UroMems Achieves Major Milestone in First-Ever Smart Implant Study for Female SUI Patientsv

 UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that the entire treatment cohort in the first-of-its-kind clinical feasibility study in female patients has successfully reached the six-month primary endpoints. This milestone indicates a new era for millions of women suffering from SUI, and signals an exciting transition for surgeons treating SUI not only in France, where the study was conducted, but also across the U.S. and Europe.

One-year results for the first patient will be presented for the first time by Professor Emmanuel Chartier-Kastler, Urology Chair, Sorbonne University and Pitie-Salpetriere Hospital, Paris, during the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Winter Meeting in Palm Springs, Calif., on Feb. 27th.

"With women suffering from higher rates of SUI and currently no effective solutions available to them, we are ecstatic to be the first to demonstrate the feasibility of our breakthrough technology now in a total of 12 women and men," said Hamid Lamraoui, UroMems chief executive officer and co-founder. "All of the female patients participating in our study have returned to living life fully after years of struggling with SUI. We sincerely thank them for participating in our study along with their physicians and our team for bringing this one step closer to providing a new and effective option to the millions of people suffering from SUI in the U.S. and Europe."

The female feasibility assessment of the UroActive System was completed through a prospective multicenter clinical study. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI, and the only one to reach this critical milestone. All six women are now implanted for at least seven months and close to two years for the first patient, with their devices operating as expected and no need for revision nor explant. In addition, phenomenal follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires.

Patients who participated in the study cohort shared unanimous positive feedback: "I am living again. It's night and day," stated one of the study participants. "It's fabulous. Thank you for this innovative product," said another.

UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS). This innovative system is placed around the urethral duct and is controlled based on the patient's activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.

UroMems has successfully achieved critical milestones in research and development, clinical outcomes and building the organization, including recently securing $47 million in funding on the heels of exceptionally strong results from the first-in-man multicenter clinical study six-month endpoint, and now the successful six-month primary endpoint for the first-ever female patients to receive a smart automated AUS.

SUI, 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.