PARK CITY, Utah--(BUSINESS WIRE)--BlueWind Medical, Ltd., a leader in implantable Tibial NeuroModulation (iTNM) and the developer of the Revi® System, today announced that new two-year data from its OASIS pivotal study were presented at the American Urogynecologic Society (AUGS) Pelvic Floor Disorders (PFD) Week 2024 in Washington, D.C., October 22-25 and the International Continence Society (ICS) 2024 Annual Meeting in Madrid, October 23-25.
Findings from a two-year, multi-center, single-arm pivotal trial demonstrated sustained efficacy and safety of iTNM for the treatment of urgency urinary incontinence (UUI) Key highlights include:
- High Therapy Satisfaction: At 24 months, 97% of participants reported satisfaction with Revi Therapy, and 80% felt "much better" or "very much better," according to the Patient Global Impression of Improvement (PGI-I).
- Durable Efficacy: The therapy's effectiveness in reducing UUI episodes was consistent over time, with 79% of the 97 participants who completed the 24-month assessment continuing to experience significant symptom relief.
- Excellent Safety Profile: There were no serious adverse events related to the device or procedure throughout the 24 months. The study recorded only one delayed surgical site-related adverse event between 12 and 24 months, which did not require device explantation.
Cindy Amundsen, M.D., Department of Obstetrics and Gynecology, Division of Urogynecology and Reconstructive Pelvic Surgery, Duke University, and investigator in the trial who presented at AUGS, said, "These data show that the therapeutic benefits of the Revi System are not only sustained over time but also result in consistently high patient satisfaction and a favorable safety profile, representing a meaningful technological advancement in the treatment of urgency urinary incontinence."
Revi, a Class II device, is an innovative iTNM device implanted near the ankle during a single outpatient procedure performed under local anesthesia, and without the reintervention rate seen with other UUI therapies (due to lead fracture, migration, or battery depletion). Patients initiate therapy at their convenience by placing a lightweight wireless wearable around their ankle once daily to provide stimulation to the posterior tibial nerve, offering relief from UUI symptoms.
"These findings reinforce the durability of significant response and high patient satisfaction of the Revi system, highlighting its status as the leading solution for implantable tibial neuromodulation,” said Roger Dmochowski, M.D., Chief Medical Officer, BlueWind Medical. “As physicians increasingly become aware of Revi as an important UUI treatment option, we are excited to share these results with the global community of healthcare professionals dedicated to advancing care for incontinence."
For more information on BlueWind Medical and the Revi System, please visit bluewindmedical.com.
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 wellbeing of patients with an initial focus on those living with urge urinary incontinence (UUI). BlueWind’s Revi System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA marketing authorization for 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.
