CryoLife, Inc. Receives ''CE'' Mark For International Distribution Of New BioGlue Delivery System
BioGlue is a protein-based surgical adhesive which exhibits versatility in vascular surgical procedures and the repair of aortic aneurysms. The Company has been distributing BioGlue internationally since March 1998 using a first generation two-barrel cartridge delivery system, achieving sales of $900,000 during the last seven months of 1998.
The CE mark, granted by Lloyd's Register Quality Assurance, Limited (LRQA) of Croyden, England, allows for commercial distribution of the BG 3000 delivery system for vascular repair within the European Community member countries.
The BG 3000 pre-filled delivery system is designed to make using BioGlue in the operating room easier and quicker. The new system, which allows surgeons to quickly and easily exchange an empty cartridge for a new one, can now be stored at room temperature, eliminating the previous necessity of refrigerating. In addition, the system is more cost-effective in that it can be purchased in five-packs, the shelf life has increased from 12 months to 18 months, and the dispenser has been approved, after sterilization, for reuse. The Company expects to launch the new product in early April 1999.
Steven G. Anderson, President and Chief Executive Officer of CryoLife, Inc., noted, ``We expect this new CE-marked delivery system to increase acceptance of BioGlue in international markets because it is easier to use and more cost-effective. As a result, we have expanded our manufacturing facility capacity and delivery capabilities to enable us to increase our production and delivery of BioGlue delivery systems from 10,000 per year to up to 300,000.''
Roberto Di Bartolomeo, M.D., a cardiovascular surgeon located in Bologna, Italy, said ``I am impressed with the potential of the new CryoLife BG 3000. I have been using BioGlue Surgical Adhesive, and the CE mark certification now allows access to a better delivery system.''
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® 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® 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 Company's ability to ready its BG 3000 BioGlue delivery system for marketing in early April 1999, the possibility that physicians will not find the BG 3000 delivery system easier to use and/or more cost-effective, 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: 1-800-438-8285 (U.S. and Canada); 1-770-419-3355 (International); 1-770-590-3753 (International fax); E-mail: customerservice@cryolife.com
For additional information about the Company, visit CryoLife's web site: http://www.cryolife.com