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CryoLife, Inc. Receives ``CE'' Mark for Distribution of BioGlue for Pulmonary Applications in the European Union.


ATLANTA--(BUSINESS WIRE)--March 16, 1999--CryoLife, Inc. (NYSE NYSE

See: New York Stock Exchange
:CRY), the leader in the development and commercialization of implantable living human tissues 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, announced today that it has received "CE" (product certification) mark approval for the distribution 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
 of its BioGlue(R) Surgical Adhesive for pulmonary applications. Pulmonary applications include the sealing of trachea trachea (trā`kēə) or windpipe, principal tube that carries air to and from the lungs. It is about 4 1-2 in. (11.4 cm) long and about 3-4 in. (1.9 cm) in diameter in the adult. , esophageal and lung incisions.

BioGlue is a protein-based surgical adhesive which the Company has been distributing internationally since March 1998 for vascular surgical procedures and the repair of aortic aneurysms. In addition, the company recently received "CE" (product certification) mark approval for the distribution in European markets of the new 3000 Series of BioGlue(R) Surgical Adhesive (BG 3000), which includes a pre-filled delivery system and 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.
 which is easier to use and more cost-effective than the original delivery system.

The CE mark, granted by Lloyd's Register Quality Assurance, Limited (LRQA LRQA Lloyd's Register Quality Assurance ) of Croydon, England, expands the distribution of BioGlue within the European Community member countries for pulmonary applications in addition to the previously granted European distribution rights.

Steven G. Anderson, President an Chief Executive Officer of CryoLife, Inc., noted, "We are very excited to receive this CE mark for distribution of BioGlue for use in lung and bronchial bronchial /bron·chi·al/ (brong´ke-al) pertaining to or affecting one or more bronchi.

bron·chi·al
adj.
Relating to the bronchi, the bronchial tubes, or the bronchioles.
 applications. We have been pleased with our initial sales of BioGlue in Europe, and, when you consider our recently enhanced delivery system and our upcoming entry into the lung sealing market, we expect increased acceptance by European surgeons. The potential market for use of BioGlue for lung sealing applications is large, with an estimated 250,000 pulmonary surgical procedures done annually in Europe. We are also pleased that the expansion of our BioGlue manufacturing capabilities has been completed, allowing us to produce up to 300,000 units per year."

Professor Joachim Hasse, M.D., the Chairman of Thoracic Surgery Thoracic Surgery Definition

Thoracic surgery is the repair of organs located in the thorax, or chest. The thoracic cavity lies between the neck and the diaphragm, and contains the heart and lungs (cardiopulmonary system), the esophagus, trachea, pleura,
 at the University of Freiburg University of Freiburg can refer to:
  • Albert Ludwigs University of Freiburg in Freiburg, Germany
  • University of Fribourg in Fribourg, Switzerland (Freiburg)
 in Freiburg, Germany, stated "Historically, a non-toxic, durable and easy to use tissue adhesive had not been available for lung surgery. Tissue adhesives currently available in Europe for use in pulmonary applications have frequently presented adverse side effects. Our institution was sponsored by CryoLife to investigate the use of BioGlue as a surgical adjunct in the repair of lung parenchyma Parenchyma

A ground tissue of plants chiefly concerned with the manufacture and storage of food. The primary functions of plants, such as photosynthesis, assimilation, respiration, storage, secretion, and excretion—those associated with living
 lesions and bronchial anastomoses in animal models. We found that the use of BioGlue allowed a tight air seal with less potential damage to the underlying tissue at the repair sites. Based on our use of this product in our animal studies, I endorse the use of this surgical adhesive in general pulmonary repair surgery."

BioGlue Surgical Adhesive is currently distributed only in the European Union and certain other countries outside the United States. Although clinical trials are currently underway in the United States for the repair of aortic dissections, BioGlue is not approved for commercial distribution in the United States.

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 for use in vascular 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.

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 physicians will not find BioGlue to be acceptable for use in pulmonary applications, or even if they do, that they will not increase their usage of BioGlue, 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:

800/438-8285 (U.S. and Canada)

770/419-3355 (International)

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.
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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Publication:Business Wire
Geographic Code:1USA
Date:Mar 16, 1999
Words:713
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