Avation Medical announced more than $22 million in equity financing in its oversubscribed Series C round, led by new investors ShangBay Capital and Asahi Kasei, which included Angelini Ventures, JobsOhio Growth Capital Fund, and others. Additional investments were also provided by multiple existing investors, including Arboretum Ventures, Tonkawa, Medtronic, and Avestria Ventures. The funding in the round, which remains open, will be used for the U.S. launch of the company’s Vivally System.
The Vivally System is a non-invasive, FDA-cleared wearable neuromodulation system for home use that delivers closed-loop, autonomously adjusted electrical stimulation to treat patients with urge urinary incontinence (UUI) and urinary urgency caused by overactive bladder (OAB) syndrome, which affects more than 46 million people in the U.S. Using proprietary algorithms and electromyographical sensors, the System detects and calibrates to the level of energy being delivered to the tibial nerve during stimulation to ensure optimal, customized therapeutic output in a true real-time, closed-loop operation. Worn on the ankle, Vivally is used at home for therapy sessions lasting only 30 minutes, as little as once per week.
A surgery- and drug-free at-home wearable neuromodulation system represents a huge advancement in the treatment of OAB. While neuromodulation has traditionally been effective in treating OAB symptoms, to date it has required in-office visits or invasive surgical procedures, relegating it to less than 10 percent of patients seeking treatment. Vivally can be used earlier in the care pathway to treat the approximately nine million people seeking treatment annually for their symptoms. In two multi-center clinical trials, the Vivally System was shown to significantly reduce daily void, incontinence, and urgency episodes and improve patient quality of life. Additionally, the System facilitated an 88-percent therapy compliance rate. Symptom reduction was demonstrated out to one year, even with a decrease in therapy frequency. Full details of the study were recently published in the journal Urology.
Avation Medical is launching the Vivally System, which is available with a prescription, in key markets in early Spring 2024.
