Mobia Medical, Inc. (Nasdaq: MOBI) announced the publication of two-year follow-up data from the VNS-REHAB clinical trial in Neurology, the peer-reviewed journal of the American Academy of Neurology, reporting sustained improvements in upper-limb motor function among chronic ischemic stroke survivors treated with its Vivistim Paired VNS Therapy.

The study followed 49 participants from the original VNS-REHAB pivotal trial. Results showed that 76% of participants achieved a clinically meaningful response on at least one of two standard assessments: the Fugl-Meyer Assessment of Upper Extremity impairment or the Wolf Motor Function Test. Average improvement on the Fugl-Meyer scale was 7.5 points from baseline, exceeding the minimum clinically important difference of six points. Average improvement on the Wolf Motor Function Test was 0.63 points, exceeding the threshold of 0.4 points.

Participants also showed statistically significant improvements in patient-reported measures, including ability to perform activities of daily living, perceived ease of using the affected hand and arm, and overall stroke-specific quality of life. A subset of 16 participants provided data at three years, with results described as consistent with the two-year findings. No long-term serious adverse events related to the therapy or stimulation were reported through two years of follow-up.

The original VNS-REHAB trial was a multicenter, triple-blinded, sham-controlled randomized controlled trial involving 108 participants. Its pivotal results were published in The Lancet and supported FDA Premarket Approval of the Vivistim System in 2021. One-year follow-up data were published in Stroke in 2025.

"Publication of these two-year outcomes in Neurology represents an important milestone in the continued development of our clinical evidence base for Vivistim Therapy," said Richard Foust, President and CEO of Mobia Medical.

Teresa Jacobson Kimberley, a lead researcher on the study and Director of the Brain Recovery Lab at the MGH Institute of Health Professions, said the two-year outcomes "reinforce that the benefits are sustained over a long period of time."