Avation’s Vivally® System, the only FDA-cleared, non-invasive, closed-loop, at-home wearable, changes the way urinary incontinence and urgency caused by overactive bladder syndrome is treated
Columbus, OH (Feb. 01, 2024) – Avation Medical, an innovative neuromodulation and digital health company with a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions, 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 the only 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. Unlike other implantable neuromodulation approaches for bladder treatment, Vivally requires no surgery and no drugs.
Avation Co-Founder and CEO Jill Schiaparelli confirms, “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.
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’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,” stated William Dai, managing partner of ShangBay Capital, Palo Alto. “We are pleased to partner with Avation’s leadership team to drive the successful commercialization of this beneficial therapy.”
“Angelini Ventures is honored to support Avation Medical in redefining OAB treatment,” said Thomas Thestrup, PhD, principal at Angelini Ventures, the venture capital firm of Angelini Industries, Rome, Italy. “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.”
“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,” commented Dr. Thomas Shehab, managing partner of Arboretum Ventures and Avation Medical board chair. “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.”
Avation Medical is launching the Vivally System, which is available with a prescription, in key markets in early Spring 2024.
About Avation Medical and the Vivally System
Avation Medical is an innovative neuromodulation and digital health company with a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions. The Company’s Vivally System is the only FDA-cleared, closed-loop, at-home wearable 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 overactive bladder syndrome (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 is available by prescription in select geographies in the United States. Learn more at Avation.com.