UroMems Receives FDA and ANSM Clearance for Pivotal Trial of Smart Artificial Urinary Sphincter
Key Insights
UroMems (search) received investigational device exemption approval from the FDA and French ANSM (search) to begin the SOPHIA2 pivotal trial of its UroActive (search) smart implant for treating male stress urinary incontinence (search).
The UroActive (search) system represents the first automated artificial urinary sphincter (search) with smart technology, utilizing a MyoElectroMechanical System that adapts treatment based on patient activity without complex manipulation.
The multicenter trial follows strong feasibility study results in France showing over one year with no need for revision or explant, with the study serving as the basis for regulatory submissions to commercialize in US and European markets.
UroMems (search) has achieved a significant regulatory milestone with 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 (search)) to initiate the SOPHIA2 pivotal clinical trial. This prospective, multicenter study will evaluate the safety and efficacy of the UroActive (search) System, the first smart automated artificial urinary sphincter (search) (AUS) for treating stress urinary incontinence (search) (SUI) in men.
The regulatory approvals follow strong feasibility study results for both women and men conducted in France, marking what company leadership describes as a decade-long development effort reaching a critical juncture.
Revolutionary Smart Implant Technology
The UroActive (search) system is powered by a MyoElectroMechanical System (MEMS) that represents a fundamental departure from existing treatment approaches. This innovative system is placed around the urethral duct (search) and is controlled based on the patient's activity, without the need for complex manipulation, intending to provide patients with ease of use and a better quality of life than current options.
"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 (search) has the potential to provide patients suffering from SUI," says Hamid Lamraoui, UroMems (search) chief executive officer 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."
Clinical Leadership and Study Design
The SOPHIA2 study will be led by prominent co-principal US investigators including Dr. Melissa Kaufman, FPMRS, professor and chief reconstructive surgery at Vanderbilt University in Nashville and Dr. Drew Peterson, FPMRS, professor at Duke University (search) in Durham, NC.
"We have seen first-hand the shortcomings of current SUI treatment options for our male and female patients," said Dr. Kaufman on behalf of both co-principal investigators. "That's why we're so excited to be leading the SOPHIA2 trial, as it's showing promise to provide significant improvements in addressing these issues. Based on the feasibility study data we've seen, UroActive (search) has the potential to be a transformational technology."
Promising Feasibility Results
The French feasibility study data has demonstrated encouraging outcomes across multiple parameters. Professor Emmanuel Chartier-Kastler, Urology Chair, Sorbonne University (search) and Pitié-Salpêtrière Hospital in Paris, reported exceptionally strong results for both men and women in France as part of the feasibility clinical study, including over one year with no need for revision nor explant and extremely high praise from patients who had been suffering from SUI for years.
"We look forward to conducting the pivotal SOPHIA2 study in France in lock step with the U.S. sites," Professor Chartier-Kastler noted.
Addressing Significant Unmet Medical Need
Stress urinary incontinence (search), or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma.
The UroMems (search) technology platform is protected by more than 180 granted patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. UroActive (search) is the first active implantable electronic artificial urinary sphincter (search) (AUS) that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI.
Regulatory and Commercial Strategy
The SOPHIA2 study will serve as the basis for UroMems (search)' regulatory submission to the FDA and supports its broader strategy to commercialize UroActive (search) in the U.S. and European markets. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.
The development of this innovative technology is financially supported by the European Innovation Council and France 2030, underscoring the significant investment in advancing treatment options for this widespread condition.