CryoLife, Inc. BioGlue Surgical Adhesive Study Results Presented At American Association for Thoracic Surgery Meeting

May 8, 2001 at 8:59 AM EDT

ATLANTA, May 8 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a life-science company involved in the development and commercialization of tissue-engineered implantable heart valves, vascular and orthopaedic grafts, and surgical adhesives, announced the results of a clinical study on the use of BioGlue(R) surgical adhesive in acute thoracic aortic dissection. The paper was presented at the Annual Meeting of the American Association for Thoracic Surgery, held in San Diego, California, May 7, 2001, by Joseph E. Bavaria, M.D., Associate Professor of Surgery, Cardiovascular and Thoracic Surgery, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania. Dr. Bavaria is also Director, Thoracic Aortic Surgery Program and Director, Lung Transplantation Program.

The randomized study compared the outcome after surgical repair of acute thoracic aortic dissections using BioGlue vs. the standard procedures, conducted at the University of Pennsylvania Medical Center and the Methodist Hospital in Indianapolis, Indiana. The 17 month study from August 1998 to February 2000, compared the surgical results of 35 patients, 17 utilizing BioGlue and 18 patients in the control group utilizing standard surgical procedures. The results indicated that the use of BioGlue effectively reduces the time necessary for surgical repair.

BioGlue is currently approved for vascular and pulmonary repair in 42 foreign countries and is commercially available in the United States under a Food and Drug Administration (FDA) approved Humanitarian Use Device Exemption (HDE) for use as an adjunct in the repair of acute thoracic aortic dissections, a life-threatening condition.

The Company filed a Premarket Approval (PMA) for BioGlue's use in all vascular repair and sealing on February 1, 2001. Also in February of 2001, the Company announced that it had received approval to market BioGlue surgical adhesive in Australia.

Steven G. Anderson, President and Chief Executive Office, CryoLife, Inc., noted, "BioGlue has proven itself in clinical trials in Europe to be a life saving product when used in emergency cardiac surgery and repair. We anticipate the FDA taking action on our PMA for BioGlue later this year."

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 approved as an adjunct for acute thoracic aortic dissections under HDE regulations in the United States and is CE Marked in the European Community and approved in Canada and Australia for use in vascular and pulmonary sealing and repair. The Company also manufactures the SynerGraft heart valve, the world's first tissue-engineered heart valve replacement 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 trade names of CryoValve(R)SG and CryoVein(R)SG, respectively.

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 BioGlue test results will prove less encouraging than current results, that BioGlue 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, 2000.

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/