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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. Our principal executive offices are located at 2802 Flintrock Trace, Suite 226, Austin, TX.
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