CryoLife, Inc. Receives ''CE'' Mark for Distribution of BioGlue for Pulmonary Applications in the European Union
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 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) 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 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 at the University of 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 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 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 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.
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CONTACT: CryoLife, Inc.
Roy Vogeltanz, 800/438-8285