Medical Device Network

UroMems eyes regulatory filings for SUI treatment after $60m fundraise

UroMems plans to use the funds to complete a pivotal trial to support regulatory filings for its UroActive system in the US and Europe.

UroMems has raised $60m, priming the French company to complete a pivotal trial of its stress urinary incontinence (SUI) treatment, the data from which will support regulatory filings for the implant in the US and Europe.

Representing the largest fundraise to date for UroMems and bringing its total funding to date to around $140m, all proceeds originated from PE firm Ajax Health’s Fund I.

UroMems’ UroActive system is an automated artificial urinary sphincter (AUS) designed to control urine flow in SUI patients. Intended to treat SUI and provide a better quality of life than existing treatments such as urethral bulking injections and mid-urethral taping, the system is comprised of a cuff placed around the urethra and a control unit featuring a pump and sensor that is implanted in the abdomen. Powered by UroMems’ MyoElectroMechanical System (MEMS), the system automatically changes the sphincter opening by pressure adjustments based on the patient’s activity.

UroMems obtained an investigational device exemption (IDE) for UroActive from the US Food and Drug Administration (FDA) and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM) in July 2025, greenlighting the company’s initiation of the SOPHIA2 (NCT06968741) study of the system across 21 sites across the US and France. The funds from Ajax will support this trial’s completion, the data from which will be used to support regulatory filings for UroActive in the US and Europe.

SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans. The condition can impact patients’ quality of life, often leading to depression and diminished self-esteem.

Asserting that UroActive could be a “game-changer” in treating SUI patients, UroMems CEO, Hamid Lamraoui, said: “Ajax Health Fund I's support strengthens our position as we approach the pivotal points of FDA PMA submission and commercialisation, and we're grateful for their investment, partnership and confidence in UroActive.”

While there are currently no neuromodulation products approved for SUI, big medtech players such as Boston Scientific have been bulking up their urology portfolios to treat similar bladder dysfunctions such as urge urinary incontinence (UUI), suggesting the treatment modality could have a future role to play in addressing SUI. According to a report by GlobalData, the global neurological devices market will reach a valuation of $20.9bn by 2033, up from $12.5bn in 2023.