FemPulse Corp. has secured FDA Investigational Device Exemption (IDE) approval to commence its EVANESCE II pivotal clinical trial. The trial will evaluate the FemPulse Ring, a novel wearable bioelectronic device, in female patients suffering from overactive bladder (OAB).
The EVANESCE II trial is designed as a randomized study comparing the FemPulse Ring against first-line medication (tolterodine) to confirm the ring as a first-line alternative to medications. The company aims to address the limited efficacy and intolerable side effects of current medications, which often lead to discontinuation of use by patients.
The FemPulse Ring: A Novel Approach to OAB Treatment
The FemPulse Ring is a vaginally-inserted, removable device designed to provide continuous OAB neuromodulation therapy without requiring surgery. According to Dr. Alexandra Haessler, founder and Chief Medical Officer of FemPulse, the ring is discreet and patient-managed, offering a 'set it and forget it' approach. This aims to improve patient compliance and satisfaction compared to existing treatments.
Dr. Haessler noted that medications for OAB often have limited efficacy and intolerable side effects, leading to discontinuation rates as high as 80%. Implanted sacral neuromodulation therapy, while effective, is invasive and has limited accessibility, with less than 1% of OAB sufferers receiving this treatment in the 25 years it has been available.
Prior Clinical Evidence
The FemPulse Ring has been evaluated in two previous clinical trials. An initial in-clinic usability study demonstrated that all subjects could identify and localize sensations at various thresholds on the device. Furthermore, 50% of patients experienced a reduction in urge-related bother, 67% experienced a longer maximum time between voids, and 57% achieved dry status. No device-related adverse events were reported.
The EVANESCE-OAB study, a prospective trial involving 21 patients, showed that 83% of patients in the treatment cohort experienced a reduction of greater than 1 void per day associated with urgency, compared to 33% in the control cohort. Additionally, 67% of patients in the treatment arm experienced an improvement in UUI-related quality-of-life versus 33% in the control arm.
Trial Design and Endpoints
The EVANESCE-II trial's primary aims are to confirm the safety of the FemPulse System and to establish non-inferiority to first-line tolterodine. The trial will provide further data on the efficacy and safety of the device in a larger patient population.
Regulatory Pathway and Future Availability
The FemPulse System has also advanced to the final stage of the Medical Device Regulation (MDR) process for commercial clearance in the European Union (EU). FemPulse anticipates potential commercial availability in the EU in 2025 and hopes to serve OAB patients in both the EU and the U.S.
Suzette Sutherland, MD, Director of Female Urology at the University of Washington, expressed her support for the device, stating, "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."
