-----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, W0mAZzPe24hfL2KKHnjwCoOB3Mx8hHtbXhuZlvmHo7dIfMcf7qXx+6gpm3Cn8qGs U7SHIuQ3Bzp7EQ5RJCAL2Q== /in/edgar/work/20000801/0001005477-00-005432/0001005477-00-005432.txt : 20000921 0001005477-00-005432.hdr.sgml : 20000921 ACCESSION NUMBER: 0001005477-00-005432 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20000725 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20000801 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: 683804 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) July 25, 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 July 25, 2000, the Registrant issued a press release announcing that the Food and Drug Administration (FDA) has scheduled a meeting of its Circulatory System Devices Panel with the Registrant for September 11, 2000. The panel, comprised of independent medical experts, will provide advice and make a recommendation to the FDA whether the Registrant's Beta-Cath(TM) System should be approved for commercial sale in the United States. There can be no assurance that the Registrant will receive the FDA approval that is required to market the Beta-Cath(TM) System in the United States. 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 July 25, 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: July 31, 2000 NOVOSTE CORPORATION ------------------- (Registrant) By: /s/ WILLIAM A. HAWKINS ---------------------- William A. Hawkins Chief Executive Officer 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 UPCOMING MEETING WITH FDA ADVISORY PANEL NORCROSS, GA., July 25, 2000 - Novoste Corporation (Nasdaq: NOVT) announced today that the Food and Drug Administration (FDA) has scheduled a meeting of its Circulatory System Devices Panel with Novoste for September 11, 2000. The panel, comprised of independent medical experts, will provide advice and make a recommendation to the FDA whether Novoste's Beta-Cath(TM) System should be approved for commercial sale in the United States. The panel meeting is scheduled to occur less than five months after Novoste's submission of its Pre-Market Approval (PMA) application to the FDA. At this time, there are no approved vascular brachytherapy devices in the U.S., and Novoste's application is undergoing expedited review by the FDA. Novoste is seeking U.S. approval of its beta radiation catheter system to treat patients suffering from in-stent restenosis, a recurrent coronary artery blockage within a previously placed stent. The Company's PMA application is based largely on the data from the 476-patient START (STents And Radiation Therapy) Trial, the results of which were announced during the American College of Cardiology meeting in March 2000. The trial demonstrated that beta radiation significantly reduces the risk of repeat blockage and additional procedures to re-open stented coronary arteries, when compared to patients treated with placebo. Additionally, the data showed that patients treated with the Beta-Cath(TM) System had a considerably lower rate of major adverse cardiac events than those in the placebo group. William A. Hawkins, President and CEO of Novoste, said, "We are very encouraged to have a panel meeting arranged so quickly after our PMA submission. We remain optimistic that, since our submission is undergoing expedited review, in-stent restenosis patients that otherwise would be sent to bypass surgery may soon have access to vascular brachytherapy, a much less invasive treatment alternative." More than 75 percent of all patients who undergo balloon angioplasty for coronary artery disease -- about 700,000 people per year in the United States -- receive stents in an effort to prolong benefits of the procedure. Unfortunately, approximately 25 percent of these patients will later suffer from "in-stent restenosis," a condition where the stent becomes clogged with new tissue growth, typically resulting in the need for additional procedures to re-open the stent. The treatment of in-stent restenosis poses a very difficult challenge to cardiologists because the probability of a recurrent restenosis in previously stented patients is in the 40 to 80 percent range. Currently there are no therapies that effectively treat in-stent restenosis other than bypass surgery, an expensive and highly invasive procedure that requires a long recuperation period. The Beta-Cath(TM) System is a small portable device that delivers beta radiation through a catheter placed inside a patient's artery following angioplasty. The radiation sources, strontium-90, reside in the artery for less than five minutes, thereby adding very little time to the angioplasty procedure. Beta radiation is a highly localized form of radiation; therefore, it requires minimal shielding and exposes medical staff to significantly less radiation than the x-ray imaging routinely performed during a typical cath lab procedure. As a result, physicians may remain in the cath lab at the patient's bedside to monitor them closely during the procedure. 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, 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. # # # -----END PRIVACY-ENHANCED MESSAGE-----