CryoLife's BioGlue(R) Surgical Adhesive Approved for Soft Tissue Repair in Canada
BioGlue, a surgical adhesive developed by CryoLife, was initially approved in Canada in January 2000 for use in cardiac and pulmonary soft tissue repair. The new indications allow BioGlue to be used as an adjunct method to repair most human soft tissue.
"This latest approval will permit BioGlue's use in Canada in most soft tissue surgical procedures throughout the human body," said Steven G. Anderson, President and Chief Executive Officer of CryoLife. "This is a critical product milestone, and more importantly, this decision will allow many more patients to experience the benefits of BioGlue."
According to industry estimates, surgical adhesives represent an annual worldwide market of approximately $2 billion.
Specifically, the new Canadian approval includes BioGlue's use for genitourinary, dural, alimentary tract (which includes esophageal, gastrointestinal, and colorectal tissues) and other abdominal soft tissues, such as pancreatic, splenic, hepatic, and biliary. BioGlue may also be used to attach surgical meshes in hernia repair.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in surgeries throughout the United States and Canada. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels 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) vascular graft, which is CE marked for distribution within the European Community. The human grafts processed by CryoLife using the SynerGraft technology are distributed in the U.S. under the trade names CryoValve(R)SG and CryoVein(R)SG.
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 BioGlue performance with respect to soft tissue surgical procedures will prove less encouraging than current results, that surgeons will not accept and use BioGlue in soft tissue or other procedures, 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-Q for the quarter ended September 30, 2002.
For additional information about the company, visit CryoLife's Web site: http://www.cryolife.com
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