Data Validate the Revi System’s Efficacy in Urgency Urinary Incontinence Therapy

BlueWind Medical Ltd. is sharing study results that confirm the efficacy, safety, and patient satisfaction associated with the Revi System for urgency urinary incontinence treatment (UUI).

Company executives claim the OASIS study data reinforce Revi’s standing as the most clinically validated implantable tibial neuromodulation (ITNM) therapy for UUI currently available. The OASIS study is a prospective, multicenter, single-arm, open-label clinical trial involving 151 adult women (mean age 58.8 years) with UUI. The trial evaluated the efficacy and safety of Revi in treating UUI symptoms in patients with overactive bladder(OAB)-wet.

Key findings from the three-year data include:

• Exceptional patient satisfaction: 95% (83/87) reported therapeutic satisfaction at 36 months
• Durable long-term benefit: Therapeutic effectiveness maintained from six to 36 months (response rates of 78% and 79%, respectively)
• High responder rate: 79% (71/90) of participants were therapy responders (≥50% reduction in UUI episodes from baseline)
• Robust symptom reduction: 63% (57/90) experienced a ≥75% reduction in UUI episodes
• Improved nighttime symptoms: Nocturia episodes decreased from 1.3 to 0.9 per day
• Consistent reduction in leaks: Significant and sustained decreases observed in both UUI episodes and large urgency-related leaks through 36 months
• Excellent safety profile: No device- or procedure-related serious adverse events reported through 36 months

“With the most comprehensive and longest-term data in Implantable Tibial Neuromodulation, BlueWind has set a new benchmark for durable, patient-centered therapy for UUI,” BlueWind Medical Chief Medical Officer Roger Dmochowski, said. “Revi delivers consistent, long-lasting outcomes, proving that effective, minimally invasive treatment can be both simple and transformative. These results reinforce Revi’s position as the gold standard for clinical evidence, patient satisfaction, and sustained quality-of-life improvement in urgency urinary incontinence.”

Revi is an ITNM device designed for treating UUI. Implanted near the ankle in a single outpatient procedure under local anesthesia, Revi delivers targeted stimulation to the posterior tibial nerve through a lightweight, external wearable. This design offers patients a simple, durable, and effective long-term solution for UUI symptom relief. Patients activate therapy once daily at home, without the need for internal batteries or leads, avoiding complications such as lead fracture, migration, or battery depletion.

BlueWind Medical develops patient-centric medical technology for disease treatment. BlueWind’s Revi System is reportedly the first and only ITNM device activated by a battery-operated external wearable to receive U.S. Food and Drug Administration clearance for UUI treatment. 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.”