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Published in Health Care
CrossLiner Inc. promises a safer and simpler device to use in cardiac catheterization procedures. CrossLiner Inc. promises a safer and simpler device to use in cardiac catheterization procedures. COURTESY RENDERING

CrossLiner promises ‘breakthrough, next generation’ innovation for cardiac procedures

BY Sunday, January 17, 2021 05:33pm

KALAMAZOO — The newest invention from Tim Fischell and his business partner offers what’s promised as a safer and simpler device to use in cardiac catheterization procedures.

CrossLiner Inc., formed in Kalamazoo by Fischell and Dr. Frank Saltiel, closed in December on $700,000 in capital raised from 20 investors, according to a filing with the U.S. Securities and Exchange Commission.

The partners have since received “a little bit more” in commitments from additional investors, bringing CrossLiner closer to the goal of raising $1 million in a Series A capital round, said Fischell, the company’s CEO and a serial inventor and entrepreneur who has successfully brought other medical innovations to market.

All of the capital raised for CrossLiner came from angel investors, about two-thirds of whom are interventional cardiologists, Fischell said.

CrossLiner will couple the private investment capital with $2.1 million in two federal Small Business Innovation Research grants to commercialize the medical device, Fischell said.

CrossLiner’s device is a guide extension that helps catheter tubes through an artery during a procedure to deliver coronary stents in patients, said Fischell, who’s also a professor of medicine at Michigan State University and director of cardiovascular research at the Ascension Borgess Heart Institute in Kalamazoo.

Fischell describes the CrossLiner device as a “breakthrough, next generation” innovation that “has the potential to essentially make obsolete” existing products on the market.

The device has promise amid an aging population where cardiac procedures are becoming more complex, Fischell said.

“This is one of the coolest things I’ve ever done,” he said. “It’s used whenever there would be a challenge delivering a stent down a coronary (artery), and that can be the first time, it can be the second, third, fourth or fifth time. As people get older and they’ve had three or four stents already placed in their right coronary artery and they have a new blockage, delivering new stents down that vessel becomes harder and harder. Without something like a CrossLiner, you just fail. You just cannot deliver a stent.”

The CrossLiner device has a $100 million to $200 million a year market potential that one analysis indicated could grow to as much as $800 million worldwide in the years ahead, he said.

“This is a growing business,” Fischell said.

Fischell invented the device with Saltiel, the chief of cardiology and chair of the Ascension Borgess Heart Institute.

Fischell was behind other successful startups that brought medical innovations to market. They include the AngelMed Guardian System, an implantable diagnostic device now launching in the U.S. that monitors and warns cardiac patients of an impending heart attack. Fischell co-developed AngelMed with his father, Robert Fischell, and brother, David Fischell.

Another innovation and startup company Fischell was behind is Ablative Solutions Inc. Formed in Kalamazoo and now based in San Diego, Calif., Ablative Solutions is presently doing a pivotal clinical trial at 70 sites in the U.S. and Europe for the Peregrine catheter system to treat uncontrollable hypertension by deactivating nerves in renal arteries.

Ablative Solutions has raised $130 million over the years to develop the Peregrine system. The company two years ago closed on a $77 million  Series D financing round that included Netherlands-based Gilde Healthcare and ranks as one of the largest reported venture capital deals in Michigan.

Next steps for CrossLiner

The new investment round and grant funding provides CrossLiner plenty of capital needed to support commercialization of two versions of the device through 2021. Fischell expects CrossLiner to seek U.S. Food and Drug Administration review toward the end of the second quarter and approval by the end of 2021.

Biomerics LLC, a contract manufacturer in Brooklyn Park, Minn., will produce the medical device.

Partners in the business may sell the innovation, Fischell said. The partners have been talking to potential strategic acquirers, he said.

“We have a lot of interest in this product,” he said. “We think there’s a good chance this technology will be acquired in ’21.”

If CrossLiner does not sell and decides to launch the device on its own, it will need to pursue a Series B capital round to build out sales and marketing and ramp up production.

“If we can negotiate a deal that is appropriate for our shareholders, we may exit. If we don’t, we may raise additional capital and commercialize this ourselves,” Fischell said. “We’re looking for a possible acquisition, but in lieu of that we think we’ll have zero problems raising the capital that we will need to go it alone and commercially launch this ourselves by the end of the year.”

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