Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact: Cheryl R. Johnson
Vice President, Investor Relations
NOVOSTE CORPORATION
(770) 717-6052
NOVOSTE RECEIVES APPROVABLE LETTER FROM FDA
FOR ITS BETA-CATH(TM) SYSTEM
NORCROSS, GA., October 16, 2000 - Novoste Corporation (Nasdaq: NOVT) announced
today that it has received a letter from the U.S. Food and Drug Administration
(FDA) stating that the Company'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, a recurrent coronary artery
blockage within a previously placed stent.
This letter comes less than 180 days after Novoste's submission of its premarket
approval application in April. Issuance of an approvable letter means that the
FDA has reviewed the Company'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 Novoste's compliance with specific
final conditions. The key conditions to approval of Novoste's application are
successful conclusion of a Good Manufacturing Practices audit, which is nearing
completion, and finalizing printed labeling materials. Other conditions relate
to finalizing protocols for post-market surveillance and user training, and
responding to other information requests.
The FDA's Circulatory System Devices Panel of the Medical Devices Advisory
Committee unanimously recommended approval of the Beta-Cath(TM) System on
September 11, 2000.
William A. Hawkins, President & CEO of Novoste, commented, "We have been
impressed by the FDA's rapid and thorough review of our premarket approval
application. We are making good progress towards resolving the FDA's conditions,
and expect to have final approval of our device in the near future - perhaps in
time for the American Heart Association meeting in mid-November."
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. Further,
there can be no assurance that this approvable letter will result in approval
from the FDA for the Beta-Cath(TM) System.
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