VIENNA AND SAN FRANCISCO– FemPulseTM, a bioelectronic medical technology company with first applicaPon overacPve bladder (OAB), announced today that the Company’s FemPulse RingTM has been granted CE Mark cerPficaPon for the European Union and is now listed in the European Database on Medical Devices (EUDAMED).
CE cerPficaPon under the new Medical Device RegulaPon (MDR) is the basis for markePng 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 neuromodulaPon device that women can insert vaginally, wear conPnuously, 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 communicaPon between the bladder and the spinal cord. PosiPve 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, paPent-friendly therapy. My goal has always been to offer women around the world the proven effecPveness of neuromodulaPon without invasive surgery and as a first-line alternaPve to limited-efficacy drugs.”
“Our easy-to-try and cost-effecPve FemPulse Ring provides women the gold standard treatment, neuromodulaPon. Our AI-agenPc direct outreach to the tens of thousands of women who have self-idenPfied as without an acceptable treatment opPon, 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 paPents, clinicians, and the healthcare system of the non-invasive FemPulse Ring are overwhelming compared to surgically implanted neurosPmulators, which are expensive, invasive, and require specialists. I expect strong adopPon 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 effecPve control.”
About FemPulse
FemPulse is a bioelectronic medicine company developing a novel wearable pladorm for sensing data and providing personalized treatment of medical condiPons in women. FemPulse’s vaginally-inserted, wearable neuromodulaPon Ring is intended to provide mild electrical nerve sPmulaPon as a first-line alternaPve to pharmaceuPcal medicaPons. The iniPal applicaPon is to treat the one in five women worldwide suffering from overacPve bladder (OAB). The device is CE cerPfied for the EU but remains invesPgaPonal in the U.S. For more informaPon, visit hep://www.fempulse.com/ or hep://www.fempulse.eu/ depending on your locaPon.
EU Investor Contact:
Thomas Huber, President
FemPulse GmbH
thomas.huber@fempulse.eu
US Investor Contact:
Peter Fredericks, Chairman
FemPulse CorporaPon