UroMems has positive results for first-ever female implant of smart urinary sphincter system

The UroActive implant. [Image from UroMems]UroMems announced today that it successfully met the six-month primary endpoint for the first female patient implanted with UroActive.

Grenoble, France-based UroMems designed its smart UroActive implant to treat stress urinary incontinence (SUI). The company says it’s the first smart, automated artificial urinary sphincter (AUS) to treat SUI.

Powered by a MyoElectroMechanical system (MEMS), UroActive goes into the urethral duct in men and bladder neck in women. It’s controlled by a patient’s activity without the need for manual adjustments. This provides patients ease of use and better quality of life compared to better options. The company previously had positive early feasibility data in a study of six men, but this marks the first-ever female implant.

UroMems said the milestone indicates “a new era” for women suffering from SUI. It could also signal a transition for surgeons treating SUI, not only in…

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UroMems reports positive feasibility data for smart urology implant

The UroActive implant. [Image from UroMems]UroMems today announced that it the treatment cohort in a feasibility study of its UroActive system reached six-month primary endpoints.

Grenoble, France-based UroMems designed its smart UroActive implant to treat stress urinary incontinence (SUI). The company says it’s the first smart, automated artificial urinary sphincter (AUS) to treat SUI.

Powered by a MyoElectroMechanical system (MEMS), UroActive goes into the urethral duct. It’s controlled by a patient’s activity without the need for manual adjustments. This provides patients ease of use and better quality of life compared to better options, according to a news release.

The first-of-its-kind clinical feasibility study supports the design and implementation of a pivotal trial in Europe and the U.S.

All six men in the study received their implants at least seven months ago — and up to 15 months. The study demonstrated that devices oper…

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UroMems completes first-in-human study enrollment for smart urinary implant

The UroActive implant. [Image from UroMems]UroMems announced today that it successfully completed enrollment in its first-in-human study of its UroActive system.

Grenoble, France-based UroMems designed the UroActiv system as a smart, automated artificial urinary sphincter (AUS). It treats stress urinary incontinence (SUI). Results from the initial study should support the design and implementation of a pivotal trial in Europe and the U.S.

The study cohort features six men, all of whom underwent the UroActiv implant procedure in either Paris or Nantes, France.

In June, the SOPHIA study successfully met the primary endpoints for its initial male patient. Primary outcomes for the study include successful device activation and the rate of explants and revisions at six months. The first male patient in the SOPHIA study met the primary endpoints by remaining revision-free. This patient also experienced restored social continence.

“We are delighted wi…

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Smart implant from UroMems meets primary endpoint in first-in-human study

The UroActive implant. [Image from UroMems]UroMems announced that it successfully met the primary endpoints for the initial male patient in a study of its UroActive smart implant.

Grenoble, France-based UroMems develops mechatronics technology to treat stress urinary incontinence (SUI). Its SOPHIA study evaluates the UroActive smart, automated artificial urinary sphincter (AUS) in the treatment of SUI. The company plans for its study to support the design and implementation of its pivotal clinical trial. It has plans for trials to take place in Europe and the U.S.

Primary outcomes for the study include successful device activation and the rate of explants and revisions at six months. The first male patient in the SOPHIA study met the primary endpoints by remaining revision-free. This patient also experienced restored social continence.

UroMems also reported “extremely positive” secondary measures, including leak rate values, according to a news …

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UroMems begins first-in-human study of smart implant for treating stress urinary incontinence

The UroActive implant. [Image from UroMems]UroMems announced today that it completed the first-in-human implant of its UroActive system for treating stress urinary incontinence (SUI).

Grenoble, France-based UroMems designed UroActive as a smart, automated artificial urinary sphincter (AUS) investigational device.

The company said in a news release that UroActive represents the first smart, automated AUS. Kicking off the clinical study marks a key step in its development, UroMems said.

UroMems believes the therapy could change the treatment of SUI and establish a new standard of care.

“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 CEO and co-founder. “This is the next important step in delivering our novel technology to a large, underserved patient population with unme…

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UroMems adds $8.3M, brings Series B round to $27.3M

UroMems announced today that it added $8.3 million to its Series B financing round, bringing the total funds raised to $27.3 million.

Grenoble, France-based UroMems’ $27.3 million (€23 million) financing round had its first tranche completed in May 2020 but added the $8.3 million (€7 million) thanks to existing investors including Hil-Invent GmbH, Financière Arbevel, Wellington Partners, Bpifrance, via its FABS fund, Supernova Invest and btov Partners, according to a news release.

The additional funding in the Series B is earmarked to fund the final development, manufacturing and the first clinical trials of the eAUS active implantable medical device designed to compensate for sphincter insufficiency in patients with stress urinary incontinence (SUI).

“Our development strategy remains on track with the next major phase being the initiation of the first-in-human studies of our eAUS device, one of the most sophisticated devi…

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UroMems raises $17.6m

Electronic artificial urinary sphincter (eAUS) maker UroMems announced today that it raised $17.6 million (€16 million) in an equity and debt financing.

Grenoble, France-based UroMems intends to use the proceeds from the funding to support ongoing preclinical studies and the initiation of the first clinical studies of its eAUS device for treating stress urinary incontinence (SUI), according to a news release.

UroMems’ eAUS is an implantable device designed to compensate for sphincter insufficiency in patients with SUI, based on the latest technologies in embedded intelligent systems and software.

Hil-Invent GmbH led the financing round with co-investor Financière Arbevel. Existing investors such as Wellington Partners, Bpifrance, Cita Investissement, Supernova Invest and Btov Partners also participated along with the company’s founders. A syndicate that included Bpifrance, BNP Paribas, Caisse d’Epargne, Crédit Agricole and Banque Populaire pr…

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