CRY CryoLife Inc

CryoLife Human Heart Valve Clinical Experience Report Demonstrates Positive Long-Term Outcomes Comprehensive heart valve registry tracks more than 2,600 adult and pediatric patients for 10 years following human heart valve implantation ATLANTA, Jan. 20 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE:CRY), a biomaterials and biosurgical device company, announced updated results from its registry, tracking clinical performance of its cryopreserved human heart valve allografts. Data from this registry is used to project long-term performance by actuarial statistical analysis(1). Results indicate 100 percent of pediatric patients and 98 percent of adult patients receiving human heart valves processed by the Company were reported to be free from thromboembolic (blockage) events for a period of ten years following implantation. These and other patient outcomes were detailed in the Company's CryoValve(R) Human Heart Valve Clinical Experience 2004 report, an annual publication tracking more than 2,600 patients receiving human heart valves processed by CryoLife for a period of ten years following the implant. Additionally, 95 percent of adult recipients of heart valves processed by the Company were reported to be free from endocarditis, an inflammation of the lining of the heart and its valves, for ten years following the implant procedure. For pediatric patients, 99 percent were reported to be free from endocarditis during this period. Also, freedom from valve-related death within ten years of implantation was 93 percent and 97 percent for adult and pediatric patients, respectively. These statistics confirm the significant patient benefit conferred by human cryopreserved heart valve allografts. "We believe CryoLife is the only company that tracks and publishes long- term clinical performance of implanted human heart valves. CryoLife's Clinical Registry, which includes a large number of pediatric and adult patients, is an important source of information and a valuable tool for cardiac surgeons," said Steven G. Anderson, President and CEO of CryoLife, Inc. A registry is maintained on a subset of CryoLife allograft heart valves implanted in the United States to provide ongoing clinical data useful to surgeons in making informed decisions on the most appropriate surgical procedure for patients in need of a heart valve replacement, particularly for children with congenital heart defects. Seven implanting institutions throughout the United States participate in this registry. Cryopreserved human heart valve allografts do not require the use of anticoagulant drug therapy and so are considered the heart valve of choice for active young adults, women of childbearing age and for children under the age of 15. The study population within the registry consists of 1,788 males (68%) and 851 females (32%). The age of the recipients at the time of implant ranged from 1 day to 87 years, with 1,244 (47%) of the patients between the ages of 0-17 years (pediatric patients) and 1,395 (53%) between 18-84 years (adult patients). The data in the CryoValve Human Heart Valve Clinical Experience 2004 report, collected and analyzed on a yearly basis, includes patient survival and freedom from endocarditis, thromboembolism, and structural valve deterioration. The updated report is published annually and made available to surgeons and their patients. Since the Company was founded in 1984, more than 100,000 patients have received CryoLife-processed tissues in cardiac, vascular, and orthopaedic reconstruction surgical procedures. More than 47,000 cryopreserved allograft heart tissues have been implanted at over 800 institutions in the United States, Canada and Europe. The CryoValve Human Heart Valve Clinical Experience 2004 report is available on the Company's website, http://www.cryolife.com/ . 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, 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. The Company also manufactures the SynerGraft(R)Vascular Graft, which is CE marked for distribution within the European Community. (1) Definition: Actuarial statistical analysis is a procedure used to predict the time until an event occurs. 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 Company's 2004 report may not accurately predict outcomes for patient populations, that the report may not be a valuable tool for cardiac surgeons, that the Company's revenues and expenses may not meet its expectations, that demand for CryoLife preserved tissues may not improve, the possibility that the FDA could impose additional restrictions on CryoLife's operations or require a recall, that the Company may not have sufficient borrowing or other capital availability to fund its business, that present and future litigation may be resolved only by substantial payments by the Company in excess of available insurance coverage, the possibility of severe decreases in the Company's revenues and working capital, that to the extent the Company does not have sufficient resources, 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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