CryoLife Continues to See Positive Results in Patients Receiving SynerGraft Tissue-Engineered Heart Valves; Third and Fourth SynerGraft Heart Valve Implants Planned for this Week
BW1236 OCT 04,1999 5:31 PACIFIC 8:31 EASTERN
( BW)(GA-CRYOLIFE)(CRY) CryoLife Continues to See Positive Results in Patients Receiving SynerGraft Tissue-Engineered Heart Valves; Third and Fourth SynerGraft Heart Valve Implants Planned for this Week
Business Editors/Health and Medical Writers
ATLANTA--(BW HealthWire)--Oct. 4, 1999--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 continues to see positive results in the two human females who received tissue-engineered SynerGraft(R) replacement heart valves in the aortic position approximately six weeks ago. The Company also announced that the third and fourth such implants are expected to be performed later this week in Brisbane, Australia, by Dr. Mark O'Brien, who also performed the first two implants.
The first female patient, age 70, who received the tissue-engineered SynerGraft porcine heart valve appears to be doing well at six weeks following the procedure. A post-operative echo cardiogram showed that the SynerGraft valve appeared to be working well and functioning normally. The second female patient, age 71, also received a SynerGraft heart valve approximately six weeks ago. All indications are that the second SynerGraft heart valve is also performing well. Both patients have been discharged from the hospital and are recovering at home.
CryoLife's SynerGraft technology incorporates the use of an unfixed porcine heart valve which has been depopulated of its antigenic cells. The SynerGraft valve is expected by the Company to repopulate itself with the cells of the heart valve recipient, producing a bio-engineered human heart valve similar to the patient's own heart valve. The SynerGraft technology does not require the use of glutaraldehyde, the standard fixative in biological valves, which has been reported to cause calcification (early failure) in some patients.
Steven G. Anderson, President and Chief Executive Officer of CryoLife, said, "We continue to be pleased with the clinical results of these first-ever tissue-engineered heart valve implants. Our confidence in our SynerGraft technology grows with each and every day that we see improvement and continuing functionality in the implanted heart valves for these two patients. It is this confidence that prompted CryoLife and Dr. Mark O'Brien to schedule additional implants, which we will monitor very closely over the coming days and weeks."
Mark O'Brien, M.D., of the Department of Cardiac Surgery at The Prince Charles Hospital, Brisbane, Australia, said, "We are indeed very pleased to see that our original two patients appear to be recovering and that the SynerGraft heart valve has thus far performed up to our expectations. Given the results we have seen in our initial heart valve implants, I believe that similar procedures will be performed in the near future."
Founded in 1984, CryoLife, Inc. is the leader in the development and commercialization of living human tissue implantable devices 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(R) 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 implanted SynerGraft valve will not repopulate with the cells of the recipient, the risk that the SynerGraft valve will otherwise not perform as expected and will therefore not become an acceptable alternative to currently available implantable valves, the risk that these or other factors will discourage future implants of SynerGraft valves, 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 Form 10-K for the year ended December 31, 1998.
The Company web site is: http://www.cryolife.com
Editor's Note:
Historical timeline of heart valve replacements:
Mechanical heart valve implant - 1960
Fresh homograft implant - 1962
Stented porcine(1) heart valve implant - 1968
Stented bovine(1) pericardial implant - 1981
Cryopreserved(2) homograft implant - 1984
Stentless porcine(1) heart valve implant - 1988
Tissue engineered(3) heart valve implant - 1999
(1) Glutaraldehyde fixation
(2) Commercially available
(3) SynerGraft technology
