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 NYSE See: New York Stock Exchange :CRY), the leader in the development and commercialization of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves Heart valves Valves that regulate blood flow into and out of the heart chambers. Mentioned in: Heart Failure 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 porcine /por·cine/ (por´sin) pertaining to swine. porcine pertaining to pig. See also hog (1), swine. porcine circovirus 1 a nonpathogenic virus. 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 immunosuppression Suppression of immunity with drugs, usually to prevent rejection of an organ transplant. Its aim is to allow the recipient to accept the organ permanently with no unpleasant side effects. . 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 Mr. Anderson can refer to several fictional characters:
tr.v. de·pop·u·lat·ed, de·pop·u·lat·ing, de·pop·u·lates To reduce sharply the population of, as by disease, war, or forcible relocation. of porcine cells, leaving a collagen matrix that is repopulated with human cells, providing a bioengineered human heart valve with similar structure and biodynamics biodynamics the scientific study of the nature and determinants of the behavior of all organisms, including humans. biodynamics The formal study of vital forces, physiological interactions and behavior as the patient's own heart valve." The Company expects to file an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 calcification /cal·ci·fi·ca·tion/ (kal?si-fi-ka´shun) the deposit of calcium salts in a tissue. dystrophic 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 |
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