Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact: Cheryl R. Johnson
Vice President, Investor Relations
NOVOSTE CORPORATION
(770) 717-6052
FDA Advisory Committee Unanimously Recommends
Approval of Novoste's Beta-Cath(TM) System
GAITHERSBURG, MD., September 11, 2000 - Novoste Corporation (Nasdaq: NOVT) today
announced that its Beta-Cath(TM) System has been unanimously recommended for
approval to treat patients suffering from in-stent restenosis, a complication of
previous angioplasty and stent procedures that is currently difficult to treat.
This recommendation was made earlier today by the Circulatory System Devices
Panel of the Food and Drug Administration's (FDA) Medical Devices Advisory
Committee. The Beta-Cath(TM) System is the first intracoronary beta radiation
device to be recommended for FDA approval.
Today's recommendation by the Panel, although not binding, will be considered by
the FDA in its final review of Novoste's premarket approval application (PMA),
which was submitted to the FDA on April 17, 2000. At this time, there are no FDA
approved vascular brachytherapy devices, and the Beta-Cath(TM) System remains
under expedited review by the FDA.
William A. Hawkins, President and CEO of Novoste, commented, "With the favorable
Panel recommendation, we are one step closer to FDA approval of the
Beta-Cath(TM) System and to making this therapy available to patients with
in-stent restenosis. These patients currently have no effective treatment
alternative other than coronary bypass surgery, a highly invasive procedure."
"The Panel based its recommendation primarily on the results of the 476-patient
START Trial, which demonstrated a significant reduction in coronary blockage and
the need for repeat procedures in patients treated with beta radiation versus
placebo. In my clinical practice, I routinely see patients who could be
candidates for vascular brachytherapy, and I look forward to offering this
treatment alternative once it is approved by the FDA," said Jeffrey J. Popma,
M.D., Principal Investigator of the Stents And Radiation Therapy (START) Trial
and Director of Interventional Cardiology at Brigham and Women's Hospital in
Boston, Mass.
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 heart catheterization. As
a result, physicians may remain in the cath lab at the patient's bedside to
monitor them closely during the procedure.
<PAGE>
"As a radiation oncologist involved in the clinical trials, I found that the
Beta-Cath(TM) System involved short treatment times, straightforward dosimetry
planning, and simple inventory management. In addition, use of the device did
not require any facility modifications to the hospital's cath lab, and all
healthcare personnel were able to remain in the lab during the brief beta
radiation procedure," said Burton L. Speiser, M.D., Medical Director of Arizona
Oncology Services and a clinical investigator of the START Trial.
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.
This news release contains forward-looking statements regarding future events
and the future performance of the Company that involve risks and uncertainties
that may cause the Company's actual results to differ materially. Such factors
include demonstration of safety and efficacy of the Beta-Cath(TM) System, market
acceptance of the Beta-Cath(TM) System, receipt and timing of FDA and other
regulatory approvals, and other risks detailed in documents the Company files
from time to time with the SEC, including its most recent S-3 registration
statement and Forms 10-K, 10-Q and 8-K. The Panel's recommendation may not
result in FDA approval to market the Beta-Cath(TM) System.
# # #
