Uro Medical Corporation Acquires Micron Medical and Initiates the FDA IDE Approved “Guardian” RCT of the Protect PNS Injectable Tibial Stimulator for Treatment of Overactive Bladder
- Uro Medical’s breakthrough injectable neuromodulation product, Protect PNS, is currently under regulatory review by the FDA for market approval
Uro Medical Corporation, a privately-held urology-focused medical device company engaged in the development, manufacture, and commercialization of innovative, minimally invasive neurostimulation solutions, announced the acquisition of Micron Medical Corporation’s urology-based assets, including the continuation of the Protect randomized controlled trial (RCT), which is head to head study comparing tibial stimulation to sacral stimulation.
“Our new organization – Uro Medical Corporation – reflects our core business focus in urology and improving how neuromodulation is delivered to treat previously under-served urologic conditions,” said Matt Kemp, Chief Commercial Officer of Uro Medical. “As a company with its foundation in neuromodulation technology, we are committed to delivering breakthrough urology products, like our Protect PNS system, that we believe will increase access, lower costs and improve outcomes for millions of patients forced to seek bladder protection solutions. With our Protect PNS market approval application currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with refractory overactive bladder (OAB), we believe we are well-positioned to deliver on the company’s urology-focused mission.”
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In addition, Uro Medical announced the initiation of the Guardian clinical trial, a multi-center randomized controlled clinical trial evaluating the safety and efficacy of Protect PNS as compared to traditional medical management for the treatment for OAB. The Guardian study, which is evaluating the efficacy of tibial stimulation compared to pharmaceutical medical management, 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.
“We are excited to partner with Uro Medical as the first clinical trial site in the country to enroll for this pivotal clinical trial supporting the overall Protect PNS program,” said Dr. Larry Sirls, from Comprehensive Urology in Royal Oak, MI. “Based on the data generated to date in the earlier trials and it’s compelling product profile as an injectable device, Protect PNS has the potential to revolutionize how OAB patients are treated and become the standard of care.”
Mr. Kemp continued, “With our evolution into a fully-focused urology company complete, we are firmly dedicated to securing FDA approval of our pioneering wireless, minimally invasive, microtechnology neurostimulator, Protect PNS, for the treatment of OAB, a condition that affects over 37 million Americans, and preparing for its U.S. commercial launch.”
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