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
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NOVOSTE CORPORATION
(Exact name of registrant as specified in its charter)
Florida 0-20727 59-2787476
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification)
3890 Steve Reynolds Blvd., Norcross, GA 30093
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (770) 717-0904
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(Former name or former address, if changed since last report)
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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.
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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
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(Registrant)
By: /S/ WILLIAM A. HAWKINS
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William A. Hawkins
Chief Executive Officer
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.
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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.
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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
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Beta Placebo
Radiation Control Percent
Angiographic Results (N = 244) (N= 232) Reduction P Value
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Restenosis Rate(1):
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Stent Segment 14% 41% 66% <0.001
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Total Analysis Segment 29% 45% 36% 0.001
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Clinical Outcomes
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Target Lesion Revascularization
(TLR)(2) 13% 22% 42% 0.008
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Target Vessel Revascularization
(TVR)(3) 16% 24% 34% 0.026
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Major Adverse Cardiac Events
(MACE)(4) 18% 26% 31% 0.039
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"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
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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.
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(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.
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