Mobia Medical publishes two-year Vivistim VNS stroke trial data
Mobia Medical has announced the publication of two-year follow-up data from its VNS-REHAB pivotal trial in the peer-reviewed journal Neurology, reporting that clinically meaningful improvements in upper-limb motor function were sustained well beyond the active treatment phase in chronic ischemic stroke survivors.
The data, drawn from 49 participants in the original 108-person randomised controlled trial, showed that 76% achieved a clinically meaningful response on at least one of the two primary motor assessments: the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) or the Wolf Motor Function Test (WMFT). Mean improvement on the FMA-UE reached 7.5 points from baseline, exceeding the minimum clinically important difference of six points, while the WMFT average gain of 0.63 points similarly cleared its accepted threshold of 0.4 points.
Beyond the motor scores, participants also reported statistically significant gains across patient-reported measures of daily living, including bathing, dressing, carrying objects, and quality of life domains such as mood and social participation. A subset of 16 participants with three-year data provided additional supporting evidence that benefits can persist beyond the two-year window.
Trial design and regulatory context
The VNS-REHAB study was a multicenter, triple-blinded, sham-controlled randomised trial that underpinned FDA Premarket Approval of the Vivistim System in 2021. One-year data published in Stroke in 2025 had already confirmed that improvements were maintained at 12 months; the Neurology publication extends that longitudinal picture further. No long-term serious adverse events related to therapy or stimulation were reported through two years of follow-up.
Teresa Jacobson Kimberley, a lead researcher and Director of the Brain Recovery Lab at the MGH Institute of Health Professions, said: "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."
Market and competitive context
Vivistim occupies a relatively uncrowded space in the post-stroke rehabilitation device market. Paired vagus nerve stimulation, which combines implantable stimulation with task-specific movement therapy to promote neuroplasticity, has no direct FDA-approved implantable competitor for this indication, though non-invasive VNS devices and transcranial magnetic stimulation systems compete for rehabilitation budgets and clinical attention in stroke centres.
The broader neurorehabilitation market has attracted growing interest from both device companies and digital health players, with upper-limb robot-assisted therapy and gamified home rehabilitation platforms expanding the competitive set. For Mobia Medical, the key commercial question is payor adoption: FDA approval is necessary but not sufficient, and longitudinal outcome data published in high-impact journals such as Neurology is precisely the kind of evidence that US health systems and insurers require when evaluating coverage decisions for implantable devices.
Richard Foust, President and Chief Executive of Mobia Medical, described the Neurology publication as "an important milestone in the continued development of our clinical evidence base," noting that consistency and durability of results would be central to the company's effort to expand provider and payor awareness.
With three-year data now available for a subset of participants, and a commercial programme running since 2021, Mobia Medical is positioned to pursue broader reimbursement arguments. The next milestone to watch is whether the company seeks label expansion or initiates additional registry studies to capture real-world outcomes across a more diverse patient population than a controlled trial typically enrols.