FDA approval for use of the Cardiovascular Systems device to clear clogged coronary arteries sent the company’s stock up.
Shares of Cardiovascular Systems Inc. jumped nearly 18 percent Tuesday to a postrecession high of $26.75 after U.S. health regulators approved its Diamondback 360 device to clear calcium from clogged coronary arteries.
The U.S. Food and Drug Administration cleared the Diamondback for those with severely calcified arteries.
Cardiovascular CEO David Martin said in an interview Tuesday that bringing the Diamondback technology, now used now to clear plaque in leg arteries, to the heart opens up a $1 billion-plus market to the New Brighton company that analysts say could be worth up to $100 million in annual revenue to Cardiovascular Systems.
“This means continued growth and a path to profitability,” Martin said. “The approval of this device for another large market, coronary, has got great synergy with our existing, $100 million business in legs. Seven out of 10 of our current users are cardiologist who treat coronary arteries. These doctors … also see patients with coronary arterial disease. Now that we’ve got the cardiac approval, they can treat both.
“We routinely head off leg amputations and we are an alternative to surgery, both of which are more expensive,’’ Martin said. “Patients with severe coronary calcification have the most complications … which often lead to surgery or worse, death. Our device is extremely safe. It sands off the plaque and distinguishes between healthy tissue and plaque.”
James Terwilliger of Wunderlich Securities and other analysts raised their performance expectation for Cardiovascular Systems and set a new 12-month stock price of $30 per share.
“In fiscal 2014 and 2015, the company should be able to deliver 17 percent to 18 percent revenue growth with the now two-pronged franchise and investors will be looking for upside to estimates,” Margaret Kaczor of William Blair in Chicago said in a note to investors.
Meanwhile, Danielle Antalffy, an analyst at Leerink Swann in New York, told clients in a note that the development also increases Cardiovascular Systems’ value as a takeover target by a larger medical device company. While similar systems are approved for use in the peripheral arteries, the Diamondback orbital atherectomy device will compete only against Boston Scientific Corp.’s Rotoblator, she said.
The approval makes Cardiovascular Systems “a much more attractive acquisition target given its best-in-class atherectomy device, strong growth profile and under-penetrated market opportunity,” Antalffy told clients.
The Diamondback 360 Coronary Orbital Atherectomy System uses an electrically driven 1.25-mm diamond-coated crown to reduce calcified lesions in coronary blood vessels, according to the company. This helps enable successful stent deployment that facilitates more favorable patient outcomes.
Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute of Minneapolis was the lead investigator on the study, which the company said demonstrated that its technology produced clinical outcomes that exceeded the trial’s two primary safety and efficacy endpoints by a significant margin — within one of the most challenging patient populations.
“Patients who suffer from severely calcified coronary lesions are one of the toughest-to-treat populations — and previous studies have shown these patients have worse outcomes,” Chambers said in a prepared statement. “Thirty-day [study] results demonstrate that [Cardiovascular’s] orbital atherectomy technology is safe and effective.”
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