CRY CryoLife Inc

Cryolife Registry Demonstrates Positive Adult and Pediatric Long-Term Outcomes Following Heart Valve Implantation Comprehensive Allograft Heart Valve Registry Tracks More Than 2,600 Patients for 10 Years Following Implantation ATLANTA, Jan. 12 /PRNewswire-FirstCall/ -- CryoLife, Inc. , a human tissue processing and bio-surgical device company, announced updated results from its registry, tracking clinical performance of its cryopreserved 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 2003 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. The CryoValve Human Heart Valve Clinical Experience 2003 report is available on the Company's website, http://www.cryolife.com/ . 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. "This unique registry of patients is maintained and managed by CryoLife for the benefit of surgeons and their patients undergoing reconstructive heart valve procedures everyday at hospitals nationwide," said Steven G. Anderson, President and CEO of CryoLife. "This is the tenth consecutive year that CryoLife has published the CryoValve Human Heart Valve Clinical Experience 2003 report which has become a recognized and valuable outcomes resource within the cardiac surgeon community. We believe CryoLife is the only human tissue processor that tracks and publishes clinical performance of allograft heart valves." 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 1,782 males (68%) and 850 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 1,388 (53%) between 18-84 years (adult patients). The data in the CryoValve Human Heart Valve Clinical Experience 2003 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. "The data contained in the CryoValve Human Heart Valve Clinical Experience 2003 report is useful to surgeons making decisions on the most appropriate surgical procedure for cardiac patients, particularly in children with congenital heart defects," said Donald B. Doty, M.D., Chief, Department of Surgery, LDS Hospital. "We are pleased to participate in this registry and believe it is a valuable tool and is unique to the tissue industry." 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 44,000 cryopreserved allograft heart tissues have been implanted at over 800 institutions in the United States, Canada and Europe. 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 2003 report may not accurately predict outcomes for patient populations, revenues may not meet expectations, that demand for CryoLife preserved tissues may not return to prior levels, the possibility that the FDA could impose additional restrictions on the Company's distribution of tissues, require a recall, or prevent the Company from distributing tissues, that the Company's 510k application for SG processed heart valves may require significant time and expense and may not be cleared on a timely basis or at all, 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 present and future litigation may be resolved only by substantial payments by the Company in excess of available insurance coverage and amounts to be set aside for products liability cases by CryoLife since the outcomes of products liability securities class action and derivative cases are inherently uncertain, 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 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, 2002, 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/

Copyright