For Physicians
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For Physicians
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Bioelectronic medicine achieves therapeutic responses via electric pulses rather than via the chemicals of pharmaceutical medicine. Numerous medical conditions are currently treated by bioelectric medicine, such as Parkinson’s, pain conditions, and cardiac arrhythmias. Bioelectronic devices can be connected, meaning patients and physicians can benefit from digital health data, with patients having control from their smartphones/watches. As such, bioelectronic therapies lend themselves to closed-loop treatment applications, dramatically increasing the ability to individualize treatment regimens based on a user’s response. Trends in microelectronics miniaturization and software, including data-driven AI, facilitate this and ultimately make bioelectronic therapies more accessible, adoptable, and affordable.
Many physicians understand the promise of bioelectronics, but have been frustrated by the lack of accessibility. Bioelectronic devices have historically required surgical implantation by a specialist, making them invasive and expensive. As a result, they have often been indicated only after pharmaceuticals have failed, rather than as an alternative for physicians early in the care continuum. FemPulse’s unique wearable bioelectronic device is designed to provide physicians a fundamentally new option.
FemPulse has been granted patents worldwide, including in the US, Europe, and China, on its wearable bioelectronic device positioned in the upper vagina – a unique anatomical location for wearable bioelectronic medicine to sense data and provide therapy within the body.
Overactive bladder (OAB), which afflicts one in five women worldwide, is a clear example of a neurosensory condition in need of a convenient bioelectronic alternative to pharmaceuticals. OAB is a symptom complex that can include urinary urgency, frequency, and incontinence. The diagnosis and treatment guidelines for physicians from the European Association of Urology (EAU) are linked here.
The AUA/SUFU guidelines distinguish OAB treatment options by their invasiveness. Behavioral and traditional non-invasive therapies unfortunately often have limited efficacy. The vast majority of OAB treatment is based on pharmacologic management, with an estimated 9 million prescriptions written annually. By contrast, less than 1% of patients cumulatively have benefited from the proven safety and efficacy of surgically-implanted neuromodulation, FDA cleared since 1997, due to the inherent limitations of surgical invasiveness, expense, and need for specialist care.
OAB medications fall into the two classes of anticholinergics and β3- adrenoreceptor agonists. While some patients respond to these medications, unfortunately up to 70% discontinue them within 6 months, due to side-effects (ranging from constipation to potential dementia) and/or limited efficacy. Patient drop-off from their second medication is similarly significant. By contrast, studies show 90% of patients reporting a satisfactory reduction in symptoms from implanted sacral neuromodulation.
The FemPulse vaginal wearable is designed to afford women a significantly less invasive and more patient-friendly neuromodulation option, with the goal of increasing adoption of treatment among the millions of untreated and undertreated women suffering with OAB. Research presented at the Society of Urodynamics (SUFU) February 2021 meeting confirmed that OAB sufferers prefer to trial a wearable OAB treatment more than any other option, including behavioral modification, physical therapy, medication, and all other forms of neuromodulation.
The FemPulse bioelectronic device has eight individual electrodes to address a variety of neurosensory medical conditions. OAB is one such condition, in which bladder nerves excessively signal, causing the false sense of fullness underlying OAB. Sympathetic nerves promote bladder filling and parasympathetic nerves facilitate emptying. To treat OAB, FemPulse targets the sympathetic nerves involved in relaxation of the bladder and constriction of the urethral sphincter. The treatment is designed to prevent the abnormal nerve signaling to muscles of the bladder that are normally relaxed as the bladder fills. FemPulse directly targets the nerves causing OAB, rather than attempting to influence the muscles like other therapies.
FemPulse is currently completing a pivotal clinical study at 15 sites around the United States in support of an application for FDA clearance as a De Novo device for the overactive bladder (OAB) indication. The pivotal study follows successful achievement of primary and secondary endpoints in four previous clinical studies.
The first clinical study was an IRB-approved, blinded, randomized, sham-controlled crossover study conducted in two clinical centers. Clinical results were presented at the American Urology Association (AUA) annual meeting in San Francisco and the International Urogynecological Association (IUGA) annual meeting in Vienna, Austria. Dr. Suzette Sutherland, Director of Female Urology at University of Washington, presented that primary objectives regarding fit, comfort and safety were met, as well as positive secondary outcomes regarding patient preference, a reduction in incontinence events, and an increase in time between voids.
EVANESCE-OAB™ (Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder) trial was an IRB-approved, prospective, randomized, sham-controlled, double-blind, parallel group design clinical trial. The study enrolled 21 patients across three sites. The primary objectives of the trial were to evaluate safety, describe fit and comfort and assess potential clinical utility. The positive FemPulse improvements in voids per day and quality of life compared to leading medications were presented by the Principal Investigator at an American Urological Association (AUA) annual meeting, in 2020.
The objective of this study was to confirm the practicality of the FemPulse Ring in everyday use. Study outcomes demonstrated that the FemPulse System is easy to use from the perspective of both patients and clinicians. The clinicians reported that they would recommend the FemPulse System to their patients who suffer from OAB, assuming effectiveness in management of symptoms. The positive results led to presentations at three conferences during 2026: the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) in San Juan, Puerto Rico; the International Urogynecological Association (IUGA) in Rio de Janeiro; and the International Continence Society (ICS) in Maastricht, Netherlands.
As part of this 4-week study, data were collected not only on the usability of the FemPulse Ring, but also on improvements in OAB symptoms and quality of life. Study participants reported a substantial reduction in the average number of daily voiding episodes by 5.23 per day. In addition, a significant improvement was observed in the OAB-q SF Symptom Bother Score, which decreased from 68 to 28 (4 times the minimal clinically important difference). Participants also reported a reduction in bothersome urinary urgency and improvements in quality-of-life measures. The positive results were reported with the Ease of Use data at the three conferences in 2026.
The objective of this prospective, multicenter, randomized controlled study is to demonstrate the efficacy of FemPulse therapy as compared to pharmacological treatment with the established antimuscarinic medication tolterodine as the basis for FDA De Novo clearance of the FemPulse Ring.
The promise of FemPulse’s wearable bioelectronic medicine has been welcomed in numerous industry articles, such as MD+DI “Finally, a Wearable Neuromodulation Device for Overactive Bladder”, MedTech Insight “Neuromodulation Devices Stimulate Opportunities in Urology”, Start Up “FemPulse Pioneers on Multiple Fronts”, and Urology Times “Wearable Neuromodulation Device Shows Promise for Overactive Bladder” (linked also by the American Urogynecologic Society weekly news), as well as in more popular publications such as The Daily Mail “Could a Doughnut-Shaped Nerve Zapper Cure Overactive Bladders in Women?”