UroMems has raised $47m in its largest fundraising round so far, to finance pivotal clinical trials of the UroActive smart automated implant in the US and Europe.
The trials are expected to enable regulatory submissions for the implant, which is designed to treat stress urinary incontinence (SUI), in multiple countries.
Said to be the first smart automated artificial urinary sphincter (AUS) for SUI treatment, the UroActive implant can be placed around the urethral duct.
It can be automatically controlled based on the activity of the patient, eliminating the need for manual adjustments.
The Series C funding round was led by Crédit Mutuel Innovation and saw participation from the European Innovation Council, along with the existing investors Bpifrance, Wellington Partners, Supernova Invest, b-to-v Partners, Hil-Invent, and Financière Arbevel.
UroMems CEO Hamid Lamraoui said: “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.”
The funding follows positive results from the first-in-man multi-centre clinical trial of the UroActive System and the successful primary endpoint for the first female patient, who received it.
All study patients have had their devices functioning as expected for more than a year, without any need for revision or explant.
UroMems said the secondary outcomes, including leak rate values and patient quality of life, have also been positive.
Crédit Mutuel Innovation health division head Jérôme Feraud said: “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.”
Last year, UroMems completed enrolment in a clinical study of its automated AUS to treat SUI.
