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A Boston-based medical device company AVS (Amplitude Vascular Systems) raised $20 million in Series B funding Thursday to bring artery disease treatment closer to FDA clearance. The funding round, which brings the startup’s total funding to date to around $22 million, was led by BioStar Capital.

A team of clinicians and engineers from the University of Michigan founded AVS in 2017 to treat severe calcified arterial disease. The medical device company’s goal is to create a new system for pulsatile intravascular lithotripsy (PIVL), a method of breaking up calcified tissue in arteries using pressure waves.

“AVS creates a new opportunity to treat PIVL in both peripheral artery and coronary cases,” CEO Mark Toland said in an email. “PIVL is an emerging, minimally invasive treatment that has shown tremendous promise in addressing vascular calcification, which increases the risk of heart attacks, strokes and blood clots and can lead to limb amputations. By adding a new device to the market, we can increase patient access to the most advanced therapies.”

The system that AVS is developing uses pressure waves to break up calcium built up in the arteries. Toland suggested that people think of it like breaking a bag of ice before filling a cooler—you want to use enough force to break the ice, but not so much that the bag opens completely.

The standard treatment for arterial plaque buildup is balloon angioplasty and stents, and these treatments are made by companies such as Boston Scientific and Medtronic. But intravascular lithotripsy is less invasive. The current market leader for intravascular lithotripsy is Shockwave Medical. The company has the only established business model in this space and was expected to do $500 million in revenue last year, Toland said.

Shockwave technology uses an acoustic pressure shock wave that has a very high amplitude but low frequency, Toland said. In contrast, the AVS system uses low-intensity, high-frequency pulses to break up the calcium build-up and restore blood flow to the artery, he explained.

Before it can seriously compete with Shockwave, AVS must complete its clinical trials and receive FDA clearance for its system — an accomplishment Toland said the company expects “sometime in 2024.” Once approved, the technology will be used in outpatient procedures.

AVS has begun a clinical trial for the use of its system in patients with peripheral artery disease, and this is only the second successful human trial of intravascular lithotripsy, Toland said. Dr. John George, Interventional Cardiologist at University of Pennsylvania Health System, helped conduct the study. Toland said that when Dr. George was reviewing the initial results, he noted that patients participating in the study reported a reduction in leg pain, an increase in blood flow to the leg and an improvement in their ability to walk.

The new AVS funding will focus on two main areas: accelerating clinical trials for peripheral artery disease applications, as well as product development for coronary cases.

Despite severe economic difficulties, AVS’s Series B funding round took no longer to complete than the first, Toland declared.

“The macroeconomic challenges facing all companies have led investors to perform a deeper level of due diligence before investing. But we saw that there is still an opportunity to raise funding if you have the right technology and a market need for the technology,” he said.

In terms of advice he would give to other startups looking to raise capital, Toland had two pieces of wisdom to share. The first is to build a realistic business plan that highlights specific valuation deviations for investors—he said this is critical to building a relationship of trust. The second does not imply that all investors are equal, as each investor has a different profile. The more investors a founder can bring on board, the more successful they will be, Toland said.

Photo: iunewind, Getty Images

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