FemPulse revealed today that it has secured IDE (Investigational Device Exemption) approval from the FDA for its treatment targeting overactive bladder (OAB). This paves the way for the initiation of the EVANESCE II pivotal clinical trial focusing on female patients with OAB. The FemPulse device is already in the final stages of obtaining the EU MDR regulatory approval, aiming for a commercial release in Europe by 2025, with hopes for future U.S. approval.
The company was founded by Dr. Alexandra Haessler, who serves as its chief medical officer. She developed the FemPulse Ring, a removable, vaginally-inserted device, described in a company statement as an “internal wearable.” This technology offers continuous neuromodulation therapy for OAB patients without the need for surgical intervention.
Haessler explained that the ring provides a “set it and forget it” solution, allowing patients to manage their condition with ease. The company’s upcoming trial, which is randomized against medication, aims to establish the ring as an effective first-line therapy alternative to traditional pharmaceuticals. The goal is to counter the limited efficacy and intolerable side effects that lead many patients to stop their medication regimen.
Dr. Suzette Sutherland, who took the role of principal investigator for two earlier clinical trials involving the FemPulse Ring, also acts as the director of female urology at the University of Washington. Based on her hands-on experiences with patients and the outcomes of past trials, Sutherland expressed strong confidence in the efficacy of FemPulse’s wearable therapy. She stated, “I am delighted to back FemPulse in this multi-center IDE trial and am eager to present our findings at leading international forums.”