UroMems Raises $60M for Smart Urology Implant Trials

UroMems, a leader in mechatronic urology solutions, has raised $60 million in a strategic funding round to accelerate development of its UroActive® implant, a smart device for treating stress urinary incontinence (SUI). The company, which has now raised over $150 million, will use the funds to advance the SOPHIA2 trial—a pivotal study recruiting patients at 21 sites in the U.S. and France—following successful feasibility data from the initial SOPHIA trial, which showed a 100% successful implantation rate. UroActive differs from traditional treatments by automatically adjusting urethral pressure based on patient activity, reducing tissue atrophy and improving convenience. The device, backed by 200 issued patents, adapts to individual lifestyles and targets a market that has remained unchanged for 50 years. The SOPHIA2 trial data, expected by December 2026, will support UroMems’ submissions for FDA Pre-Market Approval (PMA) and European CE Mark certification. The funding was fully syndicated by Ajax Health Fund I, with ICONIQ Capital and Ajax Health involvement. Ajax medtech professionals have joined UroMems’ Board of Directors, bringing expertise to transition the company from clinical to commercial stages. The FDA granted an Investigational Device Exemption (IDE) for the trial, while the French National Agency for the Safety of Medicines and Health Products (ANSM) approved the study in 2024. SUI affects roughly 40 million Americans and 90 million Europeans, with current treatments relying on manual artificial urinary sphincters. UroActive’s adaptive technology aims to address limitations of existing solutions, offering a more dynamic and patient-friendly alternative. The company’s Series C funding round in mid-2024 further strengthened its position in the medtech sector.