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Mobia Medical Announces Publication of Two-Year Data from VNS-REHAB Trial Demonstrating Durable and Continued Stroke Recovery with Vivistim® Paired VNS™ Therapy

  • Mobia Medical announced the publication of two-year follow-up data from the VNS-REHAB study in the journal Neurology on July 14, 2026.
  • The data involved 49 participants & demonstrated sustained statistically significant improvements in upper-limb motor impairment, daily living activities, & quality of life.
  • 76% of participants showed a clinically meaningful response on the Fugl-Meyer Assessment or Wolf Motor Function Test.
  • Participants achieved an average improvement of +7.5 points on the Fugl-Meyer Assessment, exceeding the minimum clinically important difference of ≥6 points.
  • Participants achieved an average improvement of +0.63 on the Wolf Motor Function Test, exceeding the minimum clinically important difference of ≥0.4 points.
  • Real-world benefits included improvements in bathing, dressing, carrying objects, tying shoelaces, & overall stroke-specific quality of life.
  • Three-year outcome data from 16 participants indicated that benefits remain durable over time.
  • Some participants showed further score improvements between years one & two, suggesting recovery may continue with ongoing self-directed therapy.
  • No long-term serious adverse events related to Vivistim Therapy or stimulation were reported during the two-year follow-up period.
  • The VNS-REHAB trial was a multicenter, triple-blinded, sham-controlled randomized controlled trial that supported FDA Premarket Approval of the Vivistim System in 2021.
  • Clinicians report that real-world observations from commercially treated patients align with the published two-year clinical trial outcomes.
  • Mobia Medical views this publication as a milestone for expanding access to Vivistim Therapy for chronic stroke survivors.