Tech startup: ValveXchange Inc.



INITIAL LIGHT BULB Before moving to Colorado to start ValveXchange in 2007, biophysicist Dr. Ivan Vesely worked at the Cleveland Clinic, the Children’s Hospital Los Angeles, and the University of Southern California. His concept for a better valve system in mechanical hearts is the basis of the company’s product, the Vitality Heart Valve System.

Larry Blankenship, who has been involved with numerous medical-device startups in his career, met Vesely when he moved to Colorado through his position on the board of the Colorado BioScience Association and came aboard as CEO soon thereafter. Blankenship worked with a Minnesota-based mechanical heart valve company in the 1990s, and the experience opened his eyes to the problems with existing options for patients. “I was convinced (Vesely) had the solution,” he says.

IN A NUTSHELL Traditional mechanical hearts are long-lasting, but they cause blood clots, requiring patients to take high doses of anticoagulant Warfarin. The side effect of such high doses, says Blankenship, “renders the patient to a sedentary lifestyle. It will save one’s life – and it has saved many lives – but it renders the quality of life less than desirable.”
The alternative, tissue-based valves, allow patients to remain active but only last a decade or so. “At that point, you have to replace them,” Blankenship says. “The majority of patients have to ask themselves, ‘Do I choose high doses of anticoagulants or difficult re-operations?'”
The Vitality Heart Valve System solves this dilemma by bringing the best of both worlds. “The solution is to make the leaflets replaceable so that when they wear out, you can service it,” Blankenship says. “You can swap them out.”

Replacing valves in the Vitality system is “much faster and much easier” than is the case with tissue valves. Instead of invasive open-heart surgery, the procedure will ultimately require a puncture through the ribs, with recovery times in days instead of weeks or months. The company recently completed three years of animal testing at the Bioscience Park at Fitzsimons in Aurora and successfully implanted the Vitality system in three patients in Paraguay in September 2011. Human clinical trials will take place this year.
“We hope to have some very exciting news from our clinical trials in Europe soon,” Blankenship says.

THE MARKET Doctors replace more than 200,000 heart valves in the U.S. annually, although ValveXchange is first targeting Europe because of a more streamlined regulatory structure. Blankenship says the company is not in direct competition with transcatheter valves that can be implanted via catheter, noting that the procedure is only for inoperable patients.

FINANCING In addition to $2.2 million in grants from the National Institute of Health, ValveXchange has attracted $2.5 million in private investment as well as $3.5 million from CryoLife (NYSE:CRI, a medical technology company based in Kennesaw, Ga. The company remains majority privately owned, notes Blankenship; CryoLife’s stake is less than 20 percent. He anticipates starting his pursuit of “the next wave” of financing in early 2012.

“There is no more important prosthesis than a human heart valve – it’s got to work, and it’s got to work right.”
– ValveXchange CEO Larry Blankenship

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