ITGI Signs Strategic Cooperation Agreement with Vascular Solutions to Commercialize ITGI's Coronary Covered Stent in the U.S.
ITGI Signs Strategic Cooperation Agreement with Vascular Solutions to Commercialize ITGI's Coronary Covered Stent in the U.S. Market * The two companies will work together in order to apply for Humanitarian Device Exemption from the FDA for ITGI's Aneugraft® Dx stent, while sharing development costs. * Vascular Solutions will serve as exclusive U.S. distributor of ITGI's novel pericardium-covered stent, targeting use in emergency interventions in native coronary arteries, aneurysms and diseased saphenous vein grafts. Business Wire OR AKIVA, Israel -- November 11, 2013 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. About ITGI: ITGI (TASE:ITGI) deals with the fields of research and development, manufacturing, assembly and marketing of pericardium covered stents, which are designed for various medical uses in native blood vessels of the heart, venous bypasses in the heart, blood vessels in the brain and other peripheral blood vessels. About Vascular Solutions: Vascular Solutions, Inc., headquartered in Minneapolis, Minnesota, is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of more than 75 products in three categories: catheter products, hemostat products, and vein products and services. Vascular Solutions delivers its products to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists. In the U.S., Vascular Solutions has a direct sales force of more than 90 field sales employees, while outside the U.S. the company relies on a network of independent distributors in nearly 50 countries. Vascular Solutions was founded in 1997 and is traded on the NASDAQ Global Select Market under the symbol VASC. Contact: ITGI Liron Babian, CFO +972 (0)72- 2200330 firstname.lastname@example.org