Uromems SAS received investigational device exemption (IDE) approval from the U.S. FDA, and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM), to begin a pivotal trial of its Uroactive smart implant.

Relief Srl raised more than €1 million (US$1.08 million) in financing for Urorelief, its endourethral medical device which treats stress urinary incontinence. The Italian startup will use the funds to conduct clinical trials to validate the device as it looks to transform the lives of men and women suffering from the condition.

There is no doubt this year started with a boom for European med-tech companies. Public markets opened in the U.S. and cross-border investors are deploying capital. With many companies looking to conduct clinical trials, raising funds and bringing their devices to the market, 2025 is expected to be prosperous, mitigating the difficulties of the previous two to three years.

At least half of women experience urinary incontinence at some point in their lives but few discuss the condition with their physicians. In part, that’s because most women believe few effective treatments exist for urinary leakage – and until recently, they were right. Several advances in 2024, however, offer new hope.

Although financing is returning to the European med-tech market, it remains difficult for CEOs to raise funds for their products.

Stimvia s.r.o. recently secured Medical Device Regulation certification for its Uris neuromodulation system to deliver both percutaneous tibial nerve stimulation and peroneal electrical transcutaneous neuromodulation to treat lower urinary tract symptoms.

Uromems SAS raised $47 million in a series C financing round for its Uroactive system, the first smart automated artificial urinary sphincter device to treat stress urinary incontinence. With the funds the company will be able to “tackle the last stage of our clinical trials before commercial launch,” Hamid Lamraoui, CEO and co-founder of Uromems, told BioWorld.

Amber Therapeutics Ltd. has raised $100 million in a series A funding round to further develop its implantable closed-loop bioelectrical therapy to treat women suffering from mixed urinary incontinence. The financing is one of the largest series A rounds ever seen in Europe’s medical technology space and comes at a time when many med-tech companies are struggling to raise funds.

Affluent Medical SA said that its artificial sphincter, Artus, which treats stress urinary incontinence, was successfully implanted into the first patient. The company hopes that the device, which is the first artificial urinary sphincter that can be activated by the patient with a remote control, will be able to improve the quality of life of the millions of people suffering from urinary incontinence.

Amber Therapeutics Ltd. revealed positive data from the first-in-human investigation of its Amber-UI device, an implantable closed-loop bioelectrical therapy for urinary incontinence. Initial results highlight the safety and scalability of the Amber-UI therapy, which has the potential to meaningfully improve quality of life for patients dealing with the condition.