Results Show MTWA to Be a Strong, Independent Risk Factor for
Major Arrhythmic Events
TEWKSBURY, Mass.--(BUSINESS WIRE)--Jun. 6, 2012--
Cambridge
Heart, Inc. (OTCBB: CAMH), a developer of non-invasive
diagnostic tests for cardiac disease, today announced that results of a
prospective, 155-patient trial
reinforce the value of the Microvolt
T-Wave AlternansTM (MTWA) test as a predictor of
life-threatening heart rhythms and Sudden Cardiac Death (SCD). The
results were published this week in the journal Kardiologia Polska.
Researchers from the Medical University of Silesia in Zabrze, Poland
studied 155 patients who received an implantable cardioverter
defibrillator (ICD) for secondary prevention of SCD. Patients underwent
MTWA testing using Cambridge Heart’s analytic spectral method prior to
implantation and were followed for major arrhythmic cardiac events
(MACE) including SCD or intractable life-threatening arrhythmias
requiring ablation or heart transplant.
At a median follow-up time of 22 months, patients with an abnormal MTWA
test were 11 times more likely to experience a major arrhythmic cardiac
event than patients with a normal MTWA result. The negative predictive
value was 98.6 percent, indicating that patients with a normal or
negative MTWA test are at very low risk of experiencing life-threatening
arrhythmias.
“The most important finding of our study was that abnormal MTWA was
demonstrated to be a strong, independent risk factor for MACE following
ICD implantation,” said Dr. Beata Sredniawa, lead author of the study.
“These results suggest that standardized MTWA evaluation can be useful
for risk stratification in clinical practice.”
“This exciting new published data is an important addition to an already
extensive body of literature supporting the clinical role of MTWA in
managing patients at risk of sudden cardiac arrest,” said Ali
Haghighi-Mood, President and Chief Executive Officer of Cambridge Heart.
“These results are significant in that they confirm the prognostic value
of MTWA in predicting arrhythmic events that are truly life-threatening.”
Cambridge Heart addresses a key problem in cardiac diagnosis – the
identification of those at risk of sudden cardiac death. Sudden cardiac
arrest (SCA) accounts for approximately one fourth of all cardiac
deaths, or approximately 300,000 deaths, in the United States each year
– more than lung cancer, breast cancer and HIV/AIDS combined.
Out-of-hospital survival is less than 8 percent, making prediction and
prevention critically important. It is estimated that there are
approximately 10 to 12 million heart attack and heart failure patients
in the U.S. who can benefit from annual Microvolt T-Wave Alternans (MTWA)
testing. MTWA is a marker of SCA risk which is measured during a
non-invasive treadmill test using Cambridge Heart’s proprietary
technologies. The Company’s MTWA test is the only one of its kind that
is reimbursed by Medicare under a National Coverage Policy.
Questions can be directed to the Company's management or its investor
relations firm at the contact numbers provided.
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™ (MTWA) measurement
technologies, including the patented Analytic Spectral Method®
and ultrasensitive disposable electrode sensors. The Company's MTWA
test, originally based on research conducted at the Massachusetts
Institute of Technology, is reimbursed by Medicare under its National
Coverage Policy.
Cambridge Heart, founded in 1990, is based in Tewksbury, MA. It is
traded on the Over-The-Counter Bulletin Board (OTCBB) under the symbol
CAMH.OB. For additional information, please refer to the Company's
website at: http://www.cambridgeheart.com.
Statements contained in this press release that are not purely
historical are forward-looking statements. 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. These
forward-looking statements are based on current expectations and
assumptions that are subject to risks and uncertainties. Actual
results may differ materially from those indicated by forward-looking
statements. Factors that may cause or contribute to such
differences are identified in our most recent Annual Report on Form 10-K
under “Risk Factors”, which is on file with the SEC and available at www.sec.gov.
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.
Source: Cambridge Heart, Inc.
Cambridge Heart:
Vincenzo LiCausi, 978-654-7600
Chief
Financial Officer
vincenzol@cambridgeheart.com
or
Media:
KOGS
Communication
Edna Kaplan, 781-639-1910
kaplan@kogspr.com
or
Investor
Relations:
Allen & Caron
Matt H. Clawson,
949-474-4300
matt@allencaron.com
