Patients in Utah Now Have Access to the Novel Revi™ Implantable Tibial Neuromodulation Device for the Treatment of Urge Urinary Incontinence

2024-03-27

上市批准

Revi is a patient-centric solution that empowers patients and redefines the treatment of urge urinary incontinence in a minimally invasive, approachable outpatient procedure

PARK CITY, Utah, March 27, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a pioneer in the development and commercialization of a patient-centric implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI), is excited to announce that Revi is now available in Utah with urologist Dr. Sara Lenherr at the University of Utah.

"Revi is a solution for the millions of people dealing with Urge Urinary Incontinence (UUI). I look forward to offering Revi to my patients, especially those who are unable to tolerate, afford, or are not good candidates for drug therapy," shared Dr. Sara Lenherr. "Revi offers a patient-centered design, which allows for individually tailored therapy that patients can deliver themselves, on their schedule and at their convenience."

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 changing the treatment paradigm for UUI by providing a patient-centric solution. UUI is a common and debilitating condition, affecting approximately 16 million people in the U.S., most of whom never receive effective treatment. We are honored that Dr. Lenherr, and the University of Utah, are providing access to this life-changing therapy and we are gratified to deliver on our vision to enhance the quality of life and well-being of patients," 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 www.bluewindmedical.com

SOURCE BlueWind Medical

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