New data confirm Revi’s unmatched durability, 95% patient satisfaction, and excellent safety over three years, setting a new standard in Implantable Tibial Neuromodulation

BlueWind Medical, Ltd., a leader in Implantable Tibial Neuromodulation (ITNM) and developer of the Revi® System, a patient-centric solution for urgency urinary incontinence (UUI), today announced that three-year results from the pivotal OASIS study were presented by Roger Dmochowski, M.D., Chief Medical Officer, BlueWind Medical, at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) 2026 Winter Meeting. The data confirm Revi’s sustained efficacy, excellent safety, and exceptional patient satisfaction, reinforcing its position as the most clinically validated ITNM therapy for UUI currently available.

The OASIS study is a prospective, multicenter, single-arm, open-label clinical study 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 6 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,” said Dr. Dmochowski. “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.”

About the Revi® System

Revi® is an innovative Implantable Tibial Neuromodulation (ITNM) device designed for the treatment of urgency urinary incontinence (UUI). Implanted near the ankle in a single outpatient procedure under local anesthesia, Revi delivers targeted stimulation to the posterior tibial nerve via 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.

About BlueWind Medical Ltd.

BlueWind Medical is transforming the field of neuromodulation therapy through the development of innovative, patient-centric medical technology for the treatment of disease. BlueWind is committed to enhancing the quality of life and overall well-being of patients with an initial focus on those living with urgency urinary incontinence (UUI). BlueWind’s Revi® System is the first and only Implantable Tibial Neuromodulation (ITNM) device activated by a battery-operated external wearable to receive FDA clearance for the treatment of patients with UUI. 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.” For additional information about BlueWind Medical, please visit bluewindmedical.com.

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