli. When functional movements, such as goal- or task-oriented exercises and movements, are performed in the presence of these increased neuromodulators, the brain can create new neural connections and strengthen existing connections to a degree that would otherwise not be possible, enabling lasting improvements in motor pathways and creating greater potential for recovery.

Shortly after device implantation, patients begin Vivistim Therapy with a physical or occupational therapist. This therapy does not require patient-specific programming. In the clinic, the therapist uses a remote to activate the Vivistim System during task-specific practice, such as reaching for and grasping objects. Patients continue Vivistim Therapy at home, both during their in-clinic therapy protocol and, if desired, in the months and years that follow. At home, patients easily activate stimulation sessions by swiping the Vivistim magnet over the Vivistim implanted pulse generator (IPG) implant site, which initiates 30 minutes of periodic stimulation pulses. Patients can perform this therapy at home or during their activities of daily living to further reinforce their neural retraining. We believe the ability for patients to observe real, tangible improvements in their ability to perform activities of daily living can encourage ongoing engagement with at-home therapy, helping patients to sustain their efforts and achieve meaningful, lasting functional improvement over time.

We believe we are setting a new standard of care in chronic stroke recovery, facilitating a new treatment pathway for chronic ischemic stroke patients with moderate to severe upper extremity impairment. We believe Vivistim Therapy offers these patients a number of key benefits, including the first and only FDA-approved device clinically proven to deliver significant improvements in upper limb function; significant clinical improvement even for patients who initiate treatment many years post-stroke; durable improvements underpinned by a clinically proven mechanism of action; high patient and therapist satisfaction; and a safe and minimally invasive outpatient procedure.

We are building a robust body of clinical evidence supporting the safety, efficacy, durability, and well-understood mechanism of action of Vivistim Therapy, with additional trials ongoing and planned in 2026 and beyond. In our pivotal, triple-blind, randomized, sham-controlled VNS-REHAB trial, Vivistim Therapy resulted in an approximately two-times greater, as measured by Fugl-Meyer Assessment of Upper Extremity (FMA-UE), and approximately three-times greater, as measured by Wolf Motor Function Test (WMFT), improvement in hand and arm function compared to intensive rehabilitation alone, at the end of the in-clinic and at-home therapy protocol. Data from the trial also demonstrated a favorable safety profile, with no severe adverse events, serious adverse events or unanticipated adverse events associated with the Vivistim System. While implantation can result in procedure-related complications, such as post-operative pain and infection, the rate of surgical complications that did not resolve within a few weeks was less than 1% in the VNS-REHAB trial. These results highlight Vivistim Therapy’s distinctive ability to drive substantial neuroplastic adaptations and functional gains, which we believe sets it apart as the only therapy with robust clinical evidence for effective post-stroke motor recovery. Looking ahead, our GRASP registry is collecting real-world evidence to reinforce the durable benefits of Vivistim Therapy. We believe patient access is key to gaining market acceptance, and we remain committed to expanding patient access by developing additional evidence that further validates the benefits of Vivistim Therapy, accelerates market adoption, strengthens proof of its clinical utility, and supports broader reimbursement coverage decisions.

We continue to optimize our commercial model to support the adoption of Vivistim Therapy and gain further market acceptance. Our strategy is tailored to our unique patient and customer dynamics. Stroke survivors living with life-altering functional impairment can self-identify and are highly motivated to seek effective, long-lasting

solutions. These patients are often supported by dedicated advocates who create a strong network of care and commitment. Our target customer base consists of a highly concentrated group of approximately 1,500 primary and comprehensive stroke centers in the United States, which are hospitals that have cross-functional teams with the capabilities to treat acute stroke at the highest level of care and in compliance with AHA guidelines. These stroke centers, which are typically surrounded by a network of therapy sites with neurorehabilitation capabilities, provide the infrastructure for efficient implementation of Vivistim Therapy.

As a novel treatment, expanding market acceptance depends in part upon our ability to educate healthcare providers and others as to the distinctive characteristics, clinical and benefits, safety, durability and ease of use of Vivistim Therapy. We believe we have implemented highly effective initiatives for generating a consistent funnel of Vivistim Therapy candidates through physician and therapist referrals, as well as direct patient engagement. Stroke survivors interact with a diverse network of care providers who help identify and evaluate candidates. We directly engage each of these stakeholders through specialized events, summits, and conferences as well as through our field-based commercial team. Our commercial organization is responsible for driving adoption of the Vivistim System through customer outreach, education, and relationship management activities. Our team includes Territory Managers (TMs), who support initial customer onboarding efforts at stroke centers and maintain commercial relationships with physicians and administrators, and Therapy Development Specialists (TDSs), who focus on outreach to therapy sites and provide general educational information regarding the clinical use of the Vivistim System. These activities are intended to facilitate customer adoption and utilization of the Vivistim System.

Our commitment to offering life-changing treatments drives our passion for innovation through continuous research and development. We commenced development efforts in 2007 with an aim to pursue initial research from the University of Texas regarding the effects of vagus nerve stimulation. By early 2013, we began focusing on paired vagus nerve stimulation therapy for stroke recovery, working with a small team of fewer than ten engineers, clinicians and scientists. Over several years, this work led to the development and clinical testing of our Vivistim System, including through our feasibility, pilot and pivotal trials from 2014 to 2021. Following the results of our pivotal trial, we submitted a premarket approval (PMA) application to the FDA in March 2021. The Vivistim System received PMA approval from the FDA in 2021 and is classified by the FDA as a Class III device. In 2021, the Vivistim System was granted breakthrough device status under the FDA’s Breakthrough Devices Program. We aim to build upon these development efforts and leverage our internal expertise, clinical insights and experience gained from developing the Vivistim System to assess and prioritize research and development initiatives.

The Vivistim System implantation procedure falls under a long-established Category 1 CPT code. Effective January 1, 2026, this CPT code was assigned to a New Technology Ambulatory Payment Classification (APC) by the Centers for Medicare and Medicaid Services (CMS), establishing an elevated payment level that we believe will support sustainable access for Medicare beneficiaries. Coverage for Vivistim Therapy varies by payor. As there are currently no national coverage determinations or local coverage determinations specific to Vivistim Therapy, coverage for Medicare fee-for-service patients is made on a case-by-case basis and patients are typically able to access Vivistim Therapy when medically necessary, without prior authorization. Currently, most commercial insurers have determined that Vivistim Therapy is experimental or investigational and therefore, not covered. To that end, commercial insurance, Medicaid and Medicare Advantage generally require prior authorization. Our in-house market access team supports providers by facilitating administrative aspects of the prior authorization process, including assisting with documentation and submissions to payors in advance of implantation. As part of our longer term strategy, our market access team plans to continue to engage with payors to communicate clinical and health economic data which may impact coverage policies. We believe that expanded payor coverage will facilitate broader patient access to Vivistim Therapy.

We have experienced rapid growth since our full commercial launch in 2023. We recognized revenue of $32.0 million for the year ended December 31, 2025, compared to revenue of $15.6 million for the year ended December 31, 2024, representing 104.8% year-over-year growth. For the year ended December 31, 2025, we recognized a gross margin of 81.1% and a net loss of $46.5 million, compared to a gross margin of 79.6% and a net loss of $24.6 million for the year ended December 31, 2024. As of December 31, 2025, we had an accumulated deficit of approximately $157.8 million.

Overview of Chronic Stroke Impairment

In the United States, a stroke occurs every 40 seconds and approximately 800,000 strokes occur annually, according to a report published by the AHA in 2025. Based on the same report, we estimate that there are approximately 10 million stroke survivors in the United States, the majority of whom are living with chronic impairments. Chronic ischemic stroke is a serious medical condition characterized by physical and cognitive impairments that persist beyond the first three to six months post-stroke. The first three to six months after a stroke are commonly referred to as the sub-acute phase. These impairments can materially diminish a patient’s independence and quality of life. According to a report published by the AHA in 2025, ischemic stroke is a leading cause of serious long-term impairment for adults in the United States and has an estimated annual healthcare burden of more than $25 billion.

Chronic upper extremity impairment is among the most common and disabling consequences of stroke, with millions of survivors experiencing weakness, loss of coordination, reduced dexterity, and impaired function in the arm and hand, persisting for more than three to six months post-stroke. These impairments significantly limit the patients’ ability to perform activities of daily living, such as eating, dressing, bathing, and personal care, can impede a survivor’s ability to return to their profession, and can have a profound impact on functional independence and quality of life.

Our Market Opportunity

Based on a report published by the AHA in 2025, we estimate that there are currently approximately 10 million stroke survivors in the United States. According to the AHA, approximately 87% of strokes are ischemic. This equates to approximately 9 million ischemic stroke survivors in the United States. Based on our analysis of third-party publications, we estimate that more than 4 million of these survivors are chronic ischemic stroke survivors living with moderate to severe upper extremity impairment. For example, according to several third-party publications, up to two-thirds of stroke survivors continue to experience upper extremity disability at six months post-stroke (e.g., Lang CE, et al., Observation of amounts of movement practice provided during stroke rehabilitation, Arch Phys Med Rehabil. 2009 Oct;90(10):1692-8; and Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ., Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke, Stroke, Volume 34, Number 9, 2181-6 (2003), and approximately 81% of stroke survivors with upper extremity disability after six months post-stroke have moderate to severe upper extremity impairment (Woytowicz E, et al., Determining Levels of Upper Extremity Movement Impairment by Applying a Cluster Analysis to the Fugl-Meyer Assessment of the Upper Extremity in Chronic Stroke, Archives of Physical Medicine and Rehabilitation, 2016; 98, 456-462). We expect this large prevalence population to continue to grow over time, driven by, among others, increasing stroke survival rates due to improvements in acute thrombectomy therapies and increasing stroke incidence rates among young adults.

cognition and motivation to participate in therapy and have received some amount of post-stroke therapy. According to the AHA, two-thirds of stroke survivors receive rehabilitation therapy following a stroke. This rate of therapy generally decreases over time, with one study published in Stroke in 2023 concluding that the rate of conventional occupational therapy decreases to 21% in the three to six months following a stroke (Young, Bittany et al., Rehabilitation Therapy Doses Are Low After Stroke and Predicted by Clinical Factors, Stroke, Volume 54, Number 3, 831-839 (2023)). Based on these patient factors and post-stroke therapy rates, we estimate that this initial market opportunity comprises approximately 1 million stroke survivors within our total addressable market. We believe this patient population represents an initial market opportunity of over $30 billion based on the average selling price of the Vivistim System.

Vivistim Therapy has demonstrated meaningful clinical improvements in upper extremity function independent of the time elapsed since stroke. As such, Vivistim Therapy is appropriate for patients who initiate treatment many years post-stroke as well as more recent stroke survivors. Based on a report published by the AHA in 2025, we estimate that each year approximately 200,000 new stroke survivors in the United States meet our indication for use, with 50,000 of these survivors representative of our initial market opportunity.

The market share we ultimately achieve is subject to a number of assumptions, risks and uncertainties, including the market acceptance of Vivistim Therapy and our ability to execute on our commercial strategy. As a novel treatment, market acceptance depends, in part, on our ability to raise awareness, the adoption of Vivistim Therapy by hospitals, healthcare providers, therapists, patients, caregivers and adequate payor coverage and reimbursement, and the acceptance of Vivistim Therapy as safe, effective and cost-effective. We may be unsuccessful in attaining significant market acceptance or such acceptance may take longer or be more costly than anticipated. For more information, please see the section titled “Risk Factors — Risks Related to Our Business and Industry — The commercial success of Vivistim Therapy depends upon attaining significant market acceptance of our products by hospitals, healthcare providers, therapists, patients, caregivers and payors” and “ — The size of our market opportunity has not been established with precision and may be smaller than we estimate, possibly materially.”

Our Solution

Our breakthrough Vivistim System is the first and only FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. The Vivistim System facilitates Vivistim Therapy, which has been clinically proven to significantly improve upper limb function and help patients regain critical capabilities and independence. Vivistim Therapy leverages neuroplasticity – the ability of the nervous system to adapt and reorganize its connections – to improve upper limb function in patients with chronic stroke. The Vivistim System includes an implantable device that stimulates the vagus nerve only when intentionally activated, triggering the release of neuromodulators, including acetylcholine, norepinephrine, and serotonin. These neuromodulators create a heightened state of plasticity in the brain, such that neural networks can more readily adapt and reform in response to stimuli. When functional movements, such as goal- or task-oriented exercises and movements, are performed in the presence of these increased neuromodulators, the brain can create new neural connections and strengthen existing connections to a degree that would otherwise not be possible, enabling lasting improvements in

motor pathways and creating greater potential for recovery. The image below depicts the placement of the Vivistim System, including the IPG and lead.

Shortly after device implantation, patients begin Vivistim Therapy with a physical or occupational therapist. In the clinic, the therapist uses a remote to activate the Vivistim System during task-specific practice, such as reaching for and grasping objects. Patients can continue Vivistim Therapy at home, both during their in-clinic therapy protocol and, if desired, in the months and years that follow. At home, patients easily activate stimulation sessions by swiping the Vivistim magnet over the Vivistim IPG implant site, which initiates 30 minutes of periodic stimulation pulses.

We believe Vivistim Therapy offers the first effective therapeutic option for these patients, with the following key benefits:

•First and only FDA-approved device clinically proven to deliver significant improvements in upper limb function. In our pivotal, triple-blind, randomized, sham-controlled VNS-REHAB trial, Vivistim Therapy resulted in an approximately two-times greater, as measured by FMA-UE, and approximately three-times greater, as measured by WMFT, improvement in hand and arm function compared to intensive rehabilitation alone, at the end of the in-clinic and at-home therapy protocol. At such time, the FMA-UE score increased by 5.8 points in the treatment group. These results highlight Vivistim Therapy’s distinctive ability to drive substantial neuroplastic adaptations and functional gains, which we believe sets it apart as the only therapy with robust clinical evidence for effective post-stroke motor recovery. Based on published case studies involving patients that received Vivistim Therapy, improvements in upper limb function following Vivistim Therapy can further enable patients to perform activities of daily living, such as dressing independently, preparing meals, folding laundry, and eating (Saylor A, Patrick L, Reddy CG, Gandhi R., Vagus Nerve Stimulation Paired With Upper Extremity Rehabilitation for Chronic Stroke: Real-World Implementation and Outcomes. Arch Rehabil Res Clin Transl. (2026)). Even modest gains – particularly in wrist, hand, and finger function – can impact dignity, independence, and quality of life.

•Significant clinical improvement even for patients who initiate treatment many years post-stroke. Unlike conventional rehabilitation therapies, which have shown benefits during the sub-acute phase of stroke recovery but not in the chronic phase, Vivistim Therapy has demonstrated clinically meaningful improvements for patients even years after their stroke. We observed significant functional improvements in all cohorts of our pivotal clinical trial, with participants averaging 3.3 years post-stroke at the time of treatment and a range from nine months to 10 years into their recovery. Commercially, we have treated patients many years post-stroke, including up to 45 years, who have achieved meaningful clinical benefit,

demonstrating that improvement with Vivistim Therapy is possible regardless of time elapsed since stroke and offering hope to a large population of chronic stroke survivors.

•Durable improvements underpinned by a clinically proven mechanism of action. The functional gains achieved with Vivistim Therapy are long-lasting, providing durable, life-changing outcomes for stroke survivors. Clinical data has demonstrated sustained motor improvements, measured out to one year in our pivotal trial and three years in our pilot trial. This lasting effect is enabled by the unique mechanism of action underlying Vivistim Therapy, which creates durable neural pathways that enable motor improvements.

•High patient and therapist satisfaction, with consistently positive feedback. Based on a survey we conducted in connection with our VNS-REHAB trial, 98% of patients that received Vivistim Therapy were satisfied with their experience. In addition, based on a commercial survey conducted by us, 98% of therapists would recommend Vivistim Therapy to suitable candidates. We believe the high satisfaction rate reflects the profound impact of these functional gains on patients’ lives, and the differentiation of functional gains enabled by Vivistim Therapy.

•Safe and minimally invasive outpatient procedure. The IPG and lead are placed via a simple, 60-minute procedure using two small incisions, allowing patients to return home on the same day and quickly resume activities of daily living. This type of procedure has been safely performed by neurosurgeons, who are trained on it in their residency programs, and other qualified surgeons for over 25 years to treat other medical conditions and is considered safe and reliable. Our clinical results have validated the safety of the system and therapy, with no severe adverse events, serious adverse events or unanticipated adverse events associated with the Vivistim System in our VNS-REHAB trial. Our clinical results have also validated the safety of the procedure with a low complication rate. In our VNS-REHAB trial, the rate of surgical complications that did not resolve within a few weeks was less than 1%. The IPG battery has an indicated service life under continuous use conditions of five years. After its end of service, the IPG can be surgically replaced for continued use. For more information, please see the section titled “Risk Factors — Risks Related to Our Business and Industry — Adverse events, product recalls, or other complications or customer satisfaction issues associated with Vivistim Therapy, including regarding the finite IPG battery life, could limit its adoption.”

The Vivistim System received PMA approval from the FDA in 2021 and is classified by the FDA as a Class III device. Class III devices require approval of a PMA and are devices deemed by the FDA to pose the greatest risks, such as implantable devices, devices that have a new intended use, or devices that use advanced technology that is not substantially equivalent to that of a legally marketed device. The Vivistim System was granted breakthrough device status under the FDA’s Breakthrough Devices Program in 2021, because it is intended to provide more effective treatment of a life-threatening or irreversibly debilitating condition. For more information, please see the section titled “Business — Government Regulation” for a discussion on the FDA’s classification system of medical devices and the Breakthrough Devices Program.

Our Success Factors

We believe the continued growth of our company will be driven by the following success factors:

•First and only FDA-approved solution establishing a new standard of care in chronic stroke recovery.

•Large and untapped market opportunity with significant unmet need.

•Compelling body of clinical data demonstrating the significant and sustained benefits of Vivistim Therapy.

•Unique customer and patient dynamics to support a scalable commercial model.

•Favorable coding and payment dynamics with dedicated in-house market access team supporting patients and providers.

•Differentiated purpose-built technology for Vivistim Therapy protected by robust IP portfolio.

•Seasoned executives with extensive Med Tech commercialization expertise and a proven track record of value creation.

Our Growth Strategies

Our mission is to redefine stroke recovery for survivors living with life-altering functional impairments by establishing Vivistim Therapy as the standard of care for chronic stroke. The key elements of our growth strategy include:

•Expand our market development efforts to broaden awareness and access to Vivistim Therapy.

•Driving utilization of Vivistim Therapy by promoting awareness among patients, caregivers and healthcare providers.

•Building upon our strong base of clinical evidence to support adoption and expand payor coverage.

•Investing in research and development to drive continuous innovation, better outcomes, and improved user experience.

•Expanding clinical indications to benefit a broader patient population.

•Continue to evaluate expansion into geographies outside of the United States.

Recent Developments

2026 Convertible Notes

From January 30, 2026 through February 11, 2026, we issued convertible promissory notes to certain investors in an aggregate principal amount of $40.0 million (2026 Convertible Notes). The 2026 Convertible Notes mature on January 30, 2028 (Maturity Date). The 2026 Convertible Notes bear no interest for the first six months following the date of issuance (Interest Free Period). Following such Interest Free Period, the 2026 Convertible Notes accrue interest at a rate of 7.0% per annum through the Maturity Date, which interest payments shall be paid in kind. Immediately prior to the closing of this offering, the 2026 Convertible Notes and any accrued interest will automatically convert into shares of our common stock at the applicable conversion price. The conversion price is the lower of (a) 80% of the initial public offering price per share in this offering and (b) the valuation of the Company immediately prior to the closing of this offering divided by the number of fully diluted shares of capital stock (on an as-converted basis) outstanding immediately prior to this offering but excluding the 2026 Convertible Notes (Fully Diluted Capitalization), provided, that in no event shall such conversion price be less than the quotient obtained by dividing $226.0 million by the Fully Diluted Capitalization or greater than the quotient obtained by dividing $750.0 million by the Fully Diluted Capitalization. Based on an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and without giving effect to accrued interest (if any), the 2026 Convertible Notes will automatically convert into an aggregate of shares of our common stock immediately prior to the closing of this offering. Each $1.00 increase in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would decrease the shares of common stock issued in the Notes Conversion by shares, and each $1.00 decrease in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase the shares of common stock issued in the Notes Conversion by shares, in each case without giving effect to accrued interest (if any).

Preliminary Estimated Selected Financial Results for the Three Months Ended March 31, 2026

Our financial results for the three months ended March 31, 2026 are not yet complete and will not be available until after the completion of this offering. Accordingly, set forth below are certain preliminary estimated selected unaudited financial results for the three months ended March 31, 2026 and the corresponding period of the prior fiscal year. We have provided ranges, rather than specific amounts, for the three months ended March 31, 2026,

because our closing procedures for the quarter-end financial closing process are not yet complete. These ranges are based on the information available to us as of the date of this prospectus. These preliminary estimated results for the three months ended March 31, 2026 are derived from our preliminary internal financial records and are subject to revisions based on our procedures and controls associated with the completion of our financial reporting process, including all the customary reviews and approvals. As a result, actual results may vary from the preliminary estimated results presented below, and it is possible that actual results will not be within the currently estimated ranges. These preliminary estimates are not necessarily indicative of any future period and should be read together with “Risk Factors,” “Special Note Regarding Forward-Looking Statements,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our audited financial statements and related notes included elsewhere in this prospectus.

The preliminary unaudited financial data included in this prospectus has been prepared by, and is the responsibility of, our management. PricewaterhouseCoopers LLP has not audited, reviewed, examined, compiled, nor applied agreed-upon procedures with respect to the preliminary financial data. Accordingly, PricewaterhouseCoopers LLP does not express an opinion or any other form of assurance with respect thereto.


	Three Months Ended March 31,
	2026 (estimated low)	2026 (estimated high)	2025 (actual)
	(unaudited) (in thousands)
Preliminary estimated financial results:
Revenue	$	$	$	5,661
Cost of goods sold			1,015
Total operating expenses			$	14,950
Net loss attributable to common stockholders			$	(10,653)

For the three months ended March 31, 2026, we expect revenue to be between $ million and $ million, compared to $5.6 million for the three months ended March 31, 2025. The expected increase in net revenue is primarily due to .

For the three months ended March 31, 2026, we expect cost of goods sold to be between $ million and $ million, compared to $1.0 million for the three months ended March 31, 2025. The expected increase in cost of goods sold is primarily due to .

For the three months ended March 31, 2026, we expect total operating expenses to be between $ million and $ million, compared to $15.0 million for the three months ended March 31, 2025. The expected increase in total operating expenses is primarily due to .

For the three months ended March 31, 2026, we expect net loss attributable to common stockholders to be between $ million and $ million, compared to $10.7 million for the three months ended March 31, 2025. The expected increase in net loss is primarily due to .

As of March 31, 2026, our cash and cash equivalents balance is expected to be $ million as compared to $37.3 million as of March 31, 2025.

Risks Related to our Business

Our ability to execute our business strategy is subject to numerous risks, as more fully described in the section titled “Risk Factors” immediately following this prospectus summary. These risks include, among others:

•We have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we ever achieve profitability, we may not be able to sustain it.

•Our recurring losses from operations and financial condition raise substantial doubt about our ability to continue as a going concern.

•If we fail to manage our growth effectively, our business could be materially and adversely affected.

•The commercial success of Vivistim Therapy depends upon attaining significant market acceptance of our products by hospitals, healthcare providers, therapists, patients, caregivers and payors.

•Our success depends entirely on our currently marketed Vivistim Therapy. If we are unable to successfully market and sell Vivistim Therapy, our business prospects will be materially and adversely affected, and we may be unable to achieve revenue growth and to fund our operations.

•If we fail to effectively hire, train, and retain our direct sales force, increase our sales capabilities, or develop broad brand awareness in a cost-effective manner, our growth will be materially and adversely affected, and our business will suffer.

•Coverage and adequate reimbursement may not be available or may be subject to change for our Vivistim System, including any future products we commercialize, which could diminish our sales, increase our competition, or affect our ability to sell our currently marketed Vivistim Therapy and any future products profitably.

•We depend on a small number of third-party contract manufacturers and suppliers, some of which are single source, to produce and package all elements comprising our Vivistim System as well as certain implantation tools, and if these suppliers and manufacturers fail to supply our Vivistim System or its components or subcomponents in sufficient quantities or at all, it will have a material adverse effect on our business, financial condition, and results of operations.

•The size of our market opportunity has not been established with precision and may be smaller than we estimate, possibly materially.

•Adverse events, product recalls, or other complications or customer satisfaction issues associated with Vivistim Therapy, including regarding the finite IPG battery life, could limit its adoption.

•We have limited clinical data, evidence and experience regarding the safety and efficacy of Vivistim Therapy.

•If we are unable to maintain existing, and obtain additional, patent and other intellectual property protection for our technology and products, or if the scope of the patent protection we obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

•Our products and operations are subject to extensive government regulation and oversight in the United States, and our failure to comply with applicable requirements could materially and adversely affect our business.

•Failure to maintain marketing authorizations for our products, or to timely obtain necessary marketing authorizations for our future products, may have a material and adverse effect on our business, financial condition and results of operations.

•We have identified a material weakness in our internal control over financial reporting.

Corporate Information

We were incorporated in Delaware on March 5, 2007 as MicroTransponder, Inc. Effective February 23, 2026, we changed our name to “Mobia Medical, Inc.” Our principal executive offices are located at 2802 Flintrock Trace, Suite 226, Austin, TX 78738. Our telephone number is (855) 628-9375. Our website address is www.mobia.com. Information contained on the website is not incorporated by reference into this prospectus and the inclusion of our website address in this prospectus is an inactive textual reference only.

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

We are an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). We will remain an emerging growth company until the earliest of: (i) the last day of the fiscal year following the fifth anniversary of the consummation of this offering; (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion; (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the Exchange Act), which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

As an emerging growth company, we have elected to take advantage of certain reduced disclosure obligations in the registration statement that this prospectus is a part of, and may elect to take advantage of other reduced reporting requirements in future filings. In particular:

•we will present in this prospectus only two years of audited financial statements, plus any required unaudited financial statements, and related section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations;”

•we will avail ourselves of the exemption from the requirement to obtain an attestation and report from our independent registered public accounting firm on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002, as amended (the Sarbanes-Oxley Act);

•we will avail ourselves of relief from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on the financial statements;

•we will provide less extensive disclosure about our executive compensation arrangements; and

•we will not be required to hold stockholder non-binding advisory votes on executive compensation or golden parachute arrangements.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for any other new or revised accounting standards during the period in which we remain an emerging growth company; however, we may adopt certain new or revised accounting standards early.

We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as the market value of our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

THE OFFERING


Common stock offered by us						shares.

Option to purchase additional shares						We have granted the underwriters an option for a period of 30 days to purchase up to additional shares of our common stock at the public offering price, less the underwriting discounts and commissions.

Common stock to be outstanding immediately after this offering						shares (or shares if the underwriters exercise their option to purchase additional shares in full).

Use of proceeds						We estimate that the net proceeds to us from the sale of shares of our common stock in this offering will be approximately $ (or approximately $ if the underwriters exercise their option to purchase additional shares in full), based upon the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page on this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We currently intend to use the net proceeds from this offering to expand our direct sales force and commercial organization, continue our research and development activities and our clinical studies and trials, and for working capital and other general corporate purposes. We may use a portion of the net proceeds we receive from this offering to acquire businesses, products, services, or technologies. We periodically evaluate strategic opportunities; however, we do not have agreements or commitments for any material acquisitions or investments at this time. See the section titled “Use of Proceeds” for additional information.

Risk Factors						Investing in our common stock involves a high degree of risk. See the section of this prospectus titled “Risk Factors” beginning on page 17 and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of our common stock.

Reserved share program						At our request, the underwriters have reserved for sale, at the initial public offering price, up to % of the shares offered by this prospectus for sale to some of our directors, officers, employees, distributors, dealers, business associates and related persons. If these persons purchase reserved shares, this will reduce the number of shares available for sale to the general public. Any reserved shares that are not so purchased will be offered by the underwriters to the general public on the same terms as the other shares offered by this prospectus.

Proposed Nasdaq Global Select Market trading symbol						“MOBI”

The number of shares of our common stock to be outstanding immediately after this offering is based on shares of our common stock outstanding as of December 31, 2025, which reflects (i) the Preferred Stock Conversion described below, (ii) the issuance of the 2026 Convertible Notes and the related Notes Conversion (as defined below) and (iii) the Warrant Exercises described below, and excludes the following:

• shares of our common stock issuable upon the exercise of warrants to purchase shares of our redeemable convertible preferred stock outstanding as of December 31, 2025, with an exercise price of $2.5443 per share of redeemable convertible preferred stock, which will convert into warrants to purchase shares of our common stock immediately prior to the completion of this offering (the Warrant Conversion);

• shares of common stock issuable upon exercise of options to purchase shares of our common stock outstanding as of December 31, 2025, at a weighted-average exercise price of $ per share;

• shares of common stock issuable upon exercise of options to purchase shares of our common stock granted after December 31, 2025, at a weighted-average exercise price of $ per share;

• shares of common stock reserved for future issuance under our 2022 Equity Incentive Plan, as amended (the 2022 Plan), as of December 31, 2025, provided that we will cease granting awards under our 2022 Plan upon the effectiveness of the 2026 Incentive Award Plan (the 2026 Plan);

• shares of common stock issuable upon the exercise of stock options (the IPO Options) to be granted in connection with this offering under the 2026 Plan, which will become effective on the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus forms a part, to our non-employee directors and certain of our employees at an exercise price equal to the initial public offering price in this offering;

• shares of common stock issuable upon the vesting of restricted stock units (the IPO RSUs and, together with the IPO Options, the IPO Grants) to be granted in connection with this offering under the 2026 Plan, which will become effective immediately following the effectiveness of the applicable Form S-8 registration statement, to certain of our employees;

•a number of shares of our common stock reserved for future issuance under the 2026 Plan (which number includes the IPO Grants), which will become effective on the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus forms a part, equal to the sum of (1) a number of shares equal to 14% of the number of fully-diluted shares of our common stock upon the closing of this offering (calculated on an as-converted basis after giving effect to the number of shares of common stock to be sold in this offering and assuming the exercise in full of the underwriters’ over-allotment option and including shares subject to outstanding equity awards and the share reserve under the 2026 Plan and the 2026 Employee Stock Purchase Plan (the ESPP)), plus (2) any shares of common stock remaining available for future issuance under our 2022 Plan as of the effectiveness of the 2026 Plan, which shares will be added to the share reserve under the 2026 Plan upon its effectiveness; and

•a number of shares of common stock reserved for issuance under our ESPP, which will become effective on the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus forms a part, equal to a number of shares equal to 1% of the number of fully-diluted shares of our common stock upon the closing of this offering (calculated on an as-converted basis after giving effect to the number of shares of common stock to be sold in this offering and assuming the exercise in full of the underwriters’ over-allotment option and including shares subject to outstanding equity awards and the share reserves under the 2026 Plan and the ESPP).

Each of the 2026 Plan and the ESPP provides for annual automatic increases in the number of shares reserved thereunder, and the 2026 Plan also provides for increases to the number of shares that may be granted thereunder based on awards under the 2022 Plan that expire, are forfeited, or otherwise repurchased by us, as more fully described in the section titled “Executive and Director Compensation—Equity Incentive Plans.”

In addition, unless otherwise indicated, all information in this prospectus assumes or gives effect to:

•the filing and effectiveness of our amended and restated certificate of incorporation and the effectiveness of our amended and restated bylaws, which will occur immediately prior to the completion of this offering;

•the conversion of all outstanding shares of our redeemable convertible preferred stock as of December 31, 2025 into an aggregate of shares of our common stock, which will occur immediately prior to the completion of this offering (the Preferred Stock Conversion);

•the issuance of shares of our common stock upon the exercise of warrants to purchase 908,000 shares of our Series B redeemable convertible preferred stock outstanding as of December 31, 2025, which

exercise will occur immediately prior to the completion of this offering at an exercise price of $3.73744 per share (based upon an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover of this prospectus) (the Series B Warrant Exercise);

•the issuance of shares of our common stock upon the exercise of warrants to purchase 258,000 shares of our Series D redeemable convertible preferred stock outstanding as of December 31, 2025, which exercise will occur immediately prior to the completion of this offering at an exercise price of $4.207 per share (based upon an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover of this prospectus) (together with the Series B Warrant Exercise, the Warrant Exercises);

•the issuance of shares of our common stock upon the conversion of the 2026 Convertible Notes, based on an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, which conversion will occur immediately prior to the closing of this offering (the Notes Conversion);

•a 1-for- reverse split of our capital stock, which was effected on , 2026;

•no exercise of outstanding options or warrants after December 31, 2025; and

•no exercise of the underwriters’ option to purchase additional shares of common stock from us.

SUMMARY FINANCIAL DATA

The following tables summarize our financial data for the periods and as of the dates indicated. Except for pro forma and pro forma adjusted amounts, we have derived the statements of operations data for the years ended December 31, 2025 and 2024, and the selected balance sheet data as of December 31, 2025 from our audited financial statements and related notes included elsewhere in this prospectus. Our historical results are not necessarily indicative of results that may be expected in the future. You should read the following summary financial data together with our financial statements and the related notes appearing elsewhere in this prospectus and the information in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The summary financial data included in this section are not intended to replace the financial statements and related notes thereto included elsewhere in this prospectus and are qualified in their entirety by such financial statements and related notes thereto.

Statements of Operations Data


	Years ended December 31,
(in thousands, except share and per share amounts)	2025		2024
Revenue	$	32,041	$	15,644
Cost of goods sold	6,066		3,193
Gross profit	25,975		12,451
Operating expenses:
Research and development costs	$	6,515	$	4,243
Selling, general and administrative expenses	65,828		32,444
Total operating expenses	72,343		36,687
Loss from operations	(46,368)		(24,236)
Other income (expense):
Interest expense	(967)		(970)
Other income, net	842		617
Total other expense, net	(125)		(353)

Loss before provision for income taxes	(46,493)		(24,589)
Provision for income taxes	(5)		(14)
Net loss attributable to common stockholders	$	(46,498)	$	(24,603)
Net loss per share attributable to common stockholders, basic and diluted(1)	$	(15.73)	$	(12.29)
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted(1)	2,956,415		2,001,444
Pro forma net loss per share attributable to common stockholders, basic and diluted(2)	$
Weighted-average number of shares used in computing pro forma net loss per share attributable to common stockholders, basic and diluted(2)	$

__________________

(1)Basic and diluted net loss per share attributable to common stockholders and weighted-average number of shares used in computing basic and diluted net loss per share attributable to common stockholders for the year ended December 31, 2025 has been revised to correct an error in our previously issued financial statements, as more fully described in Note 3, “Summary of Significant Accounting and Reporting Policies Basis of Presentation—Revision of previously issued financial statements” to our audited financial statements. For the calculation of our basic and diluted net loss per share attributable to common stockholders and weighted-average number of shares used in the computation of the per share amounts, see Note 14 to our audited financial statements included elsewhere in this prospectus.

(2)The unaudited pro forma net loss per share attributable to common stockholders, basic and diluted for the year ended December 31, 2025 was computed using the weighted-average number of shares of common stock outstanding, including the pro forma effect of the Preferred Stock Conversion, the issuance of the 2026 Convertible Notes and the related Notes Conversion, the Warrant Exercises and the Warrant Conversion, as if such conversions and exercises had occurred at the beginning of the period, or their issuance dates, if later. Unaudited pro forma net loss per share attributable to common stock does not include the shares expected to be sold and related proceeds to be received in this offering.

Balance Sheet Data


	As of December 31, 2025
(in thousands)	Actual		Pro forma (1)	Pro forma as adjusted (2)(3)
Cash and cash equivalents	$	33,587
Working capital(4)	36,151
Total assets	48,149
Notes payable, net of discount and deferred financing costs	7,130
Warrant liabilities	865
Redeemable convertible preferred stock	179,773
Additional paid-in capital	6,985
Accumulated deficit	(157,789)
Total stockholders’ deficit	$	(150,774)

__________________

(1)The pro forma balance sheet data gives effect: (i) to the Preferred Stock Conversion, (ii) the issuance of the 2026 Convertible Notes and the related Notes Conversion, (iii) the Warrant Exercises, (iv) the Warrant Conversion and (v) the filing and effectiveness of our amended and restated certificate of incorporation, which will become effective immediately upon the closing of this offering.

(2)Reflects the pro forma adjustments described in footnote (1) above and the issuance and sale of shares of common stock in this offering at the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

(3)The pro forma information discussed above is illustrative only and will be adjusted based on the actual initial public offering price and other terms of our initial public offering determined at pricing. Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash and cash equivalents, total assets, additional paid-in capital, and total stockholders’ equity by approximately $ million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1.0 million shares in the number of shares offered by us at the assumed initial public offering price after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us would increase (decrease) each of cash and cash equivalents, total assets, additional paid-in capital, and total stockholders’ equity by approximately $ million.

(4)We define working capital as current assets less current liabilities. See our audited financial statements and the related notes included elsewhere in this prospectus for further details regarding our current assets and current liabilities.

We have incurred losses since our inception and expect to continue to incur losses for the foreseeable future. We reported net losses of $46.5 million and $24.6 million for the years ended December 31, 2025 and 2024, respectively. As a result of these losses, as of December 31, 2025, we had an accumulated deficit of approximately $157.8 million. We expect to continue to incur significant sales and marketing, research and development, clinical and regulatory, and other expenses as we expand our commercial organization, increase marketing efforts to drive adoption of Vivistim Therapy, expand existing relationships with our customers, conduct clinical trials on our existing and future products and develop new products or add new features to our existing products, pursue any required regulatory clearances or approvals, and seek to establish broader commercial coverage. In addition, we expect our general and administrative expenses to increase following this offering due to the additional costs associated with being a public company. Additionally, we may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown obstacles as we continue to build and scale our business. The net losses that we incur may fluctuate significantly from period to period. We will need to generate significant additional revenue in order to achieve and sustain profitability. Even if we achieve profitability, we cannot be sure that we will remain profitable for any period of time.

We have experienced recent rapid growth and anticipate further growth. For example, for the year ended December 31, 2025, our revenue was $32.0 million compared to revenue of $15.6 million for the year ended December 31, 2024, an increase of 104.8% year-over-year. This growth has placed significant demands on our management, financial, operational, technological and other resources, and we expect that our future growth will continue to place significant demands on our management and other resources and will require us to continue developing and improving our operational, financial and other internal controls. In particular, continued growth increases the challenges involved in a number of areas, including managing our third-party manufacturers and supplier relationships and ensuring adequate inventory is available, recruiting and retaining sufficient skilled personnel for leadership positions, sales force and other functions, providing adequate training and supervision to maintain our high-quality standards and preserving our culture and values. We may not be able to address these challenges in a cost-effective manner, or at all.

To achieve our business objectives, we must also successfully increase our supply of products and components from third-party manufacturers to meet expected demand. If demand decreases, we will need to implement capacity and cost reduction measures involving restructuring costs. If demand increases, we will be required to make capital expenditures related to increased production. This would also put pressure on our third-party manufacturing capabilities. For example, a sudden increase in demand could require increased production of components, such as the implantable pulse generator (IPG) or stimulation lead. Adapting to changes in demand inherently involves a delay because it takes time to identify the change the market is undergoing and to implement any measures to take as a result. Finally, capacity adjustments are inherently risky because there is imperfect information, and sales trends may rapidly intensify, ebb, or even reverse. We may be unable to accurately or timely predict trends in demand and customer behavior or to take appropriate measures to mitigate risks and react to opportunities resulting from such trends. Any inability in the future to identify or to adequately and effectively react to changes in demand could have a material adverse effect on our business, financial condition and results of operations.

In the future, we may also experience difficulties with quality control, component supply and shortages of qualified personnel, among other problems. These problems could result in delays in product availability, product quality issues, delays in our ability to reach our sales potential delays in the development and launch of new products and increases in expenses. Any such delays, issues or increased expenses could adversely affect our business, financial condition and results of operations. In addition, rapid and significant growth will place a strain on our administrative and operational infrastructure, particularly as we transition to being a public company. In order to manage our operations and growth, we will need to continue to improve our operational and management controls, hiring process, reporting and information technology systems and financial internal control procedures. If we do not effectively manage our growth, we may not be able to execute on our business plan, respond to competitive pressures, take advantage of market opportunities, reach our sales potential, satisfy customer requirements or maintain high-quality product offerings, which could have a material adverse effect on our business, financial condition and results of operations.

future growth, we must continue to add highly qualified personnel to our commercial organization, with a strategic mix of TMs and TDSs, to drive further awareness and penetration within healthcare providers that interact with stroke survivors. Identifying and recruiting qualified commercial personnel and training them on our product, applicable federal and state laws and regulations, and on our internal policies and procedures requires significant time, expense, and attention. Once hired, the training process is lengthy because it requires significant education for new TMs and TDSs to achieve the level of clinical competency with our products expected by physicians and therapists. Upon completion of the training, our TMs and TDSs typically require lead time in the field to grow their network of accounts and achieve the productivity levels we expect them to reach in any individual territory. Furthermore, the use of our products may involve limited, non-contractual support activities provided in connection with initial education and setup prior to or at the time of implantation. The Company does not have an ongoing obligation to provide programming, reprogramming, or customer or technical support after implantation, and any such activities, if performed, are incidental and not considered significant. Also, to the extent we hire personnel from our competitors, we may have to wait until applicable non-competition or non-solicitation provisions have expired before deploying such personnel in restricted territories or incur costs to relocate personnel outside of such territories, and we may be subject to future allegations that these new hires have been improperly solicited, or that they have divulged to us proprietary or other confidential information of their former employers. Our business may be harmed if our efforts to expand and train our sales force and any future efforts to engage in direct-to-patient programs and direct-to-consumer marketing do not generate a corresponding increase in revenue, and our higher fixed costs may slow our ability to reduce costs in the face of a sudden decline in demand for our products. Moreover, the members of our direct sales force are at-will employees. The loss of these personnel to competitors or otherwise could have a material adverse effect on our business, financial condition, and results of operations. If we are unable to attract, train and retain our direct sales force personnel or replace them with individuals of equivalent technical expertise and qualifications, if we are unable to successfully instill technical expertise in replacement personnel, or if our direct sales force personnel are unable to reach the productivity levels we expect on the timeline we expect for any reason, our revenue and results of operations could be materially and adversely affected.

Our success depends, in part, on the acceptance of Vivistim Therapy as safe, effective and cost-effective. We cannot predict how quickly, if at all, hospitals, healthcare providers, therapists, patients, caregivers or payors will adopt Vivistim Therapy or, if adopted, how frequently Vivistim Therapy will be used. Vivistim Therapy and any future products we may develop or market may never gain broad market acceptance for some or all of our targeted indications. It is important to our success, future growth, and profitability that we are able to increase healthcare provider awareness of Vivistim Therapy and that hospitals, healthcare providers, therapists, patients, caregivers and payors believe that our products offer benefits over alternative treatment methods, and that they adopt our products. These parties may not adopt our products unless they are able to determine, based on experience, clinical data, medical society recommendations, and other analyses, that our products are safe, effective and cost-effective on a stand-alone basis and relative to competitors’ products. If physicians or payors do not find our body of published clinical evidence and data compelling or wish to wait for additional studies, they may choose not to use or provide coverage and reimbursement for or prescribe our product. Currently, there are a number of large third-party payers that have determined that our Vivistim Therapy is experimental or investigational and therefore do not cover it at this time. In addition, the long-term effects of our Vivistim Therapy beyond our current clinical trials are not yet known. Certain physicians, hospitals, therapists and payers may prefer to see longer-term safety and efficacy data than we have produced. Even if we are able to raise awareness, physicians and therapists may be slow in changing their medical treatment practices and may be hesitant to select our products for recommendation to their patients for a variety of reasons, including:

Stroke survivors interact with a diverse network of care providers, including stroke interventionalists, neurosurgeons, neurologists, physical medicine and rehabilitation physicians, occupational and physical therapists, stroke coordinators and nurses. Each of these providers can play a role in identifying and evaluating potential Vivistim Therapy candidates. We directly engage each of these stakeholders through our field-based commercial team, as well as through specialized events, summits, and conferences. As a result, our success depends, in large part, on effectively marketing Vivistim Therapy to these healthcare providers. We aim to educate these healthcare providers regarding the patient population that would benefit from Vivistim Therapy. Acceptance of Vivistim Therapy depends upon our education of healthcare providers as to the distinctive characteristics, clinical and benefits, safety, durability and ease of use of Vivistim Therapy as compared to other therapy options and any future competitor VNS devices and upon our effective communication to healthcare providers of the proper use of Vivistim Therapy as well as our ability to provide effective and timely physician, therapist and patient support, including in connection with device education and addressing any technical, quality or other concerns. However, we cannot assure you that we will achieve broad market acceptance among these practitioners. Healthcare providers may be reluctant or unwilling to invest time to learn about the benefits of Vivistim Therapy, and to deviate from practices or therapy programs which they consider to be more established. If we are not able to effectively demonstrate that the use of Vivistim Therapy is beneficial in a broad range of patients, some healthcare providers may choose to utilize Vivistim Therapy on only a subset of their total eligible patient population or not at all, and adoption of our product will be limited and may not occur as rapidly as we anticipate or at all, which would have a material adverse effect on our business, financial condition and results of operations.

In addition, government payors, such as CMS, have increased their efforts to control the cost, utilization and delivery of healthcare services. CMS establishes Medicare payment levels for hospitals and physicians on an annual basis, which can increase or decrease payment to such entities. The Vivistim System is typically implanted in the hospital outpatient setting, and all items and services paid under the Medicare hospital outpatient prospective payment system, or OPPS, are assigned to payment groups called Ambulatory Payment Classifications, or APCs, which group together items and services that are similar clinically and in terms of resource use. Reimbursement for professional services performed by physicians are reported using CPT codes and based on a different payment methodology. Implantation of the Vivistim System falls under CPT Code 64568 (“Incision for implantation of a cranial nerve (e.g., vagus) neurostimulator electrode array and pulse generator”). From January 1, 2023 through December 31, 2025, CMS granted transitional pass-through payment status for the Vivistim System under HCPCS code C1827 (“Generator, neurostimulator (implantable), non-rechargeable, with implantable stimulation lead and external paired stimulation controller”) when used in combination with CPT code 64568. This status is granted by CMS to facilitate access to innovative devices that significantly improves clinical outcomes as compared to currently available treatment options. Effective January 1, 2026, CPT code 64568 is assigned to New Technology APC 1580. A service is not paid under a New Technology APC until sufficient claims data have been collected to allow CMS to assign the procedure to a clinical APC group that is appropriate in clinical and resource terms. CMS generally expects this to occur within two to three years. We cannot provide any assurances that CPT code 64568 will continue to be assigned to APC 1580 during this time, or that reimbursement amount associated with any subsequent assignment to a clinical APC group will be adequate to cover the costs associated with our device. Individual states may also enact legislation that impacts Medicaid payments to hospitals and physicians.

We utilize a small number of qualified medical device contract manufacturers and suppliers, some of which are single source, to produce and package all elements comprising our Vivistim System as well as certain implantation tools. In certain cases, these third parties also perform design engineering activities for specific components. We generally do not have long-term contracts with our suppliers, and our supply arrangements generally do not include minimum manufacturing or purchase obligations. For these arrangements, we primarily order products through the use of purchase orders, do not have any obligation to purchase any given quantity of products, and our suppliers generally have no obligation to sell to us or to manufacture for us any given quantity of our products or components of our systems. Certain supplier arrangements include non-cancelable purchase commitments and binding forecast obligations. For these arrangements, we primarily order products through the use of purchase orders that are generally non-cancelable once accepted by the respective supplier. Although we continue to fortify our supply chain by seeking additional sourcing channels, all of the critical components of the Vivistim System, including the IPG and lead, are supplied to us from single sources that are qualified medical device contract manufacturers and suppliers. Our lead is manufactured by Cirtec Medical. Our IPG is manufactured by Integer Holdings Corporation (Integer).

We entered into supply agreements with Integer pursuant to which Integer agreed to manufacture our IPG component for us. Our first supply agreement with Integer provides that we may order from Integer on a non-exclusive, purchase order basis with no minimum purchase requirements. The agreement includes, among other provisions, customary representations and warranties by the parties, ordering and payment and shipping terms, customary provisions with respect to the ownership of any intellectual property and customary confidentiality provisions. The agreement continues until termination by the parties. Either party may terminate the agreement upon written notice in the event of a material breach that is not cured within 30 days of the other party’s written notice of such breach; upon bankruptcy, insolvency or reorganization that has not been dismissed within 30 days after commencement; or in the event that the other party commits a crime, intentionally imparts material information or misappropriates intellectual property. In addition, we may terminate the agreement if Integer fails to meet our specifications or is unable to manufacture products, or for our convenience if we are current in our payment obligations to Integer. To further support our anticipated growth and IPG supply needs, we also entered into a second supply agreement (the IPG Supply Agreement), effective September 24, 2024, with Greatbatch Ltd., a subsidiary of Integer. The IPG Supply Agreement contains, among other provisions, customary representations and warranties by the parties, ordering and payment and shipping terms, customary provisions with respect to the ownership of any intellectual property created during the term of the IPG Supply Agreement, certain indemnification rights in favor of both parties, limitations of liability and customary confidentiality provisions, and minimum purchase requirements. The minimum purchase requirements are expected to commence in 2028. Under the minimum purchase requirements, we are obligated to purchase a high double-digit fixed percentage of our IPG supply requirements from Integer and must purchase a minimum number of IPGs from Integer per year. The aggregate minimum purchase obligation for the initial five-year period is approximately $5.8 million. The IPG Supply Agreement has an initial five-year term commencing upon the first commercial shipment of product, and will automatically renew for one-year periods unless either party delivers a notice of non-renewal prior to the renewal date. Either party may terminate the IPG Supply Agreement upon written notice in the event of a material breach of the IPG Supply Agreement that is not cured within 60 days of the other party’s written notice of such breach, subject to certain conditions; or upon bankruptcy, insolvency or reorganization that has not been dismissed within 60 days after commencement. We may terminate the IPG Supply Agreement if Integer fails to adequately supply non-defective products, if the products are subject to repeating failures over time that fail to meet our specifications, or if Integer is unable to manufacture products for a specified period of time.

Any of these factors could cause delays or suspension of commercialization and marketing, clinical trials, regulatory submissions or required approvals, cause us to incur higher costs, inability to meet customer demand, and product quality issues or recalls. Furthermore, if our contract manufacturers fail to deliver the required commercial quantities of finished products of an acceptable quality on a timely basis and at commercially reasonable prices and we are unable to find one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent volumes and quality, and on a timely basis, we would likely be unable to meet demand for our products and we would lose potential revenue. Any difficulties in locating and hiring third-party manufacturers, or in the ability of third-party manufacturers to supply quantities of our products at the times and in the quantities we need, could have a material adverse effect on our business. It may take a significant amount of time and resources (including costs) to establish an alternative source of supply for our products and to have any such new source approved by the FDA. Given our reliance on certain single-source suppliers, we are especially susceptible to supply shortages because we do not have alternate suppliers currently available, which can result in increased costs and production delays and potentially adversely impact our ability to meet demand for our products in a timely manner or at all.

Moreover, some third parties or their facilities are or may in the future be located in markets subject to political, social and economic risk, corruption, infrastructure problems, tariffs and natural or man-made disasters, in addition to country-specific intellectual property protection, privacy and data security and tax risks and the risk of nationalization and expropriation, given current legal and regulatory environments. Failure of third parties to meet their contractual, regulatory, and other obligations may have a material adverse effect on our business, financial condition and results of operations. Because we rely on some suppliers in countries outside of the United States, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the United States or the governments in the countries these suppliers are located, including changes in tariff policies, political or social unrest, or unstable economic conditions. Any of these matters could materially and adversely affect our business, financial condition and results of operations.

We estimate that there are more than 4 million chronic ischemic stroke survivors living with moderate to severe upper extremity impairment in the United States and that are within the current on-label indication for our Vivistim System. We believe that an initial market opportunity comprises approximately 1 million of those survivors, which equates to an initial market opportunity of over $30 billion based on the average selling price of the Vivistim System. This initial market represents the total overall revenue opportunity that we believe is available if we achieve 100% market share for Vivistim Therapy among these survivors, and is not a representation that we will achieve any such market share. The market share we achieve is subject to a number of assumptions, risks and uncertainties, including our ability to execute on our commercial strategy and the extent of adoption of Vivistim Therapy. Further, these estimates are based on a number of internal and third-party estimates which may prove to be inaccurate. The actual size of our addressable markets may be smaller than our estimates for a number of reasons. The Vivistim System is currently the first and only FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairment. As such, we will have to expend significant resources to educate and promote awareness of this solution among patients, caregivers and healthcare providers. If we are not able to successfully drive adoption of our solution, we may not be able to access a significant part of this estimated market opportunity.

In addition to the adverse events described above, users have in the past experienced, and may in the future experience, issues with the SAPS interface and accessories and their interactions with the IPG, and we have received, and may in the future receive, complaints regarding these issues. These issues have included SAPS screen anomalies and connection errors between the SAPS user interface and the wireless transmitter, which are typically resolved by rebooting SAPS or replacing the respective laptop, and connection issues between the wireless transmitter and the IPG, which are typically resolved by reconnecting or repositioning the wireless transmitter. Our device manual includes detailed instructions regarding how to resolve these issues, and a team of field-based clinical engineers are available to provide remote and in-person support to clinicians and therapists. While these issues have not been material or presented significant risks or issues for our business to date, if any such issues become systemic, persist, or we are unable to remediate them promptly, or if they otherwise inconvenience or frustrate users, they could impair device performance, disrupt therapy, necessitate replacement procedures, dissuade patients and physicians from using Vivistim Therapy and damage our reputation. Customers may attribute these or similar issues to our products even if caused by reasons not directly related to our products, such as pre-existing conditions, complications associated with the surgical procedure or related anesthesia itself, implantation of the device too deep in the tissue, making a larger-than-necessary incision that results in device migration, movement in the body or other types of user error or patient anatomical features. Even if these types of events are not directly attributable to the devices, they could decrease acceptance of our products by our customers, including hospitals, physicians, therapists, patients or caregivers, and result in a material adverse effect on our business, financial condition, and results of operations. Our reputation among our current or potential customers and referral sources, including but not limited to, stroke interventionalists, neurosurgeons, neurologists, physical medicine and rehabilitation physicians, occupational and physical therapists, stroke coordinators and nurses could also be materially and adversely affected by safety or customer satisfaction issues involving us or our products. For example, our customer service and

Competitors may be able to offer products similar or superior to ours, including products that may, or may be perceived to, have improved features, such as smaller form factors, improved ease of use, longer battery life or rechargeable battery, aesthetics, reliability, safety and effectiveness; have improved reimbursement; be better supported by clinical evidence; more widely recognized and adopted by healthcare providers and patients; or be more cost-efficient. For example, competitors may utilize existing or newly developed products to enter the VNS market in the future, which would increase our competition and could materially and adversely affect demand for Vivistim Therapy. Increased competition may result in price reductions, reduced gross margins and loss of market share. To the extent we expand internationally, we will face additional competition in geographies outside the United States. In addition, we face competition from pharmaceutical companies that produce drugs which aim to aid in stroke recovery, and other companies that produce other devices or therapies that aim to assist in stroke recovery. Further, if medical research were to lead to the discovery of alternative therapies or technologies that address chronic stroke impairments in a way that is or is perceived to be more accurate, reliable, cost-effective, or otherwise improved relative to Vivistim Therapy, for example through alternative monitoring or testing technologies, medication, or therapies, the demand for our products could decrease significantly. For example, some of our patients have experienced pain and discomfort associated with the surgical implantation of our product, and some prospective patients have been reluctant to undergo surgery; if competitors develop or commercialize minimally invasive or non-surgical alternatives that avoid implantation, patients and providers may prefer those options over Vivistim Therapy, which could further reduce demand for our products. There can be no assurance that we will be able to compete successfully against our current or future competitors, or that competitive pressures will not have a material adverse effect on our business, financial condition and results of operations.

In addition, the current U.S. administration has expressed strong concerns about imports from countries that it perceives as engaging in unfair trade practices, and has imposed tariffs or other restrictions on products, components or raw materials sourced from those countries. The legal basis for some of these tariffs have been challenged, and recent judicial decisions, including from the U.S. Supreme Court, have invalidated or called into question certain tariff measures. However, other tariffs remain in place, new or additional tariffs have been and may continue to be imposed, and the overall trade policy environment remains fluid and subject to rapid change. Moreover, changes in U.S. trade policy have triggered and may in the future trigger retaliatory actions, countermeasures, or trade restrictions by affected countries. For example, there have been and continue to be further indications that there may be an increase in tariff rates on various types of goods imported from Canada, Mexico, South America and Europe that could apply to the raw materials we require in our products, including certain types of metal powders used for coating our products as well as entire components of our Vivistim System. In the event that any such possible tariff increases remain in place or become enacted in the future, they could significantly increase the cost of materials and components that our suppliers import and use in our systems, which in turn could increase our supply costs. At this time, there can be no assurance that we will be able to pass any portion of such increases on to customers. We currently do not hedge against our exposure to changing raw material prices and are not aware as to whether our suppliers hedge. As a result, fluctuations in raw material prices could have a material adverse effect on our business, results of operations and financial condition. Supply shortages or changes in availability for any particular type of raw material can delay supplier volume and production capabilities or cause increases in the cost of manufacturing our products. We may be materially and adversely affected by changes in availability and pricing of raw materials, which could materially and adversely affect our results of operations.

We expect our operating expenses to continue to increase for the foreseeable future as we continue to make significant investments in our commercial organization; seek to expand our marketing programs to help facilitate further awareness and adoption among healthcare providers and patients; seek payor reimbursement; continue to make investments in research and development, regulatory affairs, and clinical trials to develop future generations of products based on Vivistim Therapy, support regulatory submissions, and demonstrate the clinical efficacy of our products; and as we continue to scale the business infrastructure and manufacturing capacity. Moreover, we expect to incur additional expenses associated with operating as a public company, including legal, accounting, insurance, exchange listing and SEC compliance, investor relations, and other expenses. In addition, we may in the future seek to acquire or invest in, additional businesses, products, or technologies that we believe could complement or expand our portfolio, enhance our technical capabilities, or otherwise offer growth opportunities.

To the extent that we need additional capital to continue to fund our operations, we intend to obtain such capital through public or private equity offerings or debt financings, credit or loan facilities, or a combination of one or more of these funding sources. If we raise additional funds by issuing equity securities, our stockholders will experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments, and engage in certain merger, consolidation, or asset sale transactions. In the case of an insolvency, debt holders would be repaid before holders of our equity securities receive any distribution of our corporate assets. Any debt financing or additional equity that we raise may also contain terms that are not favorable to us or our stockholders. If we raise additional funds through licensing or collaboration arrangements with third parties, we may have to relinquish valuable rights to our current or future product candidates, or grant licenses on terms that are not favorable to us. We may also seek additional financing opportunistically. We may be unable to raise additional funds on favorable terms, or at all.

Volatility in the capital markets and general economic conditions may be a significant obstacle to raising the required funds. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from factors that include but are not limited to, tariffs, trade and socioeconomic tensions, inflation, the conflict between Russia and Ukraine and in the Middle East, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic stability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. If we are unable to raise sufficient capital on acceptable terms, or at all, our ability to finance our planned operations and support business growth, our business, financial condition and results of operations will be materially and adversely affected.

Clinical testing is difficult to design and implement, can take many years, can be expensive, and carries uncertain outcomes. Because Vivistim Therapy is relatively new in the treatment of upper extremity impairment for chronic stroke survivors, we have performed clinical trials only with limited patient populations relevant to our FDA-approved indication. The trials conducted to date have involved relatively small sample sizes, which may limit the statistical power of the findings and the precision of estimated treatment effects. For example, the largest population we studied was 108 participants in our pivotal REHAB trial. As a result, there is uncertainty as to whether the observed safety, efficacy and other outcomes will be applicable across broader patient populations and other, different sub-groups, including for variations in age, sex, race and ethnicity. The effects of using Vivistim Therapy in a large number of patients have not been studied extensively or over a long-term period, and the results of short-term clinical use of such products do not necessarily predict long-term clinical benefits or reveal long-term adverse effects. While we have one year efficacy data from our pivotal REHAB trial and three year efficacy data from our pilot trial, these results were based on a small number of participants of 74 and 14, respectively. Moreover, clinical benefits may not persist in various circumstances, including if the patient discontinues or pauses occupational or physical therapy, does not otherwise adhere to the prescribed treatment regimen, or experiences an intervening medical or functional setback, and we have not studied the durability of effect in these scenarios.

After patients complete their initial in-clinic therapy protocol, they are expected to continue Vivistim Therapy at home with functional movements for at least 90 days. At-home Vivistim Therapy sessions last thirty minutes and follow the same principles as the in-clinic therapy. Patients who do not use the device as directed, such as not turning the device on during such sessions, or who fail to engage in the recommended task-specific therapy with the appropriate frequency or at all, may experience limited or no improvement from the completion of the in-clinic therapy, may be dissatisfied with their outcomes, and may attribute such poor results to Vivistim Therapy. We have no clinical data that indicates whether functional gains from the in-clinic therapy would be reversed if patients do not complete the home therapy sessions properly or sufficiently. As such, it is possible that patient noncompliance could lead to reversal of the functional gains during in-clinic therapy. Negative patient experiences – whether due to misuse, noncompliance, or unrealistic expectations – could reduce physician and patient acceptance, harm our reputation, and adversely affect demand.

Patient enrollment in clinical trials and completion of patient follow-up depend on many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, patient compliance, competing clinical trials, and clinicians’ and patients’ perceptions as to the potential advantages of the product being studied in relation to other available therapies, including any new treatments that may be approved for the indications we are investigating. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post treatment procedures, monitoring or follow-up to assess the safety and efficacy of a product, or they may be persuaded to participate in contemporaneous clinical trials of a competitor’s product. In addition, patients participating in our clinical trials may drop out before completion of the trial or experience adverse medical events unrelated to our products. Delays in patient enrollment or failure of patients to continue to participate in a clinical trial may delay commencement or completion of the clinical trial, cause an increase in the costs of the clinical trial and delays, or result in the failure of the clinical trial.

Clinical trials must be conducted in accordance with the laws and regulations of the FDA and other applicable regulatory authorities’ legal requirements, regulations, or guidelines, and are subject to oversight by these governmental agencies and IRBs at the medical institutions where the clinical trials are conducted. In addition, clinical trials must be conducted with supplies of our devices produced under Quality Systems Regulations (the QSR) requirements and other regulations. From time to time, we engage consultants to help design, monitor and analyze the results of certain of our clinical trials, and we may have limited influence over their actual performance. The consultants we engage interact with clinical investigators to enroll patients in our clinical trials. We depend on these consultants and clinical investigators to conduct clinical trials and monitor and analyze data from these trials under the investigational plan and protocol for the study or trial and in compliance with applicable regulations and standards, such as GCP guidelines, the Common Rule, and FDA human subject protection regulations. We may face delays in our regulatory approval process if these parties do not perform their obligations in a timely, compliant, or competent manner. If these third parties do not successfully carry out their duties or meet expected deadlines, or if the quality, completeness, or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical trial protocols or for other reasons, our clinical trials or trials may be extended, delayed or terminated or may otherwise prove to be unsuccessful, and we may have to conduct additional trials, which would significantly increase our costs.

To succeed, we must continue to recruit, retain, manage, and motivate qualified executives as we build out the management team, and we face significant competition for experienced personnel. We are highly dependent on executive officers, other members of senior management, as well as on our sales personnel, which includes TMs and TDSs. If we do not succeed in attracting and retaining qualified personnel, particularly at the management level, it could adversely affect our ability to execute our business plan and harm our results of operations. In particular, the loss of one or more of our executive officers could be detrimental to us if we cannot recruit suitable replacements in a timely manner. The competition for qualified personnel in the medical device and neurostimulation field is intense and as a result, we may be unable to continue to attract and retain qualified personnel necessary for the future success of our business. We could in the future have difficulty attracting experienced personnel to our company and may be required to expend significant financial resources in our employee recruitment and retention efforts.

Many of the other medical device, life science, and technology companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better prospects for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what we have to offer. If our business performance declines, we may be unable to offer competitive compensation packages, which could make it difficult to retain our current sales personnel. Additionally, if our competitors increase the compensation offered to their sales personnel, we may be required to increase our own compensation levels, which could increase our operating expenses and negatively impact our profitability. If we fail to increase our own compensation levels to match that of competitors, we may be unable to attract or retain our existing TMs and TDSs, or to attract new TMs or TDSs, which would prevent us from expanding our business and generating sales. If we are unable to continue to attract and retain high-quality sales personnel, the rate and success at which we can discover, develop, and commercialize our current and future products will be limited and the potential for successfully growing our business will be materially and adversely affected.

We face an inherent risk of product liability as a result of the marketing and sale of our products. For example, we may be sued if our products cause or are perceived to cause injury or are found to be otherwise unsuitable. Any such product liability claim may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, or a breach of warranties. In addition, we may be subject to claims against us even if the apparent injury is due to the actions of others or the pre-existing health of the patient. For example, we rely on physicians to implant our Vivistim System in patients. If these physicians are not properly trained, do not appropriately screen out patients who are contraindicated or otherwise not well-suited for an implant procedure or general anesthesia, or are negligent, the capabilities of our products may be diminished, or the patient may suffer critical injury. We may also be subject to claims that are caused by the activities of our suppliers, such as those who provide us with components and sub-assemblies.

Although we carry product liability insurance, it may not prove to be adequate to cover all liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be able to maintain or obtain insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Our insurance policy contains various exclusions, and we may be subject to a product liability claim for which we have no coverage. The potential inability to obtain sufficient product liability insurance at an acceptable cost to protect against product liability claims could prevent or inhibit the marketing and sale of products we develop. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts, which would have a material adverse effect on our business, financial condition, and results of operations. In addition, any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, harm our reputation in the industry, significantly increase our expenses and reduce product sales.

On December 29, 2023, we entered into a loan and security agreement (the Loan and Security Agreement) with Horizon Technology Finance Corporation as lender and collateral agent. On June 1, 2024, Horizon Technology Finance Corporation assigned all of its right, title and interest in and to the loans outstanding under the Loan and Security Agreement and related warrants to Horizon Funding II, LLC, its wholly-owned subsidiary (together with Horizon Technology Finance Corporation, Horizon). The Loan and Security Agreement provides for term loans of up to an aggregate principal amount of $30.0 million, available in four equal tranches of $7.5 million available at various dates (the Commitments). The Company's ability to draw additional loans under the Loan and Security Agreement expired on December 31, 2025. The Loan and Security Agreement matures on January 1, 2029. As of December 31, 2025, there was $7.5 million outstanding under the Loan and Security Agreement, representing the full available aggregate principal amount under the Loan and Security Agreement, and no additional tranches are available to draw down under the Loan and Security Agreement in the future.

While we have not previously breached and are not currently in breach of these or any other covenants contained in the Loan and Security Agreement, there can be no guarantee that we will not breach these covenants or any covenants under any other debt arrangements in the future. Our ability to comply with these covenants may be affected by events beyond our control, and future breaches of any of these covenants could result in a default under the Loan and Security Agreement. If not waived, future defaults could cause all of the outstanding indebtedness under the Loan and Security Agreement to become immediately due and payable and terminate commitments to extend further credit and foreclose on the collateral granted to it to collateralize such indebtedness. If we do not have or are unable to generate sufficient cash available to repay our debt obligations when they become due and payable, either upon maturity or in the event of a default, our assets could be foreclosed upon and we may not be able to obtain additional debt or equity financing on favorable terms, if at all, which may negatively impact our ability to operate and continue our business as a going concern.

Cyberattacks are expected to accelerate on a global basis in frequency and magnitude as threat actors are becoming increasingly sophisticated in using techniques and tools—including AI—that circumvent security controls, evade detection and remove forensic evidence. As a result, we may be unable to detect, investigate, remediate or recover from future attacks or incidents, or to avoid a material and adverse impact to our IT Systems, Confidential Information or business. There can also be no assurance that our cybersecurity risk management program and processes, including our policies, controls or procedures, will be fully implemented, complied with or effective in protecting our IT Systems and Confidential Information. Furthermore, given the nature of complex systems, software and services like ours, and the scanning tools that we deploy across our networks and products, we regularly identify and track security vulnerabilities. We are unable to comprehensively apply patches or confirm that measures are in place to mitigate all such vulnerabilities, or that patches will be applied before vulnerabilities are exploited by a threat actor. If attackers are able to exploit critical vulnerabilities before patches are installed or mitigating measures are implemented, significant compromises could impact our IT Systems and/or Confidential Information.

We and certain of our third-party providers regularly experience cyberattacks and other incidents, and we expect such attacks and incidents to continue in varying degrees. While to date no incidents have had a material impact on our operations or financial results, we cannot guarantee that material incidents will not occur in the future. Any adverse impact to the availability, integrity or confidentiality of our IT Systems or Confidential Information can result in legal claims or proceedings (such as class actions), regulatory investigations and enforcement actions, fines and penalties, negative reputational impacts that cause us to lose existing or future customers, and/or significant incident response, system restoration or remediation and future compliance costs. Any or all of the foregoing could materially and adversely affect our business, results of operations and financial condition. Finally, we cannot guarantee that any costs and liabilities incurred in relation to an attack or incident will be covered by our existing insurance policies or that applicable insurance will be available to us in the future on economically reasonable terms or at all.

Issues in the use of AI, combined with an uncertain regulatory environment, may result in reputational harm, liability, or other adverse consequences to our business operations. As with many technological innovations, AI presents risks and challenges that could impact our business. We may adopt and integrate generative AI tools throughout our business, including into our information systems. Our vendors may incorporate generative AI tools into their services and offerings without disclosing this use to us, and the providers of these generative AI tools may not meet existing or rapidly evolving regulatory or industry standards with respect to data privacy and data protection and may inhibit our or our vendors’ ability to maintain an adequate level of service and experience. Any integration of AI in our or any third party’s operations, products or services is expected to pose new or unknown cybersecurity risks and challenges. If we, our vendors, or our third-party partners experience an actual or perceived breach or data privacy or security incident because of the use of generative AI, we may lose valuable intellectual property and Confidential Information and our reputation and the public perception of the effectiveness of our

We may in the future seek to acquire or invest in businesses, applications, technologies or intellectual property that we believe could complement or expand our portfolio, enhance our technical capabilities, or otherwise offer growth opportunities. However, we cannot assure you that we would be able to successfully complete any acquisition we choose to pursue, or that we would be able to successfully integrate any acquired business, product, or technology in a cost-effective and non-disruptive manner. The pursuit of potential acquisitions may divert the attention of management and cause us to incur various costs and expenses in identifying, investigating, and pursuing suitable acquisitions, whether or not they are consummated. We may not be able to identify desirable acquisition targets or be successful in entering into an agreement with any particular target or obtain the expected benefits of any acquisition or investment. We may also be unable to identify all material liabilities associated with companies we acquire and any indemnities which we receive from the target in connection with an acquisition may be unavailable or insufficient to cover such liabilities.

In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Code), if a corporation undergoes an “ownership change” (generally defined as a cumulative change in our ownership by “5-percent shareholders” that exceeds 50 percentage points (by value) over a rolling three-year period), the corporation’s ability to use its pre-change NOL carryforwards or certain other pre-change tax attributes to offset its post-change taxable income or income taxes, as applicable, may be limited. Similar rules may apply under state tax laws. We believe (but have not undertaken any formal analysis or other assessment to determine) that no such ownership changes have occurred to date. Our ability to utilize our NOL carryforwards or other tax attributes to offset future taxable income or income taxes, as applicable, may be limited if such ownership changes have occurred. Furthermore, we may experience ownership changes as a result of this offering or in the future as a result of subsequent shifts in our stock ownership, some of which are outside our control, which could limit (or further limit) our ability to use our NOL carryforwards and other tax attributes. We have not conducted any studies to determine future annual limitations, if any, that could result from such changes in our stock ownership. Any such limitations on our ability to utilize our NOL carryforwards and certain other tax attributes could have a material adverse effect on our business, financial condition and results of operations.

We may not be able to obtain and maintain intellectual property or other proprietary rights necessary to our business or in a form that provides us with a competitive advantage. For example, our trade secrets, data, and know-how could be subject to unauthorized use, misappropriation, or disclosure to unauthorized parties, despite our efforts to enter into confidentiality or other restrictive covenant agreements with our employees, consultants, contractors, clients, and other vendors who have access to such information, and could otherwise become known or be independently discovered by third parties. In addition, the patent prosecution process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patent applications at a reasonable cost, in a timely manner, or in all jurisdictions where protection may be commercially advantageous, or we may not be able to protect our intellectual property at all. Despite our efforts to protect our intellectual property, unauthorized parties may be able to obtain and use information that we regard as proprietary. It is also possible that we will fail to identify patentable aspects of our research and development output in time to obtain patent protection. Although we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, consultants, contractors, collaborators, vendors, and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. In addition, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were or will be the first to make the inventions claimed in our owned or any licensed patents or pending patent applications, or that we were or will be the first to file for patent protection of such inventions.

Moreover, the coverage claimed in a patent application can be significantly reduced before a patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications we license or own currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents that we hold or in-license may be challenged, narrowed, or invalidated by third parties. Additionally, our competitors or other third parties may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. Third parties may also have blocking patents that could prevent us from marketing our own products and practicing our own technology. Alternatively, third parties may seek approval to market their own products that are similar to or otherwise competitive with our products. In these circumstances, we may need to defend or assert our patents, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or agency with jurisdiction may find our patents invalid, unenforceable, or not infringed, in which case, our competitors and other third parties may then be able to market products and use manufacturing and analytical processes that are substantially similar to ours. Even if we have valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives.

Furthermore, our owned and in-licensed patents may be subject to a reservation of rights by one or more third parties. For example, this could arise if the research resulting in certain of our owned or in-licensed patent rights and technology was funded in part by the U.S. government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention for non-commercial purposes. These rights may permit the government to disclose our Confidential Information to third parties and to exercise march-in rights to use or allow third parties to use our licensed technology. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States. Any exercise by the government of such rights could materially and adversely affect our competitive position, business, financial condition, and results of operations.

The medical device industry has been characterized by extensive litigation regarding patents, trademarks, trade secrets, and other intellectual property rights, and companies in the industry have used intellectual property litigation to gain a competitive advantage. It is possible that United States and foreign patents and pending patent applications or trademarks controlled by third parties may be alleged to cover our products, or that we may be accused of misappropriating third parties’ trade secrets. Additionally, our products include components that we purchase from vendors and may include design components that are outside of our direct control. Our competitors, many of which have substantially greater resources and have made substantial investments in patent portfolios, trade secrets, trademarks, and competing technologies, may have applied for or obtained, or may in the future apply for or obtain, patents or trademarks that will prevent, limit, or otherwise interfere with our ability to make, use, sell, or export our products or to use product names. Because patent applications can take years to issue and are often afforded confidentiality for some period of time, there may currently be pending applications, unknown to us, that later result in issued patents that could cover one or more of our products. Moreover, in recent years, individuals and groups that are non-practicing entities, commonly referred to as “patent trolls,” have purchased patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. We may receive inquiries regarding our intellectual property, notices or “invitations to license,” or may be the subject of claims that our products and business operations infringe or violate the intellectual property rights of others.

Even if we believe a third party’s intellectual property claims are without merit, there is no assurance that a court would find in our favor, including on questions of infringement, validity, enforceability, or priority of patents. The strength of our defenses will depend on the patents asserted, the interpretation of these patents, and our ability to invalidate the asserted patents. In the United States, in order to successfully challenge the validity of a patent in federal court, we would need to overcome a presumption of validity. This standard of proof is a high one, requiring us to present clear and convincing evidence of the invalidity of each asserted claim of the patent. There is no assurance that the court would agree that we had met that standard. Conversely, the patent owner needs only to prove infringement by a preponderance of the evidence, which is a lower standard of proof. If a court of competent jurisdiction should hold that third-party patents are valid, enforceable, and infringed, this could materially and adversely affect our ability to commercialize any products or technology we may develop, and any other products or technologies covered by the asserted third-party patents.

Additionally, we may file lawsuits or initiate other proceedings to protect or enforce our patents or other intellectual property rights, which could be expensive, time consuming and unsuccessful. Competitors may infringe our issued patents or other intellectual property, which we may not always be able to detect. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe on their intellectual property or alleging that our intellectual property is invalid or unenforceable. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may raise challenges to the validity of certain of our owned or in-licensed patent claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). In any such lawsuit or other proceedings, a court or other administrative body may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly, or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.

Even if resolved in our favor, litigation or other proceedings relating to intellectual property claims may cause us to incur expenses and could distract our personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential or sensitive information could be compromised by disclosure in the event of litigation. Uncertainties resulting from the initiation and continuation of patent and other intellectual property litigation or other proceedings could have a material adverse effect on our business, financial condition, and results of operations.

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and other foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign national or international patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. If we or any of our current or future licensors fail to maintain the patents and patent applications that we in-license, our competitors may be able to enter the market, which would have a material adverse effect on our business.

Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first effective non-provisional filing date but can be shorter due to terminal disclaimers or similar term reductions in other jurisdictions. Although various extensions may be available, the term of a patent, and the protection it affords, are limited. Even if patents covering our technologies or products are obtained, once the patent term has expired, we may be open to competition. In addition, although upon issuance in the United States, a patent’s term can be increased based on certain delays caused by the USPTO, this increase can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. Given the amount of time required for the development, testing, and regulatory review of products, patents protecting such product candidates might expire before or shortly after such products are commercialized. If we do not have sufficient patent life to protect our technologies and products, our business, financial condition, and results of operations will be materially and adversely affected.

In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors, and other service providers to publish data potentially relating to our trade secrets. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development, or publication of information by any of our third-party collaborators. Moreover, we cannot guarantee that we have entered into such agreements with each party that may have or have had access to our Confidential Information or proprietary technology and processes. Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will be effective. If any of the third parties who are parties to these agreements breaches or violates the terms of any of these agreements, we may not have adequate remedies for any such breach or violation, and we could lose our trade secrets as a result. A competitor’s discovery of our trade secrets would impair our competitive position and have a material adverse effect on our business.

Although it is our policy to require our employees and contractors who may be involved in the conception or development of products, technology, know-how, and other proprietary materials (collectively, the Technology) to execute agreements assigning all intellectual property rights in and to such Technology to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops Technology that we regard as our own, and we cannot be certain that our agreements with such parties will be upheld in the face of a potential challenge, or that they will not be breached, for which we may not have an adequate remedy. The assignment of intellectual property rights may not be self-executing or the assignment agreements may be breached, and litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

In addition, the U.S. federal government retains certain rights in inventions produced with its financial assistance under the Patent and Trademark Law Amendments Act (Bayh-Dole Act). The federal government retains a “nonexclusive, nontransferable, irrevocable, paid-up license” for its own benefit. The Bayh-Dole Act also provides federal agencies with “march-in rights.” March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself. If we choose to collaborate with academic institutions to accelerate our preclinical research or development, we cannot be sure that any co-developed intellectual property will be free from government rights pursuant to the Bayh-Dole Act. If, in the future, we co-own or license technology which is critical to our business that is developed in whole or in part with federal funds subject to the Bayh-Dole Act, our ability to enforce or otherwise exploit patents covering such technology may be materially and adversely affected.

We may need to obtain additional licenses from our existing licensors or otherwise acquire or in-license any intellectual property rights from third parties that we identify as necessary for our products. It is possible that we may be unable to obtain any additional licenses or acquire such intellectual property rights at a reasonable cost or on reasonable terms, if at all. The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources, and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. In that event, we may be required to expend significant time and resources to redesign our technology, products, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize the affected products, which could have a material adverse effect on our business, financial condition, and results of operations.

In addition to patent protection, we also rely on other proprietary rights, including protection of trade secrets, and other Confidential Information that is not patentable or that we elect not to patent. However, trade secrets can be difficult to protect, and some courts are less willing or unwilling to protect trade secrets. To maintain the confidentiality of our trade secrets and Confidential Information, we rely heavily on confidentiality provisions and other restrictive covenants that we have in contracts with our employees, consultants, collaborators, and others upon the commencement of their relationship with us. We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by such third parties, despite the existence generally of these confidentiality restrictions. These contracts may not provide meaningful protection for our trade secrets, know-how, or other Confidential Information in the event of any unauthorized use, misappropriation, or disclosure of such trade secrets, know-how, or other Confidential Information. There can be no assurance that such third parties will not breach their agreements with us, that we will

To the extent our intellectual property or other Confidential Information protection is incomplete, we are exposed to a greater risk of direct competition. A third party could, without authorization, copy or otherwise obtain and use our products or technology, or develop similar technology. Our competitors could purchase our products and attempt to replicate some or all of the competitive advantages we derive from our development efforts or design around our protected technology. Our failure to secure, protect, and enforce our intellectual property rights could materially and adversely harm the value of our products, brand, and business. The theft or unauthorized use or publication of our trade secrets and other Confidential Information could reduce the differentiation of our products and harm our business, the value of our investment in development or business acquisitions could be reduced, and third parties might make claims against us related to losses of their confidential information. Any of the foregoing could have a material adverse effect on our business, financial condition, and results of operations.

respect to the value of patents, once obtained. Depending on actions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have licensed or that we might obtain in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions, or changes in the governmental bodies that enforce them, or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain in the future. For example, in June 2023, the European Unitary Patent system and the European Unified Patent Court (UPC) were launched. European patent applications now have the option, upon grant of a patent, of becoming a Unitary Patent which is subject to the jurisdiction of the UPC. In addition, conventional European patents, both already granted at the time the new system began and granted thereafter, are subject to the jurisdiction of the UPC, unless actively opted out. This was a significant change in European patent practice, and deciding whether to opt-in or opt-out of Unitary Patent practice entails strategic and cost considerations. The UPC provides third parties with a new forum to centrally revoke our European patents and makes it possible for a third party to obtain pan-European injunctions against us. It will be several years before we will understand the scope of patent rights that will be recognized and the strength of patent remedies that will be provided by the UPC. While we have the right to opt our patents out of the UPC over the first seven years of the court’s existence, doing so may preclude us from realizing the benefits of the UPC. Moreover, the decision whether to opt-in or opt-out of Unitary Patent status will require coordinating with co-applicants, if any, adding complexity to any such decision.

We use “open source software” in a portion of the products or technologies licensed, developed, or distributed by us, including as incorporated into software we receive from third-party commercial software vendors, and we may incorporate open source software into other products in the future. Such open source software is generally licensed by its authors or other third parties under open source licenses. Some open source licenses contain requirements that we disclose source code for modifications we make to the open source software and that we license such modifications to third parties at no cost. In some circumstances, distribution of the software we utilize in connection with open source software could require that we disclose and license some or all of our proprietary code in that software, as well as distribute our products that use particular open source software at no cost to the user. We monitor our use of open source software in an effort to avoid uses in a manner that would require us to disclose or grant licenses under our proprietary source code; however, there can be no assurance that such efforts will be successful. Open source license terms are often ambiguous and such use could inadvertently occur. There is little legal precedent governing the interpretation of many of the terms of these licenses, and the potential impact of these terms on our business may result in unanticipated obligations regarding our products and technologies. Companies that incorporate open source software into their products have, in the past, faced claims seeking enforcement of open source license provisions and claims asserting ownership of open source software incorporated into their products. If an author or other third party that distributes such open source software were to allege that we had not complied with the conditions of an open source license, we could incur significant legal costs defending ourselves against such allegations. In the event such claims were successful, we could be subject to significant damages or be enjoined from the distribution of our products. In addition, if we combine our proprietary software with open source software in certain ways, under some open source licenses, we could be required to release the source code of our proprietary software, which could substantially help our competitors develop products that are similar to or better than ours and otherwise adversely affect our business. These risks could be difficult to eliminate or manage, and, if not addressed, could materially and adversely affect our business, financial condition, and results of operations.

The regulations to which we are subject are complex, burdensome to understand and apply, and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales. The FDA enforces its regulatory requirements through, among other means, periodic unannounced inspections. We do not know whether we or any of our contract manufacturers will be found compliant in connection with any future FDA or foreign inspections. Failure to comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions such as: FDA inspectional observations; warning letters; fines; injunctions; civil penalties; termination of distribution; import alerts; recalls or seizures of products; delays in the introduction of products into the market; total or partial suspension of production; refusal to grant future clearances or approvals; withdrawals or suspensions of clearances or approvals, resulting in prohibitions on sales of our products; and in the most serious cases, criminal penalties. For example, following a routine FDA inspection in March 2026, we received a notice of inspectional observations, or Form 483, with one observation involving two events for which a medical device report was not submitted within 30 days of receiving or otherwise becoming aware of information regarding such events. These events have since been reported and we believe we have since addressed this observation with a corrective and preventative action plan, which included streamlined procedures for evaluating potential adverse events and training for relevant personnel at the Company regarding these procedures and reporting. We submitted a formal written response to FDA in April 2026. To date, the FDA has not taken any further action with respect to the inspection or its findings.

Our products are subject to extensive regulation by the FDA and the Federal Communications Commission (the FCC) in the United States and by regulatory agencies in other countries where we do business. For medical devices involving radio frequency (RF) wireless technologies, the FDA’s policies on wireless medical devices coordinate with the FCC. In the United States, before we can market a new medical device, or a new use of, or other significant modification to an existing, marketed medical device, we must first receive either clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act (the FDCA), approval of a premarket approval (PMA) application, or grant of a de novo classification request from the FDA, unless an exemption applies. In the 510(k) clearance process, before a device may be marketed, the FDA must determine that a proposed device is “substantially equivalent” to a legally-marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (pre-amendments device), a device that was originally on the U.S. market pursuant to an approved PMA and later down-classified, or a 510(k)-exempt device. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data are sometimes required to support substantial equivalence. In the process of obtaining PMA approval, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical trial, manufacturing, and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices.

The PMA approval, 510(k) clearance and de novo classification processes can be expensive, lengthy, and uncertain. The FDA’s 510(k) clearance process usually takes from three to 12 months, but can take longer. The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance process and generally takes from one to three years, or even longer, from the time the application is submitted to the FDA. In addition, a PMA generally requires the performance of one or more clinical trials. Clinical data may also be required in connection with an application for 510(k) clearance or a de novo classification request. Despite the time, effort and cost, a device may not obtain marketing authorization by the FDA. We have obtained PMA approval for Vivistim Therapy, and we must obtain marketing authorization for any future devices we develop or future additional indications for Vivistim Therapy, unless they are exempt. Marketing authorizations for any of our future products, if granted, may include significant limitations on the indicated uses for the device, which may limit the potential commercial market for the device.

In the United States, any modification to a medical device for which we have obtained a PMA may require us to submit a new PMA or PMA supplement and obtain FDA approval. For example, certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect the safety or effectiveness of the device, require submission of a PMA supplement. Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness. We have made modifications to our approved Vivistim Therapy and submitted and received approval of PMA supplements in the past. We may make modifications or add additional features in the future to Vivistim Therapy that we believe do not require a new approval of a PMA or PMA supplement. If the FDA disagrees with our determination and requires us to seek new marketing authorizations for the modifications for which we have concluded that new marketing authorizations are unnecessary, we may be required to cease

In the United States, the methods used in, and the facilities used for, the manufacture of medical devices must comply with the FDA’s Current Good Manufacturing Practices for medical devices, known as the Quality System Regulation (QSR), which is a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing, and shipping of medical devices. On February 23, 2024, the FDA issued a final rule to amend the QSR to align more closely with the International Organization for Standardization (ISO) standards. Specifically, this final rule, which the FDA expects to go into effect on February 2, 2026, replaces the QSR with the Quality Management System Regulation (QMSR), and among other things, incorporates by reference the quality management system requirements of ISO 13485:2016. Although the FDA has stated that the standards contained in ISO 13485:2016 are substantially similar to those set forth in the QSR, it is unclear the extent to which this final rule, once effective, could impose additional or different regulatory requirements on us that could increase the costs of compliance or otherwise create market pressure that may negatively affect our business. Furthermore, we are required to verify that our suppliers maintain facilities, procedures, and operations that comply with our quality standards and applicable regulatory requirements. The FDA enforces the QSR, and is expected to enforce the QMSR, through periodic announced or unannounced inspections of medical device manufacturing facilities, which may include the facilities of subcontractors. Our products are also subject to similar state regulations governing manufacturing.

Despite our efforts to ensure compliance, we or our third-party manufacturers may not take the necessary steps to comply with applicable regulations, which could cause delays in the delivery of our medical devices. In addition, failure to comply with applicable FDA requirements or later discovery of previously unknown problems with our products or manufacturing processes could result in, among other things: warning letters or untitled letters; fines, injunctions, or civil penalties; suspension or withdrawal of marketing authorizations; seizures or recalls of our products; total or partial suspension of production or distribution; administrative or judicially imposed sanctions; the FDA’s refusal to grant pending or future clearances or approvals for our products or similar decisions by foreign regulatory authorities or notified bodies; clinical holds; refusal to permit the import or export of our products; and criminal prosecution of us, our suppliers, or our employees. Any of these actions could significantly and negatively affect supply of our products. If any of these events occurs, our reputation could be harmed, we could be exposed to product liability claims and we could lose customers and experience reduced sales and increased costs. We are also subject to similar state requirements and licenses.

There have been, and there may continue to be side effects and adverse events associated with the use of our medical devices or any future devices we develop. The FDA’s medical device reporting regulations require us to assess reportability of adverse events that come to our attention and report to the FDA when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. The FDA may also disagree with our determinations that an event was not reportable. If we fail to comply with our reporting obligations, the FDA could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our marketing authorizations, seizure of our products, or delay in obtaining marketing authorizations for our future products.

Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. More recently, the One Big Beautiful Bill Act (the OBBBA) was signed into law on July 4, 2025, and contains provisions that, among other changes, are expected to reduce the number of individuals enrolled in state Medicaid programs and ACA marketplace plans, which could adversely affect commercialization of Vivistim Therapy. We cannot predict how other litigation or legislative efforts, or the healthcare reform measures of the Trump administration will impact our business. The Trump administration is currently pursuing policies to reduce regulations and expenditures across government including at the U.S. Department of Health and Human Services, the FDA, the CMS, and related agencies. It is possible that certain of these changes could impose additional limitations on the rates we will be able to charge for our current and future products or the amounts of reimbursement available for our customers for

Further, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal legislation designed to bring transparency to product pricing and reduce the cost of products and services under government healthcare programs. While some of these measures may require additional authorization to become effective, Congress and the Federal administration have each indicated that it will continue to seek new legislative or administrative measures to control product costs. Additionally, individual states in the United States have also increasingly passed legislation and implemented regulations designed to control product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures. Moreover, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what products to purchase and which suppliers will be included in their programs. Adoption of price controls and other cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures may prevent or limit our ability to generate revenue and attain profitability. Various new healthcare reform proposals are emerging at the federal and state level. Any new federal and state healthcare initiatives that may be adopted could limit the amounts that federal and state governments will pay for healthcare products and services and could have a material adverse effect on our business, financial condition and results of operations.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulation of medical devices. In addition, the FDA may change its clearance and approval policies, adopt additional regulations, or revise existing regulations, or take other actions, which may prevent or delay marketing authorization of any future products under development or impact our ability to modify any products for which we have already obtained marketing authorizations on a timely basis. For example, on January 31, 2024, the FDA issued a final rule to amend the QSR, which establishes current good manufacturing practice requirements for medical device manufacturers, to align more closely with the ISO standards. Specifically, this final rule, which the FDA expects to go into effect on February 2, 2026, replaces the QSR with the QMSR, and among other things, incorporates by reference the quality management system requirements of ISO 13485:2016. Although the FDA has stated that the standards contained in ISO 13485:2016 are substantially similar to those set forth in the existing QSR, it is unclear the extent to which this final rule, once effective, could impose additional or different regulatory requirements on us that could increase the costs of compliance or otherwise create market pressure that may materially and adversely affect our business. It is unclear to what extent any other legislative or regulatory proposal, if adopted, could impose additional or different regulatory requirements on us that could increase the costs of compliance or otherwise create competition that may materially and adversely affect our business.

We are similarly subject to various heavily enforced anti-bribery and anti-corruption laws, such as the FCPA, anti-money laundering laws, and similar laws around the world. The FCPA or other anti-corruption and anti-bribery laws generally prohibit U.S. companies and their employees and intermediaries from offering, promising, authorizing, or making improper payments to foreign government officials for the purpose of obtaining or retaining business or gaining any advantage. We face significant risks if we, which includes our third-party business partners and intermediaries, fail to comply with the FCPA or other anti-corruption and anti-bribery laws. Certain suppliers of components of our devices are located in countries known to experience corruption. Business activities in these countries create the risk of unauthorized payments or offers of payments by one of our employees, consultants, contractors, or agents that could be in violation of various laws, including the FCPA and anti-bribery laws in these countries, even though these parties are not always subject to our control. While we have implemented policies and procedures designed to discourage these practices by our employees, consultants, contractors and agents and to identify and address potentially impermissible transactions under such laws and regulations, we cannot assure you that none of our employees, consultants, contractors and agents will take actions in violation of our policies, for which we may be ultimately responsible.

We are also subject to certain economic and trade sanctions programs, including those administered by the U.S. Department of the Treasury’s Office of Foreign Assets Control, which prohibit or restrict transactions or dealings with or involving specified countries, their governments, and in certain circumstances, their nationals, or with individuals and entities that are specially-designated nationals, narcotics traffickers, terrorists or terrorist organizations, or otherwise blocked or sanctioned pursuant to applicable regulations. In addition, we are subject to export controls and similar trade restrictions, which restrict or prohibit the export, re-export, and transfer of certain goods, software, technology, and services to specified countries, governments, entities, and individuals. For example, in December 2021, the U.S. Congress enacted the Uyghur Forced Labor Prevention Act in an effort to prevent what it views as forced labor and human rights abuses in the Xinjiang Uyghur Autonomous Region, or XUAR, of China. If it is determined that our third-party suppliers and manufacturers produce or manufacture our components or products wholly or in part from the XUAR, or certain designated entities, then we could be prohibited from importing such components or products into the United States. Similarly, the U.S. government has increasingly issued new restrictions limiting access to federal contracts or funds for companies that source certain types of equipment or services from designated companies in China or other so-called countries of concern.

We provide a limited warranty that our products are free of material defects in workmanship and materials and conform to specifications, and offer to repair or replace defective products. Although we have had very few warranty claims to date, we bear the risk of potential warranty claims on our products. If we receive a significant number of warranty claims or our products require significant amounts of service after sale, our operating expenses may substantially increase and our business and financial results will be adversely affected. We have a limited history of commercial placements from which to judge our rate of warranty claims, and we expect that the number of warranty claims we receive may increase as we scale our operations and as our existing commercial placements age. If product returns or warranty claims are significant or exceed our expectations, we could incur unanticipated reductions in sales or additional operating expenditures for parts and service. In addition, our reputation could be damaged and our products may not achieve the level of market acceptance that we are targeting in order to achieve and maintain profitability. In the event that we attempt to recover some or all of the expenses associated with a warranty claim against us from our suppliers or vendors, we may not be successful in claiming recovery under any warranty or indemnity provided to us by such suppliers or vendors or that any recovery from such vendor or supplier would be adequate.

The medical device industry has historically been subject to extensive litigation over product liability claims. We may be subject to product liability claims if our products cause, or merely appear to have caused, an injury or death, even if due to physician error. In addition, an injury or death that is caused by the activities of our suppliers, such as those that provide us with components and raw materials, or by an aspect of a treatment used in combination with our products, such as a complementary drug or anesthesia, may be the basis for a claim against us by patients, hospitals, ASCs, physicians, or others purchasing or using our products, even if our products were not the actual cause of such injury or death. We may choose to settle any claims to avoid fault and complication not due to failure of our products. An adverse outcome involving one of our products could result in reduced market acceptance and demand for all of our products and could harm our reputation and our ability to market our products in the future. In some circumstances, adverse events arising from or associated with the design, manufacture or marketing of our products could result in the suspension or delay of regulatory reviews of our premarket notifications or applications for marketing. Any of the foregoing problems could disrupt our business and have a material adverse effect on our business, financial condition and results of operations.

Although we carry product liability insurance in the United States and in other countries in which we conduct business, including for clinical trials and product marketing, we can give no assurance that such coverage will be available or adequate to satisfy any claims. Product liability insurance is expensive, subject to significant deductibles and exclusions, and may not be available on acceptable terms, if at all. If we are unable to obtain or maintain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against potential product liability claims, we could be exposed to significant liabilities. A product liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could have a material adverse effect on our business, financial condition and results of operations. Defending a suit, regardless of its merit or eventual outcome, could be costly, could divert management’s attention from our business and might result in adverse publicity, which could result in reduced acceptance of our products in the market, product recalls, or market withdrawals.

We are required to file adverse event reports under Medical Device Reporting (MDR) regulations with the FDA that are publicly available on the FDA’s website. We are required to file MDRs if our products may have caused or contributed to a serious injury or death or malfunctioned in a way that could likely cause or contribute to a serious injury or death if it were to recur. Any such MDR that reports a significant adverse event could result in negative publicity, which could harm our reputation and future sales. If we fail to report events required to be reported to the FDA within the required timeframes, or at all, the FDA could take enforcement action and impose sanctions against us. Any such adverse event involving our products also could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, would require our time and capital, distract management from operating our business and may harm our reputation and have a material adverse effect on our business, financial condition and results of operations.

We are exposed to the risk that our employees, independent contractors, commercial team, consultants, commercial partners, distributors, and vendors may engage in fraudulent or illegal activity. Misconduct by these parties could include intentional, reckless or negligent conduct, or disclosure of unauthorized activities to us that violates: (i) FDA laws and laws of other similar foreign regulatory bodies, including those laws requiring the reporting of true, complete and accurate information to such regulators; (ii) manufacturing standards; (iii) healthcare fraud and abuse laws, including anti-kickback law and patient inducement laws, in the United States and similar foreign fraudulent misconduct laws; or (iv) laws that require the true, complete and accurate reporting of financial information or data. These laws may impact, among other things, future sales, marketing, and education programs. In particular, the promotion, sales, and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing, and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commissions, certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

It is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant fines or other sanctions, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, imposition of a corporate integrity agreement, additional integrity reporting, compliance and oversight obligations, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of operations, any of which could materially and adversely affect our ability to operate our business and our results of operations. Whether or not we are successful in defending against any such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations, which could have a material adverse effect on our business, financial condition and results of operations.

Our research and development and supply chain operations involve the use of hazardous substances and are subject to a variety of federal, state, local and foreign environmental laws and regulations relating to the storage, use, discharge, disposal, remediation of, and human exposure to, hazardous substances and the sale, labeling, collection, recycling, treatment, and disposal of products containing hazardous substances. Liability under environmental laws and regulations can be joint and several and without regard to fault or negligence. Compliance with environmental laws and regulations may be expensive and noncompliance could result in substantial liabilities, fines and penalties, personal injury and third-party property damage claims and substantial investigation and remediation costs. Environmental laws and regulations could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We cannot assure you that violations of these laws and regulations will not occur in the future or have not occurred in the past as a result of human error, accidents, equipment failure or other causes. The expense associated with environmental regulation and remediation could materially and adversely our business, financial condition and results of operations.

As our operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities. In the United States, HIPAA imposes data privacy, security and breach notification obligations, on certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as their business associates that perform certain services that involve creating, receiving, maintaining or transmitting individually identifiable health information for or on behalf of such covered entities, and their covered subcontractors. HIPAA requires covered entities and business associates to, among other things, develop and maintain policies with respect to the protection of, use and disclosure of protected health information (PHI). To the extent we create, receive, maintain or transmit PHI on behalf of covered entity customers or other third parties as a business associate under HIPAA, we are required to comply with applicable provisions of the HIPAA privacy, security and breach notification rules. HIPAA imposes, among other things, certain standards relating to the privacy, security, and breach reporting of individually identifiable health information. To the extent we are found to be out of compliance with HIPAA, we could face significant civil, criminal and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance. HIPAA also authorizes state Attorneys General to file suit on behalf of their residents. Courts may award damages, costs and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create a private right of action allowing individuals to sue us in civil court for violations of HIPAA, its standards have been used as the basis for duty of care in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI.

In addition, in recent years, certain states have adopted or modified data privacy and security laws and regulations that may apply to our business. For example, the California Consumer Privacy Act (CCPA) requires businesses that process personal information of California residents to, among other things: provide certain disclosures to California residents regarding the business’s collection, use, and disclosure of their personal information; receive and respond to requests from California residents to access, delete, and correct their personal information, or to opt-out of certain disclosures of their personal information; and enter into specific contractual provisions with service providers that process California resident personal information on the business’s behalf. The enactment of the CCPA is prompting a wave of similar legislative developments in other states in the United States, which creates a patchwork of overlapping but different state laws. For example, since the CCPA went into effect, comprehensive privacy statutes that share similarities with the CCPA are now in effect and enforceable in numerous states, and will soon be enforceable in several other states as well. Similar laws have been proposed in many other states and at the federal level as well. Certain states have also enacted new laws regulating specific types of personal information, such as health data, including the Washington My Health My Data Act and Nevada’s Senate Bill 370. In the event we are subject to such laws, they impose, among other things, onerous notice and consent obligations, and prohibit certain personal information processing. To the extent we are found to be out of compliance with such laws, we could face negative publicity, government investigations and enforcement actions, claims by third parties (including class action lawsuits and private litigation) and damage to our reputation, any of which could have a material adverse effect on our business, financial condition and results of operations. As a result, our processing of health data in such states may subject us to additional compliance obligations and expose us to increased risk of liability.

This risk is enhanced in certain jurisdictions and, as we expand our operations domestically and internationally, we may be subject to additional laws in other jurisdictions. Any actual or perceived failure by us or the third parties with whom we work to comply with privacy or security laws, policies, legal obligations, or industry standards, or any security incident that results in the unauthorized release or transfer of personally identifiable information, may result in governmental enforcement actions and investigations by U.S. federal and state regulatory authorities, fines and penalties, claims, proceedings or actions against us by individuals, consumer rights groups, government agencies, or others and we could incur significant costs in investigating and defending such claims, orders to make changes to our business, and/or adverse publicity, including by consumer advocacy groups and other private parties, and could cause our customers, their patients, and other healthcare professionals to lose trust in us, which could materially and adversely affect our reputation and have a material adverse effect on our business, financial condition and results of operations.

The ability of the FDA and foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s or foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions. Average review times at the FDA and foreign regulatory authorities have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new medical devices or modifications to be approved or cleared by necessary government agencies, which would materially and adversely affect our business. For example, in recent years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities. In addition, the current U.S. Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities.

Prior to this offering, no market for shares of our common stock existed and an active trading market for our shares may never develop or be sustained following this offering. We will determine the initial public offering price for our common stock through negotiations with certain of the underwriters, and the negotiated price may not be indicative of the market price of our common stock after this offering. The market value of our common stock may decrease from the initial public offering price. As a result of these and other factors, you may be unable to resell your shares of our common stock at or above the initial public offering price. The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The lack of an active market may also reduce the fair market value of your shares. Furthermore, an inactive market may also impair our ability to raise capital by selling shares of our common stock and may impair our ability to enter into strategic collaborations or acquire companies, technologies, or other assets by using our shares of common stock as consideration.

We and our executive officers, directors and the holders of an aggregate of shares of our common stock have entered into lock-up agreements with the underwriters under which they have agreed, subject to specific exceptions described in the section titled “Underwriting,” not to sell, directly or indirectly, any shares of common stock without the permission of BofA Securities, Inc., J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC for a period of 180 days following the date of this prospectus. We refer to such period as the lock-up period. When the lock-up period expires, we and our securityholders subject to a lock-up agreement will be able to sell our shares in the public market. In addition, BofA Securities, Inc., J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC may, in their sole discretion, release all or some portion of the shares subject to lock-up agreements at any time and for any reason. See the description of the lock-up agreement with the underwriters in the section titled “Underwriting” for more information. Sales of a substantial number of such shares upon expiration of the lock-up agreement, the perception that such sales may occur, or early release of these agreements, could cause our market price to fall or make it more difficult for you to sell your common stock at a time and price that you deem appropriate.

Prior to this offering, our executive officers, directors, holders of 5% or more of our capital stock, and their respective affiliates beneficially owned approximately % of our voting stock and, upon the completion of this offering, that same group will beneficially own approximately % of our outstanding voting stock (based on the number of shares of common stock outstanding as of December 31, 2025 assuming no exercise of the underwriters’ option to purchase additional shares, no exercise of outstanding options, and no purchases of shares in this offering by any of this group), in each case assuming the occurrence of the Preferred Stock Conversion immediately prior to the completion of this offering. After this offering, this group of stockholders will have the ability to control us through this ownership position even if they do not purchase any additional shares in this offering. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders. The interests of this group of stockholders may not always coincide with your interests or the interests of other stockholders and they may act in a manner that advances their best interests and not necessarily those of other stockholders, including seeking a premium value for their common stock, and might affect the prevailing market price for our common stock.

In connection with the preparation of our financial statements, we identified a material weakness in our internal control over financial reporting. Specifically, we did not design and maintain effective controls over the review of the inputs in the calculation of net loss per share attributable to common stockholders. The material weakness resulted in a revision to the weighted average number of shares and net loss per share attributable to common stockholders within the statement of operations and related disclosures as of and for the year ended December 31, 2025. Additionally, this material weakness could result in misstatements to net loss per share attributable to common stockholders and related disclosures that would result in a material misstatement to the annual or interim financial statements that would not be prevented or detected. We are in the process of implementing remediation measures, including the establishment of a control over the review of the calculation of weighted-average shares outstanding and net loss per share. The material weakness will not be considered remediated until management completes the design and implementation of the controls and the controls operate for a sufficient period of time and management has concluded, through testing, that these controls are effective.

As a public company, we will incur significant legal, accounting, and other expenses that we did not incur as a private company, and these expenses may increase even more after we are no longer an “emerging growth company.” We will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Protection Act, as well as rules adopted, and to be adopted, by the SEC. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, we expect these rules and regulations to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly, which will increase our operating expenses. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain sufficient coverage. We cannot accurately predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees, or as executive officers.

In addition, as a public company we will be required to incur additional costs and obligations in order to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act. Under these rules, beginning with our second annual report on Form 10-K after we become a public company, we will be required to make a formal assessment of the effectiveness of our internal control over financial reporting, and once we cease to be an emerging growth company, we will be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we will be engaging in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of our internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are designed and operating effectively, and implement a continuous reporting and improvement process for internal control over financial reporting.

These exclusive-forum provisions may increase costs for a stockholder to bring a claim and may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage lawsuits against us and our directors, officers and other employees. Any person or entity purchasing or otherwise acquiring any interest in any of our securities shall be deemed to have notice of and consented to these provisions. There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of forum provisions in other companies’ charter documents has been challenged in legal proceedings. We also note that stockholders cannot waive compliance (or consent to noncompliance) with the federal securities laws and the rules and regulations thereunder. It is possible that a court could find these types of provisions to be inapplicable or unenforceable, and if a court were to find either exclusive-forum provision in our amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could materially and adversely affect our business.

The initial public offering price of our common stock is expected to be substantially higher than the pro forma as adjusted net tangible book value per share of our common stock. Therefore, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our pro forma as adjusted net tangible book value per share after this offering. Based on the initial public offering price of $ per share, the midpoint of the price range set forth on the cover page of this prospectus, you will experience immediate dilution of $ per share, representing the difference between our pro forma as adjusted net tangible book value per share after giving effect to this offering and the initial public offering price. In addition, purchasers of common stock in this offering will have contributed % of the aggregate price paid by all purchasers of our common stock but will own only approximately % of our total equity outstanding immediately after this offering. Furthermore, if the underwriters exercise their option to purchase additional shares, or outstanding options and warrants are exercised, you could experience further dilution. For a further description of the dilution that you will experience immediately after this offering, see the section titled “Dilution.”

You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this prospectus primarily on our current expectations, estimates, forecasts, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, and prospects. Although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectus, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, and other factors described in the section titled “Risk Factors” and elsewhere in this prospectus. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and risks and uncertainties that we currently deem immaterial may also impair our business operations and the market price for our common stock, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this prospectus. The results, events, and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events, or circumstances could differ materially from those described in the forward-looking statements.

Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the net proceeds to us from this offering by approximately $ million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1.0 million shares in the number of shares offered by us would increase (decrease) the net proceeds to us from this offering by approximately $ million, assuming that the assumed initial public offering price remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We do not expect that a change in the initial public offering price or the number of shares by these amounts would have a material effect on our uses of the proceeds from this offering, although such change may accelerate the time at which we will need to seek additional capital.

(1)Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) our pro forma as adjusted cash and cash equivalents, additional paid-in capital, total stockholders’ deficit and total capitalization by approximately $ million, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each increase (decrease) of 1.0 million shares in the number of shares of common stock offered by us would increase (decrease) our pro forma as adjusted cash and cash equivalents, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $ million, assuming the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.

Chronic stroke recovery presents a significant market opportunity. According to the American Heart Association (AHA), approximately 87% of the strokes in the United States are ischemic. This equates to approximately 9 million ischemic stroke survivors in the United States, of which we estimate that more than 4 million are chronic ischemic stroke survivors living with moderate to severe upper extremity impairment. This population falls within the current on-label indication for the Vivistim System. We believe that an initial market opportunity comprises approximately 1 million of those survivors that demonstrate the requisite overall health, cognition and motivation to participate in therapy and have received some amount of post-stroke therapy, which we estimate represents an initial market opportunity of over $30 billion based on the average selling price of the Vivistim System. Vivistim Therapy is effective for recent stroke survivors as well as patients who initiate treatment many years post-stroke. Based on a report published by the AHA in 2025, we estimate that each year approximately 200,000 new stroke survivors in the United States meet our indication for use, with 50,000 of these survivors representative of our initial market opportunity.

Our commercial strategy is designed to encourage Vivistim Therapy adoption at stroke centers and therapy sites through a coordinated, evidence-based approach. We sell the Vivistim System to customers, primarily stroke hospitals, in the United States, and our commercial organization is responsible for driving adoption of the Vivistim System through customer outreach, education, and relationship management activities. Our team includes Territory Managers (TMs), who support initial customer onboarding efforts at stroke centers and maintain commercial relationships with physicians and administrators, and Therapy Development Specialists (TDSs), who focus on outreach to therapy sites and provide general educational information regarding the clinical use of the Vivistim System. These activities are intended to facilitate customer adoption and utilization of the Vivistim System. Our commercial efforts are currently focused on primary and comprehensive stroke centers, which are hospitals that have cross-functional teams with the capabilities to treat acute stroke at the highest level of care and in compliance with AHA guidelines. These centers see significant volumes of acute stroke patients and are typically surrounded by a

•Market development and awareness of Vivistim Therapy. Our mission is to redefine stroke recovery for survivors living with life-altering functional impairments by establishing Vivistim Therapy as the standard of care for chronic stroke recovery. As there are currently very limited options to support chronic stroke recovery, we are focused on developing this new market and driving awareness of Vivistim Therapy as a potential treatment option for stroke survivors. To accomplish this, we intend to continue to educate healthcare providers on the capabilities and benefits of Vivistim Therapy, work closely with hospitals to incorporate Vivistim Therapy as a treatment option, and activate care programs that use Vivistim Therapy at stroke centers and therapy sites. In addition, we intend to continue to expand our clinical evidence to support a robust cadence of publications regarding the benefits of Vivistim Therapy. We believe these efforts will support the growth of our business by generating broader awareness, which can support adoption and increase utilization of Vivistim Therapy. Candidates for Vivistim Therapy generally result from three primary sources: physician referrals, therapist referrals, and direct patient engagement. A diverse network of care providers, including stroke interventionalists, neurosurgeons, neurologists, physical medicine and rehabilitation physicians, occupational and physical therapists, stroke coordinators and nurses, support and interact with stroke survivors. We directly engage with each of these stakeholders through our field-based commercial team and specialized events, summits, and conferences. In addition, we engage in direct patient education activities, such as webinars, outreach through support groups, digital advertising and other targeted activities. We believe that establishing strong referral patterns between providers and engaging directly with stroke survivors and their caregivers will help to further market development, awareness and utilization. For example, we believe that as awareness and utilization increase, stroke centers will naturally integrate Vivistim Therapy into standard care pathways for stroke survivors upon discharge and establish self-sustaining care programs that use Vivistim Therapy over time. Our financial performance will be significantly impacted by the extent to which we can increase awareness and utilization, as well as the timing and rate of adoption of our products by healthcare providers.

•Reimbursement and expanding payor coverage. Healthcare providers generally rely on third-party payors, including Medicare, Medicaid, Medicare Advantage and commercial insurance plans, to cover and reimburse all or part of the cost of the Vivistim System. As a result, demand for our Vivistim System depends in part on the availability of reimbursement from such payors and the rates that such payors reimburse for implantation procedures with the Vivistim System. The Vivistim System implantation procedure falls under a long-established Category 1 CPT code. Effective January 1, 2026, this code was assigned to a New Technology Ambulatory Payment Classification (APC) by CMS, which established an elevated payment level. Future changes in payment levels could have a significant impact on patient access to the Vivistim System, and thus on our revenue, either positively or negatively. Medicare fee-for-service patients can typically access Vivistim Therapy when medically necessary, without prior authorization. Commercial insurance plans, Medicaid and Medicare Advantage generally require prior authorization. Our in-house market access team works to provide support in navigating the prior authorization process and facilitating positive coverage decisions by third-party payors, including by utilizing our robust clinical evidence, demonstrating economic value, and leveraging endorsements from key opinion leaders. Our growth in 2025 was, and our future success will be, driven in part by our ability to facilitate streamlined prior authorization processes and increase coverage by third-party payors, and improve market access.

Selling, general and administrative expenses primarily consist of compensation for personnel, including salaries, employee benefits, stock-based compensation, commissions associated with our commercial organization, spending related to sales and marketing, finance, information technology and human resource functions, expenses related to clinical studies and our registry for our current clinical indication, legal expenses related to regulatory matters, and training. Other expenses include travel expenses, advertising, conferences, trade shows, consulting and professional services fees, insurance costs, and general corporate expenses, including facilities-related expenses. The activities of our TMs and TDSs to facilitate customer adoption and utilization of the Vivistim System, and of our in-house market access team in facilitating the administrative prior authorization process, are included in selling, general and administrative expenses and do not represent contractual obligations or services provided to customers after product delivery. We expect selling, general and administrative expenses to continue to increase in absolute dollars as we expand our commercial organization, including with respect to TMs and TDSs, to both drive and support our planned growth in revenue, fund clinical studies and our registry for our current clinical indication, and incur additional expenses associated with operating as a public company, including costs related to legal, accounting, insurance, compliance with exchange listing and Securities and Exchange Commission requirements, and investor relations. We also expect an increase in our stock-based compensation expense with the establishment of a new equity plan associated with this offering and related grants either in the form of restricted stock or options. However, we expect selling, general and administrative expenses to decrease as a percentage of revenue primarily as, and to the extent, our revenue grows.


	For the three months ended
(in thousands)	March 31, 2024		June 30, 2024		September 30, 2024		December 31, 2024		March 31, 2025		June 30, 2025		September 30, 2025		December 31, 2025
Revenue	$	3,098	$	4,034	$	4,133	$	4,380	$	5,661	$	6,674	$	9,012	$	10,694
Cost of goods sold	616		719		860		998		1,015		1,185		1,836		2,031
Gross profit	2,482		3,315		3,273		3,382		4,646		5,489		7,176		8,663
Operating Expenses
Research and development costs	998		875		975		1,395		1,354		1,418		1,605		2,138
Selling, general and administrative expenses	7,611		7,515		8,370		8,949		13,596		14,532		16,828		20,872
Total operating expenses	$	8,609	$	8,390	$	9,345	$	10,344	$	14,950	$	15,950	$	18,433	$	23,010
Loss from operations	$	(6,127)	$	(5,075)	$	(6,072)	$	(6,962)	$	(10,304)	$	(10,461)	$	(11,257)	$	(14,347)
Other income (expense)
Interest expense	(232)		(232)		(235)		(271)		(239)		(241)		(244)		(244)
Other income (expense), net	110		150		110		248		(109)		214		79		659
Total other income (expense), net	$	(122)	$	(82)	$	(125)	$	(23)	$	(348)	$	(27)	$	(165)	$	415
Loss before provision for income taxes	$	(6,249)	$	(5,157)	$	(6,197)	$	(6,985)	$	(10,652)	$	(10,488)	$	(11,422)	$	(13,932)
Provision for income tax							(14)		(1)		(1)		(1)		(1)
Net loss attributable to common stockholders	$	(6,249)	$	(5,157)	$	(6,197)	$	(6,999)	$	(10,653)	$	(10,489)	$	(11,423)	$	(13,933)

We have concluded that our history of continued operating losses and negative cash flow from operations and accumulated deficit raise substantial doubt about our ability to continue as a going concern. See Note 2 to our financial statements for the fiscal year ended December 31, 2025 included elsewhere in this prospectus for additional information on our assessment. Similarly, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of and for the fiscal year ended December 31, 2025 included elsewhere in this prospectus, describing the existence of substantial doubt about our ability to continue as a going concern. Based on our current operating plan, we do not expect that our cash and cash equivalents will be sufficient to fund our operations for at least 12 months after the date of these financial statements are issued without raising additional capital through equity or debt financing, or potential collaboration proceeds. We believe that the actions presently being taken to further implement our business plan, generate revenues, and raise additional capital provide the opportunity for us to continue as a going concern. While we believe in the viability of our strategy to generate revenues and in our ability to raise additional funds, there can be no assurances that we will be successful in these efforts and the substantial doubt will be alleviated.

If these sources are insufficient to satisfy our liquidity requirements, we may seek additional financing or to raise any necessary additional capital through public or private equity offerings or debt financings, credit or loan facilities or a combination of one or more of these or other funding sources. Additional funds may not be available to us on acceptable terms or at all. If we fail to obtain necessary capital when needed on acceptable terms, or at all, we could be forced to delay, limit, reduce or terminate our commercial efforts, product development programs or other operations, and such failure would have a negative impact on our financial condition and our ability to execute our business plan. If we raise additional funds by issuing equity securities or convertible debt, our stockholders will suffer dilution and the terms of any financing may adversely affect the rights of our stockholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. If we raise additional capital through collaboration agreements, licensing arrangements or marketing and distribution or other similar arrangements, we may have to relinquish valuable rights, future revenue streams, research programs or product or grant licenses that may not be favorable to us. Debt financing, if available, is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets.

The Loan and Security Agreement includes customary affirmative and negative covenants and events of default. Upon the occurrence and continuance of an event of default, Horizon may demand immediate repayment of all principal and unpaid interest under the Loan and Security Agreement, and exercise remedies against us and the collateral securing our obligations under the Loan and Security Agreement. Events of default under the Loan and Security Agreement include, among other things: (i) insolvency, bankruptcy or similar proceedings subject to a certain grace period in respect of any involuntary insolvency, bankruptcy or similar proceedings; (ii) failure to pay any debts due under the Loan and Security Agreement or other indebtedness on a timely basis; (iii) failure to observe any covenant or other terms under the Loan and Security Agreement or the other Loan Documents (as defined in the Loan and Security Agreement), some of which are subject to a certain cure period; (iv) occurrence of a material adverse change; (v) material misrepresentations; and (vi) entry of certain final, non-appealable judgments against us in excess of $250,000 not paid or bonded within 10 days of such entry.

automatically convert into shares of our common stock at the applicable conversion price. The conversion price is the lower of (a) 80% of the initial public offering price per share in this offering and (b) the valuation of the Company immediately prior to the closing of this offering divided by the number of fully diluted shares of capital stock (on an as-converted basis) outstanding immediately prior to this offering but excluding the 2026 Convertible Notes (Fully Diluted Capitalization), provided, that in no event shall such conversion price be less than the quotient obtained by dividing $226.0 million by the Fully Diluted Capitalization or greater than the quotient obtained by dividing $750.0 million by the Fully Diluted Capitalization. Based on an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and without giving effect to accrued interest (if any), the 2026 Convertible Notes will automatically convert into an aggregate of shares of our common stock immediately prior to the closing of this offering.

We are an emerging growth company, as defined in the JOBS Act. The JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for any other new or revised accounting standards during the period in which we remain an emerging growth company; however, we may adopt certain new or revised accounting standards early. As a result, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies and our financial statements may not be comparable to other public companies that comply with new or revised accounting pronouncements as of public company effective dates. The JOBS Act also exempts us from having to provide an attestation and report from our independent registered public accounting firm on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act.

•First and only FDA-approved solution establishing a new standard of care in chronic stroke recovery. We are redefining chronic stroke recovery with a novel and clinically validated therapy. Stroke impairment is one of the leading causes of serious long-term impairment for adults in the United States. While advances in acute stroke care over the past decade have significantly reduced mortality, innovation for chronic stroke recovery has lagged, resulting in a growing number of stroke survivors living with life-altering motor impairments. Conventional treatment consists of physical or occupational therapy, which is generally performed in the first three to six months following a stroke, after which it has very limited effectiveness. Thus, patients are left with few clinically proven options beyond that point. Our breakthrough Vivistim System addresses this unmet need and is the first and only FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. During Vivistim Therapy, intentional bursts of stimulation are delivered during functional movement to increase neuroplasticity and durably restore motor function. Vivistim Therapy has demonstrated efficacy and durability even years after a stroke, offering hope and meaningful recovery where none existed before. For example, clinical data demonstrated meaningful improvements in upper limb function. Based on published case studies involving patients that received Vivistim Therapy, improvements in upper limb function following Vivistim Therapy can further enable patients to perform activities of daily living, such as dressing independently, preparing meals, folding laundry, and eating (Saylor A, Patrick L, Reddy CG, Gandhi R., Vagus Nerve Stimulation Paired With Upper Extremity Rehabilitation for Chronic Stroke: Real-World Implementation and Outcomes. Arch Rehabil Res Clin Transl. (2026)). We believe this proven therapy helps restore quality of life and sets a new standard of care in chronic stroke recovery.

•Large and untapped market opportunity with significant unmet need. Stroke is a major health burden, with someone in the United States experiencing a stroke every 40 seconds. Ischemic stroke is a leading cause of serious long-term impairment for adults in the United States and has an estimated annual healthcare burden of more than $25 billion. Nearly two-thirds of stroke survivors are left with long-term disabilities including, but not limited to, impaired motor function, speech and language difficulties, and cognitive impairments that significantly impact quality of life. We estimate there are about 9 million ischemic stroke survivors in the United States, of which more than 4 million live with moderate to severe upper extremity impairment. This population falls within the current on-label indication for the Vivistim System. We believe that our initial market opportunity comprises approximately 1 million of those survivors, which we estimate represents an initial market opportunity of over $30 billion based on the average selling price of the Vivistim System. Since Vivistim Therapy is clinically proven to be effective regardless of time since stroke, eligible Vivistim System candidates include patients who have lived with chronic stroke-related impairments for many years, as well as recent stroke survivors. Based on a report published by the AHA in 2025, we estimate that each year approximately 200,000 new stroke survivors in the United States meet our indication for use, with 50,000 of these survivors representative of our initial market opportunity.

•Compelling body of clinical data demonstrating the significant and sustained benefits of Vivistim Therapy. We have built a robust body of clinical data demonstrating the safety, efficacy, durability, and well-understood mechanism of action of Vivistim Therapy and have additional studies ongoing and planned in 2026 and beyond. Our pivotal VNS-REHAB trial, a triple-blind, sham-controlled, randomized controlled trial (RCT), proved the efficacy and safety of Vivistim Therapy in ischemic stroke survivors with moderate to severe upper extremity impairment 9 months to 10 years after stroke. Published in The Lancet in 2021, this landmark trial showed an approximately two-times greater, as measured by FMA-UE, and approximately three-times greater, as measured by WMFT, improvement in hand and arm function compared to intensive rehabilitation alone, at the end of the in-clinic and at-home therapy protocol (Dawson, Jesse et al., Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial, The Lancet, Volume 397, Issue 10284, 1545-1553 (2021)). These findings have been reinforced by subsequent publications, including a 2024 publication in Neurorehabilitation and Neural Repair, which confirmed consistent

•Unique customer and patient dynamics to support a scalable commercial model. Our market development and patient engagement strategy is tailored to our unique patient and customer dynamics. Stroke survivors living with life-altering functional impairment can self-identify and are highly motivated to seek effective, long-lasting solutions. These patients are often supported by dedicated advocates who create a strong network of care and commitment. Our target customer base consists of a highly concentrated group of approximately 1,500 primary and comprehensive stroke centers in the United States. These centers treat a high proportion of the stroke survivor population. In addition, according to stroke claims data from Definitive Healthcare, approximately 70% of acute strokes are seen at 900 hospitals. Additionally, these stroke centers are typically surrounded by a network of therapy sites with neurorehabilitation capabilities, providing the infrastructure necessary for efficient implementation of Vivistim Therapy. This unique market concentration sets the foundation for an efficiently scalable commercial model.

•Favorable coding and payment dynamics with dedicated in-house market access team supporting patients and providers. The Vivistim System implantation procedure falls under a long-established Category 1 CPT code. Effective January 1, 2026, this CPT code was assigned to a New Technology APC by the CMS, establishing an elevated payment level that we believe will support sustainable access for Medicare beneficiaries. Medicare fee-for-service patients can typically access Vivistim Therapy when medically necessary, without prior authorization. Commercial insurance, Medicaid and Medicare Advantage generally require prior authorization. We believe we have implemented a highly effective process to guide patients from initial consultation through implantation of the Vivistim System. Our in-house market access team supports providers by facilitating administrative aspects of the prior authorization process, including assisting with documentation and submissions to payors in advance of implantation. Beyond individual case support, our market access team proactively works to influence payor coverage decisions by utilizing our robust clinical evidence, demonstrating economic value, and leveraging endorsements from key opinion leaders. This team is central to reducing friction across the patient journey and serves as a cornerstone of our strategy to expand payor coverage, which we believe will significantly increase patient market access of Vivistim Therapy.

•Expand our market development efforts to broaden awareness and access to Vivistim Therapy. Since our commercial launch, we have continuously developed and refined the optimal commercial model to support the adoption of Vivistim Therapy and have established a methodical approach to market development across the key stakeholders in stroke recovery. Through our comprehensive Vivistim Therapy program, we educate providers on how to identify, screen, refer and treat stroke survivors, and work closely with hospitals to incorporate Vivistim Therapy as a treatment option. We plan to build on this foundation of commercial learning to accelerate adoption nationwide by activating Vivistim Therapy initiatives at stroke centers and therapy sites while deepening engagement within existing accounts. To broaden geographic reach and drive penetration, we will strategically expand our commercial organization and territory coverage by adding highly qualified personnel. By scaling our skilled direct sales force, we believe we can significantly increase access to Vivistim Therapy and deliver meaningful impact to patients nationwide.

•Driving utilization of Vivistim Therapy by promoting awareness among patients, caregivers and healthcare providers. We have developed highly effective initiatives for generating a consistent funnel of Vivistim Therapy candidates from three primary sources: physician referrals, therapist referrals, and direct patient engagement. Stroke survivors interact with a diverse network of care providers, including stroke interventionalists, neurosurgeons, neurologists, physical medicine and rehabilitation physicians, occupational and physical therapists, stroke coordinators and nurses. Each of these providers can play a role in identifying and evaluating potential Vivistim Therapy candidates. We directly engage each of these stakeholders through our field-based commercial team, as well as through specialized events, summits, and conferences. In each geography, our teams also work to establish strong referral patterns between these providers to ensure that potential candidates can be efficiently evaluated and receive Vivistim Therapy. Additionally, since stroke survivors and their caregivers are a highly motivated population, we engage in direct patient education activities. These initiatives include patient webinars, outreach through support groups, digital advertising, and other targeted activities. We believe that as Vivistim Therapy awareness and utilization increases, stroke centers will naturally integrate Vivistim Therapy into standard care pathways for stroke survivors upon discharge and establish self-sustaining care programs that use Vivistim Therapy over time.

While advancements in acute stroke care have helped to significantly reduce the stroke mortality rate in the United States over time, effective therapeutic options for post-stroke recovery have not advanced, and there is no standard of care for motor recovery in the chronic stage of stroke. The standard of care for post-stroke recovery in the sub-acute phase consists of several weeks or months of conventional occupational or physical rehabilitation therapy, although many patients do not receive any rehabilitation therapy at all due to lack of access or motivation. While stroke patients can, and often do, make some physical and cognitive improvements during the acute and sub-acute phases when neuroplasticity is the highest, a substantial proportion of patients continue living with long-term motor impairments and associated complications. We believe there is limited data demonstrating the clinical efficacy of conventional rehabilitation therapy beyond the sub-acute phase, leaving many patients with chronic deficits in functionality (Grefkes, C. and Fink, G.R., Recovery from stroke: current concepts and future perspectives, Neurological Research and Practice, Volume 2, Number 17 (2020)). In addition, we believe conventional rehabilitation therapy has experienced limited adoption or continuation in the chronic phase. One study published in Stroke in 2023 concluded that the delivery rate of such therapy during the first year following a stroke is low and decreases over time, with 51% of patients receiving conventional occupational therapy during the first three months following a stroke and 21% of patients receiving such therapy during the three to six months following a stroke (Young, Bittany et al., Rehabilitation Therapy Doses Are Low After Stroke and Predicted by Clinical Factors, Stroke, Volume 54, Number 3, 831-839 (2023)). In the same study, approximately one third of stroke patients received no therapy in the year following a stroke. As such, we believe these patients have generally not had an effective therapeutic option for continued recovery.

Based on a report published by the AHA in 2025, we estimate that there are currently approximately 10 million stroke survivors in the United States. According to the AHA, approximately 87% of strokes are ischemic. This equates to approximately 9 million ischemic stroke survivors in the United States. Based on our analysis of third party publications, we estimate that more than 4 million of these survivors are chronic ischemic stroke survivors living with moderate to severe upper extremity impairment. For example, according to several third-party publications, up to two-thirds of stroke survivors continue to experience upper extremity disability at six months post-stroke (e.g., Lang CE, et al., Observation of amounts of movement practice provided during stroke rehabilitation, Arch Phys Med Rehabil. 2009 Oct;90(10):1692-8; and Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ., Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke, Stroke, Volume 34, Number 9, 2181-6 (2003), and approximately 81% of stroke survivors with upper extremity disability after six months post-stroke have moderate to severe upper extremity impairment (Woytowicz E, et al., Determining Levels of Upper Extremity Movement Impairment by Applying a Cluster Analysis to the Fugl-Meyer Assessment of the Upper Extremity in Chronic Stroke, Archives of Physical Medicine and Rehabilitation, 2016; 98, 456-462). We expect this large prevalence population to continue to grow over time, driven by, among others, increasing stroke survival rates due to improvements in acute thrombectomy therapies and increasing stroke incidence rates among young adults.

Based on our FDA-approved, on-label indication for the Vivistim System, we estimate that our total addressable market opportunity in the United States consists of the approximately 4 million chronic ischemic stroke survivors living with moderate to severe upper extremity impairment. While we are pursuing this total addressable market, we believe an initial market opportunity comprises stroke survivors that demonstrate the requisite overall health, cognition and motivation to participate in therapy and have received some amount of post-stroke therapy. According to the AHA, two-thirds of stroke survivors receive rehabilitation therapy following a stroke. This rate of therapy generally decreases over time, with one study published in Stroke in 2023 concluding that the rate of conventional occupational therapy decreases to 21% in the three to six months following a stroke (Young, Bittany et al., Rehabilitation Therapy Doses Are Low After Stroke and Predicted by Clinical Factors, Stroke, Volume 54, Number 3, 831-839 (2023)). Based on these patient factors and post-stroke therapy rates, we estimate that this initial market opportunity comprises approximately 1 million stroke survivors within our total addressable market. We believe this patient population represents an initial market opportunity of over $30 billion based on the average selling price of the Vivistim System.

During the sub-acute phase, patients may also explore other rehabilitation techniques including but not limited to: neurological rehabilitation therapy, which involves practicing everyday activities (e.g., cutting a banana or folding cloths); Constraint-Induced Movement therapy, which focuses on constraining the non-affected side from moving; and Mental Practice, where patients mentally rehearse a physical movement or task without actually performing it. Although alternative therapy delivery methods such as virtual reality or video games may be helpful for increasing the amount of movement practice a patient undergoes, there is limited and low-quality clinical evidence about their benefits. Assistive tools – such as splints, braces, muscle stimulators, have been used in conjunction with therapy and adaptive equipment (e.g., one handed kitchen tools), may also be used to help patients compensate for their impairments. Importantly, while these adjunctive therapies can help improve a patient’s ability to participate in therapy during the sub-acute phase, they have not been clinically proven to provide meaningful functional gains in the chronic phase.

Our breakthrough Vivistim System is the first and only FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. The Vivistim System facilitates Vivistim Therapy, which has been clinically proven to significantly improve upper limb function and help patients regain critical capabilities and independence. Vivistim Therapy leverages neuroplasticity – the ability of the nervous system to adapt and reorganize its connections – to improve upper limb function in patients with chronic stroke. The Vivistim System includes an implantable device that stimulates the vagus nerve only when intentionally activated, triggering the release of neuromodulators, including acetylcholine, norepinephrine, and serotonin. These neuromodulators create a heightened state of plasticity in the brain, such that neural networks can more readily adapt and reform in response to stimuli. When functional movements, such as goal- or task-oriented exercises and movements, are performed in the presence of these increased neuromodulators, the brain can create new neural connections and strengthen existing connections to a degree that would otherwise not be possible, enabling lasting improvements in motor pathways and creating greater potential for recovery. The image below provides an overview of the mechanism of action of Vivistim Therapy.

We have established a robust body of clinical evidence, including three randomized control trials, supporting the safety, efficacy, durability, and well-understood mechanism of action of Vivistim Therapy. The results of our VNS-REHAB trial, our pivotal, randomized, sham-controlled, triple blinded clinical trial, demonstrated an approximately two-times greater, as measured by FMA-UE, and approximately three-times greater, as measured by WMFT, improvement in hand and arm function compared to intensive rehabilitation alone, at the end of the in-clinic and at-home therapy protocol. The 1-year follow-up of this trial demonstrated that these functional gains were maintained long-term. These results, which were first published in The Lancet in 2021, served as the basis for the Premarket Approval (PMA) of Vivistim Therapy in August 2021. The results are further supported by our previous feasibility trial and our pilot trial, which demonstrated a high response rate and meaningful improvement in upper extremity mobility without any significant safety concerns related to Vivistim Therapy. In addition, the pilot trial demonstrated sustained benefits of Vivistim Therapy for up to 3 years. Our body of clinical evidence includes over 20 peer-reviewed clinical publications on the safety, effectiveness, and durability of Vivistim Therapy, as well as the mechanism of action of paired vagus nerve stimulation, most of which were co-authored by our clinical and scientific teams.

Clinic. Based on research published in Physical Therapy, a peer reviewed medical journal and the official scientific journal of the American Physical Therapist Association, which showed that a 5.25-point improvement was associated with an excellent improvement (greater than 50% improvement) in arm function. In our VNS-REHAB trial, we defined a clinically meaningful response as a 6-point or greater improvement in FMA-UE score. In addition, p-values from the trial are an indication of statistical significance reflecting the probability of an observation occurring due to chance alone. A clinical trial result is statistically significant if it is unlikely to have occurred by chance, and the statistical significance of clinical trial results is determined by a widely used statistical method that establishes the p-value of the results. Under this method, a p-value of p<0.05 or less typically represents a 95% probability that the results did not occur by chance alone, and are generally considered statistically significant results. For purposes of the trial results, a clinically meaningful response is intended to represent an improvement in function, as measured by change in FMA-UE score, that would be clinically important and meaningful to people living with stroke, and a statistically significant result indicates that such improvement or other outcome measurement is likely due to the Vivistim Therapy as opposed to chance.

The results of the VNS-REHAB trial, published in April 2021 in The Lancet, showed statistically significant and clinically meaningful improvements for the Vivistim Therapy group versus the control group on the primary and all secondary outcome measures (Dawson, Jesse et al., Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial, The Lancet, Volume 397, Issue 10284, 1545-1553 (2021)). For the primary efficacy outcome measurement of change in FMA-UE score at First Day Post In-Clinic Therapy, the mean FMA-UE score increased by 5.0 points in the Vivistim Therapy group compared to 2.4 points in the control group (p=0.0014), demonstrating an approximate two times greater improvement. For the secondary outcome measurements of change in each of FMA-UE score and WMFT functional score at Day 90 Post In-Clinic Therapy, the mean FMA-UE score increased 5.8 points in the Vivistim Therapy group compared to 2.8 points in the control group (p=0.0077), demonstrating an approximate two times greater improvement, and the mean WMFT functional score increased by 0.46 points in the Vivistim Therapy group compared to 0.16 points in the control group (p<0.0001), demonstrating an approximate three times greater improvement. A clinically meaningful response on the FMA-UE score at Day 90 Post In-Clinic Therapy occurred in the Vivistim Therapy group at approximately twice the rate of the control group, with 47% of participants achieving this response in the Vivistim Therapy group compared to 24% in the control group (p=0.0098), based on a rigorous response threshold of greater than 6-point improvement in FMA-UE. A clinically meaningful response on the WMFT functional score at Day 90 Post-In-Clinic Therapy was also observed, with 57% of participants achieving this response in the Vivistim Therapy group compared to 22% in the control group (p<0.0001). The results were consistent across participant subgroups and characteristics, demonstrating efficacy independent of time since stroke as well as age, ethnicity and gender.

The long-term results from our VNS-REHAB trial, which were published in May 2025 in Stroke, support the long-term effectiveness of Vivistim Therapy (Kimberley, Teresa et al., Long-Term Outcomes of Vagus Nerve Stimulation Paired With Upper Extremity Rehabilitation After Stroke, Stroke, Volume 56, Number 8, 2255-2265 (2025)). One-year follow-up data were available for 74 of the original 108 participants in the VNS-REHAB trial. This data demonstrated that FMA-UE scores were maintained for at least one year following the completion of in-clinic therapy, with a mean FMA-UE score increase of 5.23 from baseline. The WMFT functional score increased by a mean of 0.5 from baseline at one year, indicating that improvements in WMFT functional scores were maintained to at least one year. Side of stroke, age, time since stroke, and sex did not significantly impact FMA-UE or WMFT outcomes at one year. Overall, 66% of participants achieved a response to Vivistim Therapy as measured by increase in either FMA-UE or WMFT score. Serious events were reported in four participants after the blinded phase and before one-year follow-up (three in the Vivistim Therapy group and one in the control group), none of which were related to the therapy or stimulation.

The study has two distinct stages. In the first stage, participants receive 36 hours of therapist-directed in-home therapy over 18 weeks, with two or more visits per week. On days without therapist-led sessions, participants will complete in-home exercises and functional activities on their own with self-activated Vivistim Therapy. In the second stage, following the initial 18-week period, participants continue to perform therapist-prescribed functional tasks at home with self-activated Vivistim Therapy for a follow-up period of up to two years. Enrollment has ended and we expect that approximately 25 patients will be implanted and provide data for final analysis. Initial results from the first 11 participants enrolled indicate that Vivistim Therapy initially implemented in the home environment is safe and effective and that participants can achieve high levels of compliance. Participants experienced a mean improvement in FMA-UE score of 7.0 points from baseline after 36 hours of therapist-directed in-home Vivistim Therapy. No serious adverse events occurred that were due to Vivistim Therapy.

•A preclinical study published in 2018 in Stroke documented the use of paired vagus nerve stimulation to promote generalization, long-lasting recovery, and structural plasticity in motor networks in rats administered with ischemic lesions (Meyers, Eric et al., Vagus Nerve Stimulation Enhances Stable Plasticity and Generalization of Stroke Recovery, Stroke, Volume 49, Number 3, 710–717 (2018)). In the study, rats receiving vagus nerve stimulation paired with a trained behavioral task demonstrated better rehabilitative training with long-lasting recovery. The study noted that it provided some of the first evidence that vagus nerve stimulation paired with rehabilitative training after stroke can improve long-lasting recovery on a complex task, improve recovery on a simple motor task as compared to the same task without vagus nerve stimulation, and enhance structural plasticity in motor networks. We believe this study represents evidence of vagus nerve stimulation-directed plasticity as a potential treatment pathway. We did not provide support for this study but one of the authors was a consultant and shareholder of our company at the time of publication. This study did not use the Vivistim System.

Our commercial efforts are currently focused on primary and comprehensive stroke centers, which are hospitals that have cross-functional teams with the capabilities to treat acute stroke at the highest level of care and in compliance with AHA guidelines. These centers see significant volumes of acute stroke patients and are typically surrounded by a network of therapy sites with neurorehabilitation capabilities, providing the infrastructure necessary for efficient implementation of Vivistim Therapy. We work with these stroke centers to establish Vivistim Therapy as a treatment option for stroke survivors. Over time, we believe these centers will naturally integrate Vivistim Therapy into standard care pathways for stroke survivors upon discharge and establish self-sustaining care programs that use Vivistim Therapy. According to data from the stroke center accreditation organizations, there were approximately 1,500 primary and comprehensive stroke centers in the United States as of December 2025. In addition, according to stroke claims data from Definitive Healthcare, approximately 70% of acute strokes in the United States are seen at 900 hospitals.

We have developed marketing programs to promote awareness of Vivistim Therapy among patients, caregivers and healthcare providers. Stroke survivors and their families interact with a diverse network of care providers, including stroke interventionalists, neurosurgeons, neurologists, physical medicine and rehabilitation physicians, occupational and physical therapists, stroke coordinators and nurses. Each of these providers can play a role in identifying and evaluating potential Vivistim Therapy candidates, and we directly engage each of these stakeholders through our direct sales force and awareness events, which include webinars for stroke survivors or healthcare professionals, therapy education summits targeted at healthcare professionals involved in chronic stroke care, and physician conferences and society meetings. We also educate neurologists and physical medicine and rehabilitation physicians in private practices and hospitals. In select territories, we also conduct targeted direct-to-patient digital advertising. We have also established a patient education team to assist prospective patients in learning about the therapy and connect them with relevant providers for further evaluation. These efforts are designed to establish and maintain a consistent funnel of chronic stroke patients who may seek a Vivistim System implant at one of our established centers.

We sell the Vivistim System and its accessories to customers, primarily to stroke hospitals, in the United States. These customers in turn bill third-party payors for the cost required to treat each patient. Our device is treated as a general supply utilized in the implantation procedure and, if covered by third-party payors, is paid for as part of such procedure. The Vivistim System is typically implanted in the hospital outpatient setting, and all items and services paid under the Medicare hospital outpatient prospective payment system (OPPS) are assigned to payment groups called Ambulatory Payment Classifications (APCs), which group together items and services that are similar clinically and in terms of resource use. Effective January 1, 2026, CPT code 64568 is assigned to New Technology APC 1580 with a national average facility payment under OPPS of $45,000. Reimbursement for professional services performed by physicians are reported using CPT codes and based on a different payment methodology. Implantation of the Vivistim System falls under CPT Code 64568 (Incision for implantation of a cranial nerve (e.g., vagus) neurostimulator electrode array and pulse generator). Under the 2026 Medicare Physician Fee Schedule (MPFS), the national average physician payment is $663. Occupational or physical therapy services provided to patients using the Vivistim System are billed by therapy providers using standard therapy codes.

Coverage for Vivistim Therapy varies by payor. Because there are currently no national coverage determinations issued by the CMS or local coverage determinations by Medicare administrative contractors specific to Vivistim Therapy, coverage determinations are made on a case-by-case basis under medical necessity standards, without the need for prior authorization. Medicaid programs are funded by both federal and state governments, and coverage and reimbursement policies vary from state to state and from year to year. Effective July 1, 2023, the New York State Medicaid fee-for-service program covers FDA-cleared vagus nerve stimulator devices used for stroke therapy in conjunction with rehabilitation to recover function in hands and arms after an ischemic stroke. Currently, most commercial insurers have determined that Vivistim Therapy is experimental or investigational and therefore, not covered. Patients with commercial insurance, Medicaid, or Medicare Advantage generally require prior authorization. Our in-house market access team assists patients and providers throughout the prior authorization process, from preparing required documentation, submitting approval requests, and managing appeals when needed. Although the prior authorization process can take several weeks, based on our experience to date, we are confident that our support can help lead to prior authorization approvals for many patients. As part of our longer term strategy, our market access team will continue to engage with payors to communicate clinical and health economic data which may impact coverage policies. We believe that expanded payor coverage will facilitate broader patient access to Vivistim Therapy.

We entered into supply agreements with Integer Holdings Corporation (Integer), pursuant to which Integer agreed to manufacture our IPG component for us. Our first supply agreement with Integer provides that we may order from Integer on a non-exclusive, purchase order basis with no minimum purchase requirements. The agreement includes, among other provisions, customary representations and warranties by the parties, ordering and payment and shipping terms, customary provisions with respect to the ownership of any intellectual property and customary confidentiality provisions. The agreement continues until termination by the parties. Either party may terminate the agreement upon written notice in the event of a material breach that is not cured within 30 days of the other party’s written notice of such breach; upon bankruptcy, insolvency or reorganization that has not been dismissed within 30 days after commencement; or in the event that the other party commits a crime, intentionally imparts material information or misappropriates intellectual property. In addition, we may terminate the agreement if Integer fails to meet our specifications or is unable to manufacture products, or for our convenience if we are current in our payment obligations to Integer.

To further support our anticipated growth and IPG supply needs, we also entered into a second supply agreement (the IPG Supply Agreement), effective September 24, 2024, with Greatbatch Ltd., a subsidiary of Integer. The IPG Supply Agreement contains, among other provisions, customary representations and warranties by the parties, ordering and payment and shipping terms, customary provisions with respect to the ownership of any intellectual property created during the term of the IPG Supply Agreement, certain indemnification rights in favor of both parties, limitations of liability and customary confidentiality provisions, and minimum purchase requirements. The minimum purchase requirements are expected to commence in 2028. Under the minimum purchase requirements, we are obligated to purchase a high double-digit fixed percentage of our IPG supply requirements from Integer and must purchase a minimum number of IPGs from Integer per year. The aggregate minimum purchase obligation for the initial five-year period is approximately $5.8 million. The IPG Supply Agreement has an initial five-year term commencing upon the first commercial shipment of product, and will automatically renew for

Intellectual property, including patents, trade secrets, trademarks and copyrights, is important to our business. Our commercial success depends in part on our ability to obtain and maintain proprietary intellectual property protection for our current products as well as for future products, product development technologies, and know-how. Our commercial success also depends in part on our ability to operate without infringing the proprietary rights of others and to prevent others from infringing our proprietary rights. We seek to maintain our proprietary position by, among other means, filing United States and foreign patent applications to obtain issued patents with claims directed to our products, products in development, technology, inventions, and improvements that are important to the development and implementation of our business. We may also license from third parties certain patent rights and proprietary know-how that we believe to be necessary or useful to our business. Additionally, we protect our proprietary know-how that may not be patentable, and other confidential information, by maintaining and implementing appropriate policies and procedures with respect to secrecy and confidentiality. We are currently

As of December 31, 2025, our exclusively licensed patent estate from UT contained 1 patent family comprising 12 issued U.S. patents, 13 issued foreign patents, 1 pending U.S. non-provisional patent application and 1 pending foreign patent application. These patents and patent applications relate to various aspects of the current Vivistim Therapy and primarily consist of method patents. The issued U.S. patents are expected to expire between 2029 and 2032, after accounting for potentially available patent term adjustments or extensions and term-limiting effects of terminal disclaimers, and assuming payment of appropriate maintenance, renewal, annuity and other governmental fees. Any patents that may issue from the pending U.S. patent applications are expected to expire in 2029, without accounting for potentially available patent term adjustments or extensions, term-limiting effects of terminal disclaimers and assuming payment of appropriate maintenance, renewal, annuity and other governmental fees. The issued foreign patents include one or more issued patents in jurisdictions such as Germany and the United Kingdom, and are expected to expire between 2029 and 2041, without accounting for potentially available patent term extensions and assuming payment of appropriate maintenance, renewal, annuity and other governmental fees. The pending foreign patent applications include one or more applications filed with the European Patent Office, and are expected to expire in 2029, without accounting for potentially available patent term adjustments or extensions and assuming payment of appropriate maintenance, renewal, annuity and other governmental fees.

Country

Status (Issued or Pending)

Application No.

Patent No.

Estimated Expiration

Types (Devices, Methods or Devices and Methods)

Related Technology

Owner (Mobia, University of Texas at Dallas (UT) or jointly between Mobia and UT)

Issued

12/485,040

9089707

6/15/2029

Method

Motor Deficit

Issued

13/651,349

8700145

6/15/2029

Method

Motor Deficit

Issued

14/252,727

9522272

6/15/2029

Method & Devices

Motor Deficit

Issued

14/538,400

9522273

6/15/2029

Method

Motor Deficit

Issued

14/538,421

9474904

6/15/2029

Method

Motor Deficit

Issued

14/538,457

9504831

6/15/2029

Method

Motor Deficit

Issued

14/550,286

9522274

1/17/2032

Method

Motor Deficit

Issued

14/550,357

9533152

6/15/2029

Method

Motor Deficit

Issued

14/560,735

9333355

6/15/2029

Device

Motor Deficit

Issued

15/382,970

11638824

6/15/2029

Method

Motor Deficit

Issued

15/496,766

11116933

6/15/2029

Method

Motor Deficit

Issued

18/310,935

12151104

6/15/2029

Method

Motor Deficit

Pending

18/959,959

Method

Motor Deficit

EPO

Issued

12778023.7

2766089

10/12/2032

Devices

Motor Deficit

UT & Mobia

EPO

Issued

19192580.9

3593856

10/12/2032

Devices

Motor Deficit

UT & Mobia

EPO

Issued

21214444.8

4032583

10/12/2032

Devices

Motor Deficit

UT & Mobia

EPO

Pending

25186521.8

Devices

Motor Deficit

UT & Mobia

Issued

DE112009001024.5T

DE112009001024

7/1/2029

Devices

Motor Deficit

UT & Mobia

Issued

12778023.7

2766089

10/12/2032

Devices

Motor Deficit

UT & Mobia

Issued

19192580.9

3593856

12/12/2032

Devices

Motor Deficit

UT & Mobia

Issued

21214444.8

4032583

10/12/2032

Devices

Motor Deficit

UT & Mobia

Issued

12778023.7

2766089

10/12/2032

Devices

Motor Deficit

UT & Mobia

Issued

19192580.9

3593856

10/12/2032

Devices

Motor Deficit

UT & Mobia

Issued

21214444.8

4032583

10/12/2032

Devices

Motor Deficit

UT & Mobia

AUS

Issued

2009267051

6/30/2029

Devices

Motor Deficit

UT & Mobia

Issued

16/018,975

11167130

1/2/2039

Devices

Cuff

Mobia

Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a premarket notification submitted under Section 510(k) of the FDCA, approval of a premarket approval application, or PMA, or classification under the de novo classification process. Under the FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation, or QSR (and once it goes into effect in 2026, the Quality Management System Regulation, or QMSR, which amended the QSR), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA’s General Controls, and special controls as deemed

Class III devices require PMA approval before they can be marketed, although some pre-amendment Class III devices for which FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process. In a PMA, the manufacturer must demonstrate that the device is safe and effective, and the PMA must be supported by extensive data, including data from preclinical studies and human clinical trials. The PMA must also contain a full description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing, and proposed labeling. Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a substantive review. If FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA, although in practice, the FDA’s review often takes significantly longer, and can take up to several years. An advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally conduct a pre-approval inspection of the applicant or its third-

The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s). The FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements to conduct additional clinical studies post-approval. The FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of the approval.

Under FDASIA, FDA is required to classify the device within 120 days following receipt of the de novo request, although the process may take significantly longer. If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device. If FDA grants the de novo request, the device may be legally marketed in the United States. However, the FDA may reject the request if the FDA identifies a legally marketed predicate device that would be appropriate for a 510(k) notification, determines that the device is not low-to-moderate risk, or determines that General Controls would be inadequate to control the risks and/or special controls cannot be developed. After a device receives de novo classification, any modification that could significantly affect its safety or efficacy, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, another de novo request or even PMA approval.

must be conducted in accordance with the FDA’s investigational device exemption, or IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. If the device under evaluation does not present a significant risk to human health, then the device sponsor is not required to submit an IDE application to the FDA before initiating human clinical trials, but must still comply with abbreviated IDE requirements when conducting such trials. A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject. An IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval.

Regardless of the degree of risk presented by the medical device, clinical studies must be approved by, and conducted under the oversight of, an Institutional Review Board, or IRB, for each clinical site. The IRB is responsible for the initial and continuing review of the IDE, and may impose additional requirements for the conduct of the study. If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and complying with labeling and record-keeping requirements. In some cases, an IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.

Following passage of the 21st Century Cures Act, the FDA implemented the Breakthrough Devices Program, which is a voluntary program offered to manufacturers of certain medical devices and device-led combination products that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and health care providers with more timely access to qualifying devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA approval, 510(k) clearance, and de novo classification. The program is available for medical devices that meet certain eligibility criteria, including that the device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and that: (i) the device represents a breakthrough technology, (ii) no approved or cleared alternatives exist, (iii) the device offers significant advantages over existing approved or cleared alternatives, or (iv) the availability of the device is in the best interest of patients. Breakthrough Device Designation provides certain benefits to device developers, including more interactive and timely communications with FDA staff; use of post-market data collection, when scientifically appropriate, to facilitate expedited and efficient development and review of the device; opportunities for more efficient and flexible clinical study design; and prioritized review of premarket submissions. When reviewing Breakthrough Device

Manufacturing processes for medical devices are required to comply with the applicable portions of the QSR (and once it goes into effect, the QMSR), which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QSR and QMSR also require, among other things, maintenance of a device master file, device history file, and complaint files. Manufacturers are subject to periodic scheduled and unscheduled inspections by the FDA. Failure to maintain compliance with the QSR and, once in effect, the QMSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of marketed products. The discovery of previously unknown problems with any marketed products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or approval, or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

Richard Foust has served as a member of our board of directors and as our Chief Executive Officer since January 2022 and has served as our President and Chief Executive Officer since October 2025. Mr. Foust co-founded 3D Strategy Consulting, LLC, a healthcare consulting services company, and has served as its Chief Executive Officer since February 2015. Mr. Foust previously served as the Chief Commercial Officer at Velano Vascular, Inc., a medical device company, from November 2018 to November 2020, and as the Chief Business Officer at Analyte Health, Inc., a digital health company, from May 2015 to February 2018. Mr. Foust also had escalating roles at Abbott Vascular, Inc., including Senior Director, West Area Endovascular Sales and Senior Director, Endovascular Global Marketing & Bioresorbable Vascular Scaffold. Mr. Foust received a B.S. in Applied Physics from Emory University and an M.S. in Mechanical Engineering with a major in Bioengineering from Georgia Institute of Technology. We believe that Mr. Foust is qualified to serve on our board of directors due to his experience as our President and Chief Executive Officer, and due to his leadership and extensive business experience in the medical device industry.

Chase Leavitt has served as our General Counsel and Corporate Secretary since February 2026. Previously, Mr. Leavitt served as General Counsel and Corporate Secretary of Oncternal Therapeutics, Inc., a publicly traded biotechnology company, from April 2021 to June 2025. Mr. Leavitt also served as General Counsel and Corporate Secretary of Lineage Cell Therapeutics, Inc. (NYSE: LCTX), a publicly traded biotechnology company, from May 2019 to April 2021. Mr. Leavitt previously served as Vice President of Legal Affairs of Tang Capital Management, LLC, a life sciences-focused investment company, and its affiliate Odonate Therapeutics, Inc., a publicly traded pharmaceutical company, from June 2018 to May 2019. Mr. Leavitt had escalating roles at Switch, Inc., a technology company, from 2014 to 2018, most recently as Deputy General Counsel through the company’s initial public offering. Mr. Leavitt was a corporate attorney at Latham & Watkins LLP from 2007 to 2014. Mr. Leavitt received a B.S. in Business Administration and a J.D. from the University of Southern California and is admitted to practice law in the States of California, Washington, and Texas.

Dana G. Mead, Jr. has served as a member of our board of directors since October 2024 and as the Chair of our board of directors since November 2025. In addition to serving on our board of directors, Mr. Mead has served on the board of directors of Pulmonx Corporation (Nasdaq: LUNG), a commercial-stage medical technology company, since 2010 and as the Chair of its board since 2019, where he also serves on its audit committee. Mr. Mead has also served on the boards of directors of Inspire Medical Systems, Inc. (NYSE: INSP), a medical technology company, since 2008, where he serves on its audit committee and quality, product supply, and technology committee, Cerapedics Inc., a global orthobiologics company, since March 2023, and Calyxo, Inc., a medical device company, since October 2025. Mr. Mead was previously the Chief Executive Officer, President and director of HeartFlow, Inc. (Nasdaq: HTFL), a medical technology company, from May 2019 to February 2021. From November 2016 to May 2019, Mr. Mead served as President and Chief Executive Officer of Beaver-Visitec International, Inc., a surgical device developer and manufacturer. Mr. Mead received a B.A. from Lafayette College and an M.B.A. from the University of Southern California. We believe that Mr. Mead is qualified to serve as a member of our board of directors because of his service on other medical technology company boards, his broad experience in the healthcare industry and the historical knowledge and continuity he brings to our board of directors.

Casey Tansey has served as a member of our board of directors since June 2022. Since 2005, he has served as a General Partner of U.S. Venture Partners, a venture capital firm. From 2001 until 2004, Mr. Tansey served as the Chief Executive Officer and President of Epicor Medical, Inc., a medical device company. Prior to Epicor Medical, Mr. Tansey was Chief Executive Officer and President of Heartport, Inc., a medical device company, which is now part of the Johnson & Johnson family of companies. Prior to that, he was with the cardiovascular division at Baxter Edwards, a medical technology company, for nearly ten years, holding various sales and marketing positions. Mr. Tansey currently serves on the boards of directors of Inspire Medical Systems, Inc. (NYSE: INSP), a medical technology company, where he also serves on its compensation committee, HeartFlow, Inc. (Nasdaq: HTFL), a commercial-stage medical technology company, and Shoulder Innovations (NYSE: SI), a commercial-stage medical technology company. He also serves on the board of directors for a number of U.S. Venture Partners’ portfolio of private companies. Mr. Tansey received a B.S. and an M.B.A. from the Notre Dame de Namur University. We

Cynthia Lucchese has served as a member of our board of directors since April 2024. Ms. Lucchese served as the Chief Strategy Officer of Penske Entertainment Corp., a subsidiary of Penske Corporation, from November 2020 to February 2023, and as the Chief Administrative Officer and Chief Financial Officer of Hulman & Company (acquired by Penske Corporation) from November 2014 to November 2020. Prior to this she was the Senior Vice President and Chief Financial Officer of Hillenbrand, Inc. (NYSE: HI), a company with multiple brands that serve a range of industries across the globe, from 2008 to 2014. She also served as the Senior Vice President and Chief Financial Officer of Thoratec Corporation, a medical device company, from 2005 to 2007, and she held various senior financial positions with Guidant Corporation, a formerly public medical device company, from 1994 to 2005. Since October 2022, Ms. Lucchese has also served on the board of directors of The Cooper Companies, Inc. (Nasdaq: COO), a global medical device and healthcare company, where she currently serves as the chair of the corporate governance and nominating committee and a member of the organization and compensation committee. Ms. Lucchese previously served on the boards of directors of Inari Medical, Inc., a formerly public medical device company, from November 2019 to February 2025, where she served as the chair of its nominating & corporate governance committee and its audit committee; Hanger, Inc., a formerly public medical device and services company, from 2015 to October 2022, where she served on its audit and compensation committees; Intersect ENT, Inc., a formerly public medical device company, from 2014 to May 2022, where she served as the chair of its audit committee and a member of its nominating & corporate governance committee; and Brightpoint, Inc., a formerly public company, from 2009 to 2012, where she was the chair of its audit committee and a member of its nominating & corporate governance committee. She also served on the Board of Trustees of Indiana University from December 2021 to June 2025, where she served as vice chair of the board and chair of the finance and audit committee. Ms. Lucchese received a B.S. in accounting and an M.B.A. from Indiana University, Kelley School of Business. We believe Ms. Lucchese is qualified to serve as a member of our board of directors because of her extensive experience as a board member of public companies and experience with the medical device industry.

Maxwell Bikoff has served as a member of our board of directors since March 2025. Mr. Bikoff is a managing director at Longitude Capital, which he joined in 2016, focusing on investments in medical technologies and solutions. Mr. Bikoff served on the board of directors of Kestra Medical Technologies (Nasdaq: KMTS), a commercial-stage, wearable medical device and digital healthcare company, from July 2024 to September 2025, and has served on the board of directors of Polares Medical, a clinical-stage medical device company, since June 2020. Mr. Bikoff previously served as a board observer at Amphora Medical (which has since been acquired), Bolt Medical (which has since been acquired), Ceribell (Nasdaq: CBLL), Eargo (a formerly public medical device company), Endogenex, FIRE1, LimFlow (which has since been acquired), Nalu Medical, and RxSight (Nasdaq: RXST). He was actively involved in Longitude’s investments in Axonics Modulation Technologies (Nasdaq: AXNX) and PROCEPT BioRobotics (Nasdaq: PRCT). Mr. Bikoff held a series of strategy, finance, and operating roles at Cardinal Health from 2010 to 2016, including director of Marketing, North America for a portfolio of cardiovascular devices from 2014 to 2016. Mr. Bikoff began his career in Deloitte Consulting’s Life Sciences Strategy practice and received a B.S.E. in Biomedical Engineering from Duke University. We believe Mr. Bikoff is qualified to serve as a member of our board of directors based on his background in biomedical engineering and prior experience as a member of the boards of directors of a number of healthcare companies.

Our board of directors has determined that Mr. Bikoff, Mr. Hanlon, Dr. Harrington, Ms. Lucchese, Mr. Mead and Mr. Tansey qualify as “independent” directors in accordance with the listing rules (the Listing Rules) of Nasdaq. Mr. Foust, Mr. Thomas Jordan Curnes II and Mr. Nelson Bunker Curnes are not considered independent by virtue of their positions as president and chief executive officer, co-founder, and chief financial officer, respectively. Under the Listing Rules, the definition of independence includes a series of objective tests, such as that the director is not, and has not been for at least three years, one of our employees and that neither the director nor any of his or her family members has engaged in various types of business dealings with us. In addition, as required by the Listing Rules, our board of directors has made a subjective determination as to each independent director that no relationship exists that, in the opinion of our board of directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In making these determinations, our board of directors reviewed and discussed information provided by the directors and us with regard to each director’s business and personal activities and relationships as they may relate to us and our management. Each of Mr. Thomas Jordan Curnes II, Mr. Nelson Bunker Curnes and Mr. Hanlon expects to resign from our board of directors prior to the closing of this offering. As a result, following this offering we expect that five of our six directors will be “independent” directors in accordance with the Listing Rules.

Our board of directors does not have a standing risk management committee, but rather administers this oversight function directly through our board of directors as a whole, as well as through various standing committees of our board of directors that address risks inherent in their respective areas of oversight. While our board of directors is responsible for monitoring and assessing strategic risk exposure, our audit committee is responsible for overseeing company-wide and information security risk assessment processes, our major financial risk exposures, regulatory compliance, and the steps our management has taken to monitor and control these risks and exposures. The audit committee then reviews these matters with the full board of directors as part of the audit committee’s reports at regular board meetings. The audit committee also approves or disapproves any related-party transactions. Our nominating and corporate governance committee monitors the effectiveness of our corporate governance guidelines and risks related to environmental, social, and governance issues and oversees management succession planning. Our compensation committee assesses and monitors whether any of our compensation policies and programs has the potential to encourage excessive risk-taking.

Prior to this offering, we granted stock options pursuant to our 2022 Equity Incentive Plan (the 2022 Plan) which was the successor to our Third Amended and Restated 2007 Stock Option Plan (the 2007 Plan and, collectively with our 2022 Plan, the Prior Plans). Certain of Mr. Foust’s outstanding stock options granted in December 2021 were granted pursuant to the 2007 Plan, and all other outstanding stock options held by our named executive officers were granted pursuant to the 2022 Plan. Following this offering, we plan to grant equity-based incentive awards under the terms of the 2026 Plan to be adopted in connection with this offering. The terms of our Prior Plans and the 2026 Plan are described in the subsection titled “—Equity Incentive Plans” below. All options are granted with an exercise price per share that is no less than the fair market value of our common stock on the date of grant of such award as determined by our board of directors based on an independent third-party valuation. Our stock option grants generally vest over a four-year period and may be subject to acceleration of vesting and exercisability under certain termination and change in control events. From time to time, our board of directors may also construct alternate vesting schedules as it determines are appropriate to motivate particular employees.

On each of March 27, 2025, April 25, 2025 and October 17, 2025, we granted Mr. Foust options to purchase 1,356,366, 222,634 and 584,128 shares of our common stock, respectively, with an exercise price of $1.07, $1.07 and $1.13, respectively, the fair market value on the date of grant as determined by our board of directors based on an independent third-party valuation. Except for the options granted to Mr. Foust in April 2025, the options vest as to 25% of the options on the first anniversary of the vesting commencement date and as to 1/48th of the options on each monthly anniversary of the vesting commencement date thereafter for 36 months, subject to Mr. Foust’s continuous service with us as of each such vesting date. Our board of directors determined that applicable corporate objectives in fiscal year 2025 were met, and accordingly the options granted in April 2025 vest as to 25% of the options on the first anniversary of the vesting commencement date and in respect of 1/48th of the total number of options on each monthly anniversary of the vesting commencement date thereafter for 36 months, subject to Mr. Foust’s continuous service with us as of each such vesting date. The performance-based corporate objectives for Mr. Foust’s options are the same as described above in the subsection titled “—Narrative to Summary Compensation Table—Cash Incentive Compensation” for our annual 2025 bonus program.

On each of March 27, 2025, April 25, 2025 and October 17, 2025, we granted Mr. Ellison options to purchase 419,991, 49,474 and 118,554 shares of our common stock, with an exercise price of $1.07, $1.07 and $1.13, respectively, the fair market value on the date of grant as determined by our board of directors based on an independent third-party valuation. Except for the options granted to Mr. Ellison in April 2025, the options vest as to 25% of the options on the first anniversary of the vesting commencement date and as to 1/48th of the options on each monthly anniversary of the vesting commencement date thereafter for 36 months, subject to Mr. Ellison’s continuous service with us as of each such vesting date. Based on our exceeding a held reorder and revenue target equal to $28,100,000 in fiscal year 2025, the options granted in April 2025 vest as to 25% of the options on the first anniversary of the vesting commencement date and in respect of 1/48th of the total number of options on each monthly anniversary of the vesting commencement date thereafter for 36 months, subject to Mr. Ellison’s continuous service with us as of each such vesting date.

In connection with this offering, we will also grant stock options and restricted stock units (“RSUs”) on the date on which this registration statement becomes effective to our non-executive employees with an aggregate grant value of $ and $ , respectively. The number of options granted will be the quotient obtained by dividing (a) the applicable grant value by (b) 55% of the initial public offering price in this offering, with the resulting number of options rounded up to the nearest 10 shares. These stock options will vest as to 25% of the stock options on the first anniversary of the grant date, with the remaining stock options vesting in 36 equal monthly installments thereafter, in each case, subject to the employee’s continued service through the applicable vesting date. The number of RSUs granted will be the quotient obtained by dividing (a) the applicable grant value by (b) the initial public offering price in this offering, with the resulting number of RSUs rounded up to the nearest 10 shares. These RSUs will vest as to 25% of the RSUs on the first four anniversaries of the grant date, subject to the employee’s continued service through the applicable vesting date.

Upon the effectiveness of the Restated Employment Agreements, each of our named executive officers will be entitled to the base salary and annual bonus targets (and, for Mr. Ellison, sales incentive targets) as described above in the sections titled “—Elements of Our Executive Compensation Program—Base Salaries” and “—Elements of Our Executive Compensation Program—Cash Incentive Compensation.” Mr. Foust’s Restated Employment Agreement provides that, in the event of a Corporate Transaction (as defined below) any then unvested stock options held by Mr. Foust that were granted prior to the consummation of this offering will become fully vested immediately prior to the consummation of such Corporate Transaction. Mr. Foust’s Restated Employment Agreement also provides that, upon termination of Mr. Foust’s employment by us under circumstances giving rise to severance under the Executive and Key Employee Severance Plan, in addition to the severance benefits thereunder, Mr. Foust will be entitled to accelerated vesting of any then-unvested portion of outstanding equity grants by 12 months from the date of termination.

•“Cause” means, unless otherwise defined in a Covered Employee’s participation agreement, any of the following: (i) the Covered Employee’s commission of an act of fraud, embezzlement or dishonesty, or the commission of some other illegal act by you, that has a demonstrable adverse impact on the Company or any successor or affiliate thereof; (ii) the Covered Employee’s conviction of, or plea of “guilty” or “no contest” to, a felony or any crime involving fraud, dishonesty or moral turpitude under the laws of the United States or any state thereof (other than traffic violations or other insignificant infractions of law that do not affect the performance of the Covered Employee’s duties to the Company); (iii) any intentional, unauthorized use or disclosure by the Covered Employee of confidential information or trade secrets of the Company or any successor or affiliate thereof; (iv) the Covered Employee’s gross negligence, insubordination or material violation of any duty of loyalty to the Company or any successor or affiliate thereof, or any other demonstrable material misconduct on the Covered Employee’s part; (v) the Covered Employee’s ongoing and intentional failure or refusal to substantially perform the Covered Employee’s assigned duties or employment obligations (other than as a result of a cause or event outside of the Covered Employee’s control) or the Covered Employee’s ongoing and repeated failure or refusal to comply with the lawful instructions given to the Covered Employee by our Chief Executive Officer or, with respect to the Chief Executive Officer, our board of directors, which failure, refusal or neglect continues for 30 days following the Covered Employee’s receipt of written notice from our board of directors stating with specificity the nature of such failure, refusal or neglect; or (vi) the Covered Employee’s willful, material breach of any written Company policy applicable to the Covered Employee or any material provision of any offer or employment letter or any confidential information agreement, proprietary information and inventions agreement to which the Covered Employee is a party;

“Good Reason” means unless otherwise defined in a Covered Employee’s participation agreement, the occurrence of any of the following events or conditions without a Covered Employee’s written consent: (i) a material reduction or material adverse change in the Covered Employee’s authority, duties or responsibilities; (ii) a material diminution in the Covered Employee’s base pay or target bonus, unless such a reduction is imposed across-the-board to all senior management of the Company; (iii) a material change in the geographic location at which the Covered Employee must perform the Covered Employee’s duties from the location that was designated as the Covered Employee’s primary location immediately prior to such change (and the Covered Employee and the Company agree that a change of more than 35 miles shall be material for this purpose, and that the Covered Employee’s primary employment location shall be the Covered Employee’s home if the Covered Employee is designated as a remote worker); or (iv) any other action or inaction that constitutes a material breach by the Company or any successor or affiliate of its obligations to the Covered Employee under any agreement between the Covered Employee and the Company or any of its affiliates or any plan maintained by the Company or any of its affiliates related to the Covered Employee’s employment in which the Covered Employee is a participant. The Covered Executive must provide written notice to the Company of the occurrence of any of the foregoing events or conditions without the Covered Employee’s written consent within 60 days of the occurrence of such event. The Company or any successor or affiliate shall have a period of 30 days to cure such event or condition after receipt of written notice of such event from the Covered Employee. The Covered Employee’s termination of employment by reason of resignation from employment with the Company for Good Reason must occur within 30 days following the expiration of the foregoing 30-day cure period.

As defined in the Foust Employment Agreement, “Good Reason” generally means any of the following done without Mr. Foust’s written consent: (i) a material diminution in his base salary, aggregate cash compensation or target bonus opportunity; (ii) a material diminution in his authority, duties or responsibility; (iii) relocation of the principal geographic location at which he must perform services to a location that is more than 35 miles from the then-current location; (iv) any requirement that he engage in illegal conduct; or (v) a material breach by us of the Foust Employment Agreement or any other agreement between us (or any of our affiliates) and Mr. Foust; provided, however, that Good Reason shall not exist unless Mr. Foust provides us with written notice specifying the claimed grounds for Good Reason within ninety (90) days following the initial existence of such event or condition, and we fail to cure such event or condition within thirty (30) days after the date of the written notice, and provided, further, that Mr. Foust must resign effective within 30 days following our failure to cure such event or condition.

Eligibility and Administration. Our employees, consultants, and directors, and employees and consultants of our subsidiaries, will be eligible to receive awards under the 2026 Plan. Following this offering, the 2026 Plan will generally be administered by our board of directors with respect to awards to non-employee directors and by our compensation committee with respect to other participants, each of which may delegate its duties and responsibilities to committees of our directors and/or officers (referred to collectively as the plan administrator below), subject to certain limitations that may be imposed under the 2026 Plan, Section 16 of the Exchange Act, applicable law and/or stock exchange rules, as applicable. The plan administrator will have the authority to make all determinations and interpretations under, prescribe all forms for use with, and adopt rules for the administration of, the 2026 Plan, subject to its express terms and conditions. The plan administrator will also set the terms and conditions of all awards under the 2026 Plan, including any vesting and vesting acceleration conditions.

Limitation on Awards and Shares Available. The number of shares initially available for issuance under awards granted pursuant to the 2026 Plan will be the sum of (i) 14% of the number of “pricing date fully-diluted shares” (as defined below), plus (ii) any shares of our common stock which, as of the effective date of the 2026 Plan, remain available for issuance under the 2022 Plan, plus (iii) any shares subject to outstanding awards under the Prior Plans as of the effective date of the 2026 Plan that become available for issuance under the 2026 Plan thereafter in accordance with its terms. The number of shares initially available for issuance will be increased on January 1 of each calendar year beginning in 2027 and ending in 2036, by an amount equal to the lesser of (a) 5% of the shares of common stock outstanding on the final day of the immediately preceding calendar year and (b) such smaller number of shares as determined by the plan administrator. No more than 250,000,000 shares of common stock may be issued upon the exercise of incentive stock options under the 2026 Plan (which number gives effect to the reverse stock split expected to be implemented in connection with this offering). Shares issued under the 2026 Plan may be authorized but unissued shares, shares purchased on the open market or treasury shares. For purposes of the 2026 Plan, the “pricing date fully-diluted shares” means, as of the date on which the registration statement of which this prospectus forms a part is declared effective, the sum of (1) the shares of our common stock outstanding on such date (calculated on an as-converted basis after giving effect to the conversion of the Company’s outstanding securities into shares in connection with the initial public offering and after giving effect to the issuance of the shares to be sold in this initial public offering and assuming the exercise in full of the underwriters’ over-allotment option in such initial public offering), (2) the shares of our common stock subject to compensatory equity awards (including stock options) outstanding on such date (with the number of shares subject to performance-based compensatory equity awards calculated at the “maximum” level of performance), and (3) all shares of common stock available for future issuance under the 2026 Plan and the ESPP as of such date.

Performance Awards. Performance awards include any of the foregoing awards that are granted subject to vesting and/or payment based on the attainment of specified performance goals or other criteria the plan administrator may determine, which may or may not be objectively determinable. Performance criteria upon which performance goals are established by the plan administrator may include, but are not limited to: net earnings or losses (either before or after one or more of interest, taxes, depreciation, amortization, and non-cash equity-based compensation expense); gross or net sales or revenue or sales or revenue growth; net income (either before or after taxes) or adjusted net income; profits (including, but not limited to, gross profits, net profits, profit growth, net operation profit, or economic profit), profit return ratios or operating margin; budget or operating earnings (either before or after taxes or before or after allocation of corporate overhead and bonus); cash flow (including operating cash flow and free cash flow or cash flow return on capital); return on assets; return on capital or invested capital; cost of capital; return on stockholders’ equity; total stockholder return; return on sales; costs, reductions in costs, and cost control measures; expenses; working capital; earnings or loss per share; adjusted earnings or loss per share; price per share or dividends per share (or appreciation in or maintenance of such price or dividends); regulatory achievements or compliance; implementation, completion, or attainment of objectives relating to research, development, regulatory, commercial, or strategic milestones or developments; market share; economic value or economic value added models; division, group or corporate financial goals; customer satisfaction/growth; customer service; employee satisfaction; recruitment and maintenance of personnel; human capital management (including diversity and inclusion); supervision of litigation and other legal matters; strategic partnerships and transactions; financial ratios (including those measuring liquidity, activity, profitability, or leverage); debt levels or reductions; sales-related goals; financing and other capital raising transactions; cash on hand; acquisition activity; investment sourcing activity; and marketing initiatives, any of which may be measured in absolute terms or as compared to any incremental increase or decrease. Such performance goals also may be based solely by reference to our performance or the performance of a subsidiary, division, business segment, or business unit, or based upon performance relative to performance of other companies or upon comparisons of any of the indicators of performance relative to performance of other companies.

Director Compensation. The 2026 Plan provides that the plan administrator may establish compensation for non-employee directors from time to time subject to the 2026 Plan’s limitations. In connection with this offering, we intend to adopt and ask our stockholders to approve the initial terms of our non-employee director compensation program, which is described in the subsection titled “Non-Employee Director Compensation” below. Our board of directors or its authorized committee may modify the non-employee director compensation program from time to time in its discretion and pursuant to the exercise of its business judgment, taking into account such factors, circumstances and considerations as it deems relevant from time to time, provided that the sum of any cash compensation or other compensation and the grant date fair value (as determined in accordance with FASB ASC 718, or any successor thereto) of any equity awards granted as compensation for services as a non-employee director during any calendar year may not exceed $1,000,000 (which limit will not apply to the compensation for any non-employee director who serves in any capacity in addition to that of a non-employee director for which he or she receives additional compensation or any compensation paid to any non-employee director prior to the calendar year following the calendar year in which this offering occurs). The plan administrator may make exceptions to this limit for individual non-employee directors in such circumstances as the plan administrator may determine in its discretion.

Foreign Participants, Clawback Provisions, Transferability, and Participant Payments. With respect to foreign participants, the plan administrator may modify award terms, establish subplans and/or adjust other terms and conditions of awards, subject to the share limits described above. All awards will be subject to the provisions of any clawback policy implemented by us and to the extent set forth in such clawback policy or in the applicable award agreement. With limited exceptions for estate planning, domestic relations orders, certain beneficiary designations, and the laws of descent and distribution, awards under the 2026 Plan are generally nontransferable prior to vesting and are exercisable only by the participant. With regard to tax withholding obligations arising in connection with awards under the 2026 Plan and exercise price obligations arising in connection with the exercise of stock options under the 2026 Plan, the plan administrator may, in its discretion, accept cash, wire transfer, or check, shares of our common stock that meet specified conditions (a market sell order) or such other consideration as it deems suitable or any combination of the foregoing.

Shares Available for Awards; Administration. The number of shares initially available for issuance pursuant to the ESPP will be equal to a number of shares equal to 1% of the number of pricing date fully-diluted shares (which term has the same meaning as under the 2026 Plan, as described above). In addition, the number of shares available for issuance under the ESPP will be annually increased on January 1 of each calendar year beginning in 2027 and ending in and including 2036, by an amount equal to the lesser of (A) 1% of the shares outstanding on the final day of the immediately preceding calendar year and (B) such smaller number of shares as is determined by the plan administrator, provided that no more than 250,000,000 shares of our common stock may be issued under the ESPP (which number gives effect to the reverse stock split expected to be implemented in connection with this offering). Our board of directors or a committee of our board of directors will administer and will have authority to interpret the terms of the ESPP and determine eligibility of participants. We expect that the compensation committee will be the initial administrator of the ESPP (referred to as the plan administrator below).

Limitation on Awards and Shares Available. The number of shares available for issuance under awards granted pursuant to the 2022 Plan is 17,805,298. Shares issued under the 2022 Plan may be authorized but unissued shares, shares purchased on the open market or treasury shares. If an award under the 2022 Plan expires, lapses, or is terminated, surrendered or cancelled without having been fully exercised or forfeited, in any case, in a manner that results in us acquiring shares covered by the award at a price not greater than the price paid by the participant for such shares or not issuing any shares covered by the award, any shares subject to such award will, as applicable, become or again be available for new grants under the 2022 Plan. Further, shares delivered (either by actual delivery or attestation) to us by a participant to satisfy the applicable exercise or purchase price of an award and/or to satisfy any applicable tax withholding obligation (including shares retained by us from the award being exercised or purchased and/or creating the tax obligation) shall be added to the number of shares available for the grant of awards under the 2022 Plan.

Certain Transactions. In connection with certain transactions and events affecting our common stock, including a change in control (as defined below), or change in any applicable laws or accounting principles, the plan administrator has broad discretion to act under the 2022 Plan to prevent the dilution or enlargement of intended benefits, facilitate such transaction or event, or give effect to such change in applicable laws or accounting principles. This includes canceling awards in exchange for either an amount in cash or other property with a value equal to the amount that would have been obtained upon exercise or settlement of the vested portion of such award or realization of the participant’s rights under the vested portion of such award, accelerating the vesting of awards, providing for the assumption or substitution of awards by a successor entity, adjusting the number and type of shares available, replacing awards with other rights or property, to cancel or arrange for cancellation of eligibility for “early exercise” of an award (if applicable) or terminating awards under the 2022 Plan. In addition, in the event of certain non-reciprocal transactions with our stockholders (an equity restructuring), the plan administrator will make equitable adjustments to the 2022 Plan and outstanding awards as it deems appropriate to reflect the equity restructuring.

transaction, including the sale by us of new shares of its capital stock or a transfer of existing shares of capital stock, the result of which is that a third party that is not an affiliate of ours or its stockholders (or a group of third parties not affiliated with us or our stockholders) immediately prior to such transaction acquires or holds capital stock representing a majority of our outstanding voting power immediately following such transaction; provided that the following events shall not constitute a “change in control”: (A) a transaction (other than a sale of all or substantially all of our assets) in which the holders of the voting securities immediately prior to the merger or consolidation hold, directly or indirectly, at least a majority of the voting securities in the successor corporation or its parent immediately after the merger or consolidation; (B) a sale, lease, exchange or other transaction in one transaction or a series of related transactions of all or substantially all of our assets to an affiliate of ours; (C) an initial public offering of any of our securities; (D) a reincorporation solely to change our jurisdiction; or (E) a transaction undertaken for the primary purpose of creating a holding company that will be owned in substantially the same proportion by the persons who held our securities immediately before such transaction. Notwithstanding the foregoing, if a change in control would give rise to a payment or settlement event with respect to any award that constitutes “nonqualified deferred compensation,” the transaction or event constituting the change in control must also constitute a “change in control event” (as defined in Treasury Regulation §1.409A-3(i)(5)) in order to give rise to the payment or settlement event for such Award, to the extent required by Section 409A.

Foreign Participants, Claw‑Back Provisions, Transferability, and Participant Payments. With respect to foreign participants, the plan administrator may modify award terms, establish subplans and/or adjust other terms and conditions of awards, subject to the share limits described above. All awards will be subject to the provisions of any clawback policy implemented by us and to the extent set forth in such clawback policy or in the applicable award agreement. With limited exceptions for estate planning, domestic relations orders, certain beneficiary designations, and the laws of descent and distribution, awards under the 2022 Plan are generally nontransferable prior to vesting and are exercisable only by the participant. With regard to tax withholding obligations arising in connection with awards under the 2022 Plan and exercise price obligations arising in connection with the exercise of stock options under the 2022 Plan, the plan administrator may, in its discretion, accept cash or certified check, delivery of shares, including shares retained from the award creating the tax obligation, valued at fair market value; or such other consideration as it deems suitable or any combination of the foregoing.

Certain Transactions. In the event of any “corporate transaction” (as defined below), each outstanding stock option would have automatically accelerated so that each such stock option would, immediately prior to the effective date of the corporate transaction, become fully exercisable for all of the shares of common stock at the time subject to such stock option and could have been exercised for any or all of those shares as fully-vested shares of common stock. However, an outstanding stock option would not have so accelerated if and to the extent: (i) such stock option was, in connection with the corporate transaction, either assumed by the successor corporation (or parent thereof) or was replaced with a comparable stock option to purchase shares of the capital stock of the successor corporation (or parent thereof), (ii) such stock option was replaced with a cash incentive program of the successor corporation which preserves the spread that existed on the unvested stock option shares at the time of the corporate transaction and provided for subsequent payout in accordance with the same vesting schedule applicable to such stock option or (iii) the acceleration of such stock option was subject to other limitations imposed by the plan administrator at the time of the stock option grant. The plan administrator had the discretion, exercisable at the time the stock option was granted or at any time while the stock option remained outstanding, to provide that any stock options which were assumed or replaced in a corporate transaction and did not otherwise accelerate at that time would have automatically accelerated (and any of our outstanding repurchase rights under an applicable shareholders agreement which did not otherwise terminate at the time of the corporate transaction automatically terminated) in the event the participant’s service should subsequently terminate by reason of an involuntary termination within 18 months following the effective date of such corporate transaction. Any stock options so accelerated remained exercisable for fully-vested shares until the earlier of (a) the expiration of the option term or (b) the expiration of the 1-year period measured from the effective date of the involuntary termination.

For purposes of the 2007 Plan, a “corporate transaction” meant and included each of the following: (i) a merger or consolidation, or series of related transactions to effect such merger of consolidation, which resulted in the voting securities outstanding immediately prior thereto failing to continue to represent (either by remaining outstanding or by being converted into voting securities of the surviving or another entity) at least 50% of the combined voting power of our voting securities or such surviving or other entity outstanding immediately after such merger or consolidation, (ii) the sale, transfer or other disposition of all or substantially all of our assets (including our subsidiaries) taken as a whole to a party that was not a subsidiary of ours or (iii) the transfer or exchange of all or substantially all of our outstanding stock existing immediately prior thereto in a single transaction or series of related transactions for shares of another entity or other property in which, after such transaction, our prior shareholders owned 50% or less of the shares outstanding of the continuing or surviving entity.

Also, pursuant to this program, on the date of each annual meeting of our stockholders following this offering, we intend to grant each eligible non-employee director an annual equity award of stock options with a grant date fair value of $130,000 (as computed in accordance with ASC Topic 718) (an Annual Award), which will generally vest in full on the earlier of (i) the day immediately prior to the date of our annual stockholder meeting immediately following the date of grant and (ii) the first anniversary of the grant date, subject to the non-employee director continuing service through such date. Following this offering, an individual who is appointed or elected to our board of directors will receive (a) an initial equity award on the date of such election or appointment of stock options with a grant date fair value of $130,000 (as computed in accordance with ASC Topic 718) (an Initial Award), which will generally vest in three substantially equal installments on the first three anniversaries of the grant date and (b) a prorated Annual Award based on the number of months remaining in the 12-month period measured from the annual meeting of the Company’s stockholders preceding the date of such election or appointment, in each case of the Initial Award and prorated Annual Award, subject to the non-employee director continuing service through each such vesting date. In the event of a change in control (as defined in the 2026 Plan), or a director’s termination of service due to death or disability, all outstanding equity awards granted to our non-employee directors pursuant to this program will accelerate and vest in full.

We expect to enter into Restated Employment Agreements with each of Mr. Jordan Curnes II and Mr. Bunker Curnes effective upon the effectiveness of the registration statement relating to this offering. The terms of these Restated Employment Agreements are generally consistent with the terms of each of the employment agreements described below, other than the Restated Employment Agreements do not include severance provisions and instead provide that each of Mr. Jordan Curnes II and Mr. Bunker Curnes are eligible to participate in our Severance Plan. Upon the effectiveness of the Restated Employment Agreements, Mr. Jordan Curnes II and Mr. Bunker Curnes will be eligible for an annual base salary of $255,000 and $430,000, respectively, and a target annual bonus equal to 40% and 60% of his annual base salary, respectively. The Restated Employment Agreement with Mr. Jordan Curnes II will also provide that (i) in the event of a change in control, or Mr. Jordan Curnes’ termination of employment without Cause, any then unvested stock options held by him that were granted prior to the consummation of this offering will immediately become fully vested immediately prior to such termination or the consummation of such change in control and (ii) in the event of a change in control, such stock options will be assumed by the successor

As defined in the Curnes II Employment Agreement, “Cause” generally means any of the following: (i) Mr. Jordan Curnes II’s repeated failure to perform his assigned duties (other than as a result of a cause or event outside of his control), or to perform and observe his employment obligations under the Curnes II Agreement, in either case if such failure is intentional or continues for 30 or more days after our board of directors gives written notice thereof to Mr. Jordan Curnes II; (ii) any material breach of the Curnes II Employment Agreement by Mr. Jordan Curnes II and such breach continues for 30 or more days after we give written notice thereof to the him; or (iii) his conviction of or a plea of guilty or nolo contendre to a charge of felony, or for a misdemeanor involving fraud, embezzlement, theft, dishonesty or breach of fiduciary duty, or other criminal conduct, or the violation of any state or federal law (other than traffic violations or other insignificant infractions of law that do not affect the performance of duties hereunder); or (iv) any material violation of our written policies and such violation continues for 30 or more days after we give written notice thereof to Mr. Jordan Curnes II.

Our board of directors will adopt a written related person transaction policy, to be effective upon the completion of this offering, setting forth the policies and procedures for the review and approval or ratification of related person transactions. This policy will cover, with certain exceptions set forth in Item 404 of Regulation S-K under the Securities Act, any transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we were or are to be a participant, where the amount involved exceeds $120,000 in any fiscal year, or, for so long as we qualify as a smaller reporting company, the lesser of $120,000 or one percent of the average of our total assets at year-end for the last two completed fiscal years, and a related person had, has or will have a direct or indirect material interest, including without limitation, purchases of goods or services by or from the related person or entities in which the related person has a material interest, indebtedness, guarantees of indebtedness and employment by us of a related person. In reviewing and approving any such transactions, our audit committee will be tasked to consider all relevant facts and circumstances, including, but not limited to, whether the transaction is on terms comparable to those that could be obtained in an arm’s length transaction and the extent of the related person’s interest in the transaction. All of the transactions described in this section will have occurred prior to the adoption of this policy.

The number of shares beneficially owned by each stockholder is determined under rules issued by the SEC. Under these rules, beneficial ownership includes any shares as to which the individual or entity has sole or shared voting power or investment power. Applicable percentage ownership is based on shares of common stock outstanding as of , 2026, assuming (i) the Preferred Stock Conversion, (ii) the Warrant Exercises, (iii) the Warrant Conversion, and (iv) the issuance of the 2026 Convertible Notes and the related Notes Conversion. In computing the number of shares beneficially owned by an individual or entity and the percentage ownership of that person, shares of common stock subject to options, warrants or other rights held by such person that are currently exercisable or will become exercisable within 60 days of , 2026 are considered outstanding, although these shares are not considered outstanding for purposes of computing the percentage ownership of any other person. The percentage ownership information under the column titled “Shares beneficially owned after this offering” assumes the foregoing and the issuance of shares of common stock in this offering, and assumes no exercise of the underwriters’ option to purchase additional shares. The table below excludes any shares of our common stock that may be purchased in this offering pursuant to the reserved share program. See “Underwriting—Reserved Shares.” Unless otherwise indicated, the persons or entities identified in this table have sole voting and investment power with respect to all shares shown as beneficially owned by them, subject to applicable community property laws.

(1)Consists of (i) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by U.S. Venture Partners Select Fund I, L.P. on its own behalf and as a nominee for U.S. Venture Partners Select Fund I-A, L.P. (“USVP SFI”), (ii) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by USVP SFI, (iii) shares of our common stock issuable upon the conversion of Series E-2 redeemable convertible preferred stock held by U.S. Venture Partners XII, L.P. (“USVP XII”), (iv) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by USVP XII, (v) shares of our common stock issuable upon the conversion of Series E-2 redeemable convertible preferred stock held by U.S. Venture Partners XII-A, L.P. (“USVP XII-A”), and (vi) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by USVP XII-A. Presidio Management Group XII, L.L.C. (“PMG XII”) is the general partner of USVP XII and USVP XII-A and may be deemed to have sole voting and dispositive power with respect to the shares held by USVP XII and USVP XII-A. Steven M. Krausz, Richard W. Lewis, Jonathan D. Root, Casey M. Tansey (a member of our board of directors) and Dafina Toncheva are the managing members of PMG XII, and may be deemed to share voting and dispositive power with respect to the shares held by USVP XII and USVP XII-A. Presidio Management Group Select Fund I, L.L.C. (“PMG Select”) is the general partner of USVP SFI and may be deemed to have sole voting and dispositive power with respect to the shares held by USVP SFI. Richard W. Lewis, Jonathan D. Root, Casey M. Tansey (a member of our board of directors) and Dafina Toncheva are the managing members of PMG Select, and may be deemed to share voting and dispositive power with respect to the shares held by USVP SFI. Each of the managing members of PMG XII and PMG Select disclaims beneficial ownership of such holdings, except to the extent of their pecuniary interest in the shares. The address for each of these entities is 1460 El Camino Real, Suite 100, Menlo Park, CA 94025.

(2)Consists of (i) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by GPG BFH, LLC (“BFH”), (ii) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by GPG Charles & Potomac, LLC (“C&P”), (iii) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by C&P, (iv) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by C&P, (v) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by GPG Dais, LLC (“Dais”), (vi) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by Dais, (vii) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by Dais, (viii) shares of our common stock issuable upon the conversion of Series E-2 redeemable convertible preferred stock held by GPG GR, LLC (“GR”), (ix) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by GPG Healthcare Opportunities Fund II, LLC (“HOF II”), (x) shares of our common stock issuable upon the conversion of Series E-2 redeemable convertible preferred stock held by HOF II, (xi) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by HOF II, (xii) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by HOF II, (xiii) shares of our common stock issuable upon the conversion of Series D redeemable convertible preferred stock held by GPG Healthcare Opportunities Fund, LLC (“HOF”), (xiv) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by HOF, (xv) shares of our common stock issuable upon the conversion of Series D redeemable convertible preferred stock held by GPG JCT, LLC (“JCT”), (xvi) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by JCT, (xvii) shares of our common stock issuable upon the conversion of Series E-2 redeemable convertible preferred stock held by JCT, (xviii) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by JCT, (xix) shares of our common stock issuable upon the conversion of Series E-2 redeemable convertible preferred stock held by GPG MTI 22, LLC (“MTI 22”), (xx) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by MTI 22, (xxi) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by MTI 22, (xxii) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by GPG MTI 25, LLC (“MTI 25”), (xxiii) shares of our common stock issuable upon the conversion of Series D redeemable convertible preferred stock held by GPG MTI 3-17 Investment, LLC (“MTI 3-17”), (xxiv) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by GPG PHL, LLC (“PHL”), (xxv) shares of our common stock issuable upon the conversion of Series D redeemable convertible preferred stock held by GPG RM Investment, LLC (“RM”), (xxvi) shares of our common stock issuable upon the conversion of Series E-2 redeemable convertible preferred stock held by GPG SC, LLC (“SC”), (xxvii) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by SC, (xxviii) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by SC, (xxix) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by GPG WG, LLC (“WG”), (xxx) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by WG, (xxxi) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by GPG MTIF, LLC (“MTIF”), (xxxii)

shares of our common stock issuable upon the conversion of Series B redeemable convertible preferred stock held by Micro TI Investment 2, LLC (“Micro TI 2”), (xxxiii) shares of our common stock issuable upon the conversion of Series B redeemable convertible preferred stock held by Micro TI Investment, LLC (“Micro TI”), (xxxiv) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by MTI 20 Investment, LLC (“MTI 20”), (xxxv) shares of our common stock issuable upon the conversion of Series C redeemable convertible preferred stock held by MTI 2015 Investment, LLC (“MTI 2015”), (xxxvi) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by HTX MCT1 0320 Investment, LLC (“HTX MCT1”), (xxxvii) shares of our common stock issuable upon the conversion of Series E-1 redeemable convertible preferred stock held by HTX MCT2 0221 Investment, LLC (“HTX MCT2”), (xxxviii) shares of our common stock issuable upon the conversion of Series E-2 redeemable convertible preferred stock held by HTX MCT3 0322 Investment, LLC (“HTX MCT3”), (xxxix) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by HTX MCT3. Green Park & Golf Ventures II, LLC (“GPG Ventures II”) is the managing member of each of BFH, C&P, Dais, GR, HOF, HOF II, JCT, MTI 22, MTI 25, MTI 3-17, MTIF, PHL, RM, SC, WG, Micro TI, Micro TI 2, MTI 20 and MTI 2015. Clay M. Heighten, MD, Carl D. Soderstrom and Gilbert G. Garcia II are managers of GPG Ventures II and share voting and dispositive power with respect to the shares held by each of BFH, C&P, Dais, GR, HOF, HOF II, JCT, MTI 22, MTI 25, MTI 3-17, MTIF, PHL, RM, SC, WG, Micro TI, Micro TI 2, MTI 20 and MTI 2015, and as a result may be deemed to beneficially own such securities. Green Park & Golf Ventures - Houston, LLC (“GPG Ventures Houston”) is the managing member of each of HTX MCT1, HTX MCT2 and HTX MCT3. Clay M. Heighten, MD, Carl D. Soderstrom and Gilbert G. Garcia II are managers of GPG Ventures Houston and share voting and dispositive power with respect to the shares held by each of HTX MCT1, HTX MCT2 and HTX MCT3, and as a result may be deemed to beneficially own such securities. The address for each of these entities is 5910 N. Central Expressway, Suite 1400, Dallas, TX 75206.

(3)Consists of (i) shares of our common stock issuable upon the conversion of Series E-2 redeemable convertible preferred stock held by Osage University Partners III, LP (“OUP III”), (ii) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by OUP III, (iii) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by OUP III, (iv) shares of our common stock issuable upon the conversion of Series F redeemable convertible preferred stock held by Osage University Partners IV, LP (“OUP IV”), and (v) shares of our common stock issuable upon the conversion of the 2026 Convertible Notes held by OUP IV. Osage University GP III, LLC (“OUP GP III”) is the general partner of OUP III and Osage University GP IV, LLC (“OUP GP IV”) is the general partner of OUP IV. William Harrington (a member of our board of directors) is one of the managers (the “OUP Managers”) of both OUP GP III and OUP GP IV. OUP GP III and OUP GP IV and the OUP Managers may be deemed to share voting, investment and dispositive power over the shares held by OUP III and OUP IV and as a result may be deemed to have beneficial ownership over such securities. Each of OUP GP III and OUP GP IV and the OUP Managers disclaims beneficial ownership over the securities held by OUP III and OUP IV, except to the extent of their respective pecuniary interests therein. The address for each of these entities is 50 Monument Road, Suite 201, Bala Cynwyd, PA 19004.

As of December 31, 2025, warrants to purchase an aggregate of up to 908,000 shares of our Series B redeemable convertible preferred stock were outstanding, with an exercise price of $3.73744 per share. Unless exercised earlier, the warrants will expire in December 2032 or February 2033. The warrants contain provisions for the adjustment of the exercise price and the number of shares issuable upon the exercise of the warrants in the event of certain stock dividends, stock splits, reorganizations, reclassifications and consolidations. The warrants have a net exercise provision under which the respective holder may, in lieu of payment of the exercise price in cash, surrender the warrants and receive a net amount of shares based on the fair market value of the shares at the time of exercise of the warrants after deduction of the aggregate exercise price. In connection with an initial public offering, the warrants will either be exercised or will expire immediately prior to the consummation of such initial public offering. Based upon an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover of this prospectus, we will issue shares of our common stock upon the exercise of the warrants immediately prior to the completion of this offering.

As of December 31, 2025, warrants to purchase an aggregate of up to 258,000 shares of our Series D redeemable convertible preferred stock were outstanding, with an exercise price of $4.207 per share. Unless exercised earlier, the warrants will expire in April 2033, May 2033, or June 2033. The warrants contain provisions for the adjustment of the exercise price and the number of shares issuable upon the exercise of the warrants in the event of certain stock dividends, stock splits, reorganizations, reclassifications and consolidations. The warrants have a net exercise provision under which the respective holder may, in lieu of payment of the exercise price in cash, surrender the warrants and receive a net amount of shares based on the fair market value of the shares at the time of exercise of the warrants after deduction of the aggregate exercise price. In connection with an initial public offering, the warrants will either be exercised or will expire immediately prior to the consummation of such initial public offering. Based upon an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover of this prospectus, we will issue shares of our common stock upon the exercise of the warrants immediately prior to the completion of this offering.

As of December 31, 2025, warrants to purchase up to $262,500 of shares of our (i) shares of Series E-2 redeemable convertible preferred stock at an exercise price of $2.5443 per share or (ii) shares of Series F redeemable convertible preferred stock at an exercise price of $2.6317 per share, were outstanding. Unless exercised earlier, the warrants will expire in December 2033. The warrant contains provisions for the adjustment of the exercise price and the number of shares issuable upon the exercise of the warrant in the event of certain stock dividends, stock splits, reorganizations, reclassifications and consolidations. The warrant has a net exercise provision under which the respective holder may, in lieu of payment of the exercise price in cash, surrender the warrant and receive a net amount of shares based on the fair market value of the shares at the time of exercise of the warrant after deduction of the aggregate exercise price. Immediately prior to the completion of this offering, the warrant will automatically convert into a warrant to purchase shares of our common stock with an average exercise price of $ per share.

From January 30, 2026 through February 11, 2026, we issued the 2026 Convertible Notes to certain investors in an aggregate principal amount of $40.0 million. The Maturity Date for the 2026 Convertible Notes is January 30, 2028. The 2026 Convertible Notes bear no interest for the first six months following the date of issuance. Following such period, the 2026 Convertible Notes accrue interest at a rate of 7.0% per annum through the Maturity Date, which interest payments shall be paid in kind. Immediately prior to the closing of this offering, the 2026 Convertible Notes and any accrued interest will automatically convert into shares of our common stock at the applicable conversion price. The conversion price is the lower of (a) 80% of the initial public offering price per share in this offering and (b) the valuation of the Company immediately prior to the closing of this offering divided by the Fully Diluted Capitalization, provided, that in no event shall such conversion price be less than the quotient obtained by dividing $226.0 million by the Fully Diluted Capitalization or greater than the quotient obtained by dividing $750.0 million by the Fully Diluted Capitalization. Based on an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and without giving effect to accrued interest (if any), the 2026 Convertible Notes will automatically convert into an aggregate of shares of our common stock immediately prior to the closing of this offering.

After the completion of this offering, the holders of up to shares of our common stock will be entitled to certain “piggyback” registration rights. If we propose to register the offer and sale of shares of our common stock under the Securities Act, all holders of these shares then outstanding can request that we include their shares in such registration, subject to certain marketing and other limitations, including the right of the underwriters to limit the number of shares included in any such registration statement under certain circumstances. As a result, whenever we propose to file a registration statement under the Securities Act, other than with respect to (1) a registration related to any employee benefit plan or a corporate reorganization or other transaction covered by Rule 145 promulgated under the Securities Act, (2) a registration relating to the offer and sale of debt securities or (3) a registration on any registration form that does not permit secondary sales, the holders of these shares are entitled to notice of the registration and have the right, subject to certain limitations, to include their shares in the registration.

any action asserting a claim against us arising pursuant to any provision of the Delaware General Corporation Law or our certificate of incorporation or bylaws; (iv) any action to interpret, apply, enforce or determine the validity of our certificate of incorporation or bylaws; or (v) any action asserting a claim governed by the internal affairs doctrine; provided that the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act, or to any claim for which the federal courts have exclusive jurisdiction. For instance, the provision would not apply to actions arising under federal securities laws, including suits brought to enforce any liability or duty created by the Securities Act, Exchange Act, or the rules and regulations thereunder. Our amended and restated certificate of incorporation further provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. Our amended and restated certificate of incorporation also provides that any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock will be deemed to have notice of and to have consented to this choice of forum provision. It is possible that a court of law could rule that the choice of forum provision contained in our amended and restated certificate of incorporation is inapplicable or unenforceable if it is challenged in a proceeding or otherwise.

Upon completion of this offering, based on our shares outstanding as of December 31, 2025 and after giving effect to the Preferred Stock Conversion, issuance of the 2026 Convertible Notes and related Notes Conversion, and Warrant Exercise, shares of our common stock will be outstanding, or shares of common stock if the underwriters exercise their option to purchase additional shares in full, assuming no exercise of outstanding options or warrants. All of the shares of common stock expected to be sold in this offering will be freely tradable without restriction or further registration under the Securities Act unless held by our “affiliates,” as that term is defined in Rule 144 under the Securities Act. The remaining outstanding shares of our common stock will be deemed “restricted securities” as that term is defined under Rule 144. Restricted securities may be sold in the public market only if their offer and sale is registered under the Securities Act or if the offer and sale of those securities qualify for an exemption from registration, including exemptions provided by Rules 144 and 701 under the Securities Act, which are summarized below.

Our officers, directors, and the holders of substantially all of our capital stock, options, and warrants have entered into market stand-off agreements with us and have entered into or will enter into lock-up agreements with the underwriters, whereby they have agreed, for a period of 180 days after the date of this prospectus, subject to certain exceptions, not to offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right, or warrant to purchase, lend, or otherwise dispose of or transfer any shares of common stock or any securities convertible into or exercisable or exchangeable for shares of common stock; exercise any right with respect to the registration of any of these securities; file, cause to be filed or cause to be confidentially submitted a registration statement related to these securities; or enter into any hedging, swap, loan or any other agreement or any transaction that transfers to another, in whole or in part, directly or indirectly, the economic consequence of ownership of the common stock. BofA Securities, Inc., J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC, may, in their sole discretion and at any time or from time to time before the termination of the lock-up period, in certain cases without public notice, release all or any portion of the securities subject to lock-up agreements. There are no existing agreements between the underwriters and any of our stockholders who will execute a lock-up agreement providing consent to the sale of shares prior to the expiration of the lock-up period. Upon the expiration of the lock-up period, substantially all of the shares subject to such lock-up restrictions will become eligible for sale, subject to the limitations discussed above. See the section titled “Underwriting” for additional information.

The following discussion is a summary of the material U.S. federal income tax consequences to Non-U.S. Holders (as defined below) of the purchase, ownership, and disposition of our common stock issued pursuant to this offering, but does not purport to be a complete analysis of all potential tax effects. The effects of other U.S. federal tax laws, such as estate and gift tax laws, and any applicable state, local, or non-U.S. tax laws are not discussed. This discussion is based on the Code, Treasury Regulations promulgated thereunder, judicial decisions, and published rulings and administrative pronouncements of the U.S. Internal Revenue Service (the IRS), in each case in effect as of the date hereof. These authorities may change or be subject to differing interpretations. Any such change or differing interpretation may be applied retroactively in a manner that could adversely affect a Non-U.S. Holder. We have not sought and will not seek any rulings from the IRS regarding the matters discussed below. There can be no assurance the IRS or a court will not take a contrary position to that discussed below regarding the tax consequences of the purchase, ownership, and disposition of our common stock.

Payments of dividends on our common stock will not be subject to backup withholding, provided the applicable withholding agent does not have actual knowledge or reason to know the holder is a United States person and the holder either certifies its non-U.S. status, such as by furnishing a valid IRS Form W-8BEN, W-8BEN-E or W-8ECI, or otherwise establishes an exemption. However, information returns are required to be filed with the IRS in connection with any distributions on our common stock paid to the Non-U.S. Holder, regardless of whether such distributions constitute dividends or whether any tax was actually withheld. In addition, proceeds of the sale or other taxable disposition of our common stock within the United States or conducted through certain U.S.-related brokers generally will not be subject to backup withholding or information reporting if the applicable withholding agent receives the certification described above and does not have actual knowledge or reason to know that such holder is a United States person or the holder otherwise establishes an exemption. Proceeds of a disposition of our

Withholding taxes may be imposed under Sections 1471 to 1474 of the Code (such Sections commonly referred to as the Foreign Account Tax Compliance Act (FATCA)) on certain types of payments made to non-U.S. financial institutions and certain other non-U.S. entities. Specifically, a 30% withholding tax may be imposed on dividends on, or (subject to the proposed Treasury Regulations discussed below) gross proceeds from the sale or other disposition of, our common stock paid to a “foreign financial institution” or a “non-financial foreign entity” (each as defined in the Code), unless (1) the foreign financial institution undertakes certain diligence and reporting obligations, (2) the non-financial foreign entity either certifies it does not have any “substantial United States owners” (as defined in the Code) or furnishes identifying information regarding each substantial United States owner, or (3) the foreign financial institution or non-financial foreign entity otherwise qualifies for an exemption from these rules. If the payee is a foreign financial institution and is subject to the diligence and reporting requirements in clause (1) above, it must enter into an agreement with the U.S. Department of the Treasury requiring, among other things, that it undertake to identify accounts held by certain “specified United States persons” or “United States owned foreign entities” (each as defined in the Code), annually report certain information about such accounts, and withhold 30% on certain payments to non-compliant foreign financial institutions and certain other account holders. Foreign financial institutions located in jurisdictions that have an intergovernmental agreement with the United States governing FATCA may be subject to different rules.

At our request, the underwriters have reserved for sale, at the initial public offering price, up to % of the shares offered by this prospectus for sale to some of our directors, officers, employees, distributors, dealers, business associates and related persons. The sales will be made at our discretion to parties identified by management through a reserved share program. Management will provide the list of potential participants to Merrill Lynch, Pierce, Fenner & Smith Incorporated, which will administer the program. Pursuant to this program, once a preliminary prospectus has been filed, an invitation package will be made available or sent to each party identified by management, which will include the preliminary prospectus and other reserved share program documentation. An invitation to participate in the program does not guarantee that the participant will receive an allocation of shares. Accordingly, we cannot provide any assurance that any director, officer, employee, distributor, dealer, business associate, related person, or participant will receive an invitation or an allocation in the program. If a potential participant is interested in participating, that participant will be required to complete the required documentation and will be required to return such documentation to the program administrator. The program administrator will not accept funds from any participant until after the registration statement for this offering is declared effective, this offering is priced, and the participants are notified of their final allocation and given an opportunity to confirm that they wish to purchase the shares allocated to them. After the registration statement has been declared effective and this offering is priced, we and the program administrator will prepare a final approved list of allocations. The program administrator will notify each participant who has been allocated shares of the number of shares that have been allocated and the total purchase price due upon confirmation of their participation. Thereafter, participants will be required to wire or transfer their funds to the program administrator. The shares under the reserved share program will be allocated following pricing and settle in the same manner as the shares sold to the general public. Any shares purchased in the program by our directors or officers will be subject to the 180-day lock-up restrictions described below. If participants purchase reserved shares, this will reduce the number of shares available for sale to the general public. Any reserved shares that are not so purchased will be offered by the underwriters to the general public on the same terms as the other shares offered by this prospectus. We have agreed to reimburse the underwriters for certain fees and expenses in connection with this reserved share program, including the fees and disbursements of counsel to the underwriters, up to an amount not to exceed $ .

underwriters’ option to purchase additional shares described above. The underwriters may close out any covered short position by either exercising their option to purchase additional shares or purchasing shares in the open market. In determining the source of shares to close out the covered short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase shares through the option granted to them. “Naked” short sales are sales in excess of such option. The underwriters must close out any naked short position by purchasing shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of our common stock in the open market after pricing that could adversely affect investors who purchase in the offering. Stabilizing transactions consist of various bids for or purchases of shares of common stock made by the underwriters in the open market prior to the completion of the offering.

This document is for distribution only to persons who (i) have professional experience in matters relating to investments and who qualify as investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended, the Financial Promotion Order), (ii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the Financial Promotion Order, (iii) are outside the UK, or (iv) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of Section 21 of the FSMA) in connection with the issue or sale of any securities may otherwise lawfully be communicated or caused to be communicated (all such persons together being referred to as relevant persons). This document is directed only at relevant persons and must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this document relates is available only to relevant persons and will be engaged in only with relevant persons.

The shares have not been offered or sold and will not be offered or sold in Hong Kong, by means of any document, other than (a) to “professional investors” as defined in the Securities and Futures Ordinance (Cap. 571) of Hong Kong and any rules made under that Ordinance; or (b) in other circumstances which do not result in the document being a “prospectus” as defined in the Companies Ordinance (Cap. 32) of Hong Kong or which do not constitute an offer to the public within the meaning of that Ordinance. No advertisement, invitation or document relating to the shares has been or may be issued or has been or may be in the possession of any person for the purposes of issue, whether in Hong Kong or elsewhere, which is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to shares which are or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” as defined in the Securities and Futures Ordinance and any rules made under that Ordinance.

This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, the shares were not offered or sold or caused to be made the subject of an invitation for subscription or purchase and will not be offered or sold or caused to be made the subject of an invitation for subscription or purchase, and this prospectus or any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of the shares, has not been circulated or distributed, nor will it be circulated or distributed, whether directly or indirectly, to any person in Singapore other than (i) to an institutional investor (as defined in Section 4A of the Securities and Futures Act (Chapter 289) of Singapore, as modified or amended from time to time (the SFA)) pursuant to Section 274 of the SFA, (ii) to a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A) of the SFA, and in accordance with the conditions specified in Section 275 of the SFA, or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA.

We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of our common stock offered by this prospectus. This prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration statement, as permitted by the rules and regulations of the SEC. For further information with respect to us and our common stock, we refer you to the registration statement, including the exhibits filed as a part of the registration statement. Statements contained in this prospectus concerning the contents of any contract or any other document is not necessarily complete. If a contract or document has been filed as an exhibit to the registration statement, please see the copy of the contract or document that has been filed. Each statement in this prospectus relating to a contract or document filed as an exhibit is qualified in all respects by the filed exhibit. The SEC maintains an Internet website that contains the registration statement of which this prospectus forms a part, as well as the exhibits thereto. These documents, along with future reports, proxy statements, and other information about us, are available at the SEC’s website, www.sec.gov.


	December 31,
	2025		2024
Assets
Current assets
Cash and cash equivalents	$	33,587,308	$	14,620,320
Accounts receivable	4,435,223		2,826,236
Inventory	5,456,757		3,429,162
Deferred offering costs	934,996		—
Other current assets	1,942,958		299,023
Total current assets	46,357,242		21,174,741
Property and equipment, net	669,130		456,376
Right-of-use-assets – operating leases	1,068,452		438,588
Other Assets	53,875		21,332
Total assets	$	48,148,699	$	22,091,037
Liabilities, redeemable convertible preferred stock, and stockholders’ deficit
Current liabilities
Accounts payable	$	2,222,970	$	1,139,326
Operating lease liabilities, current	357,522		23,646
Product warranty liability	843,671		437,219
Accrued payroll, commissions, and bonuses	4,853,892		2,738,377
Accrued offering costs	934,995		—
Accrued and other current liabilities	993,157		258,238
Total current liabilities	10,206,207		4,596,806
Warrant liabilities	865,390		1,007,342
Notes payable, net of discount and deferred financing costs	7,129,928		7,094,070
Operating lease liability – long term	947,886		603,050
Total liabilities	19,149,411		13,301,268
Commitments and contingencies (Note 15)

Redeemable convertible preferred stock issuable in series, $0.01 par value; 67,174,403 and 42,475,557 shares authorized as of December 31, 2025 and December 31, 2024, respectively; 65,591,701 and 40,892,855 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively; aggregate liquidation value of $182,255,492 and $117,255,538 as of December 31, 2025 and December 31, 2024, respectively	179,772,875		114,825,572

Stockholders’ deficit
Common stock, $0.01 par value, 86,600,000 and 54,062,688 shares authorized as of December 31, 2025 and 2024, respectively; 3,079,173 and 2,705,365 outstanding shares as of December 31, 2025 and 2024, respectively	30,791		27,053
Additional paid-in capital	6,984,755		5,228,089
Accumulated deficit	(157,789,133)		(111,290,945)
Total stockholders' deficit	(150,773,587)		(106,035,803)
Total liabilities, redeemable convertible preferred stock, and stockholders’ deficit	$	48,148,699	$	22,091,037


	Redeemable Convertible Preferred Stock			Common Stock			Paid-In Capital		Accumulated Deficit		Total Stockholders’ Deficit
	Shares	Amount		Shares	Amount
Balance, January 1, 2024	34,997,324	$	99,527,210	1,689,726	$	16,897	$	3,808,491	$	(86,687,931)	$	(82,862,543)
Net loss	—	—		—	—		—		(24,603,014)		(24,603,014)
Issuance of Series E-2 redeemable convertible preferred stock in connection with the settlement of tranche liability, net of issuance costs of $12,011	5,301,100	13,787,299		—	—		—		—		—
Related party issuance of Series E-2 redeemable convertible preferred stock in connection with settlement of tranche liability, net of issuance costs of $1,347	594,431	1,511,063		—	—		—		—		—
Exercise of common stock options	—	—		1,015,639	10,156		661,471		—		671,627
Share-based compensation	—	—		—	—		758,127		—		758,127
Balance, December 31, 2024	40,892,855	$	114,825,572	2,705,365	$	27,053	$	5,228,089	$	(111,290,945)	$	(106,035,803)
Net loss	—	—		—	—		—		(46,498,188)		(46,498,188)
Issuance of Series F redeemable convertible preferred stock and settlement of tranche liability, net of issuance costs of $264,065	22,703,940	59,701,561		—	—		—		—		—
Related party issuance of Series F redeemable convertible preferred stock and settlement of tranche liability, net of issuance costs of $23,202	1,994,906	5,245,742		—	—		—		—		—
Exercise of common stock options				373,808	3,738		309,964		—		313,702
Share-based compensation	—	—		—	—		1,446,702		—		1,446,702
Balance, December 31, 2025	65,591,701	$	179,772,875	3,079,173	$	30,791	$	6,984,755	$	(157,789,133)	$	(150,773,587)


	Years Ended December 31,
	2025		2024
Cash flows from operating activities
Net loss	$	(46,498,188)	$	(24,603,014)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization	151,657		116,010
Share-based compensation	1,446,702		758,127
Change in fair value of warrant liability	(141,952)		-
Fair value adjustment of redeemable convertible preferred stock tranche liability	234,616		12,440
Amortization of debt issuance costs	35,858		35,857
Changes in assets and liabilities
Accounts receivable	(1,608,987)		(1,386,950)
Inventory	(2,027,595)		(245,409)
Other assets	(2,611,473)		(288,570)
Accounts payable	1,083,644		(108,594)
Accrued liabilities and other	4,240,728		1,394,802
Net cash used in operating activities	(45,694,990)		(24,315,301)
Cash flows from investing activities
Purchase of fixed assets	(364,411)		(40,848)
Net cash used in investing activities	(364,411)		(40,848)
Cash flows from financing activities
Exercise of common stock options	313,702		671,627
Proceeds from issuance of Series E-2 redeemable convertible preferred stock, net of issuance costs	—		13,475,579
Proceeds from the related party issuance of Series E-2 redeemable convertible preferred stock, net of issuance costs	—		1,511,063
Proceeds from issuance of Series F redeemable convertible preferred stock, net of issuance costs	59,485,894		—
Proceeds from the related party issuance of Series F redeemable convertible preferred stock, net of issuance costs	5,226,793		—
Net cash provided by financing activities	65,026,389		15,658,269
Net change in cash and cash equivalents	18,966,988		(8,697,880)
Cash and cash equivalents, beginning of year	14,620,320		23,318,200
Cash and cash equivalents, end of year	$	33,587,308	$	14,620,320
Supplemental disclosures of cash flows information
Cash paid for interest	$	931,510	$	969,920
Cash paid for income taxes	$	2,725	$	13,913
Non-cash investing and financing activities
Settlement of redeemable convertible preferred stock tranche liability	$	915,216	$	311,800

Risks and Uncertainties – The Company’s activities are subject to significant risks and uncertainties, including, but not limited to, failure to manage growth effectively, reliance on the success of the Vivistim System, new technological innovations, dependence upon third-party payers to provide adequate coverage and reimbursement to our customers, the absence of a national coverage determination or local coverage determinations applicable to its device administrated by the Centers for Medicare and Medicaid Services (CMS), dependence on key personnel, dependence on key suppliers, protection of proprietary technology, product liability, and compliance with government regulations. The Company is also subject to risks relating to cybersecurity and the protection of confidential information and personal information, as well as risks relating to evolving regulatory requirements (including potential additional clinical evidence requirements) that could affect commercialization of existing or future products. These risks and uncertainties, as well as failure to secure additional funding, if needed, can adversely affect the Company’s future financial results, financial position, and cash flow.

Accounts receivable and allowance for credit losses – The Company records accounts receivables at the invoiced amount and accounts for credit losses in accordance with ASC 326, Financial Instruments—Credit Losses. The Company maintains an allowance for credit losses for any receivables the Company may be unable to collect. The Company estimates expected credit losses on an individual basis, as appropriate, based on the receivables’ age, customers’ expected ability to pay and collection history, current economic conditions, and reasonable and supportable forecasts, among other factors that may affect customers’ ability to pay. The Company uses its judgment, based on the best available facts and circumstances, and records an allowance against amounts due to reduce the receivable to the amount that is expected to be collected. The Company began selling its products in 2022 and has not experienced material bad debt write-offs since inception, and as of December 31, 2025 and 2024, a significant majority of outstanding receivables were current. Based on its evaluation of historical loss experience, aging of receivables, customer creditworthiness, current economic conditions, and whether reasonably foreseeable future conditions could affect collectability as required under ASC 326, the Company determined that no allowance for expected credit losses was required for the periods presented. Accordingly, no allowance for credit losses was recorded as of December 31, 2025 and 2024.

Leases – The Company recognizes and measures its leases in accordance with ASC 842, Leases. The Company determines if an arrangement is a lease, or contains a lease, at inception of a contract and when the terms of an existing contract are changed. The Company recognizes a lease liability and a right‑of‑use (ROU) asset at the commencement date of the lease. The lease liability is initially and subsequently recognized based on the present value of its future lease payments over the expected lease term. Variable payments are included in the future lease payments when those variable payments depend on an index or a rate. The discount rate is the implicit rate if it is readily determinable or otherwise the Company uses its incremental borrowing rate. The implicit rates of the Company’s leases are not readily determinable and accordingly, management uses the incremental borrowing rate based on the information available at the commencement date for all leases. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms and in a similar economic environment. The ROU asset is subsequently calculated throughout the lease term at the amount of the remeasured lease liability (i.e., present value of the remaining lease payments), plus unamortized initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received, and any impairment recognized. As a practical expedient, the Company elected not to separate non-lease components from lease components.

On March 7, 2023, the Company entered into a noncancellable operating lease for office space and warehouse space. The commencement date of this lease was July 1, 2023, with an end date of July 31, 2028. Leases for all prior years were month to month. The lease contains a renewal option to extend the term for a period of five years. Because the Company is reasonably certain to exercise its renewal option, the optional period is included in determining the lease term, and associated payments under these renewal options are included in lease payments. The Company’s lease does not include termination options for either party to the lease or restrictive financial or other covenants. Payments due under the lease contract include fixed payments plus variable payments. The Company’s office space lease requires it to make variable payments for the Company’s proportionate share of the building’s property taxes, and common area operating expenses. These variable lease payments are not included in lease payments used to determine lease liability and are recognized as variable costs when incurred.

For the years ended December 31, 2025 and 2024, management has evaluated the various tax positions reflected in income tax returns for both federal and state jurisdictions. In assessing the ability to realize deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. Management believes that there are no tax positions for which a liability for unrecognized tax benefits should be recorded as of December 31, 2025. The Company’s federal income tax returns generally remain subject to examination by the Internal Revenue Service for three years from the date the return is due, including extensions for years in which the net operating loss is utilized. The Company’s state income tax returns are subject to examination, four years from the date of filing. Deferred income tax calculations reflect the effects of temporary differences between the carrying amounts of assets and liabilities and their tax bases, as well as from net operating loss carryforwards. Federal net operating losses incurred after December 31, 2017, can only offset 80% of taxable income in tax years beginning after December 31, 2020. However, these net operating losses may be carried forward indefinitely instead of such carryforward being limited to twenty years under previous tax law.

Payment of liquidation preferences rights to preferred stockholders are in the order of: first, the Series F redeemable convertible preferred stock, then the Series E-2 and Series E-1 redeemable convertible preferred stock, then the Series D redeemable convertible preferred stock, then the Series C redeemable convertible preferred stock, then the Series B and A redeemable convertible preferred stock. The liquidation values for the Series F, Series E-2, Series E-1, Series D, and Series C redeemable convertible preferred stock are equivalent to an amount equal to the respective original issue price per share, adjusted for any recapitalization, stock split and the like, plus any dividends declared but unpaid thereon. The liquidation values for the Series B and Series A redeemable convertible preferred stock are equivalent the greater of (i) an amount equal to 1.2 multiplied by the respective original issue price per share, adjusted for any recapitalization, stock split and the like, plus any dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series B and Series A redeemable convertible preferred stock been converted into common stock immediately prior to such liquidation, dissolution or winding up. The remaining assets, if any, shall be distributed among the holders of the shares of common stock, Series C Preferred Stock, Series D Preferred Stock, Series E-1 Preferred Stock, Series E-2 Preferred Stock, and Series F Preferred Stock, pro rata based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the terms of the Amended and Restated Certificate of Incorporation immediately prior to such liquidation, dissolution or winding up of the Corporation, or deemed liquidation event.

On December 15, 2022, the Board of Directors approved the Corporation’s 2022 Equity Incentive Plan (the 2022 Plan) providing for the grants of non-qualified stock options, incentive stock options and other stock-based awards up to an aggregate of 7,575,181 shares of common stock, $0.01 par value per share. This consisted of the available reserve from the 2007 Equity Incentive Plan (the 2007 Plan) plus all returned shares. The 2022 Plan serves as the successor to and continuation of the 2007 Plan, and all options that were granted under the 2007 Plan (unless forfeited, exercised or expired) remained outstanding as of December 31, 2022. Awards issued under the 2007 Plan remain subject to the terms of the 2007 Plan, and unissued authorized 2007 shares became available under the 2022 Plan. No issued 2007 Plan awards were converted. The 2007 Plan contained an antidilution provision. Following a 1,000-for-1 common stock split in June 2022, the number of option shares for prior periods was retrospectively adjusted to reflect the split. No other terms of these existing awards were changed except for the number of option shares and the exercise price to reflect the stock split. Because the modification did not result in incremental fair value under ASC 718, no additional compensation expense was recognized in 2022.

Under the 2022 Plan, stock options generally vest and become exercisable in respect of 25% of the total number of Shares initially subject to the Options on the first anniversary of the Vesting Commencement Date, and in respect of 1/48th of the total number of Shares initially subject to the Option on each monthly anniversary of the Vesting Commencement Date thereafter, so that 100% of the Shares subject to the Option shall be vested on the fourth anniversary of the Vesting Commencement Date, in each case, subject to the Optionee remaining as a Service Provider (as defined in the Plan) through the applicable vesting date. Certain awards may vest immediately upon grant or may be subject to performance-based vesting conditions, as determined by the Board of Directors. During the year ended 2025, the Company granted two executive awards that include performance-based vesting conditions which are immaterial. The Board of Directors administers the 2022 Plan and determines the exercise prices of options based on the fair value of the Company’s common stock as determined by an independent valuation, in certain instances, options have been granted with an exercise price in excess of fair market value at the date of grant.

Section 145 of the General Corporation Law of the State of Delaware (the Delaware General Corporation Law) provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses (including attorneys’ fees), judgments, fines, and amounts paid in settlement actually and reasonably incurred by such person in connection with any threatened, pending, or completed actions, suits, or proceedings in which such person is made a party by reason of such person being or having been a director, officer, employee, or agent to the registrant. The Delaware General Corporation Law provides that Section 145 is not exclusive of other rights to which those seeking indemnification may be entitled under any bylaw, agreement, vote of stockholders or disinterested directors, or otherwise. Article 8 of the registrant’s amended and restated certificate of incorporation provides for indemnification by the registrant of its directors, officers, and employees to the fullest extent permitted by the Delaware General Corporation Law. The registrant has entered into indemnification agreements with each of its current directors, executive officers, and certain other officers to provide these directors and officers additional contractual assurances regarding the scope of the indemnification set forth in the registrant’s amended and restated certificate of incorporation and amended and restated bylaws and to provide additional procedural protections. There is no pending litigation or proceeding involving a director or executive officer of the registrant for which indemnification is sought.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☒


	Per Share	Total
Initial public offering price	$	$
Underwriting discounts and commissions (1)	$	$
Proceeds, before expenses, to us	$	$


GENERAL INFORMATION			i
PROSPECTUS SUMMARY			1
RISK FACTORS			17
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS			80
USE OF PROCEEDS			82
DIVIDEND POLICY			83
CAPITALIZATION			84
DILUTION			86
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS			89
BUSINESS			103
MANAGEMENT			138
EXECUTIVE AND DIRECTOR COMPENSATION			145
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS			167
PRINCIPAL STOCKHOLDERS			172
DESCRIPTION OF CAPITAL STOCK			176
SHARES ELIGIBLE FOR FUTURE SALE			183
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS OF OUR COMMON STOCK			186
UNDERWRITING			190
LEGAL MATTERS			199
EXPERTS			199
WHERE YOU CAN FIND ADDITIONAL INFORMATION			199
INDEX TO FINANCIAL STATEMENTS			F-1


	Shares Purchased			Total Consideration			Weighted- Average Price Per Share
	Number	Percent		Amount	Percent
Existing stockholders before this offering		%		$	%		$
Investors participating in this offering		%		$	%		$
Total		100	%	$	100	%


Name and Principal Position	Year	Salary ($)		Option Awards ($)(1)		Non-Equity Incentive Plan Compensation ($)(2)		All Other Compensation ($)(3)		Total
Richard Foust	2025	$	422,708	$	1,251,585	$	225,750	$	6,275	$	1,906,318
Chief Executive Officer and President
Prashant Rawat	2025	$	422,300	$	374,993	$	155,952	$	8,232	$	961,477
Chief Operating Officer
Douglas (Doug) Ellison	2025	$	350,000	$	339,346	$	641,503	$	14,000	$	1,344,849
Chief Commercial Officer


B. Shayne Kennedy J. Ross McAloon Latham & Watkins LLP 650 Town Center Drive, 20th Floor Costa Mesa, California 92626 (714) 755-8181			Chase Leavitt Mobia Medical, Inc. 2802 Flintrock Trace, Suite 226 Austin, Texas 78738 (855) 628-9375			Ilir Mujalovic Lesley Janzen Cleary Gottlieb Steen & Hamilton LLP One Liberty Plaza New York, New York 10006 (212) 225-2000


	As of December 31, 2025
(in thousands, except per share data)	Actual		Pro forma	Pro forma as adjusted(1)
Cash and cash equivalents	$	33,587
Notes payable, net of discount and deferred financing costs(2)	$	7,130
Warrant liabilities	$	865
Redeemable Convertible preferred stock, $0.01 par value per share; 67,174,403 shares authorized, 65,591,701 shares issued and outstanding, actual; no shares authorized, issued or outstanding pro forma and pro forma as adjusted	$	179,773
Stockholders’ (deficit) equity:
Preferred stock, $0.01 par value; no shares authorized, issued and outstanding, actual; shares authorized, no shares issued and outstanding, pro forma and pro forma as adjusted	$	—
Common stock, $0.01 par value per share; 86,600,000 shares authorized, 3,079,173 shares issued and outstanding, actual; shares authorized, shares issued and outstanding, pro forma	$	31
Additional paid-in capital	$	6,985
Accumulated other comprehensive income	$	—
Accumulated deficit	$	(157,789)
Total stockholders’ deficit(3)	$	(150,774)
Total capitalization	$	36,995	$	$


	Year ended December 31,				Change
(in thousands, except percentage)	2025		2024		$		%
Revenue	$	32,041	$	15,644	$	16,397	104.8	%
Cost of goods sold	6,066		3,193		2,873		90.0	%
Gross profit	25,975		12,451		13,524		108.6	%
Operating expenses:
Research and development costs	6,515		4,243		2,272		53.5	%
Selling, general and administrative expenses	65,828		32,444		33,384		102.9	%
Total operating expenses	72,343		36,687		35,656		97.2	%
Loss from operations	(46,368)		(24,236)		(22,132)		91.3	%
Other income (expense):
Interest expense	(967)		(970)		3		(0.3)	%
Other income, net	842		617		225		36.5	%
Total other expense, net	(125)		(353)		228		(64.6)	%

Loss before provision for income taxes	(46,493)		(24,589)		(21,904)		89.1	%
Provision for income taxes	(5)		(14)		9		(64.3)	%
Net loss	$	(46,498)	$	(24,603)	$	(21,895)	89.0	%


Named Executive Officer	Annual Base Salary
Richard Foust	$	430,000
Prashant Rawat	$	424,360
Douglas (Doug) Ellison	$	350,000


Named Executive Officer	2025 Annual Bonus Target
Richard Foust	50	%
Prashant Rawat	35	%
Douglas (Doug) Ellison	30	%


	Grant Date	Number of Securities Underlying Unexercised Options (#) Exercisable	Number of Securities Underlying Unexercised Options (#) Unexercisable	Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#)	Option Exercise Price ($)		Option Expiration Date
Richard Foust	April 27, 2021	150,000	—	—	$	0.83	May 6, 2031
	December 15, 2022	1,772,291	37,709(1)	—	$	0.97	December 14, 2032
	March 27, 2025	192,911	1,163,455(1)	—	$	1.07	March 26, 2035
	April 25, 2025	—	—	222,634(2)	$	1.07	April 24, 2035
	October 17, 2025	—	584,128(1)	—	$	1.13	October 16, 2035
Prashant Rawat	December 15, 2022	601,125	85,875(1)	—	$	0.97	December 14, 2032
	March 27, 2025	67,227	374,507(1)	—	$	1.07	March 26, 2035
	October 17, 2025	—	198,826(1)	—	$	1.13	October 16, 2035
Douglas (Doug) Ellison	March 3, 2023	429,887	159,673(1)	—	$	0.97	March 2, 2033
	March 27, 2025	57,418	362,573(1)	—	$	1.07	March 26, 2035
	April 25, 2025	—	—	49,474(3)	$	1.07	April 24, 2035
	October 17, 2025	—	118,554(1)	—	$	1.13	October 16, 2035


Name	Fees Earned or Paid in Cash ($)		Option Awards ($)(1)		Total ($)
Maxwell Bikoff	—		—		—
Edward Hanlon	—		—		—
William (Bill) Harrington	—		—		—
Cindy Lucchese	$	50,000	$	88,314	$	138,314
Dana G. Mead, Jr.	$	50,000	$	88,314	$	138,314
Casey Tansey	—		—		—


Name						Options Outstanding at December 31, 2025
Cindy Lucchese						412,285
Dana G. Mead, Jr.						412,285


	Tranche 2 Closing			Second Tranche 2 Closing
Participants(1)	Shares of Series E-2 Redeemable Convertible Preferred Stock	Aggregate Purchase Price		Shares of Series E-2 Redeemable Convertible Preferred Stock	Aggregate Purchase Price
Entities affiliated with U.S. Venture Partners (1)	1,473,882	3,749,998		1,473,883	3,750,001
Entities affiliated with GPG Healthcare Opportunities Fund, LLC(2)	705,495	$	1,794,991	705,499	$	1,795,001
Osage University Partners III, LP	982,588	$	2,499,999	982,588	$	2,499,999
Lyda Hunt – Bunker Trust – Elizabeth H Curnes	786,070	$	1,999,998	786,071	$	2,000,000
Action Potential Venture Capital, Limited(3)	978,658	$	2,490,000	978,658	$	2,490,000
Exceller Hunt Microtransponder 2017, LP	594,431	$	1,512,411	594,431	$	1,512,411


Director / Officer						Principal Stockholder
Casey Tansey						Entities affiliated with U.S. Venture Partners
Nelson Bunker Curnes						Exceller Hunt Microtransponder 2017, LP and Lyda Hunt – Bunker Trust – Elizabeth H Curnes
Jordan Curnes						Exceller Hunt Microtransponder 2017, LP
William (Bill) Harrington						Entities affiliated with Osage University Partners


BTIG


Wolfe \| Nomura Alliance


	Initial Tranche			Second Tranche
Participants	Shares of Series F Redeemable Convertible Preferred Stock	Aggregate Purchase Price		Shares of Series F Redeemable Convertible Preferred Stock	Aggregate Purchase Price
Entities affiliated with U.S. Venture Partners (1)	2,821,369	$	7,424,996.82	2,821,369	$	7,424,996.82
Entities affiliated with GPG Healthcare Opportunities Fund, LLC(2)	844,509	$	2,222,494.36	844,509	$	2,222,494.36
Entities affiliated with Osage University Partners(3)	2,089,903	$	5,499,997.74	2,089,903	$	5,499,997.74
Lyda Hunt – Bunker Trust – Elizabeth H Curnes	569,973	$	1,499,997.95	569,973	$	1,499,997.95
Action Potential Venture Capital, Limited(4)	949,956	$	2,499,999.21	949,956	$	2,499,999.21
Exceller Hunt Microtransponder 2017, LP	569,973	$	1,499,997.95	569,973	$	1,499,997.95
Curnes Fund 2001	427,480	$	1,124,999.12	427,480	$	1,124,999.12


Participants	Principal Amount of 2026 Convertible Note
Entities affiliated with U.S. Venture Partners(1)	$	3,769,090.08
Entities affiliated with GPG Healthcare Opportunities Fund, LLC(2)	$	7,438,878.52
Entities affiliated with Osage University Partners(3)	$	6,588,847.28
Exceller Hunt Microtransponder 2017, LP	$	4,000,000.00
Synapse Investment, LP	$	3,000,000.00
Coöperatieve Gilde Healthcare VG VI U.A.	$	3,971,192.75
Longitude Venture Partners V, L.P.	$	3,971,192.75
Casey Tansey	$	2,000,000.00
Curnes Fund 2001	$	2,100,937.62


Underwriter						Number of Shares
BofA Securities, Inc.
J.P. Morgan Securities LLC
Goldman Sachs & Co. LLC
BTIG, LLC
Nomura Securities International, Inc.
WR Securities, LLC
Total


			Page
Report of Independent Registered Public Accounting Firm			F-2
Audited Financial Statements
Balance Sheets as of December 31, 2025 and 2024			F-3
Statements of Operations for the Years Ended December 31, 2025 and 2024			F-4
Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit for the Years Ended December 31, 2025 and 2024			F-5
Statements of Cash Flows for the Years Ended December 31, 2025 and 2024			F-6
Notes to Financial Statements			F-7


The accompanying notes are an integral part of these financial statements.


Mobia Medical, Inc. Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit


	2025		2024
Raw materials	$	1,191,550	$	1,518,000
Finished goods	4,265,207		1,911,162
Total inventory	$	5,456,757	$	3,429,162


			Estimated Life
Furniture and fixtures			5-7 years
Machinery and equipment			5-7 years
Computers and software			3 years
Leasehold Improvements			5 years


	Years ended December 31, 2025
	As reported		Adjustment		As revised
Net loss per share attributable to common stockholders:
Basic and diluted	$	(20.64)	$	(4.91)	$	(15.73)
Weighted-average shares used to compute net loss per share attributable to common stockholders:
Basic and diluted	2,252,494		703,921		2,956,415


	Level 1		Level 2		Level 3		Total
December 31, 2025
Liabilities
Warrant liability	$	—	$	—	$	865,390	$	865,390
Total liabilities, at fair value	$	—	$	—	$	865,390	$	865,390


December 31, 2025	Series B Preferred Warrants			Series D Preferred Warrants			Series E-2 and F Preferred Warrants
Strike Price	$	3.73744		$	4.207		$	2.5443
Expected Dividend Yield	—		%	—		%	—		%
Expected Term (years)	7			7.4			8
Volatility	80		%	80		%	80		%
Risk-free rate	3.445		%	3.445		%	3.445		%


December 31, 2024	Series B Preferred Warrants			Series D Preferred Warrants			Series E-2 and F Preferred Warrants
Strike Price	$	3.73744		$	4.207		$	2.5443
Expected Dividend Yield	—		%	—		%	—		%
Expected Term (years)	8			8.4			9
Volatility	85		%	85		%	85		%
Risk-free rate	4.289		%	4.289		%	4.289		%


	2025		2024
Employee expense reimbursements	$	513,330	$	195,923
Other	479,827		62,315
Total accrued and other current liabilities	$	993,157	$	258,238


	2025		2024
Beginning balance	$	437,219	$	—
Accruals for warranties issued	720,555		529,379
Claims settled	(314,103)		(92,160)
Ending balance	$	843,671	$	437,219


Years Ending December 31,
2026	$	—
2027	—
2028	6,875,000
2029	625,000
Total	7,500,000
Less: Unamortized debt discount and deferred financing costs	(370,072)
Total future minimum payments	$	7,129,928


	2025		2024
Operating lease cost	$	191,148	$	100,460
Short-term lease cost(1)	30,460		40,860
Variable lease cost	72,868		41,456
Total lease cost	$	294,476	$	182,776


	2025		2024
Right-of-use assets
Operating lease right-of-use asset	$	1,068,452	$	438,588
Operating lease liabilities
Operating lease liabilities, current	$	357,522	$	23,646
Operating lease liability, non-current portion	947,886		603,050
Total operating lease liabilities	$	1,305,408	$	626,696


Years Ending December 31
2026	453,460
2027	466,782
2028	386,956
2029	206,117
2030	70,276
Total undiscounted future minimum lease payments	1,583,591
Less amounts representing interest	278,183
Total lease liability	$	1,305,408


	2025			2024
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows used for operating leases (including short term leases)	$	142,118		$	99,846
Weighted-average remaining lease term (years)
Operating leases	3.54			8.59
Weighted-average discount rate
Operating leases	10.82		%	12.25		%


	2025		2024
Deferred tax assets
Net operating loss and tax credit carryforwards	$	31,891,974	$	20,464,532
Share-based compensation	938,949		543,347
Accumulated depreciation & amortization	3,970,286		3,027,937
Accrued expenses	696,707		—
Right-of-use lease liability	317,956		131,606
Other	97,372		21,565
Gross deferred tax assets	37,913,244		24,188,987
Deferred tax liabilities
Right-of-use lease asset	(260,241)		(92,103)
Gross deferred tax liabilities	(260,241)		(92,103)
Net deferred income tax assets before valuation allowance	37,653,003		24,096,884
Less valuation allowance	(37,653,003)		(24,096,884)
Net deferred income tax assets	$	—	$	—