CryoLife's BioGlue(R) Surgical Adhesive Featured at Military Combat Care Conference
The conference was sponsored by the Department of Defense (DOD), and co- hosted by the Army, Navy, and Air Force Combat Casualty Care Research Programs, as well as NASA. The conference assembled participants from leading pharmaceutical and biotechnology companies to review new technologies with the potential to advance the treatment of wound care and trauma associated combat casualties.
Kirby S. Black, Ph.D., Senior Vice President of Research and Development, CryoLife, Inc., presented information on the use of BioGlue surgical adhesive as an adjunct to the use of sutures and staples in vascular and cardiac repair to achieve hemostasis. BioGlue is a protein-based surgical adhesive having exceptional strength. An important feature of the product is its unique delivery system, incorporating a dual-chamber syringe that provides ease of application at the wound site. CryoLife scientists are currently developing a gel and foam formulation of BioGlue that would further facilitate application in battlefield conditions.
BioGlue is currently available in the United States under a Food and Drug Administration (FDA) approved Humanitarian Device Exemption (HDE) for use as an adjunct in the repair of acute thoracic aortic dissections, a life- threatening condition. Earlier this month, the FDA's Circulatory System Devices Panel recommended approval of BioGlue surgical adhesive as an adjunct to the use of sutures and staples in vascular and cardiac repair to achieve hemostasis. The FDA is expected to act on the Panel's recommendation by the end of this year.
Internationally, BioGlue is currently approved in 36 foreign countries for use in vascular and pulmonary repair and to provide more effective hemostasis control.
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 is approved as an adjunct for use in acute thoracic aortic dissections under HDE regulations in the United States and is CE marked in the European Community and approved in Canada and Australia for use in vascular and pulmonary sealing and repair. The Company also manufactures the SynerGraft(R) heart valve, the SynerGraft vascular graft, the world's first tissue-engineered heart valve and vascular replacements, and the CryoLife-O'Brien(R) and CryoLife-Ross(R) stentless porcine heart valves, which are CE marked for distribution within the European Community. The human heart valves and vascular grafts processed by CryoLife using the SynerGraft technology are distributed in the U.S. under the trade names of CryoValve(R)SG and CryoVein(R)SG, respectively.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes regarding future occurrences are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may not occur when expected, if at all, and are subject to various risks and uncertainties. Such risks and uncertainties include the possibility that future FDA action will not occur as expected, future BioGlue performance, including the performance of gel and foam formulations will prove less encouraging than current results, that surgeons will not continue to accept and use BioGlue, competition from other wound closure products and other risk factors detailed in the Company's Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended December 31, 2000.
For additional information about the company, visit CryoLife's web site: http://www.cryolife.com
Contact: Roy Vogeltanz
Vice President, Corporate Communications
(800) 438-8285
SOURCE CryoLife, Inc.
CONTACT: Roy Vogeltanz, Vice President, Corporate Communications of
CryoLife, Inc., +1-800-438-8285