CryoLife, Inc. Tissue-Engineering Heart Valve Technology Featured At Cardiovascular Surgical Conference
ATLANTA, May 7 /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 two separate medical studies featuring CryoLife's patented SynerGraft(R) technology. The study results were presented by Ronald C. Elkins, M.D. Chief, Section of Thoracic and Cardiovascular Surgery, University of Oklahoma, Health Sciences Center, Oklahoma City, Oklahoma, a director of and a consultant to CryoLife, Inc., at the Fourth Stentless Bioprostheses (Heart Valve) International Symposium, held in San Diego, California, May 5-7, 2001.
Dr. Elkins reviewed the clinical results of patients implanted with human heart valve allografts processed using CryoLife's SynerGraft tissue- engineering technology. 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. When applied to a heart valve, this creates a replacement tissue structure similar to a native human heart valve with the potential to repopulate with the recipient's own cells. The SynerGraft tissue-engineered human heart valves, called CryoValve(R)SG, implanted in 66 patients were found to reduce immune responses associated with rejection that are signaled by PRA (panel reactive antibodies) and are often experienced by the recipients of transplanted tissues. These valves may therefore be appropriate for patients who have experienced previous immune response to allograft valve implants and for patients who may have immunodeficiencies.
In a second presentation before the same group, Dr. Elkins reviewed animal studies on the viability of SynerGraft technology-treated porcine heart valves for cellular remodeling. The initial results indicated that the valves implanted in sheep were repopulated with the recipients' cells following implantation.
The SynerGraft heart valve represents the world's first heart valve replacement technology that depopulates the donor cells leaving a collagen matrix that has the potential to repopulate itself with the recipients' own cells following implantation.
Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc., noted, "Our patented SynerGraft tissue-engineering technology represents a new scientific platform for development of a new family of implantable cardiovascular, vascular and orthopaedic biologic devices that have the potential to reduce negative immune responses and remodel the transplanted tissue with the patient's own cells, creating functionality similar to the patient's own tissue structure."
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 SynerGraft-treated heart valves will not have the expected long-term functionality, repopulate with human recipient cells or reduce immune response, 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: | D. Ashley Lee |
|---|---|
| Vice President and Chief Financial Officer | |
| (800) 438-8285 |
SOURCE CryoLife, Inc.
CONTACT: D. Ashley Lee, Vice President and Chief Financial Officer of CryoLife, Inc., 800-438-8285/
