CryoLife Provides Update on 510(K) Premarket Notification for CryoValve SG Decellularized Human Heart Valves
February 06 2004 - 4:13PM
PR Newswire (US)
CryoLife Provides Update on 510(K) Premarket Notification for
CryoValve SG Decellularized Human Heart Valves ATLANTA, Feb. 6
/PRNewswire-FirstCall/ -- CryoLife, Inc. , a human tissue
processing and bio-surgical device company, announced today that
the Food and Drug Administration ("FDA") has requested additional
information be provided to support the 510(k) premarket
notification for the CryoValve SG decellularized human heart
valves. The Company plans to work with the FDA to review and
address their requirements. Since February 2003, the Company has
been processing tissues without the decellularized SG technology.
Revenues from CryoValve SG processed heart valves were not included
in the Company's financial guidance for 2004; therefore, the
Company's previously announced projection of 12 percent to 18
percent revenue growth remains unchanged. 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(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 Company's 2004
revenues may not meet its expectations, that gross margins may not
improve in 2004, that SG&A expenses may be higher than
projected, 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 processing and
distribution of tissues, require a recall, or prevent the Company
from processing and 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 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 over the longer term
the Company may not have sufficient capital availability to fund
its business, 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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