UroMems Receives FDA and ANSM Clearance for Pioneering UroActive Smart Implant Study

UroMems Achieves Regulatory Milestone with FDA and ANSM Clearance

UroMems, an innovative company specializing in mechatronics technology, has reached a significant milestone by receiving investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM). This crucial step enables UroMems to initiate a landmark pivotal clinical study of its UroActive smart implant, specifically designed to combat stress urinary incontinence (SUI) in men.

The Importance of the UroActive Smart Implant

The upcoming clinical trial, referred to as the SOPHIA2 study, marks a groundbreaking effort to evaluate the safety and efficacy of the UroActive System—the first smart automated artificial urinary sphincter (AUS) intended for male patients suffering from SUI. The approvals from both the FDA and ANSM follow strong feasibility study results demonstrating success for both genders in France.

Hamid Lamraoui, the CEO and co-founder of UroMems, expressed his enthusiasm regarding this development. He stated, “This marks a key milestone that has been more than a decade in the making, and it brings us a significant step closer to delivering relief from symptoms and the ability to return to normal life for patients affected by SUI.” He further emphasized that UroActive is the first of its kind to achieve such regulatory approval, suggesting a new era for the millions affected by this condition across both the U.S. and Europe.

Innovative Technology Behind UroActive

The UroActive implant operates through a MyoElectroMechanical System (MEMS). This revolutionary technology is positioned around the urethral duct and functions based on the patient's activity level, seeking to enhance usability and improve the quality of life for individuals compared to existing treatment options.

Prominent U.S. investigators leading the trial include Dr. Melissa Kaufman, a professor and chief of reconstructive surgery at Vanderbilt University, alongside Dr. Drew Peterson from Duke University. Dr. Kaufman shared the excitement of the research team highlighting the shortcomings of current treatments for SUI.