SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form 8-K
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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
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(Exact Name of Registrant as Specified in Its Charter)
Florida 0-20727 59-2787476
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(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification No.)
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 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.
<PAGE>
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
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(Registrant)
By: /s/WILLIAM A. HAWKINS
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William A. Hawkins
Chief Executive Officer
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.
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