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.