UNITED
STATES
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 7,
2008
_______________________
CRYOLIFE,
INC.
(Exact
name of registrant as specified in its charter)
_________________________
|
Florida
|
1-13165
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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))
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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
|
|
Exhibit
99.1
FOR
IMMEDIATE RELEASE
|
Media
Contacts:
|
|
|
D.
Ashley Lee
|
Katie
Brazel
|
|
Executive
Vice President, Chief Financial
|
Fleishman
Hillard
|
|
Officer
and Chief Operating Officer
|
Phone:
404-739-0150
|
|
Phone:
770-419-3355
|
CryoLife
Receives FDA 510(k) Clearance for SynerGraft®
Processed Human Pulmonary Heart Valves
ATLANTA…(February
7, 2008)…CryoLife, Inc., (NYSE: CRY) a biomaterials, medical device and tissue
processing company, today announced that it has received 510(k) clearance from
the Food and Drug Administration (FDA) for its CryoValve®
SG
pulmonary human heart valve processed with the Company’s proprietary SynerGraft
technology. CryoLife’s proprietary SynerGraft technology is designed
to remove allogeneic donor cells and cellular remnants from the valve without
compromising the integrity of the underlying collagen matrix.
The
CryoValve SG pulmonary human heart valve is indicated for the replacement of
diseased, damaged, malformed or malfunctioning native pulmonary
valves. The valve can be used in conjunction with right ventricular
outflow tract reconstruction procedures (RVOT), commonly performed in children
with congenital heart defects. In addition, the valve can be used for pulmonary
valve replacement during the Ross Procedure, an operation in which a patient’s
defective aortic valve is removed and replaced with his own pulmonary
valve. The CryoValve SG is then surgically implanted in place of the
removed native pulmonary valve.
“CryoValve
SG may offer an
attractive valve replacement option for many children born with heart defects,”
said Steven G. Anderson, CryoLife’s president and chief executive
officer. “CryoValve SG may also be a good option for patients who
have undergone valve replacement surgery as young children, but may require
another valve replacement as they’ve grown into adulthood.”
--more--
“Children
born with heart defects often
face frequent and challenging surgeries,” stated John W. Brown, M.D., professor
of Cardiothoracic Surgery, Indiana University School of Medicine, Indianapolis,
Ind. “For certain heart defects, CryoValve SG may give these kids a great
opportunity to live active, normal lives. As a surgeon, I’m very excited to be
able to offer them and their families this treatment option.”
At
FDA’s
request, CryoLife is planning a post-clearance study to seek evidence for the
potential and implied long-term benefits of the SynerGraft
process. Data to be collected is expected to include long-term safety
and hemodynamic function, immune response, and explant analysis. CryoLife
believes that this information may help it ascertain whether the SynerGraft
process reduces the immunogenicity of the transplanted heart valve and
recellularizes with the recipients own cells.
CryoLife
will be using the SynerGraft technology for the majority of its pulmonary valve
processing and anticipates that the first CryoValve SG may be available for
shipment late in the first quarter of 2008.
About
CryoLife, Inc.
Founded
in 1984, CryoLife, Inc. is a leader in the processing and distribution of
implantable living human tissues for use in cardiac 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. BioGlue is also CE marked
in
the European Community and approved in Canada and Australia for use in soft
tissue repair. The Company also distributes the CryoLife-O'Brien®
stentless porcine heart valve, 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 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.
For
additional information about the company, visit CryoLife’s Web
site:
http://www.cryolife.com
###