FemPulse Corporation (FemPulse), a private, clinical-stage bioelectronic medicine company developing a novel therapy for the personalized treatment of overactive bladder (OAB) in women, announced that the first participant has been enrolled in the Company's 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 treatment plans for individual patients. For more information see the IDTechEx report on Bioelectronic Medicine 2019-2029.
FemPulse technology provides a self-retained neuromodulation device that is vaginally inserted, self-retaining and fits around a woman's cervix (or in the vaginal fornices of women without a cervix). The device is prescribed by a woman's routine provider and controlled by an easy-to-use app. This technology uniquely targets the nervous gateway to and from the bladder. The goal is to provide women the benefits of continuous and individualized neuromodulation with minimal hassle or embarrassment, while avoiding surgery and implants.
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.
Source and top image: FemPulse Cororation
Learn more at the next leading event on the topic: Healthcare Sensor Innovations USA 2020 on 17 - 18 Mar 2020 at San Jose, USA hosted by IDTechEx.