Under the terms of the agreement Vascular Solutions will become the exclusive U.S. distributor for the Aneugraft Dx system when it lands market approval, and the companies are sharing development costs. The project is slated to begin in Q1 2014 and should take 2-3.5 years, the companies said.
The duo is hoping to land FDA Humanitarian Device Exemption for Aneugraft Dx "in the treatment of perforations and dissections of native coronary arteries, coronary aneurysms, and diseased saphenous vein grafts."
ITGI is handling the pre-clinical research phase of development and Vascular Solutions will handle all FDA communications and executive the U.S. clinical trial, according to a company statement.
The U.S. market is "key" for ITGI, CEO Aviv Lotan said in prepared remarks. The new collaboration agreement falls nicely into the company’s plans to move into the U.S. with the help of a strategic partner.
"On top of the strategic cooperation with Vascular Solutions, ITGI will enjoy an indirect investment, as Vascular Solutions is taking up the costs involved in the clinical study which will be conducted in the U.S.," Lotan added. "We are hopeful that this cooperation will lead to the FDA HDE approval and the beginning of commercialization in the U.S. This is an additional step for the company in its strategy to enter new markets and increase the company’s product sales worldwide."
Vascular Solutions posted Q3 profits of $2.7 million, or 16¢ per share, on sales of $28 million for the 3 months ended Sept. 30. That’s a profit gain of 4.2% on sales growth of 14.1% compared with the same period last year. Excluding the $812,000 settlement with Terumo, adjusted earnings per share were 19¢, 2 pennies ahead of Wall Street’s 17¢ forecast.