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Mobia Medical Announces Addition of Paired VNS to Updated AHA Stroke Guidelines

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Mobia Medical (Nasdaq: MOBI) announced that implantable paired Vagus Nerve Stimulation (VNS) has been included in the 2026 Guideline for Adult Stroke Rehabilitation and Recovery from the American Heart Association and American Stroke Association as a treatment option to improve upper-limb function and impairment in eligible chronic stroke survivors.

The guideline notes that VNS should be paired with high-dose, task-specific training. According to Mobia Medical, its Vivistim® Paired VNS™ System is currently the only FDA-approved system delivering this approach, aligning with updated guidance that emphasizes continuity of care, intensive task-specific therapy, and patient-specific functional outcomes.

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Positive

  • AHA/ASA 2026 guideline includes paired VNS for chronic stroke upper-limb recovery
  • Vivistim Paired VNS System is the only FDA-approved paired VNS option cited by Mobia
  • Guideline emphasis on high-dose, task-specific therapy aligns with Mobia’s treatment approach

Negative

  • None.

News Market Reaction – MOBI

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$386.84M Market Cap
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AUSTIN, Texas, Aug. 28, 2026 (GLOBE NEWSWIRE) -- Mobia Medical, Inc. (Nasdaq: MOBI), a medical device company redefining stroke recovery for survivors living with life-altering motor impairments, today announced that implantable paired Vagus Nerve Stimulation (VNS) has been recognized in the 2026 Guideline for Adult Stroke Rehabilitation and Recovery: A Guideline From the American Heart Association (AHA) and American Stroke Association (ASA), published August 27, 2026 in Stroke as a treatment option to improve upper-limb function and impairment for chronic stroke survivors.

The new guideline states that VNS paired with high-dose task-specific training may be considered to improve upper-limb function and impairment for eligible patients. Mobia Medical’s Vivistim® Paired VNS™ System is the only FDA-approved system that delivers this treatment approach.

“Recognition of paired VNS in the guideline for stroke recovery is a meaningful validation of the impact of our technology, which is grounded in our evidence-based approach to long-term stroke recovery,” said Richard Foust, President and Chief Executive Officer of Mobia Medical. “This is an important step in our mission to improve the standard of care for stroke survivors, and we're committed to continuing to build the evidence base that supports it.”

The updated AHA guideline supports several core principles of Mobia Medical’s approach to stroke recovery, including:

  • The importance of continuity of care with ongoing functional assessments for at least one year
  • The recognition of high-dose, task-specific therapy as a core component of effective stroke therapy
  • The evaluation of patient-specific functional outcomes concurrent with standardized measures of impairment and function

“It’s impactful to see paired VNS included in the new guideline. As a stroke neurologist, I've noticed that most of our advancements have focused on the hyperacute treatment of stroke, without many options for patients in the chronic phase with persistent motor deficits,” said David Z. Rose, M.D., Professor of Neurology, University of South Florida Morsani College of Medicine and Co-director of the Neurocardiac Program at Tampa General Hospital. “To offer an evidence-based technology like paired VNS that supports recovery during the chronic phase, even years later, has changed how we view the continuum of stroke care at our hospital and at many centers nationwide.”

Stroke remains one of the leading causes of long-term disability in the United States. With approximately 800,000 strokes occurring annually and roughly 10 million stroke survivors living in the country today, this represents a growing patient population as stroke survival rates improve due to advancements in acute intervention.1,2 However, upper-limb motor impairment is among the most common and disabling long-term consequences of stroke, and patients often plateau in their recovery around the onset of the chronic phase, or six months post-stroke. Treatment options to address these lasting deficits have historically been limited.

References

[1] Martin, Seth S., et al. "2025 Heart Disease and Stroke Statistics: A Report of US and Global Data from the American Heart Association." Circulation 151.8 (2025): e41-e660. [2] Waziry, Reem, et al. "Time Trends in Survival Following First Hemorrhagic or Ischemic Stroke Between 1991 and 2015 in the Rotterdam study." Stroke 51.3 (2020): 824-829.

About Mobia Medical, Inc.

Mobia Medical, Inc. is a 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 potential effect of the 2026 AHA and ASA guideline on clinical practice and on adoption of Vivistim Therapy, Mobia Medical's plans for continued clinical and real-world evidence generation, and Mobia Medical’s goal of changing the standard of care in stroke recovery. Forward-looking statements can be identified by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “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 2026 AHA and ASA guideline addresses treatment approaches and does not endorse any product or manufacturer.

Investor Relations Contact

Louisa Smith
Gilmartin Group, LLC
investors@mobia.com

Media Inquiries Contact

Terri Clevenger
tclevenger@waterhousebrands.com


FAQ

What did the 2026 AHA stroke rehabilitation guidelines say about paired VNS and Mobia Medical (MOBI)?

The 2026 AHA/ASA stroke rehabilitation guideline recognizes implantable paired Vagus Nerve Stimulation as a treatment option to improve upper-limb function in eligible chronic stroke survivors. According to Mobia Medical, this formally positions paired VNS within standard stroke recovery guidance for adult patients.

How is Mobia Medical’s Vivistim Paired VNS System used in chronic stroke recovery for MOBI patients?

Vivistim Paired VNS System delivers implantable Vagus Nerve Stimulation paired with high-dose, task-specific upper-limb therapy. According to Mobia Medical, this approach targets chronic stroke survivors with persistent motor impairment, supporting functional recovery even years after the initial stroke event.

Why is inclusion of paired VNS in the 2026 AHA stroke guidelines important for Mobia Medical (MOBI)?

Inclusion in the 2026 AHA/ASA guideline provides clinical recognition of paired VNS as a stroke rehabilitation option. According to Mobia Medical, this validates its evidence-based technology and aligns its Vivistim therapy with recommended care pathways for chronic stroke survivors.

Which stroke patients may benefit from paired VNS therapy using Mobia Medical’s Vivistim system (MOBI)?

The guideline notes paired VNS may be considered for eligible chronic stroke survivors with upper-limb impairment. According to Mobia Medical, Vivistim is intended for patients with long-term motor deficits who have plateaued in traditional rehabilitation around six months post-stroke.

How large is the potential patient population for Mobia Medical’s Vivistim Paired VNS stroke therapy (MOBI)?

Mobia Medical cites about 800,000 annual strokes and roughly 10 million stroke survivors in the United States. According to the company, many experience chronic upper-limb motor impairment, representing a substantial population with historically limited long-term rehabilitation options.