-----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, ORVc0EZ4hW/IPyEK4yBd9G18FGurxDfmcQJuW7qUuJOzcCw3RKcgHxYHJxHjfTxZ GHtivDsZMSljcPWUqYkp/Q== /in/edgar/work/0001005477-00-007180/0001005477-00-007180.txt : 20001020 0001005477-00-007180.hdr.sgml : 20001020 ACCESSION NUMBER: 0001005477-00-007180 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20001018 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20001019 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVOSTE CORP /FL/ CENTRAL INDEX KEY: 0001012131 STANDARD INDUSTRIAL CLASSIFICATION: [3845 ] IRS NUMBER: 592787476 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-20727 FILM NUMBER: 742534 BUSINESS ADDRESS: STREET 1: 3890 STEVE REYNOLDS BLVD CITY: NORCROSS STATE: GA ZIP: 30093 BUSINESS PHONE: 7707170904 MAIL ADDRESS: STREET 1: 4350 C INTERNATIONAL BLVD CITY: NORCROSS STATE: GA ZIP: 30093 8-K 1 0001.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) October 18, 2000 ---------------- NOVOSTE CORPORATION (Exact name of registrant as specified in its charter) ------------------------------------------------------ Florida 0-20727 59-2787476 ------------------------------------------------------------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification) 3890 Steve Reynolds Blvd., Norcross, GA 30093 --------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (770) 717-0904 -------------- (Former name or former address, if changed since last report) Item 5. Other Events On October 18, 2000, the Registrant issued a press release announcing that interim results of the Registrant's START 40 Trial were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C. The results of the interim review demonstrated a significant reduction in restenosis in patients treated with beta radiation. A copy of the press release is attached as Exhibit 99.1 and incorporated by reference herein. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. Exhibit 99.1 Press Release dated October 18, 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. Dated: October 19, 2000 NOVOSTE CORPORATION -------------------------------- (Registrant) By: /s/ Daniel G. Hall ------------------------------------ Daniel G. Hall Vice President and General Counsel EX-99.1 2 0002.txt PRESS RELEASE Exhibit 99.1 FOR IMMEDIATE RELEASE Contact: Cheryl R. Johnson Vice President, Investor Relations NOVOSTE CORPORATION (770) 717-6052 Novoste Announces Interim Results of START 40 Trial * Beta Radiation Shown to Reduce Restenosis by 51% to 61% * NORCROSS, GA., October 18, 2000 - Interim results of Novoste Corporation's (Nasdaq: NOVT) START 40 Trial were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C. Data was presented on 137 patients, or approximately two-thirds of the patients enrolled in the study. The results of this interim review, as well as the results of the original START Trial which were announced in March 2000, demonstrated a significant reduction in restenosis in patients treated with beta radiation. The START 40 Trial was designed to evaluate the effect of intracoronary radiation delivered with the Beta-Cath(TM) System in treating in-stent restenosis. A key objective of the START 40 Trial was to determine the effect of using a longer (40-mm) radiation source with the Beta-Cath(TM) System to treat the same size lesion treated by a shorter (30-mm) radiation source, as in the START Trial. The trial used the same treatment protocol and patient enrollment criteria as that used in the original START Trial, so that the placebo arm of the START Trial could also serve as the placebo arm for the START 40 Trial. In the START 40 Trial, all patients were treated with an active radiation source train. A total of 207 patients were treated with beta radiation in the START 40 Trial at 22 clinical sites in North America and Europe. Patients were requested to return eight months after treatment with the Beta-Cath(TM) System for an angiographic (x-ray) evaluation of the treated artery. Alexandra J. Lansky, M.D., Director of the Angiographic Core Lab at Cardiology Research Foundation (Lenox Hill Hospital; New York), reviewed the following results during her presentation at the TCT today. Interim Angiographic Results of the START 40 Trial
- ----------------------------------------------------------------------------------------------- Beta PLACEBO Radiation Reduction Beta Radiation REDUCTION CONTROL START vs. Placebo START 40 VS. PLACEBO Enrolled Patients 232 244 207 Angiographic Analysis 188 198 137 Restenosis Rate(1): Stent Segment 41% 14% 66% 16% 61% Total Analysis Segment 45% 29% 36% 22% 51% - -----------------------------------------------------------------------------------------------
Commenting on these results, Dr. Lansky said, "Compared to the placebo group, we observed a 51% reduction in restenosis within the `total analysis segment', a 50 millimeter section of the artery encompassing lesions which were 17 millimeters long, on average. This is a very rigorous measure of the effect of beta radiation on restenosis, and compares favorably with the 36% reduction observed in the START Trial." William A. Hawkins, President and CEO of Novoste, remarked, "The final results of the START 40 Trial will be presented at the American Heart Association meeting in mid-November by Dr. Warren Laskey, the principal investigator of the trial. Soon thereafter, Novoste plans to submit a supplemental application with the FDA to obtain approval to market the Beta-Cath(TM) with a 40-mm radiation source train. The 40-mm device would represent a product line extension to our 30-mm device, for which we are expecting FDA approval in the near future." Novoste Corporation, based in Atlanta, Ga., is a leader in the emerging field of vascular brachytherapy to reduce the incidence of restenosis. The company's Beta-Cath(TM) System is commercially available in the European Union and other countries outside the U.S. For more information on the Beta-Cath(TM) System or Novoste, please call (770) 717-0904 or visit the company's web site at www.novoste.com. The forward-looking statements included in this news release reflect management's best judgment based on factors currently known. Actual results may differ materially from those projected in these forward-looking statements based upon risks and uncertainties, including the demonstration of safety and efficacy of the Beta-Cath(TM) System, time required to complete clinical trial data analysis, receipt and timing of FDA and other regulatory approvals, and other risks detailed in documents filed by Novoste with the SEC including its S-3 registration statement and Forms 10-K, 10-Q and 8-K. - ---------- (1) Restenosis Rate: the percentage of patients who had a greater than 50% stenosis (blockage) in the treated artery within eight months of the vascular brachytherapy procedure. The analysis was performed by analyzing x-ray images of both the stented portion of the artery (stent segment) and a longer section of the artery, beyond that treated with radiation or revascularization methods (total analysis segment). # # # -----END PRIVACY-ENHANCED MESSAGE-----