CryoLife, Inc. Advances Application of Its Tissue-Engineered Human Heart Valves

NEW YORK, Aug. 11 /PRNewswire/ -- Steven G. Anderson, President and Chief Executive Officer of CryoLife, Inc. (NYSE: CRY), in remarks today on overall Company operations also discussed clinical results of human allograft valves processed with the Company's unique proprietary SynerGraft(R) technology. This preserved allograft valve, called CryoValve(R)-SG, has been implanted in 33 patients and has been undergoing human clinical trials and evaluations since February of this year.

Anderson's presentation was given before a group of investors at the Surgical Biomaterials 2000 Institutional Investors Conference, sponsored by Stephens Inc., at the Hotel Inter-Continental, in New York City.

Anderson commented, "The SynerGraft technology, developed by CryoLife scientists, enables the depopulation the native cells of the donor heart valve leaving a collagen matrix which may repopulate with the heart valve recipient's own cells. The CryoValve-SG valve is especially designed to benefit patients, both children and adults, who have had a minor immune response to transplanted tissues. Early clinical data indicates that the new processing method mitigates the increase of PRA (panel reactive antibodies) experienced by some of the patients who received previous allograft valves." Anderson also noted that the absence of immunologic response to the decellularized allograft has the potential of improved long-term function of the allograft heart valves. The CryoValve-SG valve has received very enthusiastic response from implanting physicians.

"Our scientists have also been proactive in exploring the possibility of new and revolutionary products for the medical community utilizing animal tissues that are depopulated of their cells leaving a collagen matrix. Under the umbrella of the SynerGraft family of products, we are working on the world's first tissue-engineered replacement heart valve especially designed for pediatric treatment. Last week, we announced that we had filed an application with the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to conduct human clinical trials for the SynerGraft replacement heart valves. This is the first in a series of proposed tissue-engineered living implantable biological products that includes vascular grafts and connective tissue for repair of sports injuries under development by CryoLife scientists," Anderson added.

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(R) stentless porcine heart valves, which are distributed within the European Community.

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 clinical SynerGraft test results will not be encouraging or that SynerGraft valves will not repopulate with recipient cells as expected, that SynerGraft regulatory submissions will not be ready when planned or that anticipated regulatory approvals will not be obtained on a timely basis, if at all, 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, 1999.

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

SOURCE CryoLife, Inc.

CONTACT: Roy Vogeltanz, Vice President, Corporate Communications of CryoLife, Inc., 800-438-8285/