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-UroMems reaches an important milestone: successful results in the clinical feasibility study of the UroActive™ smart implant for the treatment of stress urinary incontinence
Successful primary and secondary results demonstrate feasibility in male patients, paving the way for the launch of a large-scale pivotal clinical study in the US and Europe.
GRENOBLE, France and MINNEAPOLIS, Dec. 13, 2023 /PRNewswire/ -- UroMems, a global company developing innovative mechatronic technology to treat stress urinary incontinence (SUI), today announced that it has reached a major milestone: the treatment cohort completed in the first clinical feasibility study of its kind has successfully met the six-month primary endpoints.
Feasibility evaluation of the UroActive system was completed through a prospective multicenter clinical study. UroActive is the first intelligent, automated artificial urinary sphincter (AUS) to treat SUI, and the only one to reach this critical milestone. The results of this initial clinical study support the design and implementation of the pivotal UroMems SUI trial in Europe and the US. All six men have now been implanted for at least seven months and up to fifteen months, with their devices functioning as expected and without the need for revision or explant. Additionally, there was extremely positive follow-up on secondary outcome measures, including leak rate values and patient quality of life questionnaires.
UroMems received very positive feedback from all patients who participated in the study cohort. "You have changed my life," said one of the study participants. "I can do all the activities again, without stress, without anxiety!"
"We are very pleased to see that our expectations for the performance of our device were met or even exceeded and we are delighted to be able to successfully treat and receive so many compliments from patients who had suffered from SUI for years," said Professor Pierre Mozer, Medical Director and co-founder of UroMems. "The results of this study will allow us to prepare our pivotal study, which will be an important step in the development of UroActive."
UroActive is the first smart active implant to treat SUI, powered by a myoelectromechanical system (MEMS). This innovative system is placed around the urethral canal and controlled based on the patient's activity, without the need for manual adjustments, with the goal of providing patients with ease of use and a better quality of life than current options.
"The very convincing results of this first-in-human clinical study demonstrate the high potential of our technology and pave the way for larger clinical trials that will allow us to demonstrate all the benefits we hope to offer to patients suffering from debilitating SUI," said Hamid Lamraoui. , CEO and co-founder of UroMems. "We could not have reached this important milestone without the enthusiastic participation of men in this initial study cohort. We are very grateful to them for being a vital part in bringing this potentially revolutionary treatment to market."
SUI, or involuntary urine loss, 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 involving high intra-abdominal pressure, such as coughing, laughing and exercising. SUI has a significant impact on quality of life as it can be debilitating and often leads to depression, low self-esteem and social stigma.
About UroActive UroActive 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.
Contact for media:Shelli Lissickshelli@bellmontpartners.com651-276-6922
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