Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact: Cheryl R. Johnson
Vice President, Investor Relations
NOVOSTE CORPORATION
(770) 717-6052
Novoste Announces Interim Results of START 40 Trial
* Beta Radiation Shown to Reduce Restenosis by 51% to 61% *
NORCROSS, GA., October 18, 2000 - Interim results of Novoste Corporation's
(Nasdaq: NOVT) START 40 Trial were presented today at the Transcatheter
Cardiovascular Therapeutics (TCT) conference in Washington, D.C. Data was
presented on 137 patients, or approximately two-thirds of the patients enrolled
in the study. The results of this interim review, as well as the results of the
original START Trial which were announced in March 2000, demonstrated a
significant reduction in restenosis in patients treated with beta radiation.
The START 40 Trial was designed to evaluate the effect of intracoronary
radiation delivered with the Beta-Cath(TM) System in treating in-stent
restenosis. A key objective of the START 40 Trial was to determine the effect of
using a longer (40-mm) radiation source with the Beta-Cath(TM) System to treat
the same size lesion treated by a shorter (30-mm) radiation source, as in the
START Trial. The trial used the same treatment protocol and patient enrollment
criteria as that used in the original START Trial, so that the placebo arm of
the START Trial could also serve as the placebo arm for the START 40 Trial. In
the START 40 Trial, all patients were treated with an active radiation source
train.
A total of 207 patients were treated with beta radiation in the START 40 Trial
at 22 clinical sites in North America and Europe. Patients were requested to
return eight months after treatment with the Beta-Cath(TM) System for an
angiographic (x-ray) evaluation of the treated artery. Alexandra J. Lansky,
M.D., Director of the Angiographic Core Lab at Cardiology Research Foundation
(Lenox Hill Hospital; New York), reviewed the following results during her
presentation at the TCT today.
Interim Angiographic Results of the START 40 Trial
<TABLE>
<CAPTION>
-----------------------------------------------------------------------------------------------
Beta
PLACEBO Radiation Reduction Beta Radiation REDUCTION
CONTROL START vs. Placebo START 40 VS. PLACEBO
<S> <C> <C> <C> <C> <C>
Enrolled Patients 232 244 207
Angiographic Analysis 188 198 137
Restenosis Rate(1):
Stent Segment 41% 14% 66% 16% 61%
Total Analysis Segment 45% 29% 36% 22% 51%
-----------------------------------------------------------------------------------------------
</TABLE>
Commenting on these results, Dr. Lansky said, "Compared to the placebo group, we
observed a 51% reduction in restenosis within the `total analysis segment', a 50
millimeter section of the artery encompassing lesions which were 17 millimeters
long, on average. This is a very rigorous measure of the
<PAGE>
effect of beta radiation on restenosis, and compares favorably with the 36%
reduction observed in the START Trial."
William A. Hawkins, President and CEO of Novoste, remarked, "The final results
of the START 40 Trial will be presented at the American Heart Association
meeting in mid-November by Dr. Warren Laskey, the principal investigator of the
trial. Soon thereafter, Novoste plans to submit a supplemental application with
the FDA to obtain approval to market the Beta-Cath(TM) with a 40-mm radiation
source train. The 40-mm device would represent a product line extension to our
30-mm device, for which we are expecting FDA approval in the near future."
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, time required to complete clinical trial data
analysis, 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.
----------
(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).
# # #
