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CryoLife Files Investigational Device Exemption (IDE) to Begin Clinical Trials for PerClot® in the U.S.
Date:4/4/2011

th congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia.  CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.  The Company's BioGlue® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels.  BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair and was recently approved in Japan for use in the repair of aortic dissections.  The Company's BioFoam™ Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.  CryoLife distributes PerClot®, an absorbable powder hemostat, in the European Community.  

Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include those regarding CryoLife's expanding distribution of PerClot within the European Union and many other markets around the world in the coming months, the estimated growth of the U.S. and European hemostatic market by 2014, and expectations of obtaining FDA approval no later than 2014.  These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties.  There is no guarantee that the FDA will approve PerClot for distribution in the U.S. in accordance with our expected timeframe, if at all.  FDA approvals are dependent upon a number of factors, many of which are outside CryoLife's control, including successful clinical tr
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SOURCE CryoLife, Inc.
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