Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact: Cheryl R. Johnson
Vice President, Investor Relations
NOVOSTE CORPORATION
(770) 717-6052
NOVOSTE ANNOUNCES UPCOMING MEETING WITH FDA ADVISORY PANEL
NORCROSS, GA., July 25, 2000 - Novoste Corporation (Nasdaq: NOVT)
announced today that the Food and Drug Administration (FDA) has scheduled a
meeting of its Circulatory System Devices Panel with Novoste for September 11,
2000. The panel, comprised of independent medical experts, will provide advice
and make a recommendation to the FDA whether Novoste's Beta-Cath(TM) System
should be approved for commercial sale in the United States. The panel meeting
is scheduled to occur less than five months after Novoste's submission of its
Pre-Market Approval (PMA) application to the FDA. At this time, there are no
approved vascular brachytherapy devices in the U.S., and Novoste's application
is undergoing expedited review by the FDA.
Novoste is seeking U.S. approval of its beta radiation catheter system to
treat patients suffering from in-stent restenosis, a recurrent coronary artery
blockage within a previously placed stent. The Company's PMA application is
based largely on the data from the 476-patient START (STents And Radiation
Therapy) Trial, the results of which were announced during the American College
of Cardiology meeting in March 2000. The trial demonstrated that beta radiation
significantly reduces the risk of repeat blockage and additional procedures to
re-open stented coronary arteries, when compared to patients treated with
placebo. Additionally, the data showed that patients treated with the
Beta-Cath(TM) System had a considerably lower rate of major adverse cardiac
events than those in the placebo group.
William A. Hawkins, President and CEO of Novoste, said, "We are very
encouraged to have a panel meeting arranged so quickly after our PMA submission.
We remain optimistic that, since our submission is undergoing expedited review,
in-stent restenosis patients that otherwise would be sent to bypass surgery may
soon have access to vascular brachytherapy, a much less invasive treatment
alternative."
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 Beta-Cath(TM) System is a small portable device that delivers beta
radiation through a catheter placed inside a patient's artery following
angioplasty. The radiation sources, strontium-90, reside in the artery for less
than five minutes, thereby adding very little time to the angioplasty procedure.
Beta radiation is a highly localized form of radiation; therefore, it requires
minimal shielding and exposes medical staff to significantly less radiation than
the x-ray imaging routinely performed during a typical cath lab procedure. As a
result, physicians may remain in the cath lab at the patient's bedside to
monitor them closely during the procedure.
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-
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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.
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