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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): August 18, 1998
Cambridge Heart, Inc.
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(Exact Name of Registrant as Specified in its Charter)
Delaware
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(State or Other Jurisdiction of Incorporation)
0-20991 13-3679946
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(Commission File Number) (I.R.S. Employer Identification No.)
1 Oak Park Drive
Bedford, Massachusetts 01730
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(Address of Principal Executive Offices) (Zip Code)
(781) 271-1200
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(Registrant's Telephone Number, Including Area Code)
Not Applicable
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(Former Name or Former Address, if Changed Since Last Report)
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ITEM 5. OTHER EVENTS.
CAMBRIDGE HEART LABELING AND FOLLOW-UP
STUDIES: SUMMARY OF RESULTS
This report contains a summary of the clinical results of the Company's Labeling
Study and Follow-up Study recently received from Medical and Technical Research
Associates, the independent contract research organization performing the
analysis of the study data. These results will form the basis for the Company's
upcoming 510(K) submission to the Food and Drug Administration for expansion of
the labeling claims for the Company's CH 2000 system.
LABELING STUDY
The primary objective of this study was to show that T-wave alternans (TWA) is
associated with an increased susceptibility to ventricular tachyarrhythmia. In
support of this objective the primary hypothesis was that, in patients referred
for electrophysiology (EP) testing for the evaluation of cardiac arrhythmias,
the presence of TWA measured during an exercise stress test using the CH 2000
Cardiac Diagnostic System and Hi-Resolution ECG electrodes is predictive of
increased susceptibility to ventricular arrhythmias. An increased
susceptibility to ventricular arrhythmias was defined as sustained monomorphic
ventricular tachycardia (VT) induced during EP testing.
Two-hundred-seventy-two (272) patients were enrolled in the study. Among the 140
patients who had determinate results for both TWA and EP study, TWA test results
were statistically significantly predictors of EP test outcome (p (lesser than)
0.0001). Sensitivity was 76% and specificity was 65% for TWA test results when
compared to EP outcome. The relative risk of having a positive EP finding for
those patients with a positive TWA finding was 3.93 compared with those patients
with a negative TWA finding.
These results are summarized below:
TWA PREDICTION OF EP OUTCOME
Sensitivity: 76%
Specificity: 65%
Relative Risk: 3.93
P value: (lesser than) 0.0001
These results meet the primary objective of the study.
The secondary objective of the study was to demonstrate that, in the same
patients, the presence of TWA measured during an exercise stress test using the
CH 2000 Cardiac Diagnostic System and Hi Resolution(TM) ECG electrodes is
substantially equivalent to, or better than, signal-averaged electrocardiography
(SAECG) as a measure of increased susceptibility to ventricular arrhythmias.
Among the 103 patients who had determinate results for TWA, EP and SAECG, TWA
showed a considerably greater sensitivity for predicting true positives (80%)
than SAECG (50%) but a somewhat lower specificity (70%) than SAECG (86%). TWA
was a somewhat better overall predictor of EP outcome as evidenced by a higher
relative risk for TWA (6.05) in predicting EP results than for SAECG (3.68) and
a greater statistical significance (p value = 0.0001) than SAECG (p value =
0.0014). A two sided McNemar's test showed TWA and SAECG were not significantly
different (i.e., were substantially equivalent) in their ability to predict the
results of EP (p-value = 0.2498). This met the predefined requirements of the
secondary hypothesis.
These results are summarized below:
COMPARISON OF TWA AND SAECG AS PREDICTORS OF EP OUTCOME
<TABLE>
<CAPTION>
TWA SAECG
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<S> <C> <C>
Sensitivity: 80% 50%
Specificity: 70% 86%
Relative Risk 6.05 3.68
P value: 0.0001 0.0014
</TABLE>
FOLLOW-UP STUDY
The objective of this study was to demonstrate that, in patients referred for EP
testing for the evaluation of cardiac arrhythmias, the presence of T-wave
alternans (TWA) measured during exercise using the CH 2000, is predictive of a
spontaneous ventricular tachyarrhythmic event (VTE) defined as sudden death,
sustained ventricular tachycardia or fibrillation, or the appropriate firing of
an implantable defibrillator (ICD). In addition, an analysis was performed of
the ability of T-wave alternans to predict a combined endpoint of VTE or death.
Finally, an analysis was made of SAECG and EP study results with regard to their
prediction of both endpoint types: (1) VTE and (2) VTE or death.
Patients referred for EP testing for evaluation of cardiac arrhythmias, enrolled
in the Labeling Study described above, (both the Pilot and Main Study), who were
not in violation of the protocol of that study were enrolled in the Follow-up
Study. Follow-up is intended to continue for one year from the last date of
enrollment. This interim report includes only patients who were enrolled on or
before February 28, 1998 and includes follow up data received as of June 30,
1998. 246 patients were enrolled for this interim report; of these follow-up
data was available for 201 patients.
Kaplan-Meier actuarial survival analysis was performed of event-free survival
for each test result (TWA, EP and SAECG) and for both endpoints. The analysis
for each test included all patients who had a determinate result for that test.
Since this differed from test to test, the sample populations and number of
endpoint events for each test were not identical.
The results of this study indicated that, in this population, TWA was a highly
statistically significant predictor of both ventricular arrhythmic events
(VTE's) and of the combined endpoint of VTE or death. In this interim report,
TWA was somewhat more predictive than EP for both endpoints and substantially
more predictive than SAECG which was not a statistically significant predictor.
The results of this interim analysis meet the goals of the Follow-up Study.
These results are summarized below:
PREDICTION OF A VENTRICULAR TACHYARRHYTHMIC EVENT (VTE)
<TABLE>
<CAPTION>
TWA SAECG EP
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<S> <C> <C> <C>
Events 9 11 13
Relative Risk 6.68 2.57 4.90
P value 0.007 0.092 0.001
PREDICTION OF A VTE OR DEATH
TWA SAECG EP
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Events 12 13 17
Relative Risk 10.99 1.79 3.12
P value 0.001 0.220 0.006
</TABLE>
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) Exhibits.
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See Exhibit Index attached hereto.
SIGNATURE
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.
Date: August 19, 1998 CAMBRIDGE HEART, INC.
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(Registrant)
By: /s/ Robert B. Palardy
_____________________________________
Robert B. Palardy
Chief Financial Officer and Vice
President, Finance and Administration
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EXHIBIT INDEX
Exhibit
Number Description
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99 Press Release dated August 19, 1998.
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EXHIBIT 99
For further information, contact Robert B. Palardy, Chief Financial Officer,
781-271-1200, ext. 231, or Evanthia K. Malliris, Communications Manager,
781-271-1200, ext. 253, Cambridge Heart; Michelle L. Linn or Jeff Mooney,
Feinstein Kean Partners Inc., 617-577-8110.
FOR IMMEDIATE RELEASE
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POSITIVE RESULTS FOR FOLLOW-UP STUDY ON CARDIAC EVENTS ANNOUNCED BY CAMBRIDGE
HEART
- - COMPANY MEETS ALL GOALS FOR ITS T-WAVE ALTERNANS TECHNOLOGY IN EVENTS FOLLOW-
UP STUDY
BEDFORD, MASS., AUGUST 19, 1998 -- Cambridge Heart, Inc. (Nasdaq: CAMH) today
announced that the Company has met all study goals in the follow-up study for
its T-wave alternans technology. In the statistical report received from
Medical and Technical Research Associates (Natick, MA), the independent contract
research organization conducting the study analysis, the noninvasive measure of
microvolt alternans was a significant predictor of major cardiac events, such as
sudden cardiac death and episodes of life-threatening arrhythmias. The Company's
current labeling does not allow it to make claims regarding the predictive
accuracy of T-wave alternans; the Company plans to submit the results of this
study to the FDA within the next few weeks for expansion of these labeling
claims.
The Company believes results of this study will significantly strengthen its
submission to the FDA in support of the expansion of its labeling claim. "When
combined with the previous studies of T-wave alternans, these data present a
powerful case that T-wave alternans is at least as good as EP study as a
predictor of cardiac events. This is a very significant result," commented
Douglas P. Zipes, a member of Cambridge Heart's Scientific Advisory Board and
Professor of Medicine at Indiana University School of Medicine, Distinguished
Professor of Medicine, Pharmacology, and Toxicology, and Director of Cardiology
Division and Krannert Institute of Cardiology, who reviewed the study results.
The Company's follow-up study was conducted with the same patient population
included in its previously concluded labeling study. The study compares the
results of T-wave alternans to results of electrophysiology testing ("EP") and
signal averaged electrocardiogram ("SAECG") in predicting episodes of life
threatening arrhythmias and sudden cardiac death. The design of the follow-up
study calls for event data collection to continue. Because the results to date
are statistically significant, the Company will be including the follow-up data
in its upcoming submission to the FDA. Additional event data will be included in
a more comprehensive report to be presented at the American Heart Association
Meeting, November 1998.
In events to date, T-wave alternans predicted tachyarrhythmic events (sudden
death and resuscitated sustained ventricular arrhythmia) with a relative risk of
6.7 (P (lesser than) 0.007) and tachyarrhythmic events and total mortality with
a relative risk of 11.0 (P (lesser than) 0.001). EP was slightly less predictive
with a relative risk of 4.9 (P (lesser than)0.001) and 3.1 (P (lesser than)
0.006), respectively.
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Relative risk is the chance of having an event if the test is positive divided
by the chance of having an event if the test is negative. The greater the
number, the more predictive the test. SAECG, an older, noninvasive method, was
not a statistically significant predictor of the events collected to date.
"We believe that the medical community has been waiting for the results of a
large scale, multi-center, controlled study on T-wave alternans," stated Jeffrey
M. Arnold, Company Chairman, President, and Chief Executive Officer. "We
couldn't be happier with the results. We plan to submit these results, together
with the positive results from our labeling study, to the FDA within the next
few weeks for expansion of our labeling claims regarding the predictive accuracy
of T-wave alternans."
Mr. Arnold and Dr. Zipes will be holding a conference call on Thursday, August
20 at 11:00 a.m. (eastern time) to discuss the completed labeling study data and
the event follow-up study data. The conference call number is (888) 836-6072
[outside US (703) 736-7363]. Interested persons unable to participate on
Thursday morning may listen to a recording of the conference call at any time
during the 48 hours immediately following the call by dialing (888) 266-2081
[outside US 703-925-2533] and keying in the reservation number 989851. This
playback will begin approximately two hours after the call ends.
Many heart attacks are caused by ventricular arrhythmia, an abnormality in the
beating pattern of the heart resulting in alterations in the rate and frequency
of the electrical impulses in the ventricles. Heart attacks caused by
ventricular arrhythmias generally cause death within minutes, known as sudden
cardiac death. In spite of the fact that patients at risk for sudden cardiac
death now have several treatment options available to them, including
implantable cardioverter-defibrillators and drug therapy, 300,000 sudden cardiac
deaths occur in the United States each year, primarily because there is no
accurate, noninvasive method to identify those at risk. T-wave alternans is an
alternating pattern which, when visible in the electrocardiogram (ECG), has been
associated with life-threatening heart rhythm disturbances and sudden cardiac
death.
Cambridge Heart is engaged in the research, development, and commercialization
of products for the noninvasive diagnosis of cardiac disease. Using innovative
technologies, the Company is addressing such key problems in cardiac diagnosis
as the identification of those at risk of sudden cardiac death, the early
detection of coronary artery disease, and the prompt and accurate diagnosis of
heart attack.
Statements made in this press release that are not historical facts include
forward-looking statements that involve risks and uncertainties. Important
factors that could cause actual results to differ materially from those
indicated by such forward-looking statements are included in Cambridge Heart's
Annual Report on Form 10-K for the year ending December 31, 1997.
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