Stealth 360 sales boost Cardiovascular Systems Q2 revenues

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Revenues from the Stealth 360° system for treating peripheral artery disease (PAD) helped Cardiovascular Systems achieve gains in the second quarter of fiscal 2012, the company reported. Net loss widened compared to the second quarter of the previous year.

St. Paul, Minn.,-based Cardiovascular Systems reported second quarter revenues of $19.7 million, a 5 percent gain over revenues of $18.8 million in the second quarter of fiscal year 2011. The Stealth 360° contributed to a 55 percent increase in revenues over the first quarter of fiscal 2012, to 67 percent of total device revenues in the just-completed quarter, according to the company. Revenues from office-based labs grew 12 percent sequentially over first quarter of fiscal 2012.

“We saw a strong increase in Stealth 360° revenues, driven by an 81 percent gain in the number of Stealth 360° accounts over the first quarter to nearly 400, as well as higher device usage in those accounts,” David L. Martin, Cardiovascular Systems president and CEO, said in a statement.

Net loss was $4.1 million for the quarter, compared to $2 million in the second quarter of last fiscal year. Net loss included expense of $0.2 million related to conversion and valuation changes of convertible debt, compared to income of $400,000 in the prior-year period. 

Cardiovascular Systems attributed the increase in net loss to higher operating expenses associated with advancing the ORBIT II clinical trial for a coronary application, additional sales and marketing staff, and payments related to disputed amounts with a former vendor. ORBIT II is currently an Investigational Device Exemption clinical trial designed to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries and is not commercially available in the U.S.

The Stealth 360°, Diamondback 360° and Predator 360° systems were developed and manufactured by Cardiovascular Systems to treat calcified and fibrotic plaque in arterial vessels in the leg. The Diamondback 360° received FDA clearance in in August 2007 and the Stealth 360° in March 2011. To date, more than 61,000 PAD procedures have been performed using the two technologies, the company reported.

Revenues increased to $38.4 million in the first six months of fiscal 2012, up 4 percent from the same period last fiscal year. Adjusted EBITDA loss increased by $1.9 million. Net loss totaled $8 million compared to $6.3 million last year. The fiscal second quarter ended Dec. 31, 2011.