Initial clinical study results will inform pivotal clinical trial in US and Europe
UroMems announced today that it has successfully completed the first-ever implant of the UroActive smart, automated AUS in a female patient to treat SUI. (Credit: PR Newswire/ UroMems)
UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive™ smart, automated artificial urinary sphincter (AUS) in a female patient. This milestone indicates a new era for millions of women suffering from SUI, and results of this clinical study will contribute to the design and implementation of UroMems’ pivotal clinical trial in Europe and the U.S.
“This is a unique accomplishment for UroMems and SUI in women,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “We are addressing the observations by so many physicians that there is a vast unmet need for a better way to definitively treat this female population.”
The robotic-assisted procedure for the first female recipient was successfully completed at La Pitié-Salpêtrière University Hospital (AP-HP, Sorbonne University, Paris, France) by Professor Emmanuel Chartier-Kastler, Dr. Aurélien Beaugerie and Dr. Christophe Vaessen. This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration).
“It’s magic,” the patient stated, as the first woman to activate the novel UroActive device. “I am so glad I can again do simple things in my daily life I was not able to do any more.”
UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS). This innovative system is placed around the urethral duct and is adjustable based on the patient’s activity, intending to provide patients with ease of use and a better quality of life than current options. The first-in-human (male) UroActive implant was announced in November 2022, and UroMems recently received the Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices.
“It’s unacceptable that women today don’t have a better option for treating their stress incontinence,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder. “Ultimately, we hope UroActive will become the therapy of choice for both physicians and their patients.”
SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the muscle (the sphincter) around the urethra, caused by activities involving high intra-abdominal pressure, like 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. While mild SUI is addressed by pelvic floor re-education and bulking agents, moderate and severe SUI historically have only had two options: mesh sling or manually-operated artificial urinary sphincter.
UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from poorly treated chronic conditions by the commitment to change the perception that these disorders are inevitable as one grows older and is simply something to endure with no real solution. UroMems is revolutionizing the treatment of SUI with smart active implants, using the latest technological advances in the field of embedded systems and micro-technologies for the development of its groundbreaking solutions.
Source: Company Press Release