cryolife8k20708.htm
 

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
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