#France #UroMems #Grenoble #UroActive #urinary incontinence

UroMems Achieves Milestone in Female Clinical Trial for UroActive® Implant

UroMems, a pioneering company in the field of mechatronic technology, recently announced the successful results of the first clinical feasibility study involving its innovative UroActive® implant, which addresses the challenging problem of stress urinary incontinence (SUI) in women. This breakthrough marks a pivotal moment for the estimated 40 million American and 90 million European adults suffering from this condition.

The latest study focused on six initial female patients, and the findings indicate that all met the primary efficacy criteria within six months. The results achieved by UroMems not only offer hope to women who have long struggled with incontinence but also present a new surgical option for urologists both in France and beyond.

The full results from the study, including data from the first patient collected over one year, will be disclosed by Professor Emmanuel Chartier-Kastler, a renowned urologist, at the upcoming Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) conference in Palm Springs, California, on February 27.

Hamid Lamraoui, CEO and co-founder of UroMems, stated, "Women who suffer from severe stress urinary incontinence currently have no effective solutions available. We are excited to be the first to demonstrate the feasibility of our revolutionary technology, which has already benefited a total of 12 patients. All participants in this study have successfully resumed their normal activities after enduring long-term incontinence issues."

Technical Details and Device Functionality

UroActive® is the first intelligent automated artificial urinary sphincter designed to manage stress urinary incontinence effectively. It is anchored around the urethral canal and is operated based on the patient’s body activity. This technology seeks to enhance user experience and significantly improve the quality of life for those affected by SUI, far surpassing existing treatment modalities.

In this multicenter, prospective clinical trial, the six women have received their implants for more than seven months, with the first patient enjoying the device for nearly two years. The implant has demonstrated a flawless operational capability, with no need for revisions or removals. The study has also spotlighted exceptional secondary outcomes, such as reduced leakage rates and enhanced quality of life for the participants.

Among the participants, testimonials highlight the transformative impact of the UroActive® system. One participant described her experience, saying, "I feel like I've regained my life. It’s a total change!" Another added, "It's incredible. Thank you for this innovative product."

Ongoing Development and Future Plans

UroMems has successfully cleared vital steps in research and development, clinical outcomes, and corporate organization. Recently, they secured €44 million ($46 million) in funding following strong results from an earlier clinical study on male patients. This substantiates UroMems’ commitment to providing effective solutions for individuals suffering from urinary incontinence in both the U.S. and Europe.

UroMems' technology innovation extends to more than 150 patents, showcasing their dedication to exceeding current limitations in treatment options by prioritizing safety, performance, and patient experience. Although the UroActive® device has not yet received FDA approval or been made available for sale in the U.S. or EU, it remains a promising project backed by the European Innovation Council and the France 2030 initiative.

This novel approach to addressing SUI could redefine care pathways for millions affected by this condition, transitioning how urologists manage incontinence while significantly enhancing patient dignity and quality of life.

For more information about UroMems and its innovative technology, please visit www.uromems.com or contact Shelli Lissick.