FemPulse Ring Gains CE Mark Certification for the EU

VIENNA and SAN FRANCISCO, Sept. 17, 2026 (GLOBE NEWSWIRE) -- FemPulse™, a bioelectronic medical technology company with first application overactive bladder (OAB), announced today that the Company’s FemPulse Ring™ has been granted CE Mark certification for the European Union and is now listed in the European Database on Medical Devices (EUDAMED).

CE certification under the new Medical Device Regulation (MDR) is the basis for marketing of a medical device in the EU. It confirms that the device has been evaluated in accordance with stringent European regulatory requirements and meets high standards of safety, quality, and clinical performance.

The FemPulse Ring is a wearable wireless neuromodulation device that women can insert vaginally, wear continuously, and remove themselves. The patented FemPulse Ring is unique in being self-retained in the upper vagina with eight programmable surface electrodes intended to directly target the nerves that control communication between the bladder and the spinal cord. Positive safety and efficacy data from four clinical studies supported grant of the CE Mark.

Dr. Alexandra Haessler, the urogynecologist-developer of the FemPulse Ring, said: “I am excited that the over 50 million women in Europe suffering from OAB will now have access to our non-invasive, patient-friendly therapy. My goal has always been to offer women around the world the proven effectiveness of neuromodulation without invasive surgery and as a first-line alternative to limited-efficacy drugs.”

“Our easy-to-try and cost-effective FemPulse Ring provides women the gold standard treatment, neuromodulation. Our AI-agentic direct outreach to the tens of thousands of women who have self-identified as without an acceptable treatment option, together with their clinicians, will help many women avoid unnecessary surgery and unnecessary drug side-effects,” added Thomas Huber, President of FemPulse GmbH in Vienna.

Jürgen Hambrecht, a German investor whose board roles have included BASF, Daimler-Benz, and Trumpf, commented: “I invested in FemPulse because the benefits to patients, clinicians, and the healthcare system of the non-invasive FemPulse Ring are overwhelming compared to surgically implanted neurostimulators, which are expensive, invasive, and require specialists. I expect strong adoption of the FemPulse Ring across Europe.”

Bill Hawkins, former Chairman and CEO of Medtronic and also an early FemPulse investor added: “I invested in FemPulse early on as I liked the concept in that it is simple, easy to use, and addresses a large market opportunity. The vaginal ring differs from other approaches as it is discreet, easily inserted and removed, and provides effective control.”

About FemPulse
FemPulse is a bioelectronic medicine company developing a novel wearable platform for sensing data and providing personalized treatment of medical conditions in women. FemPulse’s vaginally-inserted, wearable neuromodulation Ring is intended to provide mild electrical nerve stimulation as a first-line alternative to pharmaceutical medications. The initial application is to treat the one in five women worldwide suffering from overactive bladder (OAB). The device is CE certified for the EU but remains investigational in the U.S. For more information, visit http://www.fempulse.com/ or http://www.fempulse.eu/ depending on your location.

EU Investor Contact:
Thomas Huber, President
FemPulse GmbH
thomas.huber@fempulse.eu

US Investor Contact:
Peter Fredericks, Chairman
FemPulse Corporation
pfredericks@fempulse.com