-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JlKwdOTIWafsquW6j2XJP/7GtgE4m1xYPPJdEVEsnfuaOaIZUb8+F0tzRA58IF5k UDH3glkAt4PCDLbIk95a5Q== 0000914062-01-500435.txt : 20010914 0000914062-01-500435.hdr.sgml : 20010914 ACCESSION NUMBER: 0000914062-01-500435 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20010911 ITEM INFORMATION: FILED AS OF DATE: 20010913 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CRYOLIFE INC CENTRAL INDEX KEY: 0000784199 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MISC HEALTH & ALLIED SERVICES, NEC [8090] IRS NUMBER: 592417093 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-13165 FILM NUMBER: 1736539 BUSINESS ADDRESS: STREET 1: 1655 ROBERTS BOULEVARD N W STREET 2: STE 142 CITY: KENNESAW STATE: GA ZIP: 30144 BUSINESS PHONE: 7704193355 MAIL ADDRESS: STREET 1: 1655 ROBERTS BOULEVARD N W STREET 2: STE 142 CITY: KENNESAW STATE: GA ZIP: 30144 8-K 1 cryolifeform8k901.txt FORM 8-K 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) -------------------------------- (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 ---------------------------------- Name: Steven G. Anderson Title: President, Chief Executive Officer and Chairman 1395470v1 -----END PRIVACY-ENHANCED MESSAGE-----