Healthcare Industry News: CryoLife
News Release - April 26, 2006
CryoLife Announces Interim Results of European BioDisc(TM) Spinal Disc Repair System Study at BritspinePlans to Seek CE Mark for European Distribution in 2006
ATLANTA, April 26 (HSMN NewsFeed) -- CryoLife, Inc. (NYSE: CRY ), a biomaterials and biosurgical device company, today announced that preliminary results of a BioDisc(TM) clinical study show that patients experienced significantly reduced back pain and improved function after spinal disc repair with the protein hydrogel. These interim results are detailed in a poster entitled "Early clinical results of an in situ polymerizing nuclear repair system," presented today in Cardiff, Wales, at Britspine, a combined meeting of Britain's four major spinal medical associations.
"We are very pleased with the early results of the BioDisc study," said Steven G. Anderson, President and CEO of CryoLife, Inc. "It is gratifying that patients, to date, are experiencing such significant relief and improved quality of life after a BioDisc implant. We believe BioDisc may help prevent re-herniation, improve spinal stability, and preserve disc height, potentially improving range of motion for thousands of patients suffering from herniated discs."
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.
"The patients in the study underwent BioDisc implantation after a standard discectomy," said Mr. Douglas Wardlaw, orthopaedic surgeon and principal investigator for the BioDisc study. "BioDisc offers an exciting addition to existing surgical treatments of disc herniations, and I am encouraged that the BioDisc implants have been well tolerated by the patients in this early study."
BioDisc, made of fast-setting polymerizing protein hydrogel, is designed for easy, simple delivery into the spinal 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 annual worldwide market for this spinal disc repair system 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.
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 BioGlueŽ 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'BrienŽ 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 thousands of 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 2005 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, its registration statement on Form S-3 (Reg. No. 333-121406), 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
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