Initial clinical trial results will inform pivotal clinical study in U.S. and Europe

GRENOBLE, France & MINNEAPOLIS, Minnesota (September 12, 2023) – UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed enrollment in its first-in-man study of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI. The results of this initial clinical study will support design and implementation of UroMems’ pivotal SUI trial in Europe and the U.S.

The study 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) with sequential enrollment as defined by the National Agency or the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration).

“We are delighted with the rapid enrollment and positive early results we’re seeing in our SOPHIA study,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder. “And with the treatment of our final study subject complete, we are now following the full clinical cohort in preparation for the pivotal study on our unique UroActive System.”

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 automatically controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options. UroMems recently successfully completed the first-ever implant of the UroActive system in a female patient, a milestone indicating a new era for millions of women suffering from SUI. UroMems also received the Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive.

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 artificial urinary sphincter.

“We are indebted to these men for their participation in the SOPHIA study, and their enthusiastic response to their personalized therapy is heartening,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “This clinical investigation began less than a year ago and soon we will have six-month follow-up results for the complete cohort.”

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.

About UroActive:

UroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bionic platform using embedded smart, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems technology platform is protected by more than 100 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. STeP participation does not imply product authorization. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.

About UroMems:

Founded in 2011 by Professor Pierre Mozer, Hamid Lamraoui and Stéphane Lavallée, UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated 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. The first challenge for the company will be applying embedded mechatronics methods and smart systems for treating urinary incontinence. Designed by urologists and collaborating scientists and engineers, UroActive intends to provide a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.

Since the inception of the company, significant investments have been made for the development of UroMems’ first product. This includes two financing rounds totaling 46 million euros, led by Wellington Partners, Bpifrance, Supernova Invest, b-to-v Partners AG, Cita Investissement, Hil-Invent, Financière Arbevel and the founders. The company has received several awards for innovation, including the Prix Galien Award Medstart’up and the Worldwide Innovation Challenge initiated by the French government. For more information, please visit www.uromems.com.

Media Contact:
Shelli Lissick
shelli@bellmontpartners.com
651-276-6922

Initial clinical study results will inform pivotal clinical trial in U.S. and Europe

GRENOBLE, France & MINNEAPOLIS, Minnesota (July 20, 2023) – 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.

About UroActive:

UroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bionic platform using embedded smart, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems technology platform is protected by more than 100 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. STeP participation does not imply product authorization. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.

About UroMems:

Founded in 2011 by Professor Pierre Mozer, Hamid Lamraoui and Stéphane Lavallée, UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated 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. The first challenge for the company will be applying embedded mechatronics methods and smart systems for treating urinary incontinence. Designed by urologists and collaborating scientists and engineers, UroActive intends to provide a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.

Since the inception of the company, significant investments have been made for the development of UroMems’ first product. This includes two financing rounds totaling 46 million euros, led by Wellington Partners, Bpifrance, Supernova Invest, b-to-v Partners AG, Cita Investissement, Hil-Invent, Financière Arbevel and the founders. The company has received several awards for innovation, including the Prix Galien Award Medstart’up and the Worldwide Innovation Challenge initiated by the French government. For more information, please visit www.uromems.com.

Media Contact:
Shelli Lissick
shelli@bellmontpartners.com
651-276-6922

Initial clinical trial results will inform pivotal clinical study in U.S. and Europe

GRENOBLE, France & MINNEAPOLIS, Minnesota (June 6, 2023) – UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully met the primary endpoints for the initial male patient in its SOPHIA study. SOPHIA is the first-in-man study of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI. The results of this clinical study will support design and implementation of UroMems’ pivotal clinical trial in Europe and the U.S.

The primary outcome measures include the successful device activation and the rate of explants and revisions at six months. SOPHIA’s first patient has not only met the study’s primary endpoints by remaining revision-free but also experiences restored social continence. In addition, follow-up on secondary measures, including leak rate values, have been extremely positive.

“This is a life saver,” the patient stated, as the first to receive the novel UroActive device. “I am living again!”

“With the encouraging six-month post-activation results of our first study subject, we look forward to reviewing the balance of the follow-up data on our patients and advancing to the pivotal study stage of a potentially revolutionary SUI therapy,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder.

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 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.

“We are excited to reach this essential milestone in our development and especially to report the first man experiencing truly personalized continence therapy,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “We are deeply grateful to all the patients participating in this first-of-its-kind implant journey and enthusiastically await follow-up results for the complete cohort.”

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 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.

About UroActive:

UroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bionic platform using embedded smart, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems technology platform is protected by more than 100 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. STeP participation does not imply product authorization. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.

About UroMems:

Founded in 2011 by Professor Pierre Mozer, Hamid Lamraoui and Stéphane Lavallée, UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated 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. The first challenge for the company will be applying embedded mechatronics methods and smart systems for treating urinary incontinence. Designed by urologists and collaborating scientists and engineers, UroActive intends to provide a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.

Since the inception of the company, significant investments have been made for the development of UroMems’ first product. This includes two financing rounds totaling 46 million euros, led by Wellington Partners, Bpifrance, Supernova Invest, b-to-v Partners AG, Cita Investissement, Hil-Invent, Financière Arbevel and the founders. The company has received several awards for innovation, including the Prix Galien Award Medstart’up and the Worldwide Innovation Challenge initiated by the French government. For more information, please visit www.uromems.com.

Media Contact:
Shelli Lissick
shelli@bellmontpartners.com
651-276-6922

STeP inclusion reflects the potential improvements in safety of its UroActive™ System

Grenoble, France & Minneapolis, Minnesota (April 20, 2023) – UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive Smart Continence Therapy. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices.

“We are delighted to receive this designation and excited to advance the development of our UroActive system – the first-of-its-kind fully automated AUS implant designed to treat SUI in both men and women,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “We thank the FDA for acknowledging the importance of safety above all for patients.”

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 automatically controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.

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 artificial urinary sphincter.

“The STeP approval is proof that the FDA recognizes the potential for UroActive to improve upon safety for patients with severe SUI, while also designed for an improved surgical experience for the OR team, surgeons and most importantly, their patients,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder.

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.

About STeP: Launched in January of 2021, the FDA’s Safer Technologies Program is a voluntary program for certain medical devices and device-led combination products that have the potential to be safer than currently available treatments or medical diagnostics. The program is intended to help patients have more timely access to products by expediting their development, assessment, and review, while maintaining the FDA’s standards for safety and effectiveness, data requirements, and quality of review. (1)
STeP participation does not imply product authorization. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States.

About UroActive:
UroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bionic platform using embedded smart, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems technology platform is protected by more than 100 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience.

About UroMems:
Founded in 2011 by Professor Pierre Mozer, Hamid Lamraoui and Stéphane Lavallée, UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated 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. The first challenge for the company will be applying embedded mechatronics methods and smart systems for treating urinary incontinence. Designed by urologists and collaborating scientists and engineers, UroActive intends to provide a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.

Since the inception of the company, significant investments have been made for the development of UroMems’ first product. This includes two financing rounds totaling 46 million euros, led by Wellington Partners, Bpifrance, Supernova Invest, b-to-v Partners AG, Cita Investissement, Hil-Invent, Financière Arbevel and the founders. The company has received several awards for innovation, including the Prix Galien Award Medstart’up and the Worldwide Innovation Challenge initiated by the French government. For more information, please visit www.uromems.com.

Media Contact:
Shelli Lissick
shelli@bellmontpartners.com
651-276-6922

(1) https://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2023

This initial clinical trial is a key milestone in the development of its UroActive™ System

Grenoble, France (November 29, 2022) – UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive.

“This is a historic milestone for UroMems, patients, physicians and the industry as this is a first-of-its-kind fully automated AUS implant designed to treat SUI in both men and women,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “This is the next important step in delivering our novel technology to a large, underserved patient population with unmet needs not addressed by current options on the market.”

The first male patient procedure was successfully completed at La Pitié-Salpêtrière University Hospital (AP-HP, Sorbonne University, Paris, France) by Professor Emmanuel Chartier-Kastler, principal investigator, with approval from the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration).

“We believe this groundbreaking therapy will change the way SUI is treated worldwide, establishing a new standard of care,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder.

UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated 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.

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 automatically controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.

“We see a high rate of today’s AUS implants that are revised or removed after three years,” said Professor Daniel Elliott, urologist at Mayo Clinic in Rochester, Minn., and clinical advisor to UroMems. “The potential of being able to personalize the therapy to the patient automatically, post-implantation is very appealing.”

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 artificial urinary sphincter.

About UroActive: UroActive is an active implantable electronic artificial urinary sphincter that has been developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bioelectronic platform using embedded smart, AI-based, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems technology platform is protected by more than 100 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience.

About UroMems: Founded in 2011 by Professor Pierre Mozer, Hamid Lamraoui and Stéphane Lavallée, UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated 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. The first challenge for the company will be applying embedded mechatronics methods and smart systems for treating urinary incontinence: designed by urologists and collaborating scientists and engineers, UroActive intends to provide a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.

Since the inception of the company, significant investments have been made for the development of UroMems’ first product. This includes two financing rounds totaling 46 million euros, led by Wellington Partners, Bpifrance, Supernova Invest, b-to-v Partners AG, Cita Investissement, Hil-Invent, Financière Arbevel and the founders. The company has received several awards for innovation, including the Prix Galien Award Medstart’up and the Worldwide Innovation Challenge initiated by the French government. For more information, please visit www.uromems.com.

Media Contact: Shelli Lissick shelli@bellmontpartners.com 651-276-6922