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- UroMems announces the results of the first intelligent artificial urinary sphincter implant in a patient to treat stress urinary incontinence

Positive results demonstrate a promising new option for women seeking better, personalized treatment

GRENOBLE, France and MINNEAPOLIS, Feb. 14, 2024/PRNewswire/ -- UroMems, a global company developing innovative mechatronic technology to treat stress urinary incontinence (SUI), today announced that it has successfully met the primary endpoint of six months for the first patient to be implanted with the UroActive™ system, the first intelligent automated artificial urinary system. sphincter (AUS) to treat SUI. This milestone signals a new era for millions of women suffering from SUI, and signals an exciting transition for surgeons treating SUI not only in France, where the patient was treated, but also throughout Europe and the United States. It also follows closely on the heels of successful results from the full treatment cohort of the first-in-human clinical feasibility study. The results of this clinical study will contribute to the design and implementation of the pivotal clinical trial of UroMems in Europe and the United States.

"On behalf of the medical team that implanted the UroActive system in the first patient, Drs. Christophe Vaessen, Aurelien Beaugerie and I are delighted to see that our first patient has returned to fully living his life after years of battling SUI," said Professor Emmanuel Chartier-Kastler. "This promising therapy is a breakthrough technology in the treatment of SUI in both women and men."

Primary outcome measures include successful device activation and rate of explants and revisions at six months. The first patient not only met the study's primary endpoints by remaining revision-free, but she also experienced restored social continence. Monitoring of secondary measures, including leak rate values, has been extremely positive.

"As a leading advocacy organization in the United States supporting patients and caregivers with urinary incontinence, we hear weekly from patients seeking information about the safety and effectiveness of artificial sphincters. Unfortunately, we have little to inform and support their requests, as "No one in the United States actively promotes this option for women," explained Steven Gregg, Ph.D., executive director of the National Continence Association. "These results from the first UroActive system implanted in a woman represent a promising advance for treating stress urinary incontinence in both women and men. We are excited about this first-of-its-kind development and look forward to the pivotal results of the trial." of UroMems".

Pending those results, the possibility of American surgeons offering this new option is now on the horizon; Trained surgeons performing robotic-assisted surgeries such as sacrocolpopexies and hysterectomies will soon be able to add UroActive implantation to their standard practices. UroActive is the first smart active implant to treat SUI, powered by a myoelectromechanical system (MEMS). This innovative system is placed around the urethra in men and the bladder neck in women, controlled based on the patient's activity, without the need for manual adjustments, aiming to provide patients with ease of use and a better quality of life than the current options.

"We are delighted to achieve this critical achievement that contributes to the demonstration of the feasibility of the UroActive system to successfully treat women suffering from debilitating SUI," said Hamid Lamraoui, CEO and co-founder of UroMems. "The compelling results of this first-ever implant in women show the high potential of our technology, bringing us one step closer to meeting the enormous unmet need of women and doctors desperately seeking a better treatment option for SUI."

SUI, or involuntary urinary leakage, affects approximately 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the muscle (sphincter) around the urethra, caused by activities that involve high pressure intra-abdominal, such as coughing, laughing and exercising. SUI significantly impacts quality of life as it can be debilitating and often leads to depression, low self-esteem, and social stigma.

UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women around the world who suffer from poorly treated chronic diseases by committing to change the perception that these disorders are inevitable as one ages and They are simply something to be endured. no real solution. UroMems is revolutionizing the treatment of SUI with smart active implants, using the latest technological advances in the field of integrated systems and microtechnologies for the development of its innovative solutions.

About UroActiveUroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in both male and female patients with SUI. It is based on a unique bionic platform that uses integrated robotic, digital and intelligent systems that, based on the data collected from a patient, create a treatment algorithm specific to the needs of each patient. The UroMems technology platform is protected by more than 120 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon comfort. Participation in STeP does not imply authorization of the product. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or the EU.

For more information visit www.uromems.com.

Media ContactShelli Lissickshelli@bellmontpartners.com651-276-6922

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