UroMems Receives FDA and French ANSM Approval for UroActive® Clinical Study

UroMems Secures FDA and ANSM Approval for Innovative Clinical Study

In a significant advancement for the treatment of stress urinary incontinence (SUI), UroMems, a global leader in mechatronic technology, has officially received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) and authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM). This groundbreaking permission paves the way for the initiation of a pivotal clinical study, named SOPHIA2, involving the company’s UroActive® smart implant aimed at treating male SUI.

UroMems is set to explore the safety and efficacy of the UroActive system, which is noted for being the first automated and intelligent artificial urinary sphincter (AUS) designed specifically for men suffering from SUI. The green light from both regulatory bodies comes on the back of robust viabilities demonstrated in earlier studies conducted in France involving male and female patients.

Hamid Lamraoui, the CEO and co-founder of UroMems, remarked on this achievement, stating, "This milestone marks over a decade of hard work toward a solution that can alleviate the symptoms and provide recovery for those affected by SUI with the UroActive implant. This innovation is a game-changer, positioning itself as the first automated solution reaching this critical landmark in both the U.S. and Europe."

The UroActive device operates on a myoelectromechanical system (MEMS) designed to adapt to patient activity. By positioning around the urethra, the device eliminates the need for complex manual interventions, significantly enhancing user-friendliness and improving the quality of life compared to existing treatment options.

Key co-investigators for the trial include Dr. Melissa Kaufman from Vanderbilt University and Dr. Drew Peterson from Duke University. They expressed their excitement about leading the SOPHIA2 study, emphasizing the potential improvements the UroActive technology can provide. "Having witnessed the shortcomings of current SUI treatments for both male and female patients, we are eager to lead this promising study and are optimistic about UroActive's transformative potential based on the viability data we have reviewed."

Professor Emmanuel Chartier-Kastler from the University of Sorbonne and Pitié-Salpêtrière Hospital highlighted the positive outcomes observed in previous viability studies in France, stating that many patients experienced prolonged relief with no need for reoperation or explantation. "We are enthusiastic about conducting the SOPHIA2 study alongside U.S. sites, as we believe this innovation can significantly enhance treatment outlooks for SUI patients."

Stress urinary incontinence affects approximately 40 million individuals in the U.S. and around 90 million in Europe, often leading to debilitating impacts on quality of life, including depression, lower self-esteem, and social stigma.

The SOPHIA2 study will serve as a crucial foundation for UroMems’ regulatory presentation to the FDA and outlines their broader strategy to bring UroActive to markets in the U.S. and Europe. The UroActive platform is supported by over 180 granted patents and is developed to surpass current solution limitations by optimizing safety, performance, patient experience, and surgical ease. However, it’s important to note that UroActive has not yet received market authorization from the FDA, thus it isn’t available for sale in the U.S. or EU at this point.

For more information on UroMems and its groundbreaking initiatives, please visit www.uromems.com.