Mobia Medical Announces Publication of Two-Year Data from VNS-REHAB Trial Demonstrating Durable and Continued Stroke Recovery with Vivistim® Paired VNS™ Therapy
Rhea-AI Summary
Mobia Medical (Nasdaq: MOBI) reported two-year follow-up results from the pivotal VNS-REHAB trial of its Vivistim® Paired VNS™ Therapy, now published in Neurology. Among 49 chronic ischemic stroke survivors, 76% achieved a clinically meaningful response on the Fugl-Meyer Assessment of Upper Extremity impairment (FMA-UE) and/or the Wolf Motor Function Test (WMFT).
Participants showed an average FMA-UE improvement of +7.5 points from baseline (exceeding the ≥6-point MCID) and an average WMFT improvement of +0.63 (above the ≥0.4-point MCID). These gains were accompanied by statistically significant, clinically meaningful improvements in activities of daily living, hand and arm use, and stroke-specific quality of life. Three-year follow-up data from 16 participants suggest benefits can be durable long term, and some patients improved further between years one and two. No long-term serious therapy- or stimulation-related adverse events were reported through two years.
Positive
- 76% of 49 participants met clinically meaningful response on FMA-UE and/or WMFT at two years
- Mean FMA-UE change of +7.5 points at two years, above ≥6-point MCID
- Mean WMFT change of +0.63 at two years, above ≥0.4-point MCID
- Three-year outcome data available for 16 participants indicating maintained benefits
- No long-term serious therapy- or stimulation-related adverse events reported through two years
- Multicenter, triple-blinded, sham-controlled randomized trial (n=108) supporting FDA PMA in 2021
Negative
- Two-year follow-up outcomes reported for 49 participants, fewer than the original 108-patient cohort
- Three-year durability data currently limited to 16 participants
News Market Reaction – MOBI
In the Jul 15 session, MOBI gained 2.16%, reflecting a moderate positive market reaction. Argus tracked a peak move of +13.7% during that session. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 02 | Reimbursement update | Positive | -2.9% | CMS proposed maintaining Vivistim procedure payment in New Technology APC 1580. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
The last recorded news event with supportive reimbursement details was followed by a negative price reaction, hinting at a tendency to sell into positive headlines.
Key Terms
fugl-meyer assessment of upper extremity medical
wolf motor function test medical
minimum clinically important difference medical
stroke impact scale medical
motor activity log medical
premarket approval regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Findings published in Neurology® show improvements in upper-limb motor function, activities of daily living, and quality of life were sustained for at least two years
AUSTIN, Texas, July 14, 2026 (GLOBE NEWSWIRE) -- Mobia Medical, Inc. (Nasdaq: MOBI), a commercial-stage medical device company redefining stroke recovery for survivors living with life-altering motor impairments, today announced the publication of two-year follow-up data from the VNS-REHAB study in Neurology®, the official peer-reviewed journal of the American Academy of Neurology. The findings demonstrate that statistically significant and clinically meaningful improvements in upper-limb motor impairment and function, ability to perform activities of daily living, and quality of life were sustained for at least two years following completion of in-clinic Vivistim® Paired VNS™ Therapy. With its publication, this data now represents some of the most comprehensive longitudinal evidence to date for any intervention approved for chronic ischemic stroke recovery.
The two-year follow-up data, published in Neurology, reports outcomes from 49 participants in the VNS-REHAB pivotal trial, demonstrating a high responder rate and substantial improvements in impairment and function including:
- Clinically meaningful response on the Fugl-Meyer Assessment of Upper Extremity impairment (FMA-UE) and/or the Wolf Motor Function Test (WMFT) in
76% of participants - Average improvement of +7.5 points from baseline on the FMA-UE, exceeding the minimum clinically important difference (MCID) of ≥6 points
- Average improvement of +0.63 from baseline on the WMFT, exceeding the MCID of ≥0.4 points
Importantly, these upper-limb motor improvements also translated into impactful real-world changes in the daily lives of stroke survivors. Participants demonstrated statistically significant and clinically meaningful improvements across multiple patient-reported measures of activity, participation, and quality of life, including:
- Ability to perform activities of daily living, such as bathing and dressing (Activities of Daily Living subscale of the Stroke Impact Scale; SIS-ADL)
- Perceived ease of performing daily activities with the affected hand and arm, such as carrying heavy objects or tying shoelaces (Hand subscale of the Stroke Impact Scale; SIS-Hand)
- Amount of use and quality of movement of the affected hand and arm when performing activities of daily living, such as brushing teeth or typing (Motor Activity Log; MAL)
- Overall stroke-specific quality of life, such as mood, self-care, social participation and family roles (Stroke-Specific Quality of Life Scale; SS-QOL)
The study also captures positive three-year outcomes from 16 participants, providing further supporting evidence that the benefits are durable and maintained long-term. Additionally, a subset of the 49 total participants experienced further improvement in scores between years one and two, suggesting that recovery may continue over time with ongoing self-directed Vivistim Therapy.
“What distinguishes Vivistim Therapy from conventional rehabilitation is the ability to actively drive neuroplasticity and enable lasting changes. These two-year outcomes reinforce that the benefits are sustained over a long period of time and, for many individuals, they can continue to accrue. For stroke survivors who have spent years living with impairments, these results open new possibilities for continued recovery, greater independence, improved function, and a better quality of life, even years after their stroke,” said Teresa Jacobson Kimberley, PT, Ph.D., FAPTA, FASNR, a lead researcher on the study and Director of the Brain Recovery Lab at the MGH Institute of Health Professions.
In addition to data from patients enrolled in the VNS-REHAB trial, clinicians have observed similar long-term results in some of their earliest commercially treated patients. Dr. Christopher Kellner, a cerebrovascular neurosurgeon and Director of the Cerebrovascular Center at the Mount Sinai Health System in New York City noted, “The two-year outcomes published in Neurology are consistent with what I am observing with my own patients since the launch of our Vivistim Program in 2023. Beyond the measurable improvements in upper-limb motor function, patient-reported gains in daily living and quality of life are particularly meaningful. The formal publication of these findings further validates the durability of our observed in-clinic results and, I believe, will help expand access to this technology for more stroke survivors who could benefit.”
Taken together, these findings add to a growing body of evidence that Vivistim Therapy delivers meaningful recovery and durable results across multiple dimensions and are reflective of Mobia Medical’s commitment to generating broad-based clinical evidence to support expanded adoption.
“Publication of these two-year outcomes in Neurology represents an important milestone in the continued development of our clinical evidence base for Vivistim Therapy. At the heart of the data are real people who are regaining function, independence, and quality of life, and that is what drives everything we do,” said Richard Foust, President and CEO of Mobia Medical. “We believe the consistency and durability of our clinical outcomes will continue to strengthen awareness and adoption of Vivistim Therapy by key stakeholders and advance our mission to expand access for the millions of chronic stroke survivors who deserve a better path forward.”
The VNS-REHAB trial was a multicenter, triple-blinded, sham-controlled randomized controlled trial (n=108 participants) evaluating the safety and efficacy of Vivistim Paired VNS Therapy in chronic ischemic stroke survivors with moderate to severe upper extremity impairment. The pivotal results were published in The Lancet and supported FDA Premarket Approval of the Vivistim System in 2021. One-year follow-up data, published in Stroke in 2025, confirmed improvements were maintained at 12 months and the two-year data, now published in Neurology, further extend these findings. No long-term serious adverse events related to the therapy or stimulation were reported through two years of follow-up.
To learn more about the Vivistim® Paired VNS™ System, visit Vivistim.com/about. Click here to review the safety information.
References
Kimberley, Theresa J., Vora, Isha, Cramer, Steven C., Wolf, Steven L., Dawson, Jesse. (2026). Two-Year Retention of Benefits after Paired Vagus Nerve Stimulation in Stroke: Follow-Up of the VNS-REHAB Randomized Clinical Trial. Neurology, 107:e218298. doi:10.1212/WNL.0000000000218298
About Mobia Medical, Inc.
Mobia Medical, Inc. is a commercial-stage medical device company redefining stroke recovery for survivors living with life-altering motor impairments. The Company’s Vivistim® Paired VNS™ System is the first and only clinically validated, FDA-approved implantable solution designed to improve upper limb function in chronic ischemic stroke survivors with moderate to severe upper extremity impairments. Therapy with the Vivistim® Paired VNS™ System combines targeted vagus nerve stimulation with functional movement to promote neuroplasticity and drive meaningful improvements in motor function. Mobia Medical is mobilizing patients, providers, and care partners to establish a better way forward in stroke care.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the extent to which clinical benefits observed in the VNS-REHAB study may persist or continue to accrue beyond the periods studied or in other patients, the potential for continued or additional patient improvement over time with ongoing self-directed Vivistim Therapy, the number of chronic stroke survivors who may benefit from the Vivistim System, the effect of the published results and Mobia Medical’s clinical evidence on awareness and adoption of Vivistim Therapy by providers and payors and on patient access, and Mobia Medical’s plans to continue developing its clinical evidence base and expand access to Vivistim Therapy. Forward-looking statements can be identified by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “suggest,” “target,” “vision,” “will,” “would,” or similar expressions and the negatives of those terms. Mobia Medical cannot assure you that the forward-looking statements in this press release will prove to be accurate. Information in this press release may also include statements relating to past performance, which should not be regarded as a reliable indicator of future performance. Forward-looking statements are based on current expectations and assumptions together with projections of the future, which are inherently uncertain, and involve risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied. These risks and uncertainties include, among others, those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in Mobia Medical’s filings with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release, and Mobia Medical undertakes no obligation to update or revise any forward-looking statements except as required under applicable law. Mobia Medical may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. The clinical results described in this press release are based on a limited number of participants and a limited duration of follow-up and may not be predictive of long-term outcomes or results in broader patient populations.
Investor Relations Contact
Louisa Smith
Gilmartin Group, LLC
investors@mobia.com
Media Inquiries Contact
Terri Clevenger
tclevenger@waterhousebrands.com
