UroMems Secures $60 Million to Advance Smart Urinary Sphincter Toward U.S. and EU Approval

New updates have been reported about UroMems.

UroMems has raised a $60 million strategic round from Ajax Health Fund I to complete pivotal trials and prepare commercialization of UroActive, its smart automated artificial urinary sphincter for stress urinary incontinence. The funding, the largest in the company’s history, is intended to carry UroMems through key regulatory milestones, including FDA PMA submission and parallel filings in Europe.

Capital will support completion of the SOPHIA2 pivotal study across 21 centers in the U.S. and France, generating data required for market approval and launch planning in both regions. The new investment follows a $47 million Series C financing in June 2024 and strengthens the balance sheet as UroMems shifts from R&D toward late-stage clinical validation and commercialization.

UroActive is an active implantable electronic device based on a MyoElectroMechanical System that automatically adjusts around the urethra according to patient activity, aiming to reduce manual manipulation and improve usability versus current artificial sphincter options. Management positions this technology to address a large unmet need in SUI, which affects tens of millions of patients in the U.S. and Europe and often leads to significant quality-of-life and mental health burdens.

Ajax Health’s involvement also brings governance and operational support, with partner David Beylik and Dr. Jeremy Durack joining the UroMems board to help navigate regulatory, clinical, and commercialization strategy. UroMems reports it has already met critical R&D and early clinical milestones, and executives frame this round as providing the runway needed to transition from a development-stage medtech company toward a commercial organization if pivotal data and regulatory decisions are favorable.

CEO Hamid Lamraoui describes the financing as a pivotal step in positioning UroActive as a potential new standard of care for SUI, with the company now focused on executing its clinical program, preparing market entry, and scaling operations. While UroActive is not yet approved or available for sale in the U.S. or EU, investors are betting that strong early clinical signals, physician interest, and patent protection exceeding 200 granted patents can translate into competitive advantage, market disruption, and meaningful long-term growth once regulatory clearance is achieved.