Capital will continue funding pivotal clinical trials and commercial launch preparation of the UroActive®️ System, the first smart automated implant to treat stress urinary incontinence

GRENOBLE, France & MINNEAPOLIS, Minn. (May 13, 2026) – UroMems, a global company developing innovative, implantable mechatronics technology to treat stress urinary incontinence (SUI), today announced it has raised a $60 million strategic investment, the largest fundraising round to date for the company. Ajax Health Fund I[1] financed the entire round, with capital continuing to support large-scale pivotal clinical trials of the UroActive®️ implant in the U.S. and France. The resulting data will pave the way for regulatory submission in multiple countries. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI.

“We’re excited to fund this pivotal round for UroMems and apply our approach of partnering with potential industry leaders to help build and scale innovative medtech organizations,” said David Beylik, partner at Ajax Health. “Combining our industry experience and capital with the UroMems team, we believe that the UroActive smart implant has the potential to become the standard of care for SUI treatment.”

The financing will support UroMems through the completion of its ongoing SOPHIA2 clinical trial of the UroActive smart implant in 21 U.S. and French investigational centers in preparation for regulatory submission to both the U.S. and European markets.

The latest investment builds upon the momentum of a $47 million Series C financing completed in June 2024, led by Crédit Mutuel Innovation with participation from the European Innovation Council and existing investors Wellington Partners, Bpifrance, Supernova Invest, Hil-Invent, b-to-v Partners and Financière Arbevel.

“As existing investors, we’re thrilled to welcome Ajax Health Fund I to this round,” said Philippe Boucheron, deputy chief of life sciences investments for Bpifrance. “Based on strong early clinical study results and unprecedented interest from physicians, we’ve always known that the UroActive System has significant potential to improve patients’ lives and disrupt the market.”

“Ajax Health brings additional operating experience as UroActive enters its next stage, and we look forward to working together to support it through approval and commercialization,” said Johannes Fischer, partner at Wellington Partners.

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. UroMems has successfully surpassed critical milestones in research and development, clinical outcomes and building the organization.

“Ajax Health Fund I’s support strengthens our position as we approach the pivotal points of FDA PMA submission and commercialization, and we’re grateful for their investment, partnership and confidence in UroActive,” said Hamid Lamraoui, co-founder and chief executive officer of UroMems. “I believe UroActive will be a game-changer in treating patients suffering from SUI, and we are now one step closer to achieving our shared vision of delivering on the significant unmet need for patients and physicians desperately seeking a better SUI treatment option.”

David Beylik and Dr. Jeremy Durack are joining the UroMems board of directors, each bringing significant strategic expertise to the company. In addition to his partner role at Ajax Health, Beylik served as the founding chief operating officer of Ajax platform Maverix Medical. Prior to Ajax, he was an associate at Latham & Watkins LLP and a law clerk to Chief Justice John Roberts of the U.S. Supreme Court. Dr. Durack is a practicing interventional radiologist and both a partner and the senior vice president of medical affairs for Ajax Health. Prior to Ajax, he served as vice-chair of radiology at Memorial Sloan Kettering Cancer Center, where his clinical practice and research focused extensively on minimally invasive urology procedures.

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
The UroMems technology platform is protected by more than 200 granted patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. UroActive is the first active implantable electronic artificial urinary sphincter (AUS) that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU. For more information, please visit www.uromems.com.

About Ajax Health

Ajax Health is a U.S.-based private equity firm focused on the medical technology sector. Ajax specializes in forming scaled partnerships with commercial-stage medtech organizations to drive innovation and advance patient outcomes.

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[1] Ajax Health Fund I is a fund sponsored by ICONIQ and sub-advised by U.S.-based medtech-focused investment firm Ajax Health.

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

IDE approval in both countries follows strong feasibility clinical results in France

GRENOBLE, France & MINNEAPOLIS, Minnesota (July 17, 2025) – UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) and French National Agency for the Safety of Medicines and Health Products (ANSM) clearance, enabling the company to begin a first-of-its-kind pivotal clinical trial of the UroActive smart implant to treat stress urinary incontinence (SUI) in men.

This prospective, multicenter trial, called the SOPHIA2 study, will evaluate the safety and efficacy of the UroActive System, the first smart automated artificial urinary sphincter (AUS) for the treatment of SUI. The FDA IDE approval and ANSM clearance follow strong feasibility study results for both women and men in France.

“This marks a key milestone that has been more than a decade in the making, and brings us a significant step closer to delivering the relief from symptoms and return to life that UroActive has the potential to provide patients suffering from SUI,” says Hamid Lamraoui, UroMems chief executive officer and cofounder. “UroActive is the first and only smart automated AUS to reach this critical milestone, indicating a new era for millions of people suffering from SUI, while signaling an exciting transition for surgeons treating SUI across the U.S. and Europe.”

UroActive is 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 complex manipulation, intending to provide patients with ease of use and a better quality of life than current options.

Co-principal US investigators include Dr. Melissa Kaufman, FPMRS, professor and chief reconstructive surgery at Vanderbilt University in Nashville and Dr. Drew Peterson, FPMRS, professor at Duke University in Durham, NC. “We have seen first-hand the shortcomings of current SUI treatment options for our male and female patients,” said Dr. Kaufman on behalf of both co-principal investigators. “That’s why we’re so excited to be leading the SOPHIA2 trial, as it’s showing promise to provide significant improvements in addressing these issues. Based on the feasibility study data we’ve seen, UroActive has the potential to be a transformational technology.”

“We’ve seen exceptionally strong results for both men and women in France as part of the feasibility clinical study, including over one year with no need for revision nor explant and extremely high praise from patients who had been suffering from SUI for years,” said Professor Emmanuel Chartier-Kastler, Urology Chair, Sorbonne University and Pitié-Salpêtrière Hospital in Paris. “We look forward to conducting the pivotal SOPHIA2 study in France in lock step with the U.S. sites.”

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 selfesteem and social stigma. SOPHIA2 study will serve as the basis for UroMems’ regulatory submission to the FDA and supports its broader strategy to commercialize UroActive in the U.S. and European markets.

About UroActive:

The UroMems technology platform is protected by more than 180 granted patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. UroActive is the first active implantable electronic artificial urinary sphincter (AUS) that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique mechatronic platform using embedded smart, digital and robotic systems. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU. This project is financially supported by the European Innovation Council and France 2030.

One-year data for the first patient will be presented for the first time during the SUFU meeting in Palm Springs, Calif.; the promising results demonstrate proof of feasibility in female patients

GRENOBLE, France and MINNEAPOLIS, Feb. 20, 2025 /PRNewswire/ – UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that the entire treatment cohort in the first-of-its-kind clinical feasibility study in female patients has successfully reached the six-month primary endpoints. 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 study was conducted, but also across the U.S. and Europe.

One-year results for the first patient will be presented for the first time by Professor Emmanuel Chartier-Kastler, Urology Chair, Sorbonne University and Pitie-Salpetriere Hospital, Paris, during the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Winter Meeting in Palm Springs, Calif., on Feb. 27th.

“With women suffering from higher rates of SUI and currently no effective solutions available to them, we are ecstatic to be the first to demonstrate the feasibility of our breakthrough technology now in a total of 12 women and men,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “All of the female patients participating in our study have returned to living life fully after years of struggling with SUI. We sincerely thank them for participating in our study along with their physicians and our team for bringing this one step closer to providing a new and effective option to the millions of people suffering from SUI in the U.S. and Europe.”

The female 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. All six women are now implanted for at least seven months and close to two years for the first patient, with their devices operating as expected and no need for revision nor explant. In addition, phenomenal follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires.

Patients who participated in the study cohort shared unanimous positive feedback: “I am living again. It’s night and day,” stated one of the study participants. “It’s fabulous. Thank you for this innovative product,” said another.

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.

UroMems has successfully achieved critical milestones in research and development, clinical outcomes and building the organization, including recently securing $47 million in funding on the heels of exceptionally strong results from the first-in-man multicenter clinical study six-month endpoint, and now the successful six-month primary endpoint for the first-ever female patients to receive a smart automated AUS.

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:

The UroMems technology platform is protected by more than 150 granted patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. UroActive is the first active implantable electronic artificial urinary sphincter (AUS) that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique mechatronic platform using embedded smart, digital and robotic systems. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU. This project is financially supported by the European Innovation Council and France 2030.

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

This recognition, voted on by Europe’s leading growth investors, highlights our high potential and our efforts to drive innovation and progress in the medical device space.

Tech Tour Growth50 List 2025

Rose brings medical device leadership and commercialization expertise to the company as it prepares to enter into U.S. and European pivotal clinical trials of UroActive, the first smart automated artificial urinary sphincter

GRENOBLE, France & MINNEAPOLIS, Minnesota (Jan. 30, 2025) – UroMems, a global medical technology company developing the first smart automated implant to treat stress urinary incontinence (SUI), announced today that Dan Rose has been appointed as the new chairman of its board of directors.

“We are very pleased to welcome Dan as our new board chair at this very exciting time for the company,” said UroMems co-founder and CEO Hamid Lamraoui. “His proven track record in the industry and dynamic leadership capabilities position him extremely well as UroMems moves forward with our next phase of large-scale U.S. and European pivotal clinical trials of UroActive®, preparing for the commercial launch of the first smart automated artificial urinary sphincter (AUS) to treat SUI.”

Bringing more than 25 years of medical device experience to the UroMems board, Rose currently serves as the CEO of Endovascular Engineering, a Silicon Valley-based company focused on the treatment of venous thromboembolism. Previously, he also served as CEO of LimFlow S.A., a pioneer in limb salvage for patients with chronic limb-threatening ischemia (CLTI). He joined LimFlow as the first employee and successfully guided the company through its acquisition by Inari Medical for up to $415 million. Rose also held leadership roles with Direct Flow Medical, Sequana Medical AG, and Medtronic. Rose has bachelor and master of arts degrees from the University of Virginia and an MBA from the Darden School of Business.

“I am grateful to have the opportunity to move into this role and for the potential to make a real impact on the quality of life for millions of patients suffering from SUI,” said Rose. “I’m impressed by the strong momentum UroMems has built up so far and look forward to helping take their innovative, patientfocused technology into this next phase.”

UroMems has successfully achieved critical milestones in research and development, clinical outcomes and building the organization, including recently securing $47 million in funding on the heels of exceptionally strong results from the first-in-human multicenter clinical studies.

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 selfesteem and social stigma.

About UroActive:

The UroMems technology platform is protected by more than 150 granted patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. UroActive is the first active implantable electronic artificial urinary sphincter (AUS) that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique mechatronic platform using embedded smart, digital and robotic systems. 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

Sama brings operational expertise to UroMems as the company prepares for the launch of pivotal clinical trials for its UroActive System, the first smart automated implant to treat stress urinary incontinence

GRENOBLE, France & MINNEAPOLIS, Minnesota (Nov. 26, 2024) – UroMems, a global medical technology company developing the first smart automated implant to treat stress urinary incontinence (SUI), today announced the appointment of medical device veteran Rinda Sama to its board of directors.

“We are thrilled to welcome Rinda to our board of directors,” said UroMems co-founder and CEO Hamid Lamraoui. “Rinda’s deep experience in medical technology, and specifically with the Axonics sacral neuromodulation (SNM) therapy to treat overactive bladder, will be invaluable to UroMems as we embark on large-scale U.S. and European pivotal clinical trials of UroActive®, in preparation for the commercial launch of the first smart automated artificial urinary sphincter (AUS) to treat SUI.”

An accredited Public Company Director, Sama brings nearly 20 years of medical device experience, including serving as the chief operating officer of Axonics for more than 10 years where he played a critical role in implementing lean operations and compliant quality systems that helped to pave the way for Food and Drug Administration (FDA) approval and the recent acquisition of Axonics by Boston Scientific. Prior to Axonics, Sama was the director of operations and quality at Vessix Vascular, Inc., subsequently acquired by Boston Scientific. He also served on the board of directors for BioVentrix and Laser Associated Sciences. Sama holds a master’s degree in biomedical engineering from the University of Southern California and an MBA from the University of California, Irvine.

“UroMems is in a very similar position like Axonics was several years ago in terms of developing a game-changing treatment after limited innovation in the category for decades, providing underserved patients with a dramatically better option,” said Sama. “I see the same strong potential with the UroActive System in revolutionizing the treatment of SUI as the first smart AUS and I look forward to sharing my operational expertise to help successfully move it forward through FDA approval and launch.”

UroMems has successfully achieved critical milestones in research and development, clinical outcomes and building the organization, including recently securing $47 million in funding 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 a smart automated AUS.

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 the first active implantable electronic artificial urinary sphincter (AUS) that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique mechatronic 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