SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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): August 17, 1998
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.)
4350-C International Blvd., Norcross, GA 30093
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (717) 717-0904
Not Applicable
(Former name or former address, if changed since last report)
<PAGE>
Item 5. Other Events.
On August 17, 1998, Novoste Corporation (the "Registrant") issued a
press release announcing the final six month summary results of its feasibility
clinical trial, the Beta Energy Restenosis Trial (BERT). The purpose of the BERT
study was to evaluate the safety and clinical feasibility of the Registrant's
Beta-Cath(TM) System. A copy of the press release is attached as Schedule A
hereto.
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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
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David N. Gill
Chief Financial Officer
Dated: September 4, 1998
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<PAGE>
Schedule A
Press Release of Novoste Corporation
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<PAGE>
FOR IMMEDIATE RELEASE
Contact: Cheryl Johnson Desmond Towey
Vice President, Investor Relations Bernadette McLaughlin
NOVOSTE CORPORATION TOWEY & ASSOCIATES
(770) 717-0904 (212) 888-7600
NOVOSTE ANNOUNCES FINAL SUMMARY DATA FROM BERT FEASIBILITY TRIAL
NORCROSS, Georgia -- (August 17, 1998) - Novoste Corporation (Nasdaq: NOVT)
today announced the final six month summary results of its feasibility clinical
trial, the Beta Energy Restenosis Trial (BERT). The purpose of the BERT study
was to evaluate the safety and clinical feasibility of the Beta-Cath(TM) System.
According to the clinical trial protocol, patients with discrete single lesions
were to be treated with intracoronary radiation therapy (ICRT) following balloon
angioplasty. Patients were randomly assigned to receive one of three radiation
doses: 12, 14, or 16 gray. The elective use of coronary stents was not allowed
in the study.
Of the 85 patients enrolled in the BERT study, 82 successfully received ICRT
with the Beta-Cath(TM) System. Of these, 78 returned for angiographic follow-up
six months after the procedure and exhibited a restenosis rate at the lesion
site of 17%. This represents a greater than 50% improvement in restenosis when
compared to an historical control group which did not receive ICRT.
Additionally, the data demonstrated a greater than 75% improvement in the "late
loss index", a measure of how much of the artery enlargement achieved by
angioplasty is lost within six months of the procedure. There were no
complications associated with the use of intracoronary radiation therapy.
Another important finding occurred in a subgroup of 13 patients who received
coronary stents as a "bail-out" device to address acute complications which can
occur with angioplasty procedures. Within the bail-out stent subgroup, a
restenosis rate of 8% was observed at the lesion site, which suggests a major
improvement from restenosis rates typically observed in similar patients.
Results for the entire study group, as evaluated by the independent angiographic
core lab, are summarized below.
BERT Results
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(Entire Study Cohort)
<TABLE>
<CAPTION>
BERT BERT Lovastatin
(all doses) (14 & 16 Gy) Placebo Group
- -----------------------------------------------------------------------------------------
<S> <C> <C> <C>
Number of Patients 78 52 161
Restenosis at Lesion Site (% of patients) 17% 15% 42%
Late Loss Index 9% 4% 43%
Number of Patients receiving Stents 13 9 0(1)
Stent Restenosis at Lesion Site (% of patients) 8% 0% N/A
- -----------------------------------------------------------------------------------------
</TABLE>
(1) Coronary stents were not commercially available at the time of the
Lovastatin Restenosis Trial.
When reviewing the study results in more detail, it became apparent that several
cases fell outside of the clinical trial protocol. Because of the fixed length
of the device's radiation source train, the protocol placed restrictions on the
length of the lesion which could be treated and the balloon which could be used.
However, there were 12 patients enrolled in the study whose lesion length
exceeded the
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allowable range. These patients demonstrated a higher rate of restenosis than
the patients who met the lesion length requirement, suggesting that they may not
have received a sufficient dose of radiation throughout the lesion.
Additionally, there was one patient who had a greater than 50% residual stenosis
prior to receiving radiation therapy. For the 65 patients who met the
requirements for maximum lesion length and residual stenosis, the results were
as follows.
BERT Results
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(for patients with allowable lesion lengths and residual stenoses)
All doses 14 & 16 Gy
- ------------------------------------------------------------------------------
Number of Patients 65 44
Restenosis at Lesion Site (% of patients) 14% 11%
Late Loss Index 11% 6%
- ------------------------------------------------------------------------------
Within the total patient cohort, there were an additional six patients who
exhibited vessel narrowing in an area outside of the original lesion site at the
extreme edges of the radiation source train. Three of these patients were
revascularized with balloons which were much longer than that specified in the
trial protocol. Two patients appeared to experience normal disease progression
in lesions untreated by angioplasty. These lesions were at the edges of the
radiation treatment area. The sixth patient was treated per the protocol and
experienced a narrowing of the vessel outside the treated lesion.
Dr. Raoul Bonan, Novoste's Medical Director and Vice President of Clinical
Affairs, stated, "I am very pleased by the final data from our feasibility
trial, especially the improvement in late loss index. This is perhaps the most
meaningful indicator of the efficacy of restenosis therapies. These results are
very consistent with other recently published clinical studies and further
corroborate the potential of radiation to greatly reduce restenosis."
Thomas D. Weldon, Chairman and CEO of Novoste, said, "Novoste was an early
pioneer in the field of ICRT, and with the BERT trial we became the first
company to initiate an FDA approved clinical trial of ICRT in January 1996.
Novoste was also the first company to initiate a randomized multicenter trial of
ICRT to treat restenosis. The 1,100 patient Beta-Cath(TM) System Trial is
designed to definitively prove the efficacy of radiation in reducing restenosis
in treated arteries, and it reflects what we learned in the BERT trial. For
example, the dosing patterns in the current trial are correlated with artery
size, and we have eliminated the lowest dose of 12 gray. We also recognized the
need to treat longer lesions and we have developed a longer radiation source
train for this purpose. Additionally, the protocol of the pivotal trial more
closely mirrors current clinical practice in that it allows for provisional
stenting in those patients who do not achieve a good angioplasty result. In
these cases, the use of both radiation and stents may represent the best
approach to restenosis."
Novoste Corporation is a leader in the emerging field of intracoronary radiation
therapy for the treatment of restenosis. Restenosis, a re-narrowing of a
previously treated artery, is the principal limitation of coronary angioplasty.
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(TM) System, the limitations of interpreting data from small sample
sizes, receipt of regulatory approvals, the emergence of alternative restenosis
therapies, market acceptance of the Beta-Cath(TM) System and other risks
detailed in documents filed by Novoste with the SEC, including reports filed on
Forms 10-K and 10-Q.
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