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CryoLife Continues to Make Advances With BioGlue; First Clinical Use of BioGlue in Japan; BG3000 Approved in France.


ATLANTA--(BW HealthWire)--Oct. 5, 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 Heart valves
Valves that regulate blood flow into and out of the heart chambers.

Mentioned in: Heart Failure
 and surgical adhesives, today announced that CryoLife's BioGlue(R) surgical adhesive has been used in a clinical setting for the first time in Japan. The Company also announced that it recently received approval from the French Ministry of Health, Panel of Microbiological Experts (the AFSS&PS Agency) to market its BG 3000, the Company's pre-filled BioGlue surgical adhesive delivery system for vascular and pulmonary repair, in France, historically one of the largest markets for surgical adhesives.

The first clinical use of BioGlue in Japan was performed at Kobe City General Hospital. The patient, a 72-year-old male, was suffering from emphysema emphysema (ĕmfĭsē`mə), pathological or physiological enlargement or overdistention of the air sacs of the lungs. A major cause of pulmonary insufficiency in chronic cigarette smokers, emphysema is a progressive disease that commonly  and his lung tissue was too fragile for sutures. Prior to BioGlue being used, the surgeon performing the operation had assessed that other surgical adhesives or fibrin sealants would not effectively stop the air leaks in this patient. The surgeon observed that BioGlue had been successful in stopping the air leaks, showed good strength quickly after application, and, because it was not too stiff, was a good choice for the patient's lung surface.

The French approval of CryoLife's pre-filled cartridges and reusable delivery system will now give French surgeons a surgical adhesive that is ready to use and a delivery system that will assist in placing the surgical adhesive precisely and with control. Surgical adhesives have been used in France since 1977 for aortic dissections.

Steven G. Anderson, President and Chief Executive Officer of CryoLife, said, "We are extremely pleased and encouraged by our recent advances with our BioGlue surgical adhesive, an animal protein-based surgical adhesive with the potential to reduce the amount of sutures and staples in some surgical procedures Surgical procedures have long and possibly daunting names. The meaning of many surgical procedure names can often be understood if the name is broken into parts. For example in splenectomy, "ectomy" is a suffix meaning the removal of a part of the body. "Splene-" means spleen. . BioGlue began commercial distribution in Europe in 1998 and is currently in clinical trials in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . We hope to receive additional approvals for BioGlue in other foreign countries later this year. The clinical use of BioGlue in Japan represents a first for this product in Asia, and we are excited about the potential this holds for further expansion of the market for BioGlue and related products.

"We are also very pleased to be able to offer the physicians in France BioGlue Surgical Adhesive with a pre-filled, ready-to-use delivery device for application in the operating room operating room
n. Abbr. OR
A room equipped for performing surgical operations.
. To my knowledge, BioGlue is now the only commercially available surgical adhesive in the world that does not require significant preparation time in the operating room. It is stored at room temperature, ready to use the minute it is removed from the package, and has a reusable applicator ap·pli·ca·tor
n.
An instrument for applying something, such as a medication.


applicator,
n a device for applying medication; usually a slender rod of glass or wood, used with a pledget of cotton on the end.
, making it more cost effective than disposable products."

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 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 porcine /por·cine/ (por´sin) pertaining to swine.

porcine

pertaining to pig. See also hog (1), swine.


porcine circovirus 1
a nonpathogenic virus.
 heart valves which are distributed within the European Community European Community: see European Union.
European Community (EC)

Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community.
.

Statements made in this letter 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 risk that BioGlue surgical adhesive will not perform in humans as it has in animals or that unforeseen complications may arise subsequent to the application of BioGlue surgical adhesive, the possibility that the application of BioGlue surgical adhesive in humans could involve unanticipated costs and greater skill levels or more invasive procedures than currently anticipated, 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)

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

Editor's Note Editor's Note (foaled in 1993 in Kentucky) is an American thoroughbred Stallion racehorse. He was sired by 1992 U.S. Champion 2 YO Colt Forty Niner, who in turn was a son of Champion sire Mr. Prospector and out of the mare, Beware Of The Cat.

Trained by D.
: 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
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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