CryoLife(R), Inc.'S BioGlue Surgical Adhesive Approved for General Surgery Procedures in Europe

February 12, 2002 at 8:32 AM EST

BioGlue Surgical Adhesive Receives Third CE Mark

ATLANTA, Feb 12, 2002 /PRNewswire-FirstCall via COMTEX/ --CryoLife, Inc. (NYSE: CRY), a life-science company involved in the development and commercialization of cryopreserved and tissue-engineered implantable heart valves, vascular and orthopaedic grafts, and surgical adhesives, today announced that it has been awarded a CE product certification mark for its BioGlue surgical adhesive for use in general surgery procedures.

The award represents the third CE product certification mark for surgical application of BioGlue within the European Union. In 1998, BioGlue was awarded the CE mark for use in vascular repair and in 1999 it was awarded a second CE mark extending application of BioGlue to pulmonary repair.

This latest product certification in the European Union extends application of BioGlue for soft tissue repair including cardiac, genitourinary, dural, alimentary tract (which includes esophageal, gastrointestinal, and colorectal tissues) and other abdominal soft tissues, such as pancreatic, splenic, hepatic, and biliary. BioGlue may also be used in the fixation of surgical meshes in hernia repair. Clinical data used to support the CE application found that BioGlue was effective in these types of soft tissue repair in general surgery.

Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc., noted, "We believe this latest CE certification will permit BioGlue's use in most surgical procedures throughout the human body. Presently, BioGlue is approved for cardiac, vascular and pulmonary repair in 36 countries outside the U.S."

According to industry estimates, surgical adhesives address a worldwide market of approximately $2 billion annually. Domestically, BioGlue has been approved by the Food and Drug Administration (FDA) for application as an adjunct to standard methods of achieving hemostasis, (such as sutures and staples) in adult patients in the surgical repair of large vessels such as aorta, femoral and carotid arteries.

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 surgical adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels and is CE marked in the European Community and approved in Canada and Australia for use in vascular and pulmonary sealing and repair and for use in general surgery procedures. The Company also manufactures the SynerGraft(R) heart valve, the SynerGraft vascular graft, the world's first tissue-engineered heart valve and vascular replacements, and the CryoLife-O'Brien(R) and CryoLife-Ross(R) stentless porcine heart valves, which are CE marked for distribution within the European Community. The human heart valves and vascular grafts processed by CryoLife using the SynerGraft technology are distributed in the U.S. under the trademarks of CryoValve(R)SG and CryoVein(R)SG, respectively.

Editors Note: The CE (product certification) mark is granted by Lloyd's Register Quality Assurance Limited (LRQA) of Coventry, England.

Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes regarding future occurrences are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may not occur when expected, if at all, and are subject to various risks and uncertainties. Such risks and uncertainties include the possibility that future BioGlue performance with respect to soft tissue surgical procedures will prove less encouraging than current results, that surgeons will not accept and use BioGlue in soft tissue or other procedures, competition from other wound closure products and other risk factors detailed in the Company's Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended December 31, 2000.

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

    Contact:   Roy Vogeltanz
               Vice President, Corporate Communications
               (800) 438-8285