Periodic Reporting for period 2 - UroAct (Restoring a normal life and dignity for women and men suffering from severe Stress Urinary Incontinence)
Berichtszeitraum: 2024-04-01 bis 2024-12-31
Stress urinary incontinence (SUI) affects an estimated 90 million Europeans and 40 millions Americans, primarily women. It 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. It is an ignored public health problem, as it is often a taboo. Yet, SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. In most severe cases, it turns people lives into a living hell, especially since existing therapies are unsatisfactory.
For men, manual artificial urinary sphincters (AUS) have been on the market since the 1970s, with little or no improvement since then. These archaic manual devices require the scrotum to be manipulated for each urination, sometimes with the help of a relative for dependent people. It's humiliating. These devices are associated with a significant rate of revision and explantation, notably because of manually manipulated implantable components, which are fragile and fail, and because the constant pressure exerted on the urethra often leads to erosion and atrophy. Unfortunately, in these cases, the surgeon is obliged to remove the device, and the patient returns to the hell of incontinence for good.
For women, the most commonly used solution is mesh slings, initially developed for cases of prolapse. This solution leaves 15% of women incontinent, with potential serious adverse effects, to such an extent that they are the subject of over 100,000 lawsuits in the USA. The UK and Australia have already banned the product. Manual artificial urinary sphincters are not a viable solution for women. The pump is placed in the labia majora, and handling it involves urinating on the hands. In the US, Boston Scientific's "gold standard" (AMS 800™) is not approved for women. In Europe, fewer than 500 are implanted per year. But these implants demonstrate the demand from women suffering from severe stress-induced urinary incontinence, who are so desperate that they will accept such an inconvenient device. Severely incontinent people urgently need a safe and decent solution.
Based on this damning observation, UroMems was born with the aim to restore normal life and dignity to patients suffering from severe stress urinary incontinence. The strategy was to study the devices on the market, understand their weaknesses and shortcomings, and design a device that solves all of them and fully meets the expectations of male and female patients and their doctors. After 5 years of fundamental research and 6 years of technological development, the result is an outstanding medical device, UroActive™, which has been successfully implanted in humans since 2022. Its features are exceptional in terms of functionality, safety, performance and robustness.
UroActive™ is:
• Adapted to both men and women
• Easy to use for patients with a simple remote control (no more manual manipulation of the genitals)
• Safer. Several safety functions protect the patient and the pressure on the urethra can be adjusted at the minimum needed (depending on patient’s activity) to avoid leaks, with the aim to prevent the urethra from erosion.
• Easy to operate for healthcare professionals and fully personalized for the patient.
• Easy to implant, through a less invasive surgery than current devices (fewer components to implant, implantation kit) and thus potentially less prone to peri-operational infections.
• Connected. The surgeon can collect functioning and physiological data which are extremely useful for therapy personalization and patient follow-up.
UroActive™ device will restore the quality of life, dignity and self-esteem of the millions of men and women worldwide suffering from severe SUI, with a decent, effective and safe therapy.
For men, manual artificial urinary sphincters (AUS) have been on the market since the 1970s, with little or no improvement since then. These archaic manual devices require the scrotum to be manipulated for each urination, sometimes with the help of a relative for dependent people. It's humiliating. These devices are associated with a significant rate of revision and explantation, notably because of manually manipulated implantable components, which are fragile and fail, and because the constant pressure exerted on the urethra often leads to erosion and atrophy. Unfortunately, in these cases, the surgeon is obliged to remove the device, and the patient returns to the hell of incontinence for good.
For women, the most commonly used solution is mesh slings, initially developed for cases of prolapse. This solution leaves 15% of women incontinent, with potential serious adverse effects, to such an extent that they are the subject of over 100,000 lawsuits in the USA. The UK and Australia have already banned the product. Manual artificial urinary sphincters are not a viable solution for women. The pump is placed in the labia majora, and handling it involves urinating on the hands. In the US, Boston Scientific's "gold standard" (AMS 800™) is not approved for women. In Europe, fewer than 500 are implanted per year. But these implants demonstrate the demand from women suffering from severe stress-induced urinary incontinence, who are so desperate that they will accept such an inconvenient device. Severely incontinent people urgently need a safe and decent solution.
Based on this damning observation, UroMems was born with the aim to restore normal life and dignity to patients suffering from severe stress urinary incontinence. The strategy was to study the devices on the market, understand their weaknesses and shortcomings, and design a device that solves all of them and fully meets the expectations of male and female patients and their doctors. After 5 years of fundamental research and 6 years of technological development, the result is an outstanding medical device, UroActive™, which has been successfully implanted in humans since 2022. Its features are exceptional in terms of functionality, safety, performance and robustness.
UroActive™ is:
• Adapted to both men and women
• Easy to use for patients with a simple remote control (no more manual manipulation of the genitals)
• Safer. Several safety functions protect the patient and the pressure on the urethra can be adjusted at the minimum needed (depending on patient’s activity) to avoid leaks, with the aim to prevent the urethra from erosion.
• Easy to operate for healthcare professionals and fully personalized for the patient.
• Easy to implant, through a less invasive surgery than current devices (fewer components to implant, implantation kit) and thus potentially less prone to peri-operational infections.
• Connected. The surgeon can collect functioning and physiological data which are extremely useful for therapy personalization and patient follow-up.
UroActive™ device will restore the quality of life, dignity and self-esteem of the millions of men and women worldwide suffering from severe SUI, with a decent, effective and safe therapy.
Significant milestones have been reached by the company :
- The first-of-its-kind clinical feasibility study in men (NCT05547672) of UroActive device was successfully conducted. The cohort is comprised of six men, all of whom underwent the UroActive™ implant procedure at either La Pitié-Salpêtrière University Hospital (AP-HP, Sorbonne University, Paris, France) or Nantes University Hospital (Nantes, France). End of 2024, all devices were activated and operating as expected with no need for revision nor explant after more than 1-year follow-up. .
- A feasibility study was also conducted in women (NCT05828979). The study enrolled six female patients in France (Paris & Nantes). The six-month primary endpoints have been successfully reached early 2025 with the devices operating as expected and no need for revision nor explant.
For both pilot studies, phenomenal follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires. These milestones indicate a new era for millions of women and men suffering from SUI across the U.S. and Europe.
In parallel of the pilot studies, the company worked on the design and preparation of pivotal clinical trial in Europe and the U.S which will be implemented in 2025.
- The first-of-its-kind clinical feasibility study in men (NCT05547672) of UroActive device was successfully conducted. The cohort is comprised of six men, all of whom underwent the UroActive™ implant procedure at either La Pitié-Salpêtrière University Hospital (AP-HP, Sorbonne University, Paris, France) or Nantes University Hospital (Nantes, France). End of 2024, all devices were activated and operating as expected with no need for revision nor explant after more than 1-year follow-up. .
- A feasibility study was also conducted in women (NCT05828979). The study enrolled six female patients in France (Paris & Nantes). The six-month primary endpoints have been successfully reached early 2025 with the devices operating as expected and no need for revision nor explant.
For both pilot studies, phenomenal follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires. These milestones indicate a new era for millions of women and men suffering from SUI across the U.S. and Europe.
In parallel of the pilot studies, the company worked on the design and preparation of pivotal clinical trial in Europe and the U.S which will be implemented in 2025.
UroMems has successfully achieved critical milestones in research and development, clinical outcomes and building the organization, including securing €44 million in funding on the heels of exceptionally strong results from the first-in-man multicenter clinical study six-month endpoint, and more recently the successful six-month primary endpoint for the first-ever female patients to receive a smart automated AUS.
The company will now focus on large-scale U.S. and European pivotal clinical trials of the UroActive™ implant, paving the way for regulatory submission in multiple countries.
The company will now focus on large-scale U.S. and European pivotal clinical trials of the UroActive™ implant, paving the way for regulatory submission in multiple countries.