Grenoble, France-based UroMems develops mechatronics technology to treat stress urinary incontinence (SUI). Its SOPHIA study evaluates the UroActive smart, automated artificial urinary sphincter (AUS) in the treatment of SUI. The company plans for its study to support the design and implementation of its pivotal clinical trial. It has plans for trials to take place in Europe and the U.S.
Primary outcomes for the study include successful device activation and the rate of explants and revisions at six months. The first male patient in the SOPHIA study met the primary endpoints by remaining revision-free. This patient also experienced restored social continence.
UroMems also reported “extremely positive” secondary measures, including leak rate values, according to a news release. The patient called the UroActive device “a lifesaver.”
“With the encouraging six-month post-activation results of our first study subject, we look forward to reviewing the balance of the follow-up data on our patients and advancing to the pivotal study stage of a potentially revolutionary SUI therapy,” said Pierre Mozer, UroMems chief medical officer and co-founder.
More about the UroMems UroActive device and the SOPHIA study
A MyoElectroMechanical system (MEMS) powers the UroActive device, the first smart active implant for treating SUI. The device is placed around the urethral duct and adjustable based on patient activity. UroMems designed it to provide patients with ease of use and a better quality of life compared to current options.
The company announced the first-in-human implant in November 2022. It also received Safer Technologies Program (STeP) designation from the FDA for UroActive. STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices.
“We are excited to reach this essential milestone in our development and especially to report the first man experiencing truly personalized continence therapy,” said Hamid Lamraoui, UroMems CEO and co-founder. “We are deeply grateful to all the patients participating in this first-of-its-kind implant journey and enthusiastically await follow-up results for the complete cohort.”
UroMems said it designed its technology to restore quality of life, dignity and self-esteem to those suffering with SUI and other chronic conditions.
