AVS Raises $20 Million in Series B Round to Advance Pulsatile Intravascular Lithotripsy (PIVL) Solutions

BioStar Capital leads round to accelerate clinical trials and development in peripheral and coronary solutions

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 raised $20 million in Series B financing. The new funding will accelerate clinical trial timelines for the company’s device for peripheral application in pulsatile intravascular lithotripsy (PIVL) cases and advance development and preclinical work on a PIVL device for coronary cases.

BioStar Capital, the lead investor in the company’s Series A round, also led the Series B round. BioStar Capital is focused on transformational investments in medical technologies with an emphasis on cardiovascular and orthopedics.

“AVS is one step closer to offering a new treatment solution for patients with severely calcified peripheral arterial disease and progressing toward preclinical studies for coronary cases,” said Mark Toland, Managing Director for BioStar Capital and Executive Chairman/CEO of AVS. “Patients in this disease state too often face the prospect of limb amputation due to a lack of treatment options. We see a significant opportunity to address that need and advance the intravascular lithotripsy space through minimally invasive technology in both peripheral and coronary therapy.”

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. AVS’s novel balloon-based platform, the PULSE™ IVL System, shatters calcium with pressure waves in frequent bursts and expands calcified arteries, all with a single device.

“We are proud to support AVS in both its successful Series A and Series B funding rounds,” said Louis Cannon, MD Founder and Senior Managing Partner of BioStar Capital. “The preclinical results of the PULSE IVL System have shown the potential to raise the standard of care and significantly impact the wellbeing of patients with calcified arterial disease. We are excited to partner with AVS as it looks to future clinical trials and development.”

In September 2022, AVS announced enrollment, successful treatment, and positive 30-day follow-up data of the first patients in its POWER PAD I clinical trial, a first-in-human study. Jon George, MD, MBA an interventional cardiologist at the University of Pennsylvania Health System and medical advisor to AVS, assisted in trial cases in the Dominican Republic.

“Our early trial results showed that we can successfully treat patients with multiple lesions using a single device,” said Dr. George. “We saw patients report a reduction in leg pain, increase in blood flow to the leg, and improvement in their ability to walk in our initial study. This is a patient population that needs easier access to advanced therapies and this platform has the potential to provide that access.”

Executive leadership from AVS will attend the 41st Annual J.P. Morgan Healthcare Conference in San Francisco from January 9-12 and will be available for meetings to discuss the company’s recent momentum. To learn more about AVS and the PULSE IVL System, please visit: https://www.avspulse.com/

About AVS

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.