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blood processing disposable, is used to prepare fibrin sealants from
plasma in about an hour. We received FDA approval to market the
CryoSeal FS System in liver resection surgeries in July 2007. The
CryoSeal FS System has received the CE-Mark. From a marketing
perspective, the CE Mark is the European equivalent to an FDA approval,
in that it allows sales of the product throughout the European
community. Asahi Medical is the exclusive distributor for the CryoSeal
System in Japan and the Company markets through independent
distributors in Europe and South America.
-- The Thrombin Processing Device(TM) (TPD(TM)) is a sterile blood
processing disposable that prepares activated thrombin from a small
aliquot of plasma in less than 30 minutes. The CE-Marked TPD is
currently being marketed in Europe by Biomet, Inc., subsidiary Biomet
Biologics, Medtronic, Inc. and independent distributors.
This press release, including statements regarding financial
information for future periods, contain forward-looking statements, and
such statements are made pursuant to the safe harbour provisions of the
Private Securities Litigation Reform Act of 1995. These statements involve
risks and uncertainties that could cause actual outcomes to differ
materially from those contemplated by the forward-looking statements.
Several factors, including timing of FDA approvals, changes in customer
forecasts, our failure to meet customers' purchase order and quality
requirements, supply shortages, production delays, changes in the markets
for customers' products, introduction timing and acceptance of our new
products scheduled for fiscal year 2008, and introduction of competitive
products and other factors beyond our control, could result in a materially
different revenue outcome and/or in our failure to achieve the revenue
levels we
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