UroMems is set to enter the pivotal trial phase with its device for treating stress urinary incontinence (SUI).
The company was awarded an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM), paving the way for the study.
The prospective, multi-centre trial, named the SOPHIA2 study (NCT06968741), will confirm the safety and efficacy of the French company’s UroActive System in treating SUI in men. An estimated 13 million individuals in the US are affected by SUI, with a higher incidence rate in women than men.
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UroMems’ pivotal trial follows the SOPHIA study (NCT05547672) in which UroActive met the six-month primary endpoint in male patients, including the rate of explants and revisions for the device and the rate of device activation success. In 2024, the device also met the same six-month primary endpoints in the first patient enrolled in UroMems’ female first-in-human feasibility trial (NCT05828979).
UroActive is an automated artificial urinary sphincter (AUS) designed to control urine flow in SUI patients. Comprising a cuff placed around the urethra, the active implantable is powered by UroMems’ MyoElectroMechanical System (MEMS) and collects data to create treatment algorithms tailored for each patient’s needs. The system’s overall aim is to treat SUI and provide a better quality of life than existing treatments such as urethral bulking injections and mid-urethral taping.
UroMems’ CEO and co-founder Hamid Lamraoui commented: “This marks a key milestone that has been more than a decade in the making and brings us a significant step closer to delivering the relief from symptoms and return to life that UroActive has the potential to provide patients suffering from SUI.”
Lamraoui claims that UroActive is the “first and only smart automated AUS to reach this critical milestone”.
UroMems’ pivotal trial will form the basis of regulatory approval filings for UroActive in the US and Europe. The pivotal trial is supported by a $47m Series C financing round completed by UroMems last year, bringing the company’s funding to date to around $85m.
