UroMems announced a $60 million strategic investment from Ajax Health to continue funding pivotal clinical trials and commercial launch preparation for the UroActive System, the company’s smart automated implant designed to treat stress urinary incontinence (SUI).
The financing marks the largest fundraising round to date for UroMems, with Ajax Health Fund I fully financing the investment. The capital will support ongoing large scale pivotal clinical trials for the UroActive implant across investigational centers in the U.S. and France, with the resulting clinical data expected to support regulatory submissions in multiple countries.
UroActive is designed as the first smart automated artificial urinary sphincter for SUI treatment. The implant uses MyoElectroMechanical System technology and is intended to automatically adapt based on patient activity without requiring manual adjustments. The company believes the system could improve ease of use and quality of life compared to currently available treatment options.
The financing will support completion of the ongoing SOPHIA2 clinical trial, which is being conducted across 21 U.S. and French investigational centers in preparation for regulatory submissions in both the U.S. and European markets.
The latest round follows a $47 million Series C financing completed in June 2024, which was led by Crédit Mutuel Innovation with participation from the European Innovation Council and existing investors including Wellington Partners, Bpifrance, Supernova Invest, Hil-Invent, b-to-v Partners and Financière Arbevel.
As part of the transaction, David Beylik and Jeremy Durack joined the UroMems board of directors.
UroMems said the UroActive platform is protected by more than 200 granted patents. The device has not yet received marketing authorization from the U.S. Food and Drug Administration or regulators in the European Union.
Stress urinary incontinence affects an estimated 40 million Americans and 90 million Europeans, according to the company. The condition can significantly impact quality of life and is often associated with depression, low self esteem and social stigma.
KEY QUOTES:
“We’re excited to fund this pivotal round for UroMems and apply our approach of partnering with potential industry leaders to help build and scale innovative medtech organizations. Combining our industry experience and capital with the UroMems team, we believe that the UroActive smart implant has the potential to become the standard of care for SUI treatment.”
David Beylik, Partner, Ajax Health
“As existing investors, we’re thrilled to welcome Ajax Health Fund I to this round. Based on strong early clinical study results and unprecedented interest from physicians, we’ve always known that the UroActive System has significant potential to improve patients’ lives and disrupt the market.”
Philippe Boucheron, Deputy Chief of Life Sciences Investments, Bpifrance
“Ajax Health brings additional operating experience as UroActive enters its next stage, and we look forward to working together to support it through approval and commercialization.”
Johannes Fischer, Partner, Wellington Partners
“Ajax Health Fund I’s support strengthens our position as we approach the pivotal points of FDA PMA submission and commercialization, and we’re grateful for their investment, partnership and confidence in UroActive. I believe UroActive will be a game-changer in treating patients suffering from SUI, and we are now one step closer to achieving our shared vision of delivering on the significant unmet need for patients and physicians desperately seeking a better SUI treatment option.”
Hamid Lamraoui, Co-Founder and Chief Executive Officer, UroMems
