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): September 11, 2001
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)
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(Former name or former address, if changed since last report)
Item 9. Regulation FD Disclosure.
On September 11, 2001, The U.S. Food and Drug Administration's (FDA)
Circulatory System Devices Panel unanimously recommended to approve CryoLife
Inc.'s BioGlue Surgical Adhesive as an adjunct to the use of sutures and staples
in vascular and cardiac repair to achieve hemostasis. The Panel's recommendation
will be reviewed by the FDA, which is ultimately responsible for market approval
decisions.
In December 1999, BioGlue was made available in the U.S. under an FDA
approved Humanitarian Device Exemption for use as an adjunct in the repair of
acute thoracic aortic dissections, a life-threatening condition. For this
indication, BioGlue has received Institutional Review Board (IRB) approval to be
shipped to over 600 hospitals in the United States. Internationally, BioGlue is
currently approved in 36 foreign countries for use in vascular and pulmonary
repair and to provide more effective hemostasis control.
Pursuant to the rules of the Securities and Exchange Commission, the
information contained in this report shall not be deemed "filed" for the
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and
will not be incorporated by reference into any filing of the Company under such
Act or the Securities Act of 1933, as amended.
Statements made herein that look forward in time or that express
management's beliefs, expectations or hopes regarding future occurrences are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These future events may not occur when expected,
if at all, and are subject to various risks and uncertainties. Such risks and
uncertainties include the possibility that the FDA may not ultimately approve
BioGlue Surgical Adhesive as an adjunct to the use of sutures and staples in
vascular and cardiac repair to achieve hemostasis or for the general
distribution of BioGlue Surgical Adhesive and other risk factors detailed in the
Company's Securities and Exchange Commission filings, including the Company's
Form 10-K for the year ended December 31, 2000.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CRYOLIFE, INC.
Date: September 13, 2001 By: /s/ Steven G. Anderson
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Name: Steven G. Anderson
Title: President, Chief Executive
Officer and Chairman
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