UroMems Achieves Groundbreaking FDA and ANSM Approval for UroActive Implant Clinical Study

UroMems Secures FDA and ANSM Approval for Pivotal Clinical Study

In a groundbreaking achievement, UroMems, a frontrunner in the development of innovative mechatronics technology, has received clearance from the U.S. Food and Drug Administration (FDA) and the French National Agency for the Safety of Medicines and Health Products (ANSM). This pivotal approval will allow UroMems to launch an unprecedented clinical trial for the UroActive smart implant, targeting the treatment of male stress urinary incontinence (SUI).

Significance of the Approval

This investigational device exemption (IDE) marks a crucial step forward for UroMems, enabling the commencement of the SOPHIA2 study—an extensive multicenter trial set to evaluate the safety and efficacy of the UroActive system, the world’s first smart automated artificial urinary sphincter (AUS). The green light from both regulatory bodies comes on the heels of promising results from prior feasibility studies in France involving both male and female participants.

Hamid Lamraoui, CEO and co-founder of UroMems, expressed his enthusiasm, stating, "This marks a key milestone that has been more than a decade in the making and brings us a significant step closer to delivering relief from symptoms and a return to life for patients suffering from SUI. 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."

The UroActive device utilizes a pioneering MyoElectroMechanical System (MEMS) to autonomously regulate the pressure around the urethra, improving patient comfort and interactions with the device without necessitating complex adjustments.

Insight from Leading Urology Experts

Leading the SOPHIA2 trial in the United States are Dr. Melissa Kaufman and Dr. Drew Peterson, both renowned in the field of female pelvic medicine and reconstructive surgery. Dr. Kaufman noted the limitations of current SUI treatments for both genders, stating, "That's why we're so excited to be leading the SOPHIA2 trial, as it shows the promise of delivering significant improvements. Based on feasibility data, UroActive has the potential to be a transformational technology."

Furthermore, Professor Emmanuel Chartier-Kastler from Sorbonne University echoed the significance of the trial results for both genders, sharing the enthusiastic feedback from patients who had suffered from SUI for years without satisfactory solutions. He looks forward to conducting the pivotal SOPHIA2 study in collaboration with U.S. sites.

The Impact of SUI

Stress urinary incontinence affects around 40 million people in the United States and 90 million in Europe, creating profound impacts on their quality of life. Many individuals experience debilitating social stigma, depression, and diminished self-esteem due to this condition.

The SOPHIA2 study will provide the foundational data for UroMems’ regulatory submission to the FDA and support its broader commercialization strategy for UroActive in both U.S. and European markets.

About UroActive

The innovative UroMems technology platform is protected by over 180 patents and aims to resolve the shortcomings of current treatment options by prioritizing safety and performance. UroActive is designed to assist patients, both men and women, suffering from SUI and represents a groundbreaking direction in active implantable medical devices.

It is noteworthy that UroActive has not yet received marketing authorization in the U.S. and is not available for sale within the U.S. or EU at this time. This project, however, has received backing from the European Innovation Council and the France 2030 initiative.

For further information, visit UroMems’ official website.