Healthcare Industry News:  discectomy 

Devices Orthopaedic Neurosurgery

 News Release - May 9, 2006

CryoLife's BioDisc(TM) Nucleus Pulposus Replacement To be Featured at Two Medical Conferences in Montreal

ATLANTA, May 9 (HSMN NewsFeed) -- CryoLife, Inc. (NYSE: CRY ), a biomaterials and biosurgical device company, today announced that its BioDisc(TM) Nucleus Pulposus Replacement will be featured at two separate medical conferences in Montreal, Canada, this week. BioDisc, now undergoing clinical evaluation, is a fast-setting protein hydrogel designed to fill the void created during the removal, or discectomy, of nucleus material after a lumbar spinal disc herniation.

At the Spine Technology Summit, being held Tuesday, May 9, Gerald B. Seery, Senior Vice President, Sales and Marketing at CryoLife, will present an overview on BioDisc and CryoLife's plans for development and commercialization of the product during a session highlighting nucleus replacement technologies.

On Wednesday, May 10, during the Spine Arthroplasty Society (SAS) meeting in Montreal, CryoLife is conducting an industry workshop for attendees entitled: "BioDisc NPR: An emerging technology for nucleus pulposus replacement." SAS is a special interest group of medical and associated specialists working in the field of spinal restoration.

On Friday, May 12, also at the SAS meeting, Mr. Douglas Wardlaw, Ch.M. FRCS, an orthopaedic surgeon and Principal Investigator for a BioDisc study underway in Aberdeen, Scotland, will present interim results from that study, in a paper entitled "Early clinical results of an in situ polymerizing nuclear repair system." The study targets patients with disc herniations in the lumbar spine at the L4/L5 and L5/S1 intervertebral levels and is designed to gather basic safety and performance data.

"We are very pleased with the interest that BioDisc is generating in the medical community," said Steven G. Anderson, President and CEO of CryoLife, Inc. "Preliminary results show that BioDisc can significantly reduce pain and improve function in patients with spinal disc herniations. The therapeutic goal of the BioDisc treatment is to reduce re-herniation, improve spinal stability, preserve disc height, and improve range of motion."

The human spinal disc is comprised of the nucleus pulposus and the surrounding fibrous tissue, known as the annulus. The nucleus pulposus is a gelatinous material that acts as a cushion or shock absorber to the spinal column. Weakening of the spinal disc can be caused by both injury and the natural aging process. When the outer layers of the disc become weak, a herniation (bulging of the nucleus pulposus outside of the natural border of the annulus fibrosus) can occur. These herniations often become a source of debilitating back and leg pain. A discectomy, or surgical removal of the herniation, leaves a void within the spinal disc that may lead to spinal instability, loss of disc height, and risk of recurrent herniation.

BioDisc is designed for quick and easy delivery into the nuclear void to prevent or reduce these complications. With more than 300,000 discectomies performed in the U.S. and approximately 120,000 in Europe each year, the worldwide market for this device is estimated at about $800 million.

CryoLife, one of the few companies with a nucleus pulposus replacement device in development for the lumbar spine, anticipates filing for a CE Mark in the fourth quarter of 2006, which we anticipate would allow for European commercial distribution of BioDisc in early 2007.

About CryoLife

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiovascular, vascular, and orthopaedic surgeries throughout the United States and Canada. The Company's BioGlue® 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. The Company also distributes the CryoLife- O'Brien® stentless porcine heart valve and the SG Model #100 vascular graft, which are CE marked for distribution within the European Community.

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 actual results of the study may not meet expectations, that BioDisc may not prove beneficial to individuals suffering from herniated discs, that BioDisc may not prove beneficial in preventing or reducing spine instability, preserving disc height and range of motion, or preventing re-herniation, that, due to circumstances beyond its control, CryoLife may not file for a CE mark for BioDisc in the fourth quarter of 2006, that CryoLife's 2006 revenues and expenses may not meet its expectations, the possibility that as a result of its recent inspection of the Company's facilities the FDA could impose additional restrictions on the Company's operations, require a recall, prevent the Company from processing and distributing tissues or manufacturing and distributing other products, or take other actions which the Company may not be able to address in a timely or cost-effective manner if at all, 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, 2005, CryoLife's most recent Form 10-Q, and its 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


Source: CryoLife

Issuer of this News Release is solely responsible for its content.
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