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CryoLife Announces First SynerGraft -R- Biologic Heart Valve Implants in Human Patients; Trans-species Transplant Performed Without Use of Immunosuppression.


ATLANTA--(BW HealthWire)--Aug. 31, 1999--

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 and surgical adhesives, today announced that two human females had each received a tissue-engineered SynerGraft(R) porcine heart valve in the aortic position. Dr. Mark O'Brien, a paid consultant to CryoLife, Inc. and a member of the CryoLife Cardiovascular Medical Advisory Board, performed the first implants of tissue-engineered heart valves in Brisbane, Australia. The research and development which led to this unprecedented surgery were made possible, in large part, by grants totaling over $1.1 million from the National Institutes of Health (NIH "Not invented here." See digispeak.

NIH - The United States National Institutes of Health.
). Additional SynerGraft research is also being funded by a $2 million grant from the U. S. Department of Commerce, National Institute of Standards and Technology National Institute of Standards and Technology, governmental agency within the U.S. Dept. of Commerce with the mission of "working with industry to develop and apply technology, measurements, and standards" in the national interest.  (NIST (National Institute of Standards & Technology, Washington, DC, www.nist.gov) The standards-defining agency of the U.S. government, formerly the National Bureau of Standards. It is one of three agencies that fall under the Technology Administration (www.technology. ).

CryoLife's SynerGraft technology incorporates the use of a porcine heart valve which is depopulated de·pop·u·late  
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 its cells and is expected by the Company to repopulate following implantation with the cells of the heart valve recipient, producing a bio-engineered human heart valve similar to the patient's own heart valve.

Steven G. Anderson, President and Chief Executive Officer of CryoLife, said, "I believe the successful implant of a tissue-engineered heart valve is an enormous milestone for our company and our SynerGraft technology. The SynerGraft technology has multiple applications, but holds particular promise for cardiac surgery in children since we believe that the bio-engineered heart valve should have the capability to remodel itself with the recipient's own cells, potentially growing with the child. I believe the implantation of a tissue-engineered heart valve represents a revolutionary breakthrough in implantable device technology. SynerGraft technology enables a trans-species transplant of an unfixed biologic heart valve without requiring the use of 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.
."

Mark O'Brien, M.D., of the Department of Cardiac Surgery at The Prince Charles Hospital An NHS district hospital in Merthyr Tydfil, South Wales. It opened in 1978. External links
  • Prince Charles Hospital
, Brisbane, Australia, said, "The implantation of these two heart valves, which took place one week ago, is a landmark event in heart surgery. To our knowledge, these are the first implantations of tissue-engineered heart valves in the world. This SynerGraft technology may revolutionize the replacement of heart valves, making life-saving surgery available to expanded numbers of patients."

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.(TM) stentless porcine heart valves which are distributed within the European Community.

Statements ma meaning of the Private Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 Rehe valve will not grow with pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 recipients, the risk that the SynerGraft valve will otherwise not perfnomic cycles, competition from other companies, rm 10-K for the year ended December 31, 1998.

The Company web site is: http://www.cryolife.com

Edi1962 Stented porcine(1) heart valve implant - 9

(1) Glutaraldehyde glutaraldehyde /glu·ta·ral·de·hyde/ (gloo?tah-ral´de-hid) a disinfectant used in aqueous solution for sterilization of non-heat–resistant equipment; also used as a tissue fixative for light and electron microscopy.  fixation (2) Commercially available (3) SynerGraft technology
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