Biolectronic Medicine
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) Treatments
Overactive bladder (OAB), which afflicts one in six 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 definitive diagnosis and treatment guidelines for physicians from the American Urological Association (AUA)/Society of Urodynamics (SUFU) and endorsed by the American Urogynecologic Society (AUGS), are linked here.
The AUA/SUFU guidelines distinguish 1st-line behavioral therapies, 2nd-line pharmacologic management, and 3rd-line neuromodulation. While 1st-line therapy includes “electrical stimulation”, in practice most patients forgo or discontinue currently available transvaginal pelvic floor stimulators, given the inconvenience of using a daily hand-held probe and the uncertain benefit of intermittent stimulation. The vast majority of OAB treatment is based on pharmacologic management, with an estimated 9 million prescriptions written annually. By contrast, far less than 1% of patients cumulatively have benefited from the proven safety and efficacy of 3rd line sacral 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 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.
FemPulse wearable therapy is designed to afford women a significantly 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.
Bioelectronics for OAB
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 influences the nerves causing OAB, rather than attempting to influence the muscles like other therapies.
FemPulse Clinical Evidence
FemPulse is preparing to complete a pivotal clinical study 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 two previous clinical studies, one in-clinic and the other in-home.
In-clinic study completed
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.
In-home study completed
The 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 investigation. The study enrolled 21 patients across three sites to assess in an ambulatory setting the treatment in adult women with a diagnosis of overactive bladder. The primary objectives of the trial were to evaluate safety, describe fit and comfort and assess the potential clinical utility of FemPulse’s proprietary device therapy. The positive results of the trial were again presented by the Principal Investigator at an American Urology Association (AUA) annual meeting, in 2020. The improvements in voids per day as well as on other validated metrics using the FemPulse device were positive compared to published clinical results for the leading medications.
Articles on FemPulse
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?”
