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.
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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.