CryoLife Presents Positive Preclinical Results for Its BioDisc(TM) Spinal Disc Nucleus Repair System

November 11, 2004 at 12:06 PM EST

ATLANTA, Nov 11, 2004 /PRNewswire-FirstCall via COMTEX/ -- CryoLife, Inc. (NYSE: CRY), a biomaterials and biosurgical device company, announced that positive preclinical results for its BioDisc(TM) spinal disc nucleus repair system were presented today at the IN SPINE Medtech conference in Dallas, Texas. BioDisc, a protein-based hydrogel, demonstrated durability by withstanding 10 million cycles of compression that mimicked physiological stresses. These studies compared the mechanical properties and the range of motion (flexibility) of intact normal calf spinal segments, denucleated calf spinal segments, and BioDisc repaired calf spinal segments. Findings of these studies showed that the denucleated calf spinal segments resulted in a significant loss of stability as compared to the normal and BioDisc repaired calf spinal segments. Stability and range of motion was restored to within normal range after repair with BioDisc.

The nucleus pulposus is surrounded by fibrous tissue (annulus) and is located in the center of the vertebral disc. The nucleus pulposus is composed of a gelatinous-like material that acts as a cushion or shock absorber to the spinal column. If it herniates through the annulus, it may be removed in a procedure known as a discectomy. BioDisc is designed to fill the area where the nucleus pulposus was removed, and is intended to prevent reherniation and maintain disc height.

In these preclinical bench studies, BioDisc provided stability over denucleation alone and preserved range of motion. "These data continue to support the potential use of BioDisc as a durable nucleus pulposus replacement in spinal disc repair," said Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc.

BioDisc is based on the same protein hydrogel technology as BioGlue(R) Surgical Adhesive, approved by the U.S. Food and Drug Administration to control bleeding as an adjunct to sutures and staples for use in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada for use in soft tissue 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 results obtained from other studies of BioDisc may not support the potential use of BioDisc as a durable nucleus pulposus replacement in spinal disc repair. 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