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CAMBRIDGE
HEART’S NON-INVASIVE MICROVOLT T-WAVE ALTERNANS TEST ACCURATELY PREDICTS
RISK OF SUDDEN CARDIAC ARREST, META-ANALYSIS FINDS
Evidence from 13 clinical studies involving 6,000 heart patients and four
additional papers published today support MTWA testing
Tewksbury, Mass., March 3, 2009 –
Cambridge Heart, Inc. (OTCBB-CAMH), today
announced the publication of five articles supporting the use of Microvolt T
Wave Alternans™ (MTWA) testing in a supplement to the March issue of the
Heart Rhythm journal. Featured
in the supplement is a comprehensive meta-analysis of 6,000 patients
confirming the value of MTWA as a non-invasive marker of risk for sudden
cardiac arrest (SCA).
The
MTWA test
<http://www.cambridgeheart.com/content/Shared/FAQ.shtml> , administered
much like a stress test on a treadmill, was developed by Cambridge Heart as
a diagnostic tool to help physicians determine a patient’s risk of sudden
cardiac arrest -- the leading cause of death in the United States.
The meta-analysis,
conducted by a group led by Stefan Hohnloser, MD, FHRS, of the JW Goethe
University Division of Cardiology in Frankfurt, Germany, assessed 13 MTWA
clinical studies involving approximately 6,000 cardiac patients.
“The results demonstrate
that MTWA testing is a consistently accurate predictor of sudden cardiac
death and cardiac arrest in patients who do not already have implantable
cardiac defibrillators (ICDs),” said Dr. Stefan Hohnloser. “These
are the patients for whom MTWA testing is intended."
The meta-analysis
authors also conclude that:
·
Patients who
test negative for MTWA abnormalities are at extremely low risk (0.3%) for
SCA in the next 12 months.
·
MTWA testing can
help doctors guide ICD therapy to appropriate patients and overcome the
widespread reluctance of patients and referring physicians to accept ICD
therapy.
·
In clinical
trials, appropriate ICD shocks are an unreliable surrogate endpoint for SCA
and can skew results of risk stratification studies.
“This comprehensive
analysis confirms the findings of numerous peer-reviewed studies which
underscore the important role of MTWA in assessing a patient’s risk of
sudden cardiac arrest,” said Ali Haghighi-Mood, PhD, Chief Executive Officer
of Cambridge Heart.
The Heart Rhythm
supplement also includes:
·
A second
meta-analysis of MTWA testing in patients with non-ischemic heart disease,
authored by Gaetano De Ferrari, MD and Antonio Sanzo, MD of the Department
of Cardiology at Fondazione IRCCS Policlinico San Matteo, Pavia Italy. Analyzing
eight available trials involving 1,450 patients, the paper indicates that in
this population negative MTWA results can help patients and their physicians
decide whether ICD therapy may safely be avoided.
·
An article by
Michael J. Mirro, MD, Medical Director of the Parkview Health System
Clinical Research Center in Fort Wayne Indiana, who describes how his center
has incorporated MTWA testing into clinical practice to complement other
methods for identifying and educating patients about the risk of SCA.
·
A review of
numerous studies concerning the underlying cellular mechanisms of T-wave
alternans. The authors
conclude that microvolt T-wave alternans is a marker of cellular changes
that make the heart susceptible to sudden cardiac arrest. The review was
carried out by Michael Cutler, DO, PhD, and David S. Rosenbaum, MD, of the
Heart and Vascular Research Center at the Department of Biomedical
Engineering at Case Western Reserve University in Cleveland.
·
A review by
Navinder Sawhney, MD and Sanjiv Narayan, MD of the University of California
at San Diego that underscores the value of MTWA testing in patients who have
had heart attacks but do not fall within current guidelines for ICD
implantation.
The articles in the
supplement can be found on the Heart Rhythm journal website at:
http://www.heartrhythmjournal.com/issues/contents?issue_key=S1547-5271(09)X0006-8
<http://www.heartrhythmjournal.com/issues/contents?issue_key=S1547-5271(09)X0006-8>
About Cambridge Heart, Inc.
Cambridge Heart develops and
commercializes non-invasive diagnostic tests for cardiac disease, with a
focus on identifying those at risk for sudden cardiac arrest (SCA). The
Company’s products incorporate proprietary Microvolt T-Wave Alternans
measurement technologies including the patented Analytic Spectral Method®
and ultrasensitive disposable electrode sensors. Medicare reimburses the
Analytic Spectral Method® under its National Coverage Policy. Cambridge
Heart, founded in 1990, is based in Tewksbury, MA. The company’s Microvolt
T-Wave Alternans™ (MTWA) test, developed by Cambridge Heart (OTCBB: CAMH),
is based on research originally conducted at the Massachusetts Institute of
Technology. http://www.cambridgeheart.com
<http://www.cambridgeheart.com/>
.
Statements contained in this press release are forward-looking statements
for purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995. In some cases, we use words such as
“believes”, “expects”, “anticipates”, “plans”, “estimates”, “could”, and
similar expressions that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Actual results may differ
materially from those indicated by these forward-looking statements.
Factors that may cause or contribute to such differences include failure to
achieve broad market acceptance of the Company’s MTWA technology, failure of
our sales and marketing organization to market our products effectively,
inability to hire and retain qualified clinical applications specialists in
the Company's target markets, failure to obtain or maintain adequate levels
of third-party reimbursement for use of the Company's MTWA test, customer
delays in making final buying decisions, decreased demand for the Company's
products, failure to obtain funding necessary to develop or enhance our
technology, adverse results in future clinical studies of our technology,
failure to obtain or maintain patent protection for our technology and other
factors identified in our most recent Annual Report on Form 10‑K/A under
“Risk Factors”, which is on file with the SEC and available at www.EDGAR.com.
In addition, any forward-looking statements represent our estimates only as
of today and should not be relied upon as representing our estimates as of
any subsequent date. While we may elect to update forward-looking
statements at some point in the future, we specifically disclaim any
obligation to do so except as may be legally necessary, even if our
estimates should change.
###
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