FemPulse has received FDA Investigational Device Exemption (IDE) approval to begin its EVANESCE II pivotal clinical trial for its wearable bioelectronic device targeting overactive bladder (OAB) in women. The device, called the FemPulse Ring, is designed as a vaginally-inserted, removable treatment option.
“We want to thank everyone at FDA for their thorough review and clear dedication to patient safety. This is an important milestone towards serving the 1 in 6 women worldwide suffering with OAB,” said Peter Fredericks, Chairman.
“I created the vaginally-inserted and removable FemPulse Ring as an ‘internal wearable’ to provide continuous OAB neuromodulation therapy without requiring surgery. The wearable ring is discreet and patient-managed with a ‘set it and forget it’ approach. Medications can have limited efficacy and intolerable side-effects, so patients discontinue them up to 80% of the time. The trial is randomized against medication to confirm the FemPulse Ring as a first-line alternative to medications,” said Alexandra Haessler, MD, founder and Chief Medical Officer.
Dr. Suzette Sutherland, who served as Principal Investigator on two previous clinical trials of the device, added: “My hands-on experience using the FemPulse Ring with patients and the clinical trial results confirmed my strong belief in FemPulse’s wearable therapy. I am thrilled to support FemPulse in this multi-center IDE trial and look forward to once again sharing the results at international conferences.”
The company is also pursuing commercial clearance in the European Union, with potential availability in 2025. “It is exciting that our FemPulse Ring may be commercially available in the EU in 2025. We certainly hope to serve as many OAB patients in the EU as in the U.S.,” said Dr. Haessler.
