UroMems Reveals Major Advances in Smart Implant for Women's Health in Clinical Study

UroMems Announces Groundbreaking Results in Clinical Feasibility Study

In a pioneering development, UroMems, a global leader in innovative mechatronic technologies, has released promising findings from the first-ever clinical feasibility study concerning its UroActive® smart implant, designed to treat stress urinary incontinence (SUI) in women. This revelation signifies a substantial leap forward for millions of women suffering from SUI, marking an exciting transition in surgical approaches to this condition not only in France, where the study took place, but also extending its implications to the US and Europe.

During the Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) held in Palm Springs, California, Professor Emmanuel Chartier-Kastler, a urology expert from the University of Sorbonne and Pitie-Salpetriere Hospital in Paris, presented the one-year results for the first patient involved in the study.

Hamid Lamraoui, the Chief Executive Officer and co-founder of UroMems, expressed enthusiasm regarding the results. He stated, “Since women frequently face stress incontinence and currently lack effective solutions, we are thrilled to demonstrate the feasibility of our groundbreaking technology across a total of 12 men and women.” This study has allowed women who have endured years of suffering from SUI to reclaim their lives, leading to renewed appreciation for daily activities.

The feasibility assessment of the UroActive system was conducted through a prospective multicenter clinical study, with UroActive being the first intelligent, automated artificial urinary sphincter targeted at treating SUI. Impressively, all six participating women have been implanted for at least seven months, with the first patient maintaining her implant for almost two years, all without the need for revisions or removals. Furthermore, remarkable follow-up results were noted concerning secondary endpoints, including leakage rates and patients’ quality of life questionnaires.

Feedback from participants in the study has been overwhelmingly positive, reflecting life-changing impacts. One patient shared, “I’m living again. It’s like day and night,” while another added, “It’s fabulous. Thank you for this innovative product.”

UroActive deploys a MyoElectroMechanical System (MEMS) to function around the urethra, regulating based on patient activity automatically, thereby allowing a simpler application for patients and significantly enhancing their quality of life compared to existing options.

UroMems has made notable strides in research and development, securing significant funding of $47 million owing to the impressive outcomes of the initial multicenter clinical study conducted six months prior. By achieving the primary endpoint after six months in the first female patients receiving this intelligent automated AUS, UroMems is effectively paving the way for a revolutionary treatment alternative for those affected by SUI.

SUI is estimated to affect around 40 million Americans and 90 million Europeans, drastically impairing quality of life and often leading to depression and social stigma.

The UroActive technology, protected by over 150 patents, aims to overcome the challenges posed by existing treatments, optimizing safety, performance, and patient experience along with comfort for surgeons. Nonetheless, it is crucial to note that UroActive has yet to obtain FDA approval and is currently unavailable for sale in the US or EU. The project receives financial support from the European Innovation Council and France 2030.

For more details, visit UroMems’ official website.