CryoLife to Label High-Dose Irradiated Orthopaedic Tissue Sterile
ATLANTA, Aug. 11 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), a biomaterials and biosurgical device company, announced today that its cryopreserved high-dose irradiated human orthopaedic tissues will be labeled sterile. This sterility claim on the label is based on a comprehensive validation that was completed by the Company in the second quarter of 2005. In May 2005, CryoLife began distributing cryopreserved high-dose irradiated patellar, tibialis, achilles, quadriceps, and peroneus tendons to surgeons for reconstructive knee surgery.
"The Company's orthopaedic tissues benefit patients who require surgery to repair damaged, painful, unstable knees, which oftentimes are the result of a sports injury," said Steven G. Anderson, President and Chief Executive Officer of CryoLife, Inc. "This sterile claim will provide surgeons and hospitals with increased confidence regarding the safety of processed human orthopaedic tissues."
This patented tissue processing technology, licensed from Clearant, Inc. (OTC Bulletin Board: CLRI), is based on gamma irradiation and a radio protectant that is designed to inactivate pathogens, including microorganisms. The tissues' strength and structural properties are maintained after irradiation.
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiovascular and vascular 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 for use in soft tissue repair and approved in Australia for use in vascular and pulmonary sealing and repair.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties. These risks and uncertainties include that the sterile claim for tissues processed using the Company's cryopreservation and high-dose irradiation processes may not lead to increased confidence in surgeons, hospitals or patients, that 2005 revenues and expenses may not meet its expectations, the possibility that the FDA could impose additional restrictions on the Company's operations, require a recall, or prevent the Company from processing and distributing tissues or manufacturing and distributing other products, that the Company may not have sufficient borrowing or other capital availability to fund its business, that pending litigation cannot be settled on terms acceptable to the Company, that the Company may not have sufficient resources to pay punitive damages (which are not covered by insurance) or other liabilities in excess of available insurance, the possibility of severe decreases in the Company's revenues and working capital, that to the extent the Company does not have sufficient resources to pay the claims against it, it may be forced to cease operations or seek protection under applicable bankruptcy laws, changes in laws and regulations applicable to CryoLife and other risk factors detailed in CryoLife's Securities and Exchange Commission filings, including CryoLife's Form 10-K filing for the year ended December 31, 2004, its registration statement on Form S-3 (Reg. No. 333-121406) and the Company's other SEC filings. The Company does not undertake to update its forward-looking statements.
For additional information about the company, visit CryoLife's Web site: http://www.cryolife.com
Contact: Joseph T. Schepers
Vice President, Corporate Communications
(770) 419-3355
SOURCE CryoLife, Inc.