Uro Medical is strengthening its urology portfolio with the acquisition of Micron Medical. As part of the acquisition Boca Raton, Fla-based Uro Medical will initiate the Guardian randomized control trial of the Protect PNS Injectable Tibial Stimulator for the treatment of overactive bladder (OAB).
The Guardian study will compare the efficacy of tibial stimulation against pharmaceutical medical management. The study is expected to enroll about 600 patients and the results will be used to support long term, nationwide payor reimbursement coverage as a mainline therapy option.
“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 FDA for the treatment of patients with refractory overactive bladder, we believe we are well-positioned to deliver on the company’s urology-focused mission.”
The competitive landscape in the treatment of OAB is a fierce one. About 37 million Americans suffer from symptoms of OAB, which can have a significant impairment on a patient’s day-to-day activities.
There are newcomers like Bluewind Medical. The firm is developing a device small enough to be implanted in the ankle that is powered by a wearable, rather than an implantable pacemaker-like device.
Based in Herzliya, Israel — with U.S. headquarters in Park City, UT — BlueWind Medical began enrolling patients in a pivotal study of its Renova iStim implantable tibial neuromodulation system last year.
The biggest players in the space are Medtronic and Axonics Modulation Technologies – two companies that have been embroiled in patent wars in recent years.
Dublin-based Medtronic pioneered the sacral neuromodulation (SNM) market over 20 years ago with its InterStim device, used to treat various bladder and bowel conditions. In 2019, Axonics won FDA approval for a rechargeable version of a similar device.