#USA #Minneapolis #UroMems #UroActive #Stress Incontinence

UroMems Receives FDA and ANSM Approval for Pivotal Clinical Study

UroMems, an innovative company specializing in mechatronic technology for medical treatment, has ambitious plans ahead. The company has recently secured approval from both the U.S. Food and Drug Administration (FDA) and the French National Agency for the Safety of Medicines and Health Products (ANSM). This approval paves the way for the initiation of a landmark clinical study for their product, the UroActive® implant, aimed specifically at treating stress urinary incontinence (SUI) in men.

The Significance of SUI

Stress urinary incontinence is a condition that affects millions of individuals worldwide, significantly impacting their quality of life. With estimates suggesting that about 40 million Americans and 90 million Europeans suffer from this condition, the need for effective treatment options is becoming imperative. SUI can result in a host of emotional challenges, including depression, low self-esteem, and social stigmatization.

Trailblazing Clinical Study

The new clinical trial, called SOPHIA2, is designed to explore the safety and efficacy of the UroActive system, the world’s first intelligent, automated artificial urinary sphincter (AUS) created for this male-specific treatment. The initial phase of research has indeed yielded promising outcomes; UroMems cites encouraging findings from earlier feasibility studies conducted in France that supported this progression.

Hamid Lamraoui, CEO and co-founder of UroMems, stated, “This is a major milestone that we’ve been working towards for over a decade. It brings us significantly closer to providing relief for patients suffering from SUI.” He emphasizes that UroActive is unique in its capability to potentially transform the lives of those affected by this condition while presenting an exciting opportunity for urologists treating SUI across the US and Europe.

Innovative Technology Behind UroActive

UroActive operates on a MyoElectroMechanical System (MEMS), ensuring a novel approach to treatment. This sophisticated system is positioned around the urethra and managed according to the patient's physical activity, eliminating the need for cumbersome adjustments. This design aspires to enhance patient comfort and quality of life significantly compared to traditional treatment avenues.

Renowned researchers Dr. Melissa Kaufman and Dr. Drew Peterson, who guide the study, echoed Lamraoui’s enthusiasm. Dr. Kaufman expressed the urgency for better treatment alternatives: “We are thrilled to lead the SOPHIA2 trial, as it promises substantial advancements in addressing the challenges our patients face.” Dr. Peterson further added, “Based on the promising data we've encountered from earlier studies, UroActive appears poised to emerge as a transformative technology.”

Professor Emmanuel Chartier-Kastler from the University of Sorbonne also reflected on the clinical feasibility study’s success, noting tremendous patient satisfaction and lasting improvements in symptom management. The collaborative effort between French and American researchers underscores the global commitment to finding effective solutions for urinary conditions.

Looking Ahead

The SOPHIA2 study is a crucial step for UroMems, as it lays the foundation for regulatory submissions in both the FDA and European markets. According to the company, UroActive's design is backed by more than 180 granted patents, underscoring the innovation encapsulated within this revolutionary medical device.

This project receives substantial support from the European Innovation Council and France 2030, which reflects confidence in UroMems' potential to reshape therapeutic interventions for SUI. UroActive is not yet available for sale in the US or EU as it awaits market approval.

For more information, visit UroMems' Website.

Contact:
Shelli Lissick
Email: shelly.lissick@example.com
Phone: 651-276-6922