CryoLife, Inc. Advances Its SynerGraft Tissue-Engineering Technology For Transpecies Applications
Animal Study Centered on Use of Bovine Tissue in Development of A-V Access Grafts for Hemodialysis Patients
CryoLife, Inc. (NYSE: CRY), a life-science company involved in the development and commercialization of cryo-preserved and tissue-engineered implantable heart valves, vascular and orthopedic grafts, and surgical adhesives, presented the results of an animal study, on the use of animal tissues to create A-V (arteriovenous) access grafts in hemodialysis applications using the Company's patented SynerGraft(R) technology, before the 2001 Joint Annual Meeting of The Society for Vascular Surgery and The American Association for Vascular Surgery, held at the Baltimore Convention Center in Baltimore, Maryland, June 10-13, 2001. The SynerGraft technology centers around the removal of antigens from human and animal tissues leaving a collagen matrix that has the potential to then be repopulated, in vivo, with the patient's own cells. The canine animal study involved the use of bovine tissues processed with the SynerGraft tissue engineering technology and implanted as A-V access grafts.The paper was submitted by John H. Matsuura, M.D., F.A.C.S., Assistant Professor of Surgery, Medical College of Georgia, Atlanta, Georgia, and presented by Jeremy D. Ollerenshaw, Ph.D., Director, Vascular Technologies, CryoLife, Inc. Dr. Matsuura is one of CryoLife's vascular medical advisors. The results of the animal study indicate that the functional parameters of the SynerGraft biologic conduits are favorable for hemodialysis access. Following the six-month animal implants, the SynerGraft A-V access graft demonstrated a lack of infection and improved sealing ability as compared to synthetic grafts.
In 2000 CryoLife began processing human vascular grafts with its SynerGraft technology. The CryoVein(R) SG, which has the potential to re-model itself in vivo, is directed toward patients that have experienced negative reactions with synthetic or tissue access grafts and as a result require replacement grafts that reduce the risk of infection and provide long-term functionality.
Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc., noted, "The successful development of biologic devices that re-model themselves in vivo with the patient's own cells would be a revolutionary achievement. I believe the SynerGraft technology will provide cardiovascular, vascular and orthopedic surgeons with new alternative treatments for severely ill patients."
As a result of its SynerGraft technology, CryoLife is the first company in the world to produce tissue-engineered vascular grafts and heart valves that have been implanted in humans. The Company's porcine SynerGraft tissue- engineered replacement heart valves have been awarded the CE (product certification) Mark and are currently in commercial distribution in the European community.
Founded in 1984, CryoLife, Inc. is the leader in the development and commercialization of implantable living human tissues for use in cardiovascular, vascular, and orthopedic 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 bovine A-V access grafts will not have the expected long-term functionality, repopulate with human recipient cells, reduce immune response, remain infection free or continue to seal effectively, that future clinical SynerGraft test results will prove less encouraging than current results, 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, 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
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SOURCE CryoLife, Inc.
CONTACT: Roy Vogeltanz, Vice President, Corporate Communications of
CryoLife, 800-438-8285