CryoLife, Inc. Announces New CryoValve-SG for Transplant
ATLANTA--(BW HealthWire)--Jan. 26, 2000--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 expanded its human heart valve program to include a new human allograft heart valve processing method. Valves processed by this new method will be designated as CryoValve(R)-SG to differentiate them from valves processed by the Company's standard CryoValve process.
The CryoValve-SG process depopulates the native cells of the donor heart valve leaving a collagen matrix with the same functionality as the Company's other cryopreserved heart valves. The CryoValve-SG human heart valve process is being applied to human pulmonary heart valves, cardiac patches and pericardium tissue for use in both pediatric and adult patients who may have had a immunological response to prior human valve implants and patients that may have an exaggerated calcification reaction. The CryoValve-SG will be available to cardiovascular surgeons in mid-February 2000 and will be featured, along with CryoLife's other products and services, at the 36th Annual Meeting of the Society of Thoracic Surgeons in Ft. Lauderdale, Florida, January 31 to February 2, 2000.
Steven G. Anderson, President and Chief Executive Officer of CryoLife, Inc., noted, "The application of the Company's new CryoValve-SG technology to human tissue preservation represents a major step in providing more human heart valves for transplant in selected patient populations."
Anderson went on to say, "We are also continuing our plans to create a broad new line of depopulated porcine heart valve products that are expected to provide life-saving alternatives for patients concerned with the effects of anticoagulation drugs, potential endocarditis situations and calcification associated with mechanical and fixed porcine heart valves."
On May 17, 1999, the Company announced the successful animal implants of SynerGraft processed porcine heart valves. (The SynerGraft process is based on a proprietary process that depopulates the native cells of the porcine heart valve leaving a collagen matrix that can be repopulated with the recipient's own cells.) Post-operative studies of these animal implants demonstrated that the depopulated porcine heart valves were repopulated by the recipient's own cells in vivo. In August 1999, SynerGraft (porcine) tissue-engineered replacement heart valves were implanted into two human female patients in Australia. The six month post-operative echocardiograms for these patients indicate that the SynerGraft valves appear to be functioning normally.
Founded in 1984, CryoLife, Inc. is the leader in the development and commercialization of living tissues for use in cardiovascular, vascular, and orthopaedic 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 Union for use in vascular and pulmonary repair. The Company also manufactures CryoLife-O'Brien(R) and CryoLife-Ross(R) Stentless porcine heart valves which are distributed only 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 the new heart valves will not be widely accepted by surgeons, changes in economic cycles, competition from other companies, changes in laws and governmental regulations application 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 Form S-3 (No. 333-46545).
For additional information about the Company,
visit CryoLife's web site: http://www.cryolife.com
CONTACT: CryoLife Inc., Atlanta
Roy Vogeltanz, 800/438-8285
