CRY CryoLife Inc

Positive Results of Cryolife's Synergraft(R) Arteriovenous Access Device In Dialysis Patients Presented At A European Medical Congress 83% Secondary Patency at One Year ATLANTA, Sept. 16 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE:CRY), a biomaterials and biosurgical device company, announced today that Mr. Chris Darby, of the Oxford Transplant Center at Churchill Hospital in Oxford, UK, presented positive results of the SynerGraft(R) arteriovenous (AV) access device, which showed secondary patency of 83% and freedom of infection of 94% at one year in patients undergoing dialysis. These results were presented today at the Advances in Tissue Engineering and Biology of Heart Valves Conference in Florence, Italy. CryoLife's SynerGraft AV access device, made of a bovine ureter, is only approved in Europe for dialysis patients. Mr. Darby implanted the SynerGraft AV access device in 17 high-risk patients who failed previous access methods for dialysis. "The SynerGraft AV access device may offer advantages over synthetic grafts, which are prone to early failure due to infection," said Mr. Darby. "Based on the data from these 17 patients, this device has the ability to repair damage from needling and remove infection from needle holes. It provides an alternative when an autologous vein is not available." The SynerGraft AV access device is not available in the U.S. This SynerGraft device utilizes the Company's antigen reduction technology (ART). This patented process removes antigens from the tissues, which appears to allow the patient to receive the implant without using immunosuppressant therapy. 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 results obtained from other implants of the SynerGraft arteriovenous access device may not prove as positive as those reported, that the SynerGraft arteriovenous access device may not offer advantages over synthetic grafts, may not repair damage from needling, or remove infection from needle holes, and that patients receiving implants processed using the company's antigen reduction technology may require immunosuppressant therapy despite current indications to the contrary. The risks and uncertainties also include the risk that the Company's 2004 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 FDA regulation of the Company's CryoValve SG and CryoVein SG may require significant time and expense, 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, 2003, 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 DATASOURCE: CryoLife, Inc. CONTACT: Joseph T. Schepers, Vice President, Corporate Communications of CryoLife, Inc., +1-770-419-3355 Web site: http://www.cryolife.com/

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