CryoLife Receives Approval to Market BioGlue Surgical Adhesive in Canada

January 19, 2000 at 8:02 AM EST

ATLANTA--(BW HealthWire)--Jan. 19, 2000--CryoLife, Inc. (NYSE:CRY), the leader in the development and commercialization of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves and surgical adhesives, today announced that its Medical Device License Application has been approved by the Canadian Government's Therapeutic Products Programme (TPP) for the use of BioGlue(R) surgical adhesive in vascular and pulmonary repair. The TPP is comparable to the United States' Food & Drug Administration (FDA).

Steven G. Anderson, President and Chief Executive Officer of CryoLife, said, "With the approval of the Canadian Medical Device License Application, CryoLife will be able to begin shipping BioGlue immediately to all Canadian hospitals. Prior to approval of the application, 14 hospitals were using BioGlue surgical adhesive under TPP's Special Access Program (SAP). With a potential market for BioGlue surgical adhesive in Canada estimated to be $50 million, we expect that number of hospitals to increase. Including Canada, BioGlue is now in use in 34 countries with a combined market potential for approved applications estimated to be in excess of $550 million."

CryoLife, Inc. was awarded "CE" (European community approval/product certification) marks for its BioGlue surgical adhesive in January 1998 for vascular repair (sealing and reconstruction) and in March 1999 for pulmonary repair (sealing of trachea, esophageal and lung incisions). The CE marks, granted by Lloyds Register Quality Assurance of Cryodon, England, allows for unrestricted commercial distribution within the European community, a market currently estimated for approved applications at approximately $500 million. In December 1999, the Food and Drug Administration (FDA) granted CryoLife, Inc. a Humanitarian Device Exemption for the use of BioGlue surgical adhesive in the repair of acute thoracic aortic dissections, a market which the Company estimates to be approximately $12 to $15 million.

Founded in 1984, CryoLife, Inc. is the leader in the development and commercialization of implantable living human tissues for use in cardiovascular, vascular, and orthopaedic surgeries throughout the United States and Canada. The Company's BioGlue(R) surgical adhesive, CE marked in the European Union for use in vascular and pulmonary sealing and repair, is distributed throughout Europe. The Company also manufactures CryoLife-O'Brien(R) and CryoLife-Ross(TM) stentless porcine heart valves which are distributed within the European Community.

Statements made in this press release which look forward in time involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such risks and uncertainties include the possibility that Canadian surgeons may choose not to utilize BioGlue surgical adhesive, the possibility that BioGlue surgical adhesive could have currently unforeseen side effects which could render it undesirable for use in vascular and pulmonary applications, changes in economic cycles, competition from other companies, changes in laws and governmental regulations applicable to the Company, and other risk factors detailed in the Company's Prospectus dated March 30, 1998, contained in its Registration Statement on Form S-3 (No. 333-46545).

Editor's Note:

CryoLife Customer Service may be accessed by telephone:

1-800-438-8285 (U.S. and Canada)

1-770-419-3355 (International)

1-770-590-3753 (International fax)

E-mail: customerservice@cryolife.com

For additional information about the Company, visit CryoLife's web site: http://www.cryolife.com


     CONTACT:  CryoLife Inc., Atlanta
               Roy Vogeltanz, 800/438-8285