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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 6, 2004
CRYOLIFE, INC.
(Exact name of registrant as specified in its charter)
Florida
(State or other jurisdiction of incorporation)
1-13165 59-2417093
(Commission File Number) (IRS Employer Identification No.)
1655 Roberts Boulevard N.W., Kennesaw, Georgia 30144
----------------------------------------------------
(Address of principal executive offices, including zip code)
(770) 419-3355
(Registrant's telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
ITEM 5. OTHER EVENTS AND REGULATION FD DISCLOSURE.
On February 6, 2004, CryoLife issued a press release announcing an update on its
510K premarket notification for CryoValve SG decellularized human heart valves.
CryoLife hereby incorporates by reference herein the information set forth in
its Press Release dated February 6, 2004, a copy of which is attached hereto as
Exhibit 99.1. Except as otherwise provided in the press release, the press
release speaks only as of the date of such press release and such press release
shall not create any implication that the affairs of CryoLife have continued
unchanged since such date.
Except for the historical information contained in this report, the statements
made by CryoLife are forward-looking statements that involve risks and
uncertainties. All such statements are subject to the safe harbor created by the
Private Securities Litigation Reform Act of 1995. CryoLife's future financial
performance could differ significantly from the expectations of management and
from results expressed or implied in the Press Releases. For further information
on other risk factors, please refer to CryoLife's Form 10-K, as amended, for the
year ended December 31, 2002, as filed with the Securities and Exchange
Commission, and CryoLife's subsequent filings with the Securities and Exchange
Commission. CryoLife disclaims any obligation or duty to update or modify these
forward-looking statements.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(a) Financial Statements.
Not applicable.
(b) Pro Forma Financial Information.
Not applicable.
(c) Exhibits.
Exhibit Number Description
-------------- -----------
99.1 Press Release dated February 6, 2004
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, CryoLife
has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
CRYOLIFE, INC.
Date: February 9, 2004 By: /s/ D. A. Lee
---------------------------------------
Name: D. Ashley Lee
Title: Vice President, Chief Financial
Officer and Treasurer
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EXHIBIT INDEX
Exhibit Number Description
- -------------- -----------
99.1 Press Release dated February 6, 2004
4
Exhibit 99.1
[COMPANY LOGO]
FOR IMMEDIATE RELEASE
CONTACT: JOSEPH T. SCHEPERS
VICE PRESIDENT, CORPORATE COMMUNICATIONS
(770) 419-3355
CRYOLIFE PROVIDES UPDATE ON 510K PREMARKET NOTIFICATION
FOR CRYOVALVE SG DECELLULARIZED HUMAN HEART VALVES
ATLANTA, GA...(February 6, 2004)...CryoLife, Inc. (NYSE: CRY), 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 510k 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.
-More-
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
END