ITGI (TASE:ITGI) announces today the initiation of its activity in the U.S. market. The company has signed a strategic cooperation agreement with U.S.-based Vascular Solutions, Inc. (NASDAQ:VASC), an international leader in the interventional cardiology device market. The companies will collaborate to complete a U.S. development program and apply to the Food and Drug Administration for approval under the Humanitarian Device Exemption (HDE) process for ITGI’s novel Aneugraft Dx coronary covered stent.
Upon approval, Vascular Solutions will distribute ITGI’s coronary stent in the U.S. for use in the treatment of perforations and dissections of native coronary arteries, coronary aneurysms, and diseased saphenous vein grafts.
Under the U.S. clinical development program, ITGI will be responsible for the pre-clinical research phase, while Vascular Solutions will be responsible for all communications with the FDA and the execution of the clinical study in the U.S. ITGI expects the U.S. development program to start during the first quarter of 2014 and expects the development and review process to take approximately two and a half to three years.
Aviv Lotan, the CEO of ITGI, stated that “The U.S. 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.” The coronary covered stent developed by ITGI (Aneugraft® Dx) is a unique stent that has been engineered to allow easy, convenient navigation and deployment, with a flexible delivery system that allows tracking through tortuous blood vessels. The marketing of the stent commenced in 2011 in Europe after receiving CE approval.