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.
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 andthe 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.
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
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
Liron Babian, CFO
+972 (0)72- 2200330
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