GRENOBLE, France & MINNEAPOLIS, Minnesota (June 25, 2024) – UroMems, a global company developing innovative, implantable mechatronics technology to treat stress urinary incontinence (SUI), today announced it has raised $47 million in its Series C financing, the largest fundraising round to date for the company. The capital will support large-scale U.S. and European pivotal clinical trials of the UroActive™ implant, paving the way for regulatory submission in multiple countries. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI.

The financing round was led by Crédit Mutuel Innovation and joined by the European Innovation Council as well as the existing investors Wellington Partners, Bpifrance, Supernova Invest, Hil-Invent, b-to-v Partners and Financière Arbevel. “We are thrilled to lead this record round for UroMems,” aid Jérôme Feraud, Head of Health Division at Crédit Mutuel Innovation. “Based on very positive data and feedback from patients and physicians in the pilot clinical trials, we strongly believe that the UroActive smart implant has the potential to become the standard of care as the next-generation SUI treatment.”

Under the strong and steady leadership, energy and guidance of co-founders Chief Executive Officer Hamid Lamraoui and Chief Medical Officer Professor Pierre Mozer, UroMems has successfully surpassed critical milestones in research and development, clinical outcomes and building the organization. The funding comes on the heels of exceptionally strong results from the first-in-man multicenter clinical study six-month endpoint, and successful six-month primary endpoint for the first-ever female patient to receive the UroActive System. For all study patients the devices are operating as expected for over one year now with no need for revision nor explant. In addition, extremely positive follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires.

“We’ve invested in UroMems from the start and our confidence that the UroActive System will improve patients’ lives continues to grow as the company reaches one major milestone after the other,” said Dr. Johannes Fischer, Partner at Wellington Partners. “We look forward to continue supporting the company as they move closer to bringing this promising technology to both women and men suffering from SUI.”

“On behalf of our entire exceptional team and the patients whose lives have been restored thanks to our technology, we are grateful to our investor partners for their continued support as we approach the critical milestone of launching our pivotal clinical trial,” said Lamraoui. “The confidence of our new and existing investors combined with the strength of our compelling results and tremendous physician interest shows the high potential of our technology. This brings us one step closer to delivering on the massive unmet need for men, women and physicians desperately seeking a better SUI treatment option.”

SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans. SUI significantly impacts 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 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 150 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.

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 150 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.

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

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

GRENOBLE, France & MINNEAPOLIS, Minnesota (Feb. 14, 2024) – UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI. This milestone indicates 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 female patient was treated, but also across Europe and the U.S. It also follows closely on the heels of the successful results of the complete treatment cohort of the first-in-man clinical feasibility study. Results of this clinical study will contribute to the design and implementation of UroMems’ pivotal clinical trial in Europe and the U.S.

“On behalf of the medical team who implanted the UroActive System in the first female patient, Drs. Christophe Vaessen, Aurelien Beaugerie and I are over the moon to see our first patient has returned to living life fully after years of struggling with SUI,” said Professor Emmanuel Chartier-Kastler. “This promising therapy is a breakthrough technology in treating SUI in both women and men.”

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

“As the leading advocacy organization in the U.S. supporting patients and caregivers with urinary incontinence, we hear from patients weekly looking for information on the safety and efficacy of artificial sphincters. Unfortunately, we have little to report back and support their requests as no one in the U.S. actively promotes this option for women,” said Steven Gregg, Ph.D., executive director of the National Association for Continence. “These results of the first UroActive System implanted in a female represent a promising development to treat stress urinary incontinence in both women and men. We’re excited about this first-of-its-kind development and look forward to UroMems’ pivotal trial results.”

Pending those results, the potential for U.S. surgeons to offer this new option is now on the horizon; skilled surgeons performing robotic-assisted surgeries such as sacrocolpopexies and hysterectomies may soon be able to add implanting UroActive to their standard practices. UroActive is the first smart active implant that treats 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, intending to provide patients with ease of use and a better quality of life than current options.

“We are elated to reach this critical achievement contributing to the demonstration of the feasibility of the UroActive System to successfully treat women suffering from debilitating SUI,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “The compelling results of this first-in-female implant show the high potential of our technology, bringing us one step closer to delivering on the massive unmet need for women and physicians desperately seeking a better SUI treatment option.” 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.

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 120 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.

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

Successful primary and secondary results demonstrate proof of feasibility in male patients, paving way for launch of large-scale pivotal clinical study in the U.S. and Europe

GRENOBLE, France & MINNEAPOLIS, Minnesota (December 13, 2023) – UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today it has reached a significant milestone: the complete treatment cohort in the first-of-its-kind clinical feasibility study has successfully reached the six-month primary endpoints.

The feasibility assessment of the UroActive System was completed through a prospective multicenter clinical study. UroActive is the first smart 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 design and implementation of UroMems’ pivotal SUI trial in Europe and the U.S. All six men are now implanted for at least seven months and up to fifteen months, with their devices operating as expected and no need for revision nor explant. In addition, extremely positive follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires.

UroMems received very positive feedback from all patients participating in the study cohort. “You have changed my life,” stated one of the study participants. “I can do all activities again, without stress, without anxiety!”

“We’re so pleased to see that our expectations about our device’s performance were met or even exceeded and delighted to successfully treat and receive such high praise from patients who had been suffering from SUI for years,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder. “The results of this study will allow us to prepare our pivotal study which will be a major step in the development of UroActive.”

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 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.

“The very compelling results of this first-in-man 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 are expecting to offer patients suffering from debilitating SUI,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “We could not have reached this important milestone without the enthusiastic participation of the men in this initial study cohort. We’re extremely grateful to them for being a vital part in bringing this potentially revolutionary treatment to market.”

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.

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 120 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.

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

Funds will support pivotal clinical study in U.S. and Europe

GRENOBLE, France & MINNEAPOLIS, Minnesota (November 13, 2023) – UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), is delighted to announce it will receive a financial award from the European Innovation Council Accelerator program. The funding will go toward pivotal SUI trials for the UroActive™ System treating women and men in the U.S. and Europe.

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.

“We are thrilled to receive this award and grateful to the EIC for validating our high potential for improving the lives of millions of women and men,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “It’s a welcome recognition of our innovation and the dedicated team advancing SUI therapy for the betterment of our community.”

UroMems is one of only 47 companies to have won in the latest competitive round, out of almost 650 full proposals.

The EIC Accelerator program is part of the European Innovation Council (EIC) project, which is an element of the European Union’s €95 billion Horizon Europe framework program for research and innovation. The EIC Accelerator provides support to leading SMEs with very high potential to help them develop and bring to market innovative products that can stimulate economic growth.

UroMems aims to restore the quality of life, dignity and self-esteem of millions of people worldwide suffering from poorly treated chronic conditions by first revolutionizing the treatment of SUI with smart active implants, using the latest technological advances in embedded systems and micro-technologies.

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