CryoLife, Inc Receives Approval to Market BioGlue Surgical Adhesive in Australia
ATLANTA, Feb. 7 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), the leader in the development and commercialization of tissue-engineered implantable heart valves, vascular grafts and protein based surgical adhesives announced today that the Australian Therapeutic Good Administration (TGA) has issued a Certificate of Registration for BioGlue Surgical Adhesive. This approval allows the commercial distribution of BioGlue Surgical Adhesive in Australia. The TGA is comparable to the Food and Drug Administration (FDA) in the United States.
BioGlue has been approved for vascular and pulmonary repair in 41 countries worldwide and is commercially available in the U.S. under an FDA approved Humanitarian Device Exemption (HDE) for use as an adjunct in the repair of acute thoracic dissections, a life-threatening condition. More recently, CryoLife, Inc. has filed a Premarket Approval Application (PMA) with the FDA for the use of BioGlue in vascular and cardiac repair.
Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc., noted, "BioGlue is quickly becoming the surgical adhesive of choice for literally thousands of vascular and cardiovascular surgeons around the world."
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 and approved in Canada for use in vascular and pulmonary sealing and repair. The Company also manufactures the SynerGraft(R) heart valve, the world's first tissue- engineered heart valve replacement 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 Company's SynerGraft processed human heart valves and vascular grafts are distributed 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 BioGlue performance with respect to wound closure will prove less encouraging than current results, that BioGlue regulatory submissions will not be ready when planned or that anticipated regulatory approvals will not be obtained on a timely basis, if at all, 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, 1999.
For additional information about the company, visit CryoLife's web site: http://www.cryolife.com .
| CONTACT: | Roy Vogeltanz, Vice President, Corporate Communications of |
|---|---|
| CryoLife, Inc., 800-438-8285 |
SOURCE CryoLife, Inc.
CONTACT: Roy Vogeltanz, Vice President, Corporate Communications of CryoLife, Inc., 800-438-8285/
