-----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, SXVzRWi8iCOh56cxYgD/Fy/DHAe8cKp6bGw6Gw/+/Khwf3FiNyrAmS+/KUmxB91w c53I0SaDuvDRkSkqX6BZ6Q== 0001005477-00-002140.txt : 20000315 0001005477-00-002140.hdr.sgml : 20000315 ACCESSION NUMBER: 0001005477-00-002140 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20000310 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20000314 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: 568480 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) March 10, 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 March 10, 2000, Novoste Corporation (the "Registrant") issued a press release announcing that David N. Gill has resigned as the Registrant's Chief Operating Officer and Chief Financial Officer. A copy of the press release is attached as Exhibit 99.1 and incorporated by reference herein. On March 12, 2000, the Registrant issued a press release announcing the results of the START trial which shows that beta radiation reduces the risk of repeat blockage and additional treatment for patients suffering from clogged stents, when compared to patients treated with placebo. A copy of the press release is attached as Exhibit 99.2 and incorporated by reference herein. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. (c) Exhibit 99.1 - Press Release dated March 10, 2000. Exhibit 99.2 - Press Release dated March 12, 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: March 13, 2000 NOVOSTE CORPORATION ------------------- (Registrant) By: /S/ WILLIAM A. HAWKINS ---------------------- William A. Hawkins Chief Executive Officer EX-99.1 2 PRESS RELEASE DATED MARCH 10, 2000. FOR IMMEDIATE RELEASE Contact: Cheryl Johnson Vice President, Investor Relations NOVOSTE CORPORATION (770) 717-6052 NOVOSTE ANNOUNCES RESIGNATION OF CHIEF OPERATING OFFICER / CHIEF FINANCIAL OFFICER NORCROSS, GA., March 10, 2000 - Novoste Corporation (Nasdaq: NOVT) announced today that David N. Gill has resigned as the company's Chief Operating Officer and Chief Financial Officer. Mr. Gill had been with Novoste since July 1996. William A. Hawkins, President and CEO, said, "David has made tremendous contributions to Novoste in the last four years. He had the chance to join a pre-IPO telecommunications company in a very senior level position, and I wish him the best in his new venture." The Company expects to fill the Chief Financial Officer position in the near future. Until that time, the Company's controller will assume all financial management responsibilities. 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 System or Novoste, please call (770) 717-0904 or visit the company's web site at www.novoste.com. # # # EX-99.2 3 PRESS RELEASE DATED MARCH 12, 2000. FOR IMMEDIATE RELEASE Contacts: Cheryl Johnson Kathy Lee-Sepsick Vice President, Investor Relations Sr. Marketing Manager (770) 717-6052 (770) 717-6061 Novoste Announces Results of START TRIAL Randomized Clinical Trial Shows Significant Reduction of Restenosis in Patients Treated with Beta Radiation ANAHEIM, CALIF., March 12, 2000 - New research presented today at the 49th Annual Scientific Sessions of the American College of Cardiology shows that beta radiation reduces the risk of repeat blockage and additional treatment for patients suffering from clogged stents, when compared to patients treated with placebo. Results of the pivotal START Trial, sponsored by Novoste Corporation (Nasdaq: NOVT), were presented today by Jeffrey J. Popma, M.D., Director of Interventional Cardiology at Brigham and Women's Hospital in Boston, Mass., during the ACC's "Late Breaking Clinical Trials" session on Sunday morning. Background 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 START Trial This landmark clinical trial is the first randomized, multicenter, placebo-controlled study to evaluate the safety and effectiveness of beta, rather than gamma, radiation in treating in-stent restenosis. With 476 patients enrolled at 50 clinical sites in North America and Europe, the START Trial is also the largest such study of vascular brachytherapy to date. Vascular brachytherapy is radiation therapy delivered inside an artery with the objective of reducing the incidence of restenosis. Patients eligible for the START trial included those with native artery lesions treatable with a 20-mm angioplasty balloon. On average, patients enrolled in the study had 16-mm long lesions in arteries 2.8-mm in diameter. Immediately following the procedure to open their blocked stents, patients were then treated with the Beta-Cath(TM) System. They were randomized to either an inactive (placebo) or active radiation source train, substantially all of which were 30-mm in length. Depending on the artery diameter, a dose of either 16 or 20 gray was administered. Patients returned for follow-up examinations eight months after the vascular brachytherapy procedure. According to Dr. Popma, the Principal Investigator of the study, "The results of the START Trial are definitive. All endpoints of the study showed a statistically significant difference between the radiation-treated group and the placebo group. Additionally, the data show 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." In recent clinical trials of vascular brachytherapy, there has been some concern about late thrombosis (clot) in patients receiving new stents in conjunction with radiation. Of the 21% of patients in the START study who were implanted with new stents, no cases of clinical stent thrombosis were reported. The results of the START Trial are presented in the table below: Summary Results of the START Trial - -------------------------------------------------------------------------------- Beta Placebo Radiation Control Percent Angiographic Results (N = 244) (N= 232) Reduction P Value - -------------------------------------------------------------------------------- Restenosis Rate(1): - -------------------------------------------------------------------------------- Stent Segment 14% 41% 66% <0.001 - -------------------------------------------------------------------------------- Total Analysis Segment 29% 45% 36% 0.001 - -------------------------------------------------------------------------------- Clinical Outcomes - -------------------------------------------------------------------------------- Target Lesion Revascularization (TLR)(2) 13% 22% 42% 0.008 - -------------------------------------------------------------------------------- Target Vessel Revascularization (TVR)(3) 16% 24% 34% 0.026 - -------------------------------------------------------------------------------- Major Adverse Cardiac Events (MACE)(4) 18% 26% 31% 0.039 - -------------------------------------------------------------------------------- "Novoste is very pleased with the results of the START Trial, which confirm our belief that vascular brachytherapy will play a vital role in treating patients with failed coronary stents. These are patients who routinely return to the hospital for multiple procedures, and they currently have no reliable solution to their problem. We congratulate the START investigators on their contribution to this important research," said William A. Hawkins, President and CEO of Novoste Corporation. The Beta-Cath(TM) System The Beta-Cath(TM) System, developed by Novoste Corporation, contains Strontium-90 seeds that deliver beta radiation through a closed-end lumen catheter temporarily placed inside a patient's artery following angioplasty. Beta radiation is a highly localized form of radiation, so it requires little or no incremental shielding and exposes medical staff to significantly less radiation than the x-ray imaging associated with angioplasty procedures. The treatment only adds about ten minutes to the time it takes to perform angioplasty. "I am very excited about the prospects for beta radiation, which enables the brachytherapy treatment to be completed in very little time and with minimal radiation exposure to healthy tissues in the patient. Additionally, the use of beta radiation allows the treating physicians to stay at the patient's bedside throughout the procedure, a key consideration at our hospital," said Dr. Mohan Suntharalingam, Vice Chairman and Clinical Director of the University of Maryland's Department of Radiation Oncology, and the trial's Radiation Oncology Principal Investigator. Mr. Hawkins commented further, "With the START trial successfully completed, Novoste is on schedule to file its premarket approval (PMA) application with the FDA during the next quarter. We are also on track to announce the results of our other two pivotal clinical trials, the START 40 and Beta-Cath(TM) System Trials, no later than the fourth quarter of this year. Assuming the results of these trials are positive, Novoste will file additional applications with the FDA to expand our product line and the indications for use of the device." 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 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 continued demonstration of safety and efficacy of the Beta-Cath(TM) System, receipt and timing of 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 and 10-Q. - ---------- (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). (2) Target Lesion Revascularization (TLR): the percentage of patients who required an additional procedure such as bypass surgery within eight months to re-open their artery at the site of the original blockage. (3) Target Vessel Revascularization (TVR): the percentage of patients who required an additional procedure such as bypass surgery within eight months to re-open the originally treated artery at any location within the treated vessel. (4) Major Adverse Cardiac Events (MACE): a composite clinical endpoint that encompasses all adverse cardiac events, including TVR, myocardial infarction (heart attack), and death. # # # -----END PRIVACY-ENHANCED MESSAGE-----