BlueWind Medical Shares Two-Year Study Results for Revi System

BlueWind Medical Ltd.’s Revi System is safe and can help significantly reduce urgency urinary incontinence (UUI) episodes, two-year study results demonstrate.

Trial results from the pivotal OASIS study appear in this month’s issue of the Journal of Urology. OASIS is a prospective, multicenter, single-arm, open-label clinical study of 151 adult women (mean age 58.8 years) with UUI (urgency urinary incontinence; overactive bladder-wet syndrome [OAB-wet]). The trial evaluated the efficacy and safety of Revi in treating UUI symptoms in patients with OAB-wet. Primary efficacy and safety endpoints were assessed at six and 12 months, with 97 participants consenting to and completing the 24-month assessment.

Key findings at two years demonstrate Revi’s durable efficacy, highly favorable safety profile, and high patient satisfaction, supporting its use for treating UUI. Notably, a sustained therapy response was observed utilizing a more flexible provider and patient-driven schedule in year two (≥ two 30-minute sessions/week) compared to the first year (30-minute daily sessions). Patients averaged at least one treatment session on eight of 10 days, tailored to individual symptom needs.

Related: New Data Shows Benefits of BlueWind Medical’s Implantable Tibial Neuromodulation Tech

The OASIS study’s two-year analysis demonstrated that Revi provided sustained therapy response with:

• Durable reduction in UUI episodes, with 79% of participants experiencing a ≥50% reduction in UUI episodes and 56% achieving a ≥75% reduction in UUI.
• High satisfaction rates, with 97% of participants satisfied and 97% reporting feeling “better” to “very much better.”
• Freedom from leaks, with 28% of patients dry on a three-day voiding diary.
• Substantial reduction in large volume urgency-related leaks, one of the most debilitating aspects of UUI, from 0.9/day to 0.1/day.
• An excellent safety profile, with no device- or procedure-related serious adverse events, no device migrations, and no device revision procedures.

“What sets Revi apart is its patient centricity. The system allows patients to tailor treatment intervals to their symptoms and providers to individualize treatment plans to each patient,” said John Heesakkers, M.D., chairman of the Department of Urology of the Maastricht University Medical Center in the Netherlands. “It is encouraging to see that the OASIS study long-term data continues to validate the Revi System as a durable and effective treatment for UUI.”

With recent concerns about the potential link between anticholinergic agents and dementia risk, there is an increased need for flexible, non-pharmacologic treatment options. Revi is the first iTNM device for treating UUI labeled for use without prior failure of more conservative therapies. Revi, with its unique label, offers an effective treatment option, supported by the newly updated 2024 Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, which advocates for early consideration of minimally invasive therapy and emphasizes shared decision-making in OAB and UUI management.

“The two-year study results affirm the Revi System’s significant impact in improving OAB and UUI symptoms and underscore its innovation and effectiveness as a minimally invasive neuromodulation option,” BlueWind Medical Chief Medical Advisor Roger Dmochowski, M.D., said. “Our commitment remains steadfast to enhancing treatment options and elevating the quality of life for people grappling with UUI.”

BlueWind Medical develops neuromodulation therapy to treat disease, with an initial focus on UUI. The Revi System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive U.S. Food and Drug Administration clearance for patients with UUI, according to the company. Revi is the only neuromodulation therapy on the market that allows physicians to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System rather than mandating “step-therapy.”