Funding secured to advance development of Pulse IVL system

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AVS has announced that it raised US$20 million in Series B financing, which the company says will accelerate clinical trial timelines for its 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 orthopaedics.

“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.”

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, 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 enrolment, 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 (University of Pennsylvania Health System, Philadelphia, USA) an interventional cardiologist at the 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 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.”


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