Medical device startup AVS recently closed $20M in Series B funding to advance novel treatments for severely calcified arterial disease.
AVS is at the forefront of pulsatile intravascular lithotripsy (PIVL) technology, which releases sonic pressure waves in frequent bursts to gently shatter calcium and open arteries.
- Although still under development, AVS’s therapy is delivered through a balloon-based platform called the Pulse IVL System, and is the only minimally invasive technology to treat calcified arterial disease with a single device.
- Vascular calcification not only increases the risk of major cardiovascular events, but it can also lead to limb amputations – presenting a huge opportunity for minimally invasive solutions that can address the problem.
The fresh funding will accelerate AVS’s clinical trial timelines for FDA approval, now expected sometime in 2024. The Series B will also advance the development and preclinical work on a PIVL device for coronary cases.
- 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, its first-in-human study.
- Early trial results showed that PIVL can successfully treat patients with multiple lesions using a single device, leading to a reduction in leg pain, an increase in blood flow to the leg, and improved ability to walk. No major adverse events were reported.
AVS is now one step closer to offering a minimally invasive treatment for patients with severely calcified peripheral arterial disease, paving the way for it to begin reducing the number of vascular surgeries needed to treat severe cases. If AVS can successfully prove the efficacy of its Pulse IVL system, physicians will likely welcome another tool in their intravascular lithotripsy toolbox.