CryoLife, Inc. Receives Approval by 83 Hospitals for Use of BioGlue In Acute Thoracic Aortic Dissections
ATLANTA--(BW HealthWire)--Feb. 22, 2000--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 it has received approval from the Institutional Review Boards (IRB) at 83 hospitals in the United States for the use of BioGlue surgical adhesive in acute thoracic aortic dissections.
The approval by the IRB follows the action by the Food & Drug Administration (FDA) in granting Humanitarian Device Exemption (HDE) status for BioGlue in the treatment and repair of acute thoracic aortic dissections, recognized as one of the most life-threatening clinical conditions of the thoracic aorta.
Steven G. Anderson, President and Chief Executive Officer of CryoLife, Inc., noted, "Over 450 hospitals nationwide routinely repair about 4,000 acute thoracic aortic dissections each year. These aortic dissections represent an estimated market for BioGlue of about $12 million per year. We are very pleased with the acceptance BioGlue has gained among cardiovascular and thoracic surgeons. With these results, we are very close to achieving our six-month objective of 100 IRB approvals within the first two months of the year. Further, nearly half of the IRB-approved hospitals have already placed orders and received BioGlue."
In January 2000, CryoLife, Inc. submitted an Investigational Device Exemption (IDE) supplement with the FDA for an expanded clinical study of its BioGlue to include use in vascular and certain cardiac repairs.
BioGlue surgical adhesive is "CE" (product certification) marked in Europe for vascular sealing and pulmonary repair, including air leaks in lungs. BioGlue is currently in distribution in over 34 countries for use in vascular and pulmonary repairs addressing a significant portion of the $2 billion USD worldwide market for surgical adhesives and sealants.
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 is approved as an adjunct for acute thoracic aortic dissections under HDE regulations in the United States and is CE marked in the European Union for use in vascular and pulmonary repair. The Company also manufactures CryoLife-O'Brien(R) and CryoLife-Ross(R) Stentless porcine heart valves which are distributed only within the European Community.
Statements made in this press release that 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 the demand for BioGlue surgical adhesive will not continue to increase because (i) surgeons may choose not to utilize BioGlue surgical adhesive, (ii) BioGlue surgical adhesive could have currently unforeseen side effects which could render it undesirable for use in vascular and pulmonary applications, (iii) because future human clinical results with respect to BioGlue could prove less encouraging or (iv) BioGlue surgical adhesive could possibly be found not to be effective in reducing bleeding in humans. Additional risks and uncertainties that could affect the forward-looking statements contained herein include 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).
For additional information about the Company, visit CryoLife's web site: http://www.cryolife.com
CONTACT: CryoLife Inc., Atlanta
Roy Vogeltanz, 800/438-8285