17% of women around the world suffer with overactive bladder

Overactive bladder (OAB), the sudden and urgent need to urinate, affects 17% of women worldwide and over 20 million women in the US alone. The strong, compelling desire to pass urine is difficult to defer and greatly limits a woman's quality of life. Current treatments are inadequate with first line behavioral options requiring frequent, time-consuming office visits or cumbersome handheld vaginal stimulators and second line pharmaceutical therapy being expensive and often causing intolerable side-effects. Patients often consider the therapies cumbersome and forgo treatment, resulting in compliance issues, and opt to live with their symptoms creating a huge, unmet need. Implanted sacral neuromodulation is often effective and provides continual therapy with ease-of-use, but is invasive, requiring a surgical implant performed by a physician with specialized skills and is quite expensive. The $4 billion spent annually on urinary incontinence drugs in the US alone does not account for the impact on the lives of women.

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New, elegant way to deliver neuromodulation therapy for women

FemPulse technology is designed to deliver neuromodulation therapy to nerves contributing to the symptoms of overactive bladder. The current technology focuses on providing personalized, discreet, and affordable therapy for females with OAB via a 30-day-use ring controlled by an easy-to-use app. The self-administered, vaginal ring provides mild nerve stimulation to help regulate bladder sensation and relieve the symptoms of OAB. The therapy is prescribed by a woman’s routine provider and placed by the patient herself at home. Independently programmable electrodes allow stimulation regimens individualized to a woman’s needs.

FemPulse schematic

Developed by a female surgeon to help her patients

Dr. Alexandra Haessler, a urogynecologist, was as frustrated as her OAB patients. Standard of care treatment options have drawbacks and often left patients unsatisfied with unalleviated symptoms. Some therapies were not covered by insurance and while implanted neuromodulation worked better than handheld vaginal stimulators, it required a surgical procedure and great expense. Dr. Haessler kept waiting for advances in technology to provide women with a vaginal wearable, rather than an implanted, neuromodulation option. But when an alternative never arrived, she took it upon herself to develop it based on her years of experience with neuroanatomic and physiologic principles from urogynecology practice. Her knowledge of the state of the science combined with her understanding of women's treatment goals enabled her to develop an effective, patented system to treat the source of the issue.

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FemPulse Trajectory

FemPulse Science

Neuromodulation, using low-level electrical current, is a common therapy to treat medical conditions. It is believed to work by altering aberrant nerve behavior. Electrical impulses are delivered to positively influence nerve communication and muscle and end-organ sensation and function. FemPulse wearable technology is based on the neuroanatomy and neurophysiology of bladder control. 
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AUA Guideline

FemPulse’s mission is to offer non-implanted electrical stimulation (neuromodulation) as first-line treatment for OAB and the additional indications addressed by the FemPulse neuromodulation platform. The American Urological Association (AUA) 2014 OAB guideline recommends noninvasive first-line treatment to all patients with OAB and outlines that these treatments can include electrical stimulation. Medication is classified second-line and more invasive neuromodulation third-line. To read the full AUA guideline click here.

FDA Guidance

FemPulse will seek initial FDA 510(k) clearance as a “nonimplanted electrical continence device”.  This class of devices has generally carried the nonsignificant risk (NSR) designation, and often not required clinical trials for FDA 510(k) clearance.  FDA guidance listing nonimplanted electrical continence devices as an example of NSR devices is available here. The FDA provides guidance documents for incontinence device trials. FemPulse has completed both in-clinic and in-home OAB trials and plans to study other indications, for which it may then seek additional 510(k) clearance.