Overactive bladder (OAB) and urinary incontinence are chronic conditions that impact more than 500 million people globally, significantly reducing their quality of life and, in many cases, substantially reducing their work productivity. Traditional treatments for these conditions range from medications to neurotoxin injections to surgical implantation of stimulators to provide neuromodulation therapy. These treatment options come with such significant drawbacks that more than 90% of patients drop out of the treatment pathway – choosing to wear diapers rather than have therapy.

The Vivally System is the only FDA-cleared, closed-loop, at-home, non-invasive neuromodulation device system. Combined with a companion mobile application, Vivally offers a comprehensive therapy and support system for patients suffering from urge urinary incontinence and urinary urgency caused by OAB. Vivally is prescribed by a clinician following a brief clinical evaluation which includes personalized calibration. Personalization establishes an EMG target and range of neuromodulation energy associated with the detection of an EMG signal to indicate nerve activation. Vivally delivers clinically effective therapy in just 30 minutes, as little as once per week.

Vivally employes an innovative, physiologic closed-loop design, a feature that sets it apart from conventional neuromodulation devices. Vivally dynamically adjusts therapy delivery in response to real-time physiological feedback from the patient’s EMG signal, ensuring that the nerve target, the tibial nerve, remains activated during therapy. Continuous monitoring of the EMG signal allows Vivally to automatically adjust therapeutic output based on the patient’s electrical demand during therapy.

Vivally’s electrical signal is personalized for each patient during an office visit where a physician calibrates Vivally and sets a therapeutic output range. During at-home therapy sessions, electrical output will automatically adjust within the range established by the care provider.

The convenience of Vivally's approach makes it accessible to all patients. Administered in just 30 minutes per session as little as once per week, Vivally offers a non-invasive, time-efficient solution that can be incorporated seamlessly into patients' daily routines, ensuring that treatment compliance remains high.

Beyond clinical efficacy, Vivally extends its impact through its companion mobile application, which serves as a comprehensive therapy and support platform for patients. With personalized therapy reminders and progress tracking, a bladder and fluid intake diary, and remote clinician connectivity, the mobile application empowers patients with tools and resources necessary to navigate their treatment journey with confidence.

Vivally is manufactured using multiple innovative and proprietary components and can be easily scaled. Its design allows the product to be extremely cost effective versus other treatment options and its use will reduce utilization and landfill impact from diapers.

The transformative potential of the Vivally System impacts patients, providers and payors alike. By offering a cost-effective, non-invasive alternative to traditional treatment modalities, Vivally reduces healthcare expenditures associated with OAB management while simultaneously improving patient outcomes and quality of life. Furthermore, its remote monitoring capabilities enable clinicians to remotely assess patient progress, adjust therapy parameters, and intervene proactively as needed, thereby streamlining care delivery.