UroMems announced that it received FDA investigational device exemption (IDE) approval to begin a first-of-its-kind trial for its smart implant.
The trial evaluates the UroActive smart implant to treat stress urinary incontinence (SUI) in men. Grenoble, France-based UroMems also received approval for the trial from the French National Agency for the Safety of Medicines and Health Products (ANSM).
UroMems’ SOPHIA2 study evaluates the safety and efficacy of the smart automated artificial urinary sphincter (AUS) in treating SUI. Powered by a MyoElectroMechanical system (MEMS), UroActive goes into the urethral duct in men and bladder neck in women. It’s controlled by a patient’s activity without the need for manual adjustments. This provides patients ease of use and better quality of life compared to other options.
The company previously had positive early feasibility data in a study of six men, then reported the first-ever female implant last year. In June 2024, the company raised $47 million to support clinical trials
UroMems plans to use SOPHIA2 findings as the basis for its regulatory submission to the FDA. It expects outcomes to support its broader commercialization goals in the U.S. and Europe.
“This marks a key milestone that has been more than a decade in the making, and brings us a significant step closer to delivering the relief from symptoms and return to life that UroActive has the potential to provide patients suffering from SUI,” said Hamid Lamraoui, UroMems CEO and co-founder. “UroActive is the first and only smart automated AUS to reach this critical milestone, indicating a new era for millions of people suffering from SUI, while signaling an exciting transition for surgeons treating SUI across the U.S. and Europe.”
