CryoLife's SynerGraft, First Effective ''Tissue Engineered'' Heart Valve Implant, Highlighted At International Symposium
ATLANTA--(BW HealthWire)--May 17, 1999--
Paper Presented by Dr. Mark O'Brien, Renowned Heart Surgeon
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 it has transplanted an unfixed pig valve into a sheep without the valves calcifying or being rejected. This procedure was the subject of a paper presented by Dr. Mark O'Brien, a paid consultant to CryoLife, Inc. and a member of the CryoLife Cardiovascular Medical Advisory Board, today at the Stentless Bioprostheses Third International Symposium held in the Cayman Islands. In the paper, which is the first clinical presentation of CryoLife's SynerGraft(R) heart valve technology, Dr. O'Brien stated that he believes that the CryoLife technology could potentially represent a significant breakthrough in heart valve replacement.
The Company also announced that it expects to file an
Investigational Device Exemption (IDE) with the FDA in the fourth
quarter of 1999 seeking approval to begin its human clinical trials of
its SynerGraft technology.
Steven G. Anderson, President and Chief Executive Officer of
CryoLife, said, "The goal of CryoLife's SynerGraft program is the
development of a new biologic human heart valve. The program
incorporates the use of a porcine heart valve which is depopulated of
porcine cells, leaving a collagen matrix that is repopulated with
human cells, providing a bioengineered human heart valve with similar
structure and biodynamics as the patient's own heart valve."
In conclusion, Mr. Anderson added, "The technology discussed in
this presentation represents a major advance for our SynerGraft
program. The paper presented by Dr. O'Brien demonstrates that the
SynerGraft porcine valves which were implanted in sheep were
functional and the valve leaflets showed no evidence of calcification
after 160 days. The conclusion of the paper was that the SynerGraft
valves reduced the risk of calcification, and it suggests that
prolonged functionality of such valves is attainable."
Dr. Mark O'Brien said, "Applying SynerGraft technology to porcine
heart valves appears promising. The lack of calcification and
rejection, along with continued functioning, bodes very well for
future trials. Although a great deal of work remains to be done, if we
are ultimately successful, SynerGraft technology could be an early
stage in finding a solution to the shortage of human heart valves
throughout the world."
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,
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(TM) stentless
porcine heart valves which are distributed within the European
Community.
Statements made in this press release which look forward in time
involve risks and uncertainties and are "forward-looking" statements
within the meaning of the Private Securities Litigation Reform Act of
1995. Such risks and uncertainties include the possibility that the
FDA will not approve human clinical trials of SynerGraft technology,
the risk that SynerGraft heart valve technology will not perform in
humans as it has in animals or that unforeseen complications may arise
subsequent to the use of SynerGraft heart valves such as those
relating to calcification and functionality, the possibility that
SynerGraft heart valve technology will not be successfully developed,
or if successfully developed, that surgeons may choose not to utilize
SynerGraft heart valve technology, changes in economic cycles,
competition from other companies, changes in laws and governmental
regulations applicable to the Company and other risk factors detailed
in the Company's Securities and Exchange Commission filings, including
the Company's Prospectus dated March 30, 1998, contained in its
Registration Statement on Form S-3 (No. 333-46545).
For additional information about the Company, visit CryoLife's
web site: http://www.cryolife.com
Editor's Note:
CryoLife Customer Service may be accessed by telephone:
1-800-438-8285 (U.S. and Canada)
1-770-419-3355 (International)
1-770-590-3753 (International fax)
E-mail: customerservice@cryolife.com
--30--AR/na*
CONTACT: CryoLife Inc.
Roy Vogeltanz, 800/438-8285
KEYWORD: GEORGIA INTERNATIONAL CANADA
INDUSTRY KEYWORD: MEDICINE BIOTECHNOLOGY