Defense Bill Passed by the U.S. Senate and U.S. House of Representatives Provides Funding for BioFoam(TM) Development
July 29 2004 - 1:41PM
PR Newswire (US)
Defense Bill Passed by the U.S. Senate and U.S. House of
Representatives Provides Funding for BioFoam(TM) Development
ATLANTA, July 29 /PRNewswire/ -- CryoLife, Inc. (NYSE:CRY), a human
tissue processing and bio-surgical device company, announced today
that the U.S. Senate and the U.S. House of Representatives have
passed the 2005 Defense Appropriations Conference Report which
included $1 million for the development of BioFoam(TM). The bill
will now go to President Bush for his approval and signature to be
enacted. BioFoam is a protein hydrogel adhesive that is in the
pre-clinical stage of development. BioFoam contains an expansion
agent and sets quickly while expanding, thus providing an
opportunity to rapidly arrest bleeding of large vessel injuries and
sealing the wound. BioFoam is based on the same technology as
BioGlue(R), a CryoLife product approved by the U.S. Food and Drug
Administration to control bleeding as an adjunct to sutures and
staples for use in open surgical repair of large vessels. BioGlue
is also CE marked in the European Community and approved in Canada
for use in soft tissue repair. "BioFoam is being developed for use
in battlefield situations to treat gunshot and mortar wounds, which
will allow more time for soldiers to reach a medical facility,"
said Congressman Phil Gingrey. Steven G. Anderson, CryoLife
President and Chief Executive Officer, stated "We appreciate the
support of Congressman Gingrey and Senator Saxby Chambliss, as we
believe this funding for the development and potential use of
BioFoam may save the lives of U.S. soldiers serving our country in
the armed forces." Founded in 1984, 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 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
SG Model #100 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 funding for development of BioFoam may not be made
available even though the bill has passed, that BioFoam may not
prove effective or commercially feasible, that 2004 BioGlue
revenues may not meet expectations, that the Company's aggregate
2004 revenues and expenses may not meet its 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 operations, require a recall, or
prevent the Company from processing and distributing tissues or
manufacturing and distributing other products, that the Company's
SG Model #100 bovine ureter product may not meet expectations, 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 protein hydrogel products under development may
not be commercially feasible, 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 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, 2003, 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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