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could be developed, Gish could incur signicant costs to obtain alter-
nate components. The alternate components could also require regulatory
approval, the denial or delay of which, could adversely affect Gish’s ability to
provide products to its customers.
Our Gish Subsidiary Faces a Risk of Declining
Average Selling Prices for Its Products
Gish is currently facing and may continue to face increasing pricing pres-
sures from its current and future competitors, especially from competitors in
the cardiovascular surgery products market. As a result of such pressures,
Gish may be forced to lower prices in order to maintain its market share.
There can be no assurance that Gish will be able to maintain its market
share in the cardiovascular surgery products market in the face of continuing
pricing pressures. Any material reduction in the prices for Gish’s products
would negatively affect CardioTech’s gross margin.
We Have Limited Manufacturing Experience in Arterial Grafts
and Once Our Products Are Approved, We May Not Be Able
to Manufacture Sufcient Quantities at an Acceptable Cost
We are still in the research and development phase of our arterial grafts.
Accordingly, once our products are approved for commercial sale we will
need to establish the capability to commercially manufacture our product(s)
in accordance with FDA and other regulatory requirements. We have lim-
ited experience in establishing, supervising, and conducting commercial
manufacturing. If we fail to adequately establish, supervise, and conduct
all aspects of the manufacturing processes, we may not be able to com-
mercialize our products. We do not presently own manufacturing facilities
necessary to provide clinical or commercial quantities of our coronary artery
bypass graft.
We presently rely on a third party contractor, LeMatre Vascular,Inc., to
manufacture our coronary artery bypass grafts. This exposes us to the risk
of not being able to directly oversee the production and quality of the man-
ufacturing process. This contractor, may experience regulatory compliance
difculty, mechanical shut downs, employee strikes, or any other unforesee-
able acts that may delay production.