GRENOBLE, France & MINNEAPOLIS, June 25, 2024 /PRNewswire/ -- UroMems, a global company developing innovative, implantable mechatronics technology to treat stress urinary incontinence (SUI), today announced it has raised $47 million in its Series C financing, the largest fundraising round to date for the company. The capital will support large-scale U.S. and European pivotal clinical trials of the UroActive™ implant, paving the way for regulatory submission in multiple countries. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI. "We are thrilled to lead this record round for UroMems," said Jérôme Feraud, Head of Health Division at Crédit Mutuel Innovation. "Based on very positive data and feedback from patients and physicians in the pilot clinical trials, we strongly believe that the UroActive smart implant has the potential to become the standard of care as the next-generation SUI treatment."
Under the strong and steady leadership, energy and guidance of co-founders Chief Executive Officer Hamid Lamraoui and Chief Medical Officer Professor Pierre Mozer, UroMems has successfully surpassed critical milestones in research and development, clinical outcomes and building the organization. The funding comes on the heels of exceptionally strong results from the first-in-man multicenter clinical study six-month endpoint, and successful six-month primary endpoint for the first-ever female patient to receive the UroActive System. For all study patients the devices are operating as expected for over one year now with no need for revision nor explant. In addition, extremely positive follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires. "We've invested in UroMems from the start and our confidence that the UroActive System will improve patients' lives continues to grow as the company reaches one major milestone after the other," said Dr. Johannes Fischer, Partner at Wellington Partners. "We look forward to continue supporting the company as they move closer to bringing this promising technology to both women and men suffering from SUI." "On behalf of our entire exceptional team and the patients whose lives have been restored thanks to our technology, we are grateful to our investor partners for their continued support as we approach the critical milestone of launching our pivotal clinical trial," said Lamraoui. "The confidence of our new and existing investors combined with the strength of our compelling results and tremendous physician interest shows the high potential of our technology. This brings us one step closer to delivering on the massive unmet need for men, women and physicians desperately seeking a better SUI treatment option."
SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. UroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bionic platform using embedded smart, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient's needs. The UroMems technology platform is protected by more than 150 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU. For more information, please visit www.uromems.com.