CryoLife's BioDisc(TM) Nucleus Pulposus Replacement to be Featured at Two Medical Conferences in Berlin
ATLANTA, April 30 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, today announced that its BioDisc(TM) Nucleus Pulposus Replacement will be featured at two separate medical conferences in Berlin, Germany, 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 Monday, April 30, Scott B. Capps, vice president and general manager of CryoLife Europa, Ltd., will present an overview on BioDisc and CryoLife's plans for development and commercialization of the product during a session highlighting nucleus replacement technologies.
At the Spine Arthroplasty Society (SAS) meeting, May 1 - 4, in Berlin, Mr. Douglas Wardlaw, Ch.M., FRCS, orthopaedic surgeon and principal investigator for the initial BioDisc study underway in Aberdeen, Scotland, will present a poster on the interim study results entitled "Early clinical results of an in situ polymerising protein hydrogel nuclear replacement." 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 initial clinical data.
On Friday, May 4, also at the SAS meeting, 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.
"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 may have the potential to 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 the risk of recurrent herniation.
BioDisc is designed for quick and efficient 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, filed a CE Mark submission for BioDisc in February 2007.
About CryoLife
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac 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. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. The Company also distributes the CryoLife-O'Brien(R) 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 regarding the potential benefits and uses of and market for BioDisc 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 future 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 CE Mark or other regulatory approvals for BioDisc may not be obtained when expected, if at all, that the Company's recently announced strategic directives may not generate anticipated revenue and earnings growth, the RTI exchange and service agreement may not result in some or all of the positive benefits anticipated, that sources of cardiovascular and vascular tissue procurement for RTI may choose not to make that tissue available to the Company or may not be able to meet the Company's tissue processing standards, or the Company may otherwise be unable to replace the orthopedic revenues that it expects to decrease as a result of the RTI agreement with cardiovascular or vascular revenues, that expected cost savings and synergies from the RTI agreement may not occur when and as anticipated, the Company's efforts to continue to increase revenue may not be effective, since their effectiveness is subject to such factors as competitive pressures and tissue availability, that the Company's efforts to develop and introduce new products outside the U.S. may be unsuccessful, that the Company's efforts to improve procurement and tissue processing yields may not continue to prove effective, 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 products and services under development, including BioDisc, may not be commercially feasible, the Company's SynerGraft products may not receive FDA approval when anticipated or 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 decreases in the Company's working capital if cash flow does not improve, 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, 2006, its most recent Form 10-Q, 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
Media Contacts:
D. Ashley Lee
Executive Vice President, Chief Operating Officer and Chief Financial Officer
Phone: 770-419-3355
Katie Brazel
Fleishman Hillard
Phone: 404-739-0150
SOURCE CryoLife, Inc.
