ATLANTA, Nov. 2 /PRNewswire-FirstCall/ -- CryoLife, Inc. , a biomaterials and biosurgical device company, announced today at the MedTech Insight In Spine & Orthopedics Meeting in North Dallas, Texas that BioDisc(TM) Spinal Disc Repair System, a nucleus pulposus repair device, has been successfully implanted in four patients. The implants are part of a 10 patient feasibility study conducted at a hospital located in the United Kingdom. The study, targeted to address spinal disc herniations at the L4/L5 and L5/S1 levels, is designed to gather basic safety and performance data. The early clinical course of these patients is proceeding as expected.
"We are pleased with the early preliminary results in these first BioDisc patients. BioDisc has the innovative potential to provide spinal stability and preserve range of motion for thousands of patients suffering from herniated discs. Early patient followup indicates that the patients are pain free after the surgery. We expect to increase patient enrollment and the number of clinical sites over the next several months. We hope to file for CE Mark approval sometime during late 2006, and eventually file an Investigational Device Exemption to begin clinical trials in the U.S.," stated Steven G. Anderson, President and CEO of CryoLife, Inc.
The spinal disc is comprised of the nucleus pulposus and the surrounding fibrous tissue, known as the annulus. The nucleus pulposus is composed of a gelatinous-like material that acts as a cushion or shock absorber to the spinal column. Through either the natural process of aging or an injury, the spinal disc may weaken, resulting in a herniation. The herniation may occur adjacent to a nerve, resulting in debilitating back or leg pain. The herniation may be removed via a surgical procedure known as a discectomy, which leaves an empty void within the spinal disc.
The implantation of BioDisc into this void may prevent or reduce spine instability, preserve disc height, and prevent recurrent disc herniation. BioDisc is designed for easy, simple delivery into the void and the material quickly sets in just a few minutes. Presently, over 300,000 discectomies are performed in the U.S. each year and approximately 120,000 are performed each year in Europe. CryoLife is one of few companies in the world with a nucleus pulposes replacement device. The worldwide market for this device is estimated at about $800 million.
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(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 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(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 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 despite expectations, the Company may face difficulties in enrolling additional patients for the BioDisc study, that actual results of the the study may not meet expectations, that BioDisc may not prove beneficial to thousands of individuals suffering pain attributable to herniated discs, that BioDisc may not prove beneficial in preventing or reducing spine instability, preserving disc height, or preventing recurrent disc herniation, 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, 2004, 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 Contact: D. Ashley Lee EVP, COO & CFO (770) 419-3355
CryoLife, Inc.CONTACT: D. Ashley Lee, EVP, COO & CFO of CryoLife, Inc., +1-770-419-3355
Web site: http://www.cryolife.com//