FemPulse Enrolls First Participant in Clinical Study of Personalized OAB Treatment

FemPulse Corporation (FemPulse) has enrolled the first participant in its clinical trial evaluating physiological responses to therapy delivered with the FemPulse System. Observations from this feasibility study can further help elucidate the mechanisms of action and facilitate tailoring overactive bladder (OAB) treatment plans for individual patients.
 
Dr. Adam Loavenbruck, a neurologist at Hennepin Healthcare in Minneapolis and the principal investigator of the study, commented, “The FemPulse System is a promising advancement in the OAB field as it represents a potential solution that could offer women the ability to improve their quality of life and regain their independence. This study will help further establish the ability to individualize therapy parameters and I look forward to working with more patients.”
 
Dr. Alexandra Haessler, chief medical officer and founder of FemPulse, added, “Currently, there are limited convenient and effective treatment options for women suffering with OAB. The enrollment of our first participant in this study is an important milestone as we strive to provide a minimally invasive treatment that will improve the quality of life for women impacted by this condition. We look forward to the final results as a further validation of our mission to address this unmet need with a truly unique solution.”
 
The clinical trial is an open-label, single group assignment to investigate the FemPulse system for the treatment of OAB in women. Participants will wear a FemPulse device and will be monitored non-invasively during activation of the device for up to six hours. The company anticipates data readout in the second half of 2019.
 
FemPulse Corporation is a privately held clinical-stage bioelectronic medicine company focused on treating women with overactive bladder. The company is developing the FemPulse System, a neuromodulation platform, intended to provide mild electrical nerve stimulation to regulate bladder function and relieve the symptoms of OAB. The small, vaginal ring is disposable and may remain indwelling for days or weeks, affording discreet, personalized, continuous and self-managed therapy.