BlueWind Medical Revi™ Patient-Centric Solution for Urge Urinary Incontinence Now Available at Mount Carmel Health in Ohio

2024-04-09

上市批准

PARK CITY, Utah, April 9, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a trailblazer in patient-centric healthcare innovations, announced that distinguished urologist Dr. Jeffrey Carey of the Central Ohio Urology Group is now offering Revi implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI).

"Many of my patients are looking for an alternative to ongoing drug therapy" shared Dr. Jeffrey Carey. "Revi provides individually tailored therapy that patients deliver themselves, on their schedule, and at their convenience. Coupled with the excellent safety and efficacy of Revi, it's a welcome choice for urge incontinence patients."

Revi is an innovative Implantable Tibial NeuroModulation (iTNM) device placed near the ankle in a single predictable procedure under local anesthesia and is powered by a lightweight external wearable that is used at the patient's convenience once or twice daily to provide therapy. When activated, the Revi implant stimulates the posterior tibial nerve to provide relief from UUI. In the OASIS pivotal trial, Revi was proven safe and effective, without the potential adverse events seen with drugs and other surgical UUI therapies. Revi received FDA marketing authorization in August 2023, with no conditions of approval or post-market study requirements. 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".

"Revi is revolutionizing the approach to treating UUI by offering a patient-centered approach. UUI, a prevalent and incapacitating condition, impacts around 16 million individuals in the U.S., with most never receiving adequate treatment. We feel privileged that Dr. Carey and the central Ohio community now have access to this transformative therapy, fulfilling our mission to improve patients' quality of life and well-being" said Dan Lemaitre, Chief Executive Officer of BlueWind Medical.

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.

For additional information about BlueWind Medical, please visit https://bluewindmedical.com/

SOURCE BlueWind Medical

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