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) October 16, 2000
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NOVOSTE CORPORATION
(Exact name of registrant as specified in its charter)
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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 October 16, 2000, the Registrant issued a press release announcing that
it has received a letter from the U.S. Food and Drug Administration (FDA)
stating that the Registrant's Beta-Cath(TM) System is approvable. The
Beta-Cath(TM) System is an intracoronary radiation catheter system designed to
treat patients suffering from in-stent restenosis. Issuance of an approvable
letter means that the FDA has reviewed the Registrant's premarket approval (PMA)
application, as well as its own Advisory Committee's report and recommendation,
and that the FDA is prepared to approve the application, pending the
Registrant's compliance with specific final conditions. A copy of the press
release is attached as Exhibit 99.1 and incorporated by reference herein.
The Registrant also announced that it intends to present interim results
of the START 40 Trial at the Transcatheter Cardiovascular Therapeutics (TCT)
meeting to be held later this week in Washington, D.C. The Registrant also
intends to announce the final results of the START 40 Trial at the American
Heart Association meeting in November 2000, and the results of the Beta-Cath(TM)
System Trial during the first quarter of 2001. The exact timing of the
announcements of such results will depend upon the completion of clinical trial
data analyses.
On October 17, 2000, the Registrant issued a press release announcing the
third quarter 2000 financial results. 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.
Exhibit 99.1 Press Release dated October 16, 2000.
Exhibit 99.2 Press Release dated October 17, 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: October 17, 2000
NOVOSTE CORPORATION
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(Registrant)
By: /s/ Edwin Cordell
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Edwin Cordell
Chief Financial Officer
