CryoLife(R) Signs Exclusive Distribution Agreement With curasan AG
Company Will Handle U.S. Distribution of curasan's Ceramic Bone Replacement Products
ATLANTA, Feb 5, 2003 /PRNewswire-FirstCall via COMTEX/ --CryoLife, Inc. (NYSE: CRY), a human tissue processing and medical device company, today announced that it has signed an exclusive agreement with curasan AG, located in Kleinostheim, Germany, for U.S. distribution of Cerasorb(R) Ortho, curasan's resorbable bone graft substitute. Curasan is a leader in the development of implantable, regenerative biomaterials for orthopaedic reconstructive surgery. The five- year agreement gives CryoLife exclusive rights to market Cerasorb Ortho for all non-spine, non-dental orthopaedic indications such as trauma, general, and sports medicine.Cerasorb, a resorbable, beta-tricalcium phosphate bone regeneration material was first introduced in Germany in 1998 for dental use. Awarded the "Innovative Prize 2000" by the German Center for Oral Implantology (DZOI), the product captured 60 percent of the synthetic dental bone regeneration market in Germany within four years. In 2001, curasan received CE certification for Cerasorb use in general orthopaedics, and in 2002 received FDA 510(k) approval for orthopaedic use.
"Orthopaedic reconstructive surgery is one of the fastest growing areas of medicine in the U.S., and we believe this product offers superior functionality for patients in need of surgery," said Steven G. Anderson, CryoLife president and chief executive officer. "Cerasorb Ortho ceramic biomaterial, and its unique regenerative properties, will complement our overall product focus on regenerative medicine and is the first step in our strategy to expand our orthopaedic offerings and re-introduce our sports medicine business."
CryoLife introduced Cerasorb Ortho to the U.S. market February 5 at the American Academy of Orthopedic Surgeons meeting in New Orleans.
"Curasan's entry into the U.S. market is an important element of our international growth strategy," said Hans Dieter Roessler, chief executive officer of curasan AG. "We are pleased to be working with CryoLife, a company that has excellent capabilities in the field of regenerative medicine. Together we have a great opportunity to make Cerasorb Ortho the leading product in bone regeneration in U.S. sports medicine and trauma surgery."
About CryoLife
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in 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 and Australia for use in vascular and pulmonary sealing and repair. The Company also manufactures the SynerGraft(R) vascular graft, the world's first tissue-engineered vascular replacement, which is CE marked for distribution within the European Community. The human grafts processed by CryoLife using the SynerGraft technology are distributed in the U.S. under the trade names CryoValve(R)SG and CryoVein(R)SG.
About curasan
Founded in 1988, curasan is headquartered in Kleinostheim, Germany and its shares are traded on the Frankfurt Stock Exchange (Neuer Markt/Prime Standard: CUR). It is a leader in the development and marketing of innovative biomaterials for regenerative medical applications and the company also sells a broad line of pharmaceutical products for anesthetic applications. Curasan's major product is Cerasorb, a resorbable, beta-tricalcium phosphate bone regeneration material, manufactured by curasan in its ISO9001 and EN46001 certified facilities.
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 are subject to various risks and uncertainties. Such risks and uncertainties include the risk that a reinspection by the FDA may not demonstrate progress satisfactory to the FDA, that CryoLife may not be able to meet FDA requirements in a timely manner or at all, that even if the FDA requirements are satisfied, surgeons may not accept or use orthopedic tissues preserved by the Company, that U.S. surgeons may not accept or use Cerasorb Ortho, that CryoLife may be forced to discontinue all or a portion of its tissue processing business due to the FDA Order or subsequent FDA actions, and other risk factors detailed in the Company's Securities and Exchange Commission filings, including the Company's Form 10-Q filing for the quarter ended September 30, 2002.
For additional information, visit CryoLife's web site: http://www.cryolife.com or curasan's web site: http://www.curasan.de .
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