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Company intends to use the money to jump-start sales of its closed-loop wearable neuromodulation technology for bladder treatment.
April 4, 2024
By: Michael Barbella
Managing Editor
Avation Medical has raised more than $22 million in equity financing in an oversubscribed Series C round, led by new investors ShangBay Capital and Asahi Kasei. Other investors included Angelini Ventures and JobsOhio Growth Capital Fund as well as existing supporters Arboretum Ventures, Tonkawa, Medtronic, and Avestria Ventures. Asahi Kasei and Angelini Ventures representatives will now join Avation Medical’s Board of Directors. “This new capital will jump-start the launch of Vivally. 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 technology to market,” Avation Co-Founder/CEO Jill Schiaparelli said. Funding in the round, which remains open, will be used for the U.S. launch of the company’s Vivally System. The system is reportedly the only non-invasive, U.S. Food and Drug Administration-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 U.S. residents. 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 real-time, closed-loop operation. Worn on the ankle, Vivally is used at home for 30-minute therapy sessions as little as once per week. “Avation Medical’s Vivally technology, with its efficacy and 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 therapy.” Unlike other implantable neuromodulation approaches for bladder treatment, Vivally requires no surgery and no drugs. A surgery- and drug-free at-home wearable neuromodulation system represents a significant advancement in OAB treatment. 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 can be used earlier in the care pathway to treat the approximately 9 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% therapy compliance rate. Symptom reduction was demonstrated out to one year, even with a decrease in therapy frequency. “Angelini Ventures is honored to support Avation Medical in redefining OAB treatment,” said Thomas Thestrup, Ph.D., principal at Angelini Ventures, the venture capital firm of Angelini Industries, Rome, Italy. “OAB is 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.” Avation Medical is launching the Vivally System—available by prescription—in key markets in early spring. “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,” noted Dr. Thomas Shehab, managing partner of Arboretum Ventures and Avation Medical board chair. “After witnessing the clinical outcomes of the Vivally System, we were ready to increase our investment in Series C.” Avation Medical is a neuromodulation and digital health company aiming to make wearable peripheral neuromodulation accessible to patients across various clinical conditions. 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. Vivally delivers clinically effective therapy in 30 minutes, as little as once per week.
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