BOSTON--(BUSINESS WIRE)--AVS, an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its PIVL™ therapy, announced today that it closed an additional $8.8 million in new financing, bringing its Series B round to $28.8 million total. The funding will continue to support clinical trials for the company’s device for pulsatile intravascular lithotripsy (PIVL) in peripheral cases, while advancing preclinical work for an expanded indication in coronary cases.
“We are pleased to see the investor excitement around this technology,” said Mark Toland, Chairman of the Board for AVS. “Intravascular lithotripsy represents an emerging therapy that demands new solutions for patients with severely calcified arterial disease. With the support of our partners, we can continue our work toward U.S. approval for both peripheral and coronary applications.”
AVS successfully enrolled, treated and collected positive 30-day follow-up with patients in a first-in-human study, the POWER PAD I clinical trial, in September 2022. The prospective, single-arm, multi-center feasibility study is evaluating the technical and clinical success of the PULSE™ IVL System for treating patients with calcific femoropopliteal arteries.
BioStar Capital, an investor in transformational medical technologies, led the Series B financing with CUE Growth Partners, a private equity firm focused on healthcare.
“AVS’s technology has demonstrated promise in treating peripheral arterial disease and we are excited to play a role in future trials in the coronary space,” said Louis Cannon, MD Founder and Senior Managing Partner of BioStar Capital. “We have supported AVS through both of its funding rounds because we firmly believe in the company’s potential to improve the options available to patients and ultimately drive improved health outcomes for patients.”
Vascular calcification has been shown to increase the risk of major cardiovascular events, such as heart attacks, strokes or blood clots, and can lead to limb amputations in peripheral arteries. The PULSE IVL System is a novel, balloon-based platform that expands calcified lesions by gently shattering calcium with pressure waves in frequent bursts, all through a single device.
“Cardiovascular disease remains the leading cause of death globally and requires continued investment in novel technologies,” said Ben Cannon, Co-Founder and Partner at CUE Growth Partners. “We are committed to supporting medical devices, such as the PULSE IVL System, that can impact areas of need in medicine through innovative new solutions.”
To learn more about AVS and the PULSE IVL System, please visit: https://www.avspulse.com/
AVS is an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease. It was founded in 2018 by Hitinder Gurm, M.D., Interventional Cardiologist and Chief Clinical Officer at University of Michigan, and Robert Chisena, Ph.D., Chief Technical Officer at AVS. It is redefining interventional therapy for severely calcified lesions with the Pulse IVL System, which uses a novel pulsatile mechanism of action to shatter calcium and expand narrowed vessels, all with a single device. To learn more about pulsatile intravascular lithotripsy, visit www.avspulse.com.
The Pulse Peripheral Intravascular Lithotripsy (IVL) System is in development. It is not yet cleared for commercial distribution in any country. Its future availability cannot be guaranteed.