UroMems Receives FDA and ANSM Approval for Innovative UroActive Implant Study

UroMems Achieves FDA and ANSM Approval for Pivotal Study on UroActive Implant

In a significant advancement for men's health, UroMems, a global leader in mechatronic technology, has recently obtained essential approvals from both the U.S. Food and Drug Administration (FDA) and France's National Agency for the Safety of Medicines and Health Products (ANSM). These endorsements will enable the company to initiate the pivotal clinical study of their innovative smart implant, UroActive®, aimed specifically at treating stress urinary incontinence (SUI) in men.

The upcoming multicentric prospective study, labeled SOPHIA2, marks the first of its kind and is designed to evaluate the safety and effectiveness of the UroActive system, which is touted as the world's first automatic smart artificial urinary sphincter (SUA) for managing SUI. This monumental approval comes after UroMems reported successful clinical feasibility results from trials conducted in France with both male and female patients.

Hamid Lamraoui, the CEO and co-founder of UroMems, shared his thoughts on this milestone: "This is a critical turning point that has been over a decade in the making, propelling us closer to our goal of alleviating symptoms and restoring normalcy for those afflicted with SUI. UroActive is poised to provide hope for millions struggling with this condition and presents an exciting transition for surgeons treating SUI across the U.S. and Europe."

The UroActive device operates through a unique myoelectromechanical system that encircles the urethra. This technology responds to the patient's activity and requires less complex manipulation, thereby promising enhanced usability and improved quality of life compared to existing treatment methods.

UroMems has appointed prominent experts in the field to lead the study. Dr. Melissa Kaufman, an esteemed urologist specializing in pelvic reconstructive surgery at Vanderbilt University in Nashville, TN, along with Dr. Drew Peterson, who shares similar expertise at Duke University, are both co-investigators for the SOPHIA2 study. Dr. Kaufman noted, "We have personally observed the shortcomings of current therapeutic options for SUI in our male and female patients, which fuels our excitement in leading the SOPHIA2 trial that aims to revolutionize the management of these disorders. Preliminary data from our feasibility study suggests that UroActive holds the potential to be a groundbreaking technology."

Additionally, Professor Emmanuel Chartier-Kastler, Chief of Urology at Sorbonne University and Pitié-Salpêtrière Hospital in Paris, expressed optimism: "In our clinical feasibility study in France, we witnessed exceptional results in both men and women, with over a year of no revision or explantation required and extremely positive feedback from patients who had suffered from urinary incontinence for years. We anticipate conducting the pivotal SOPHIA2 study in France while closely collaborating with U.S. sites."

SUI is a significant health issue, impacting approximately 40 million Americans and 90 million Europeans. The condition can severely affect an individual's quality of life, often leading to depression, low self-esteem, and social stigma.

The SOPHIA2 study is slated to serve as a foundation for UroMems' regulatory submission to the FDA while supporting their broader strategy to bring UroActive to market in the U.S. and European regions.

About UroActive

UroMems’ technological platform is safeguarded by over 180 issued patents and has been developed to overcome the limitations of current treatment solutions by enhancing safety, effectiveness, patient experience, and convenience for surgeons. The UroActive system is the premier actively implantable electronic artificial urinary sphincter, designed to compensate for sphincter insufficiency in both male and female patients suffering from SUI.

Although UroActive has not yet gained commercialization approval from the FDA and remains unavailable for sale in the U.S. and EU, it has received substantial support from the European Innovation Council and the France 2030 Plan. For additional information, visit www.uromems.com.