Published Data Demonstrate Excellent Safety and Efficacy and Reinforce Patient Satisfaction with Revi™ System in the Treatment of Urge Urinary Incontinence

PARK CITY, Utah, April 23, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a pioneer in implantable Tibial NeuroModulation (iTNM) and the developer of Revi^TM, a patient-centric solution for urge urinary incontinence (UUI), today announced that the peer-reviewed results from the OASIS pivotal trial were published in the Journal of Neurourology and Urodynamics (NAU). OASIS, a prospective, multicenter, single-arm, open-label clinical study of 151 women, was designed to demonstrate the safety and efficacy of Revi in reducing symptoms of overactive bladder (OAB).

The trial results demonstrate a statistically significant improvement with a 78.4% clinical success rate as defined by at least a 50% reduction in UUI at 12 months in the intention to treat (ITT) analysis (p<.0001). In the completers analysis, at the 12-month follow-up, 82.0 % of participants achieved at least a 50% reduction in UUI episodes, 66.9% achieved at least a 75% reduction, and 50% were dry for at least 3 consecutive days. Notably, there were no procedure- or device-related serious adverse events and no surgical reintervention/revisions as a consequence of implant migration, lead breakage, or battery replacement.

"OAB is a chronic and debilitating condition that significantly impairs quality of life with significant financial costs for many people. One in six adults in Europe and the U.S. have OAB," said John Heesakkers, M.D., Chairman of the Department of Urology of the Maastricht UMC, the Netherlands, and the International Continence Society General Secretary. "The data published in NAU underscore the effectiveness of Revi as a valuable therapy for individuals living with UUI who oftentimes go untreated."

Additional 12-month data highlights include:

• 93.5% of participants with available PGI‐I data reported their symptoms were better, much better, or very much better
• 84.6% of participants had a mean improvement greater than the 10-point minimum clinically important difference in Health-Related Quality of Life
• 88.0% of participants demonstrated a significant improvement in either UUI or large volume (severe) incontinence episodes

These strong efficacy results, a compelling safety profile combined with high patient satisfaction and clinically significant improvements in quality of life, clearly demonstrate the value of the Revi System in reducing OAB symptoms. In addition, the unique patient-centric nature of the therapy, which allows for individually tailored treatment, resulted in an increasing improvement in UUI over time.

"The publication of the OASIS pivotal data within the Journal of Neurourology and Urodynamics marks a significant milestone for Revi, showcasing our commitment to advancing treatment options for people living with UUI," said Dan Lemaitre, chief executive officer of BlueWind Medical. "Moreover, BlueWind is dedicated to supporting the patients who are impacted by urge incontinence and the health care providers who care for them."

OAB is a chronic condition that requires consistent and long-term therapy to manage symptoms. Drug therapy is often used to manage OAB and UUI, however, concerns have emerged regarding the long-term use of anticholinergics, the most common medications used. Anticholinergics, in addition to poor tolerability due to side effects, have in recent years come under the spotlight due to significant associations between their use and increased risk of cognitive impairment and dementia.¹ Increasingly, providers are discontinuing anticholinergic prescribing, however, the alternative medications for OAB, the b3-adrenergic receptor agonists, are not available to many patients due to cost and insurance plans with limited access.² Thus, Revi presents a safe and effective long-term solution for those suffering with UUI.

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 https://bluewindmedical.com/

1. Clinical Consensus Statement: Association of Anticholinergic Medication Use and Cognition in Women With Overactive Bladder. Female Pelvic Med Reconstr Surg. 2021;27(2):69-71. doi:10.1097/SPV.0000000000001008

2. Dmochowski RR, Newman DK, Rovner ES, Zillioux J, Malik RD, Ackerman AL. Patient and Clinician Challenges with Anticholinergic Step Therapy in the Treatment of Overactive Bladder: A Narrative Review. Adv Ther. 2023;40(11):4741-4757. doi:10.1007/s12325-023-02625-8

SOURCE BlueWind Medical