Israeli bio-medical engineering company ITGI Medical has signed a strategic cooperation agreement with Vascular Solutions, a medical device company, to commercialize ITGI's Aneugraft Dx coronary covered stent in the US market.
Pursuant to the terms of the agreement, ITGI Medical and Vascular Solutions will work together in order to apply for humanitarian device exemption (HDE) from the US Food and Drug Administration for ITGI’s Aneugraft Dx coronary covered stent.
The two companies will collaborate to complete the US development program and also share the development costs related to ITGI’s coronary stent.
Under the US clinical development program, ITGI will carry out the pre-clinical research phase for the coronary stent and Vascular Solutions will be responsible for all communications with the FDA and the execution of the clinical study in the US.
ITGI anticipates initiation of the US development program during the first quarter of 2014 and the company anticipates the completion of the development and review process by 2016.
Once approved by the FDA, ITGI’s Aneugraft Dx coronary stent will be distributes by Vascular Solutions in the US for use in the treatment of perforations and dissections of native coronary arteries, coronary aneurysms, and diseased saphenous vein grafts.
ITGI CEO Aviv Lotan noted the US market is the key target market for the company’s products.
"In line with ITGI’s previous announcements, that the U.S. clinical development and regulatory review process will commence only with a strategic partner that would bear part of the costs and assist in advancing the process, we are happy to join forces with Vascular Solutions and are pleased with the confidence the company has expressed in our coronary stent.
"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. "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," Lotan added.
The marketing of the Aneugraft Dx coronary covered stent began in 2011 in Europe after receiving CE approval.