French medical technology company UroMems has secured $60 million in strategic funding from U.S.-based Ajax Health Fund I to accelerate clinical trials for its smart implant designed to treat stress urinary incontinence (SUI). The investment marks a major milestone for the company as it moves closer to regulatory submissions in the United States and Europe for its next-generation urinary sphincter technology.
The funding will primarily support the ongoing SOPHIA2 pivotal clinical trial, which is currently underway across investigational centers in the U.S. and France. UroMems said the study will provide the clinical evidence required for future U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) submissions and European regulatory filings.
Stress Urinary incontinence is a common condition that causes involuntary urine leakage during activities such as coughing, exercising, laughing, or lifting heavy objects. The condition affects nearly 40 million people in the United States and around 90 million people across Europe, according to company data.
UroActive Aims to Modernize SUI Treatment
UroMems is developing UroActive, a smart, automated artificial urinary sphincter designed to improve treatment outcomes for patients living with SUI. Unlike traditional artificial urinary sphincters that require patients to manually control a pump, the UroActive system automatically adjusts pressure around the urethra depending on the patient’s physical activity.
The implant uses MyoElectroMechanical Systems (MEMS) technology along with embedded sensors to monitor movement and respond in real time. The company believes the automated system could help reduce complications associated with older mechanical devices, including pump handling difficulties and device failures.
Hamid Lamraoui, co-founder and chief executive officer of UroMems, said the investment strengthens the company’s ability to move toward commercialization.
“Ajax Health Fund I’s support strengthens our position as we approach the pivotal points of FDA PMA submission and commercialization,” Lamraoui said in a statement.
Funding Pushes Total Capital Beyond $140 Million
The latest financing increases UroMems’ total funding to more than $140 million. The company previously raised $47 million in a Series C financing round in June 2024 with support from existing investors and healthcare-focused investment firms.
The new investment also expands the company’s leadership network. Ajax Health partner David Beylik and Dr. Jeremy Durack have joined the UroMems board of directors as part of the agreement.
Ajax Health specializes in supporting clinical-stage medical technology companies and helping them advance toward regulatory approval and commercial growth. David Beylik said Ajax Health sees strong long-term potential in UroMems’ technology.
“We believe that the UroActive smart implant has the potential to become the standard of care for SUI treatment,” Beylik said.
SOPHIA2 Trial Continues Across U.S. and France
The SOPHIA2 clinical trial is active across 21 investigational centers in the United States and France. The study is evaluating the safety and effectiveness of the UroActive implant in patients with stress urinary incontinence.
The company expects the trial data to play a central role in upcoming regulatory submissions. UroMems has not yet received commercial approval for the UroActive device in the United States or Europe.
The latest funding reflects growing investor interest in advanced medtech solutions that combine automation, sensors, and smart implant technology to improve patient care and long-term treatment outcomes.
