UroMems raises $60M to support clinical trials for smart urology implant

UroMems raised a $60 million strategic investment to support clinical trials and prepare for the commercial launch of its smart automated artificial urinary sphincter, the company announced today.

The Grenoble, France–based startup — which has its U.S. headquarters in Minneapolis —  received an FDA investigational device exemption (IDE) last year to begin a clinical trial to assess the safety and effectiveness of its UroActive smart implant to treat stress urinary incontinence in men. Soon after, the company commenced its SOPHIA2 clinical trial.

UroMems said the financing will support the company through the completion of its ongoing SOPHIA2 clinical trial in 21 U.S. and French investigational centers. The startup intends to use the results of the trial for its regulatory submission to the FDA and European regulators.

The UroActive smart automated artificial urinary sphincter is powered by a myolectromechanical system placed around the patient’s urethral duct. It’s remotely controlled based on the patient’s activity, without the need for manual adjustments.

Each patient’s activity is measured in real-time through microsensors inside the implant. Advanced algorithms embedded in the device’s electronics are designed to interpret data from those microsensors and transmit that data to the myolectromechanical system for the application of appropriate urethral pressure and manage stress urinary incontinence.

UroActive’s functionality is expected to “provide patients with ease of use and a better quality of life than current options,” UroMems said.

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Last year, UroMems reported positive outcomes in its France-based clinical trial evaluating the device in women. Prior to this study, the company reported “very compelling results” from its clinical feasibility study with the device implanted in men.

Ajax Health Fund I financed the recent round, which builds upon the startup’s $47 million Series C financing led by Crédit Mutuel Innovation that closed in June 2024.

“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,” said UroMens co-founder and CEO Hamid Lamraoui. “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.”