SAN FRANCISO, Dec. 11, 2024 (GLOBE NEWSWIRE) — FemPulse™ announced today Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin its EVANESCE II pivotal clinical trial in female patients suffering from overactive bladder (OAB). OAB is the first application of FemPulse’s patented female health platform.
Peter Fredericks, Chairman, said, “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.”
Alexandra Haessler, MD, founder and Chief Medical Officer, commented, “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. Implanted sacral neuromodulation therapy is effective but invasive, and access to surgical implantation is limited, especially outside the U.S. In 25 years as the ‘gold standard’ treatment, less than 1% of OAB sufferers have been treated with this approach. We look forward to increasing access to neuromodulation therapy for the millions of women suffering from OAB.”
Suzette Sutherland, MD, who served as the Principal Investigator (PI) on two previous successful clinical trials of the FemPulse Ring while Director of Female Urology at the University of Washington, commented, “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 FemPulse System™ has advanced to the final stage of the new Medical Device Regulation (MDR) process for commercial clearance in the European Union (EU), with the Technical File submitted. Dr. Haessler said, “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.”
About FemPulse
FemPulse Corporation is a bioelectronic medicine company developing a novel wearable bioelectronic platform for the personalized treatment of medical conditions in women. FemPulse’s vaginally-inserted, wearable neuromodulation device is intended to provide mild electrical nerve stimulation as a first-line alternative to pharmaceutical medications. The initial application is to treat the one in six women worldwide suffering from overactive bladder (OAB). For more information, visit www.fempulse.com.
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the effectiveness of the Company’s technology, future clinical studies, future regulatory submissions, and potential regulatory approvals. Actual results may differ materially from those in the forward-looking statements. FemPulse undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future.
Investor Contact:
Peter Fredericks
Chairman, FemPulse
415-577-5441
pfredericks@fempulse.com
FemPulse, The Elegant Solution, FemPulse System, and FemPulse Ring are trademarks of FemPulse.
©2024 FemPulse. All Rights Reserved.
CAUTION: The FemPulse System is for investigational use only.
