CryoLife SynerGraft Technology Highlighted At World Symposium On Heart Valve Disease
ATLANTA--(BW HealthWire)--June 14, 1999--
Paper Presented on Transpecies Heart Valve Transplants
Indicates Reduced Rejection Rates
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 its SynerGraft(R) technology was featured in a presentation delivered yesterday, June 13, 1999, co-authored by Dr. Mark O'Brien, a paid consultant to CryoLife, Inc. and a member of the CryoLife Cardiovascular Medical Advisory Board. The paper, presented at the World Symposium on Heart Valve Disease in London, England, documents the use of CryoLife's SynerGraft technology in transplanting heart valves in laboratory animals. As detailed in the paper, porcine aortic valves which underwent the SynerGraft decellularization process and were implanted in sheep demonstrated minimal rejection as measured by inflammatory response.
Dr. Mark O'Brien said, "Based on the animal heart valve implants
documented in this paper, I believe that the SynerGraft technology
significantly reduces the potential for rejection of the donor organ
by its host. In addition, the study indicates that not only is risk of
rejection decreased, but there is also promise that host cells would
repopulate the decellularized implant."
Steven G. Anderson, President and Chief Executive Officer of
CryoLife, said, "This paper signals the potential importance our
SynerGraft program can have in transpecies heart valve transplants
without immunosuppression. We believe that our auto-xenograft
technology reduces the risk of rejection and that SynerGraft
regenerated tissue could become the basis for a new form of
bioengineered heart valve which could be recellularized with host
cells prior to implant."
Mr. Anderson added, "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."
The Company expects to file an Investigational Device Exemption
(IDE) with the FDA in the fourth quarter of 1999 seeking approval to
begin human clinical trials of its SynerGraft technology.
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).
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
For additional information about the Company, visit CryoLife's web
site: http://www.cryolife.com
--30--md/na*
CONTACT: CryoLife Inc., Atlanta
Roy Vogeltanz, 800/438-8285
KEYWORD: GEORGIA
INDUSTRY KEYWORD: MEDICINE BIOTECHNOLOGY