CryoLife, Inc. Tissue-Engineered Replacement Heart Valve Featured at International Conference
ATLANTA, June 18 /PRNewswire/ -- 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, presented results of studies on CryoLife's tissue-engineered porcine replacement heart valves processed with the Company's SynerGraft(R) technology at the First Biennial Meeting of the Society for Heart Valve Disease, held in London, England, June 15-18, 2001. The SynerGraft technology centers around the removal of antigens from animal and human tissue leaving a collagen matrix that has the potential to be repopulated with the recipient's own cells. The studies were presented by Steven Goldstein, Ph.D., Director, Tissue Technologies, CryoLife, Inc.
The first study concentrated on the functionality of the tissue-engineered porcine heart valves compared to the human counterpart under normal and hypertensive pulsatile flow conditions. Results indicated that the tissue- engineered SynerGraft heart valve matched the normal test parameters of human valves. The study compared both children and adults' human heart valve parameters to the SynerGraft heart valve.
A second study reported on the implantation of SynerGraft processed heart valves into sheep to confirm that the remodeling process had occurred. Upon explant, the results verified that the implanted SynerGraft processed heart valves had remodeled with the recipient's cells. CryoLife produces two SynerGraft porcine heart valves for distribution in international markets. Both the SynerGraft aortic (Model 500) and pulmonary (Model 700) valves have been awarded the CE (product certification) Marks and are currently in distribution throughout the European community.
Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc., noted, "The successful introduction of our tissue-engineered porcine heart valves in the European Community provides an alternative for cardiovascular surgeons in the international arena to the use of mechanical heart valves, which require a lifetime of anticoagulation drug therapy."
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 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(R) 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 SynerGraft-treated tissues will not have the expected long-term functionality, repopulate with human recipient cells, reduce immune response, or remain infection free, that future clinical SynerGraft test results will prove less encouraging than current results, that SynerGraft regulatory submissions will not be ready when planned, that anticipated regulatory approvals will not be obtained on a timely basis, if at all, and that SynerGraft treated tissues may not be accepted or utilized by international cardiovascular surgeons, 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 of |
|---|---|
| CryoLife, Inc., 800-438-8285, or UK Contact, Robert N. Hanley, | |
| Ph.D., President of CryoLife Europa, Ltd., 011-44-1329-229810 |
SOURCE CryoLife, Inc.
CONTACT: Roy Vogeltanz, Vice President, Corporate Communications of CryoLife, Inc., 800-438-8285, or UK Contact, Robert N. Hanley, Ph.D., President of CryoLife Europa, Ltd., 011-44-1329-229810/
