|Diamondback 360 system--Courtesy of FDA.gov|
Cardiovascular Systems ($CSII) hauled in a gross $102 million in a stock offering, cash that'll help the company hit the ground running with its recently approved atherectomy device.
After deducting expenses, the Minnesota medtech firm expects to walk away with $84.5 million to market its Diamondback 360 device, designed to get rid of arterial calcium buildups in vessels before stenting. The device has been FDA-cleared to treat leg and heart vessels since 2007, but with last month's agency approval for calcified coronary arteries, Diamondback is poised to contend in a $1.5 billion market dominated by last-generation technologies, CEO David Martin said.
After years of development and millions in red ink, Cardiovascular is counting on its banner product to lead it to profitability. The company went back to the Wall Street well to bankroll the device's launch. Cardiovascular is in the midst of a phased rollout, targeting the country's top medical centers over the next few quarters while running postmarket studies to affirm Diamondback's value in coronary atherectomy.
In pivotal studies, the device outstripped its two primary endpoints, charting a procedural success rate of 89.1% and leaving 89.8% of patients free of major adverse cardiac events.
The device is "the first new coronary atherectomy system in more than two decades," Martin said in a statement, providing a solution for "an underestimated problem in medicine with limited options for treatment."
Cardiovascular's shares have leapt about 48% since winning FDA approval for Diamondback on Oct. 22, trading at around $33.53 Wednesday morning.
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