Avation Medical, a neuromodulation and digital health company, today announced the publication of safety and efficacy results from a multi-center study, "FREEOAB," for its novel Vivally System in Urology, a peer–reviewed journal for urologists.
"The Vivally System represents a significant advancement in bladder control therapy as a non-invasive, patient-centered therapy providing patients with effective treatment, performed in the home, without the need for surgery or drugs," said Dr. Colin Goudelocke, Principal Investigator for the FREEOAB Study. "In our study, significant reductions in symptom burden were observed at 12 weeks which, notably, persisted out to 12 months, even with a reduction in frequency of therapy sessions."
"Physician and patient response to Vivally has been overwhelmingly positive. Vivally will bring meaningful relief to millions of patients seeking treatment for symptoms of OAB that do not want the risks of surgery, or the side-effects of drug therapies," said Avation CEO, Jill Schiaparelli. "We are grateful to the investigators and patients that participated in the study for helping us bring the Vivally System to market."
The Vivally System is a non-invasive bladder control therapy device and companion mobile application to treat patients with urge urinary incontinence (UUI) and urinary urgency caused by OAB, without the need for surgery, drugs, or needle-electrodes. Vivally is the only noninvasive, wearable neuromodulation system for bladder control with personalized calibration and automated closed-loop adjustment through electromyographic (EMG) monitoring cleared for sale in the United States. Worn on the ankle, Vivally is used at-home with therapy sessions lasting only 30 minutes, as little as once per week.
Results of the FREEOAB Study demonstrated significant reductions in three-day diary parameters for daily void, incontinence, and urgency episodes at 12 weeks. Quality of life (QOL) measures exceeded the minimal clinically important difference in all questionnaires. Long-term efficacy results remained robust at 12 months, with sustained improvement in diary parameters. Device-related adverse events were mild and there were no device-related significant adverse events. Mean therapy compliance at 12 weeks was 88.5%. High satisfaction rates were also reported for the device overall, including device ease of use.
Vivally is FDA-cleared and available by prescription in select geographies in the United States.