<PAGE> 1
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): MARCH 12, 1999
NOVOSTE CORPORATION
(Exact name of registrant as specified in charter)
FLORIDA 0-20727 59-2787476
(State or other jurisdiction of (Commission File Number) (IRS Employer
incorporation) Identification No.)
3890 STEVE REYNOLDS BLVD., NORCROSS, GA 30093
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (770) 717-0904
NOT APPLICABLE
(Former name or former address, if changed since last report)
<PAGE> 2
ITEM 5. OTHER EVENTS.
On March 12, 1999, Novoste Corporation (the "Registrant") issued a
press release announcing its intention to increase the number of patients
anticipated to be enrolled in the stent subgroup of the Beta-Cath System Trial
thereby delaying the projected completion of the trial. This trial is one of
the two pivotal clinical trials being conducted by the Registrant to support
anticipated applications to the FDA for pre-market approval to sell the
Registrant's Beta-Cath System in the United States. A copy of the press release
is attached hereto as Annex A and incorporated herein.
2
<PAGE> 3
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.
Novoste Corporation
(Registrant)
By: /s/ David N. Gill
-----------------------
David N. Gill
Chief Financial Officer
Dated: March 12, 1999
3
<PAGE> 4
ANNEX A
Press Release of Novoste Corporation dated March 12, 1999
4
<PAGE> 5
ANNEX A
Novoste to Increase Enrollment in Beta-Cath System Trial
NORCROSS, Ga.--March 12, 1999--
START Trial on Schedule for Enrollment Completion
Novoste Corporation (Nasdaq:NOVT) announced today that it is on track to
complete enrollment of 1,100 patients into the Beta-Cath(TM) System Trial by
the end of this month.
However, the Company now plans to increase patient enrollment in the stent
subgroup of the trial by up to 300 patients pending FDA approval. The planned
increase is a result of a recommendation made by the Data Safety and Monitoring
Board (DSMB) after its regularly scheduled meeting held during the American
College of Cardiology scientific sessions in New Orleans earlier this week. The
DSMB is an independent committee of clinicians and statisticians that have
responsibility for review of the study protocol and clinical events on regular
intervals during patient enrollment into the trial.
Based on the review of the currently available data set, the DSMB proposed
increasing patient enrollment in the stent subgroup to demonstrate the safety
and effectiveness of the Beta-Cath System Trial with the revised anti-platelet
therapy protocol implemented in November 1998 to address potential stent
thrombosis concerns. The trial protocol was modified for the stent subgroup to
extend the anti-platelet therapy from two weeks to 60 days and to provide for
additional follow-up contact with these patients in the few months after
treatment. The Company expects that patient enrollment into the Beta-Cath
System Trial will now be finished by mid-year 1999.
Novoste remains on track with its Stents And Radiation Trial (START) which is
designed to determine the safety and effectiveness of vascular brachytherapy in
treating "in-stent restenosis." The treatment of in-stent restenosis poses a
difficult challenge to cardiologists because the likelihood of a recurrent
restenosis in previously stented patients is significantly higher than in the
general angioplasty or stent population, and currently there are no therapies
which effectively treat in-stent restenosis other than bypass surgery. As
previously communicated, Novoste expects to enroll approximately 386 patients
into this trial by the second quarter of 1999, of which 299 patients have
already been accrued. The data analysis center for both trials, the
Cardiovascular Data Analysis Center (CDAC), has reviewed the data to date and
reported to the Company that there are no similar stent thrombosis issues in
the START Trial.
William A. Hawkins, President of Novoste, remarked, "We remain committed to
filing our PMA application with the FDA in a timely fashion. Because changes to
the Beta-Cath System Trial do not affect the START Trial, we expect to complete
enrollment in the START Trial as scheduled during the second quarter of 1999,
prior to completion of enrollment in the Beta-Cath System Trial. The results of
the START trial are now expected to be the basis of our initial PMA filing which
Novoste expects to file during the second quarter of 2000. We expect to file an
amendment to our PMA application during the third quarter of 2000 to seek
approval for the clinical indications being investigated in the Beta-Cath System
Trial, or reduction of coronary restenosis following either angioplasty or first
time stent placement."
Commenting on the trial modifications, Dr. Richard E. Kuntz, the Principal
Investigator of the Beta-Cath System Trial, said, "We believe the decision to
expand the stent subgroup of the Beta-Cath System Trial is a positive change to
the protocol. We continue to optimize vascular brachytherapy over time, as is
typical with new technologies."
Novoste Corporation is a leader in the emerging field of vascular brachytherapy
for the treatment of restenosis. Brachytherapy is radiation therapy which is
administered with a radioactive source placed in or near the target tissue.
For more information on the Company, please call Investor Relations at Novoste
at (770) 717-0904 or visit the Company's website, http://www.novoste.com.
The forward looking statements included in this news release, which reflect
management's best judgment based on factors currently known, involve risks and
uncertainties including the demonstration of safety and efficacy of the
Beta-Cath System, receipt of regulatory approvals, speed of patient enrollment,
and other risks detailed in documents filed by Novoste with the SEC, including
forms 10-K and 10-Q.
CONTACT: Novoste Corp., Norcross
Cheryl R. Johnson, 770/717-0904
