FemPulse announced today that it received FDA investigational device exemption (IDE) approval for its overactive bladder (OAB) therapy.
The company can now begin the EVANESCE II pivotal clinical trial in female patients suffering from OAB. Its FemPulse system is already at the final stage of the EU MDR process for regulatory approval in that region. The company hopes for commercial availablility in Europe in 2025 and potentially U.S. approval down the line.
Dr. Alexandra Haessler, the company’s founder and chief medical officer, created the vaginally-inserted, removable FemPulse Ring. It’s an “internal wearable,” she said in a news release, providing continuous OAB neuromodulation therapy without requiring surgery.
According to Haessler, the discreet, patient-managed ring features a “set it and forget it” approach. The company plans for its trial — randomized against medication — to confirm the ring as a first-line alternative to medications. Haessler said the company wants to address the limited efficacy and intolerable side effects of medications that cause patients to discontinue use.
Dr. Suzette Sutherland served as the principal investigator on two previous successful clinical trials of the FemPulse Ring. She also holds the post of director of female urology at the University of Washington. Sutherland said: “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.”
