Cryolife Inc - Current report filing (8-K)
February 12 2008 - 11:57AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
washington,
d.c. 20549
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 7,
2008
_______________________
CRYOLIFE,
INC.
(Exact
name of registrant as specified in its charter)
_________________________
Florida
|
1-13165
|
59-2417093
|
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
1655
Roberts Boulevard, N.W., Kennesaw, Georgia 30144
(Address
of principal executive office) (zip code)
Registrant's
telephone number, including area code: (770) 419-3355
_____________________________________________________________
(Former
name or former address, if changed since last report)
_________________________
Check
the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation
of
the registrant under any of the following provisions (see General Instruction
A.2. below):
o
|
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
o
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
o
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
|
o
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
|
Section
8 Other Events
Item
8.01 Other Events.
On
February 7, 2008, CryoLife, Inc.
(“CryoLife” or the “Company”) issued a press release announcing that the Food
and Drug Administration (“FDA”) notified CryoLife that it has received 510(k)
clearance from the FDA for its CryoValve SG pulmonary heart valve processed
with
the Company’s proprietary SynerGraft technology. CryoLife hereby
incorporates by reference herein the information set forth in its Press Release
dated February 7, 2008, a copy of which is attached hereto as Exhibit
99.1
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.
These
statements include those regarding anticipated effectiveness, benefits and
indications for use of CryoValve SG as well as the timing of use of the
SynerGraft technology. 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
CryoValve SG may not perform as well as expected or provide all of the benefits
anticipated, the Company may not be able to begin processing the majority of
its
pulmonary valves by the anticipated time, nor may the first shipments of
CryoValve SG occur as expected, 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, 2006, its most recent Form 10-Q,
and
the Company's other SEC filings. The Company does not undertake to update its
forward-looking statements.
Section
9
Financial Statements
and
Exhibits
Item
9.01(c)
Exhibits.
(a)
Financial
Statements.
Not
applicable.
(b)
Pro Forma Financial
Information.
Not
applicable.
(c)
Shell Company
Transactions.
Not
applicable.
(d)
Exhibits.
|
Exhibit
Number
|
Description
|
|
|
|
|
99.1
|
Press
release dated February 7, 2008
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, CryoLife, Inc.
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
CRYOLIFE,
INC.
|
|
|
|
|
|
|
Date: February
11, 2008
|
By:
/s/ D. A. Lee
|
|
Name:
D. Ashley Lee
|
|
Title:
Executive Vice President, Chief
|
|
Operating
Officer and Chief
|
|
Financial
Officer
|
|
|
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