Uro Medical Wireless MicroStimulator Secures CMS Coverage of 2nd Clinical Trial for Treatment of Overactive Bladder

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Jun 30, 2022, 06:00 ET

BOCA RATON, Fla., June 30, 2022 /PRNewswire/ -- Uro Medical Corporation, a privately-held urology-focused medical device company engaged in the development, manufacture, and commercialization of innovative, minimally invasive neurostimulation solutions leveraging nanotechnology creating the smallest stimulators in existence, today announced the Center for Medicare and Medicaid Services (CMS) coverage for participants in the GUARDIAN™ clinical trial, a multi-center randomized controlled clinical study evaluating the safety and efficacy of the Protect PNS neurostimulator medical device, as compared to traditional pharmaceutical medical management for the treatment for overactive bladder (OAB).

"CMS support of the Guardian clinical trial furthers our goal of establishing Protect PNS as a viable treatment option for patients suffering from refractory OAB", said Shanice Saunders, Executive Vice President of Clinical Affairs for Uro Medical. This study is expected to enroll approximately 600 subjects with refractory OAB across multiple clinical sites in the United States. The results of this study, which is the second randomized clinical trial conducted for the Protect PNS device, will be used to support long term, nationwide payor reimbursement coverage as a mainline therapy option post FDA market authorization.

"Our on-going Protect randomized controlled trial supporting registration, combined with Guardian creates a unique opportunity to examine Protect PNS clinical utility in both third and second-line applications", said Shanice Saunders, Vice President of Clinical. "As a clinician seeing patients routinely fail medical management of OAB, I'm excited to learn how Protect PNS may play an earlier role as an alternative to pharmaceuticals", said Dr. Larry Sirls, investigator in the Guardian clinical trial.

Learn more about Uro Medical Corporation at www.uromedical.com.

About Protect PNS

Protect PNS is a wirelessly powered, minimally invasive, microtechnology neurostimulator intended to treat overactive bladder (OAB). Protect PNS is currently being studied for the treatment of OAB and is under regulatory review for market approval by the FDA.

About Uro Medical

Uro Medical is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with convenient, safe, minimally invasive, and highly cost-effective urological solutions that are easily incorporated into their daily lives. Uro Medical's goal is to evolve its patented, cutting-edge platform for neuromodulation to standard of care, increasing the accessibility for patients worldwide while lowering the economic impact of urology care management. www.uromedical.com.

Contact: Michael Perryman, [email protected]

SOURCE Uro Medical Corporation