CryoLife Licenses Novel Technology for Microorganism Inactivation of Orthopaedic Tissue
December 15 2003 - 8:25AM
PR Newswire (US)
CryoLife Licenses Novel Technology for Microorganism Inactivation
of Orthopaedic Tissue Patented Irradiation Process is Designed to
Render Pathogenic Organisms Non-Infectious While Preserving Tissue
Integrity ATLANTA, Dec. 15 /PRNewswire-FirstCall/ -- CryoLife, Inc.
, a human tissue processing and bio-surgical device company,
announced today that it has licensed a patented technology from
Clearant, Inc. designed to inactivate microorganisms, including
pathogens, from tissue obtained from human donors. A pathogen is
any agent that causes disease in humans, including bacteria,
viruses and fungi. CryoLife plans to further develop and employ
this technology in processing human orthopaedic tissue primarily
used in the repair of sports injuries. This unique, patented
technology is based on gamma irradiation and is designed to
substantially reduce microbial contamination and other pathogens,
while maintaining tissue integrity. "We are pleased to finalize
this agreement with Clearant, which gives us access to their unique
technology for processing human orthopedic tissue allografts. Our
ultimate goal is to provide patients with sterile orthopaedic
tissue," said Steven G. Anderson, President and CEO of CryoLife.
Since the Company was founded in 1984, more than 100,000 patients
have received CryoLife processed tissues in cardiac, vascular, and
orthopaedic reconstruction surgical procedures. CryoLife, Inc. is a
leader in the processing and distribution of implantable living
human tissues for use in cardiovascular 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 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
manufactures the SynerGraft(R) Vascular Graft, which is 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 the technology licensed from Clearant
may not prove effective in inactivating microorganisms, may not
preserve tissue integrity, or may prove too expensive, revenues may
not meet expectations, that demand for CryoLife preserved tissues
may not return to prior levels, the possibility that the FDA could
impose additional restrictions on the Company's distribution of
tissues, require a recall, or prevent the Company from distributing
tissues, that the Company's 510k application for SG processed heart
valves may require significant time and expense and may not be
cleared on a timely basis or at all, that FDA regulation of the
Company's CryoValve SG and CryoVein SG may require significant time
and expense, that the Company may not have sufficient borrowing or
other capital availability to fund its business, that present and
future litigation may be resolved only by substantial payments by
the Company in excess of available insurance coverage and amounts
to be set aside for products liability cases by CryoLife since the
outcomes of products liability securities class action and
derivative cases are inherently uncertain, 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 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, 2002,
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/ Contact: Joseph T. Schepers Vice
President, Corporate Communications (770) 419-3355 DATASOURCE:
CryoLife, Inc. CONTACT: Joseph T. Schepers, Vice President,
Corporate Communications of CryoLife, Inc., +1-770-419-3355 Web
site: http://www.cryolife.com/
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