UroMems 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. The company said UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI.
UroMems has surpassed milestones in research and development, clinical outcomes and building the organization. The funding comes on the heels of strong results from the first-in-man multi-center 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, positive follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires.
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.
