CryoLife's BioGlue Surgical Adhesive Eliminates Need for Sutures in Experimental Coronary Bypass Surgery On Animals
ATLANTA (April 21) BW HEALTHWIRE -April 21, 1999--CryoLife, Inc. (NYSE: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 its BioGlue(R) surgical adhesive has been used in experimental cardiac bypass surgery to reconnect saphenous vein grafts and internal mammary arteries to goat hearts. Subsequent to this experimental surgery, the connected vessels are open and appear normal at 12 months.
This new BioGlue sutureless technique was the subject of a paper presented by Dr. Steven R. Gundry of Loma Linda Medical Center, which took place this morning at the 79th annual meeting of the American Association of Thoracic Surgeons in New Orleans.
BioGlue is a protein-based surgical adhesive which the Company has been distributing outside the United States since March 1998. BioGlue surgical adhesive is "CE" marked for vascular and pulmonary repair applications. In addition, the Company recently received "CE" (product certification) mark approval for the distribution in European markets of the new 3000 Series of BioGlue surgical adhesive (BG 3000), which includes a pre-filled delivery system and a reusable applicator that is easier to use and more cost-effective than the original delivery system.
Steven G. Anderson, President and Chief Executive Officer of CryoLife, said, "We believe that these successful procedures performed by Dr. Gundry could make possible sutureless reattachment of coronary arteries in minimally invasive heart surgery in humans. We also believe that these procedures indicate that there are numerous potential applications for our BioGlue adhesive in a wide variety of surgical procedures. What we have here is a win/win situation: If these procedures are successful in humans, the patient, the physician and the payor should all benefit because the procedure should be less invasive, easier to perform and less expensive."
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 and pulmonary 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 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 to coronary bypasses 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.) 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.
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CONTACT: CryoLife Inc., Atlanta
Roy Vogeltanz, 800/438-8285
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