Avation Medical – an innovative neuromodulation and digital health company with a goal to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions – announced over $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 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 the only non-invasive, FDA-cleared, and 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. This affects more than 46 million people in the U.S.
Utilizing 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 and closed-loop operation. Worn on the ankle, Vivally is used at home for therapy sessions that last only 30 minutes as little as once per week. Unlike other implantable neuromodulation approaches for bladder treatment, Vivally does not require surgery or drugs.
A surgery- and drug-free at-home wearable neuromodulation system represents a major advancement in the treatment of OAB. And 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% of patients seeking treatment.
Vivally could be used earlier in the care pathway to treat the approximately nine million people seeking treatment annually for their symptoms. And 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. And the System facilitated an 88% therapy compliance rate. The symptom reduction was demonstrated out to one year, even with a decrease in therapy frequency.
Avation Medical is launching the Vivally System – which is available with a prescription – in key markets in early Spring 2024.
KEY QUOTES:
“This new capital will jump-start the highly anticipated launch of Vivally, which sets a new standard for OAB care. We are thrilled to welcome new investors and grateful for the unwavering support of existing investors who share our belief that non-invasive wearable neuromodulation therapy will significantly benefit patients and clinicians. We could not ask for a stronger group of institutional investors as we accelerate our efforts to bring this innovative technology to market.” Schiaparelli noted that representatives from Asahi Kasei and Angelini Ventures will now join Avation Medical’s board of directors.
– Avation Co-Founder and CEO Jill Schiaparelli
“Avation Medical’s Vivally technology, with its excellent efficacy and unprecedented safety profile, proven in two multi-center clinical trials, is designed for patients who don’t want surgery or drugs. We are pleased to partner with Avation’s leadership team to drive the successful commercialization of this beneficial therapy.”
– William Dai, managing partner of ShangBay Capital, Palo Alto
“Angelini Ventures is honored to support Avation Medical in redefining OAB treatment. OAB a prevalent medical condition that hasn’t seen breakthrough innovation in 25 years. A patient-friendly, at-home wearable has a significantly larger market opportunity to reach patients than existing invasive neuromodulation options, especially when you consider that this product will allow clinicians who are not surgically trained to provide relief to their patients.”
– Thomas Thestrup, PhD, principal at Angelini Ventures, the venture capital firm of Angelini Industries, Rome, Italy
“Arboretum Ventures led Avation’s Series B round because of our strong belief that a new treatment approach for OAB was being sought by both patients and physicians. After witnessing the strength of the Avation team and the excellent clinical outcomes of the Vivally System, we were ready to increase our investment in Series C.”
– Dr. Thomas Shehab, managing partner of Arboretum Ventures and Avation Medical board chair
