-----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, SzS10NaJPqmK9MenhEjZcQ6NV///IgMV05QmJzc3R2mWjgYKRQsQSE7QklRvb3Lt KFd+OaSvI+iozjIfw2Bo8Q== 0001005477-00-003267.txt : 20000420 0001005477-00-003267.hdr.sgml : 20000420 ACCESSION NUMBER: 0001005477-00-003267 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20000417 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20000419 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVOSTE CORP /FL/ CENTRAL INDEX KEY: 0001012131 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [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: 604751 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 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) April 17, 2000 NOVOSTE CORPORATION - -------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in Its Charter) Florida 0-20727 59-2787476 - ---------------------------- ------------ ---------------------- (State or Other Jurisdiction (Commission (I.R.S. Employer of Incorporation) File Number) Identification No.) 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 April 17, 2000, the Registrant issued a press release announcing that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration for its Beta-Cath(TM) System. 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 April 17, 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: April 19, 2000 NOVOSTE CORPORATION ------------------- (Registrant) By: /s/WILLIAM A. HAWKINS --------------------- William A. Hawkins Chief Executive Officer EX-99.1 2 PRESS RELEASE Exhibit 99.1 FOR IMMEDIATE RELEASE Contact: Cheryl Johnson Vice President, Investor Relations NOVOSTE CORPORATION (770) 717-6052 NOVOSTE SUBMITS PREMARKET APPROVAL APPLICATION TO FDA FOR BETA-CATH(TM) SYSTEM NORCROSS, GA., April 17, 2000 - Novoste Corporation (Nasdaq: NOVT) announced today that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration for its Beta-Cath(TM) System. Novoste is the first company to submit a PMA application for an intravascular beta radiation device. The FDA has granted expedited review for vascular brachytherapy devices to treat in-stent restenosis. Novoste's PMA application is based primarily on the recently announced results of the START (STents And Radiation Therapy) Trial. The 476-patient START Trial demonstrated that beta radiation significantly reduces the risk of repeat blockage and additional treatment for patients suffering from in-stent restenosis (clogged stents), when compared to patients treated with placebo. Additionally, the data showed that patients treated with Novoste's Beta-Cath(TM) System had a considerably lower rate of major adverse cardiac events than those in the placebo group. The Company estimates that approximately 15% to 20% of the more than 1.5 million coronary interventions performed worldwide annually are for treatment of in-stent restenosis. This clinical condition poses a difficult challenge to cardiologists because the likelihood of recurrent restenosis in this group of patients is much higher (between 40% and 80%) than in the general angioplasty or stent population, and there are currently no therapies that effectively treat in-stent restenosis other than coronary bypass surgery. William A. Hawkins, President and CEO of Novoste, said, "The filing of our PMA represents a major milestone in our company's history. Since the announcement of the START Trial results, the clinical community's interest in using beta radiation has accelerated for treating patients who are at risk for restenosis." Novoste Corporation, based in Atlanta, Ga., is a leader in the emerging field of vascular brachytherapy to reduce the incidence of restenosis. More than 3,000 patients worldwide have now been treated with the Beta-Cath(TM) System, which is commercially available in the European Union, Israel, Turkey, Australia, New Zealand, China, Singapore and India. 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, receipt and timing of FDA and other regulatory approvals, market acceptance and availability of the Beta-Cath(TM) System, and other risks detailed in documents filed by Novoste with the SEC, including Forms 10-K, 10-Q and 8-K. # # # -----END PRIVACY-ENHANCED MESSAGE-----