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UroMems' Smart Urinary Sphincter Implant Achieves Primary Endpoints in Pioneering Female SUI Study

• UroMems' UroActive implant, a smart artificial urinary sphincter system, successfully met all primary endpoints in a first-of-its-kind female-only clinical study with six participants.

• The innovative MEMS-powered device, implanted at the bladder neck in women, demonstrated sustained effectiveness over seven months, with the longest-running case approaching two years without requiring revisions.

• Study participants reported significant improvements in quality of life and leak rate measures, marking a potential breakthrough for the millions of women affected by stress urinary incontinence.

In a groundbreaking development for stress urinary incontinence treatment, UroMems has announced successful primary endpoint achievement in the first-ever female-only study of their smart artificial urinary sphincter implant. The milestone marks a significant advance in addressing a condition that disproportionately affects women.
The prospective multicenter clinical trial, conducted in France, evaluated the company's UroActive system - an innovative implant powered by MyoElectroMechanical system (MEMS) technology. The device, positioned at the bladder neck in female patients, automatically adjusts to the patient's activity patterns without requiring manual intervention.

Clinical Performance and Patient Outcomes

All six women enrolled in the study have maintained their implants for at least seven months, with the first participant approaching the two-year mark post-implantation. Notably, none of the devices required revision or explantation during the study period, demonstrating robust operational reliability.
Secondary outcome measures have yielded particularly promising results. Patients showed marked improvements in leak rate values, while quality of life questionnaires indicated significant positive impacts on daily living. These outcomes suggest potential advantages over existing treatment options.

Technical Innovation in Incontinence Treatment

The UroActive system represents a technological leap in SUI management. Unlike traditional treatments, the MEMS-powered device automatically adapts to patient activity, potentially offering superior ease of use and quality of life improvements. This self-adjusting capability distinguishes it from conventional solutions that may require manual adjustments or offer less dynamic responses to patient needs.

Expanding Treatment Horizons

"With women suffering from higher rates of SUI and currently no effective solutions available to them, we are ecstatic to be the first to demonstrate the feasibility of our breakthrough technology now in a total of 12 women and men," stated Hamid Lamraoui, UroMems CEO and co-founder.
The company's recent $47 million funding round, secured in June 2024, will support further clinical trials of the UroActive system. This financial backing underscores the potential market impact of the technology and its importance in addressing an significant unmet medical need.
The successful trial outcomes in France are expected to influence SUI treatment approaches across Europe and the United States, potentially offering new hope to millions of patients seeking effective solutions for stress urinary incontinence.
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