CryoLife's BioGlue Surgical Adhesive Presented At Thoracic Surgical Association Meeting

June 26, 2000 at 8:33 AM EDT

ATLANTA, June 26 /PRNewswire/ -- 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 a presentation on a preliminary animal study on the use of its BioGlue(R) surgical adhesive as an alternative to the standard lung volume reduction (LVR) surgical procedure was made at the Annual Meeting of The Western Thoracic Surgical Association, in Hawaii, on June 23, 2000. The paper was presented by Steven Gundry, M.D. F.A.C.S., Professor and Chair, Division of Cardiothoracic Surgery, Department of Surgery, Loma Linda University Medical Center, Loma Linda, California. Dr. Gundry is also a member of CryoLife's Cardiovascular Medical Advisory Board.

Standard lung volume reduction (LVR) is a radical invasive surgical procedure that removes a portion of the diseased lung in end-stage emphysema patients to improve respiratory function and the quality of life and to extend the life of the patient. Approximately 90,000 of the estimated 1.8 million Americans with emphysema are considered to be end-stage emphysema patients. The National Institutes of Health (NIH) have launched a nationwide trial, known as the National Emphysema Treatment Trial (NETT), to define the efficacy of the LVR surgical procedure. The study, involving about 4,000 patients, is expected to be completed in three to four years.

As an alternative to the highly invasive LVR surgical procedure, Dr. Gundry investigated the use of BioGlue in a procedure that instilled the surgical adhesive intra-bronchially using a balloon-tipped catheter to produce lung volume reduction. The initial animal trials involved sheep lung tissue harvested from adult sheep. Dr. Gundry's presentation noted that preliminary results suggest that BioGlue delivered in vitro directly to the lung bronchoscopically via a balloon catheter can result in significant lung volume reduction. Dr. Gundry noted, "If we achieve the same results in vivo (human trials), we would have a procedure for treating end-stage emphysema patients in an economic, minimally invasive manner and possibly on an outpatient basis."

Results of Dr. Gundry's study are being made available to thoracic surgeons in Canada and Europe where LVR surgery is available to end-stage emphysema patients and where BioGlue is currently approved for vascular and pulmonary repair.

BioGlue has been approved by the Food and Drug Administration (FDA) for distribution in the United States under a Humanitarian Device Exemption (HDE), as an adjunct for repair of acute thoracic aortic dissections, a life- threatening condition. More recently, the FDA expanded the Investigational Device Exemption (IDE) for BioGlue for clinical investigation in vascular and cardiac repair.

CryoLife expects to file an additional BioGlue application with the FDA in early 2001 to expand the IDE to include BioGlue use in pulmonary sealing and repair.

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, 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 that 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 in vivo BioGlue test results will prove less encouraging than current in vitro 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, 1999.

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

SOURCE CryoLife, Inc.

/EDITORS' ADVISORY: Emphysema: The physical destruction of the lung tissue that results in obstruction of air flow and development of enlarged air sacs. Emphysema is about ten times more common than lung cancer, with an estimated 1.8 million patients with the disease in the U.S.

In vitro: In an artificial environment

In vivo: In a living environment/

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