Cambridge Heart reports a key milestone today,
securing reimbursement coverage in Japan. Its MTWA test is important because it
can help identify patients who might later experience ischemic events, as well
as those at risk of sudden cardiac arrest. The patient population for moderate
to high risk coronary artery disease is approximately 30 million to 40 million
in the U.S. alone. This represents a key milestone to further validate MTWA since Japan represents a lucrative market with
more than 127 million consumers. Japan's medical device market is third in size
behind the US and European markets; and obtaining regulatory approval and
qualifying medical device for reimbursement in Japan is a long process.
Full press release below.
Cambridge Heart Announces Microvolt T-Wave
Alternans Receives Reimbursement Coverage in Japan
Published: March 16, 2012
Decision Allows for
Broader Adoption of MTWA in Japan
TEWKSBURY, Mass.--(BUSINESS WIRE)--Mar. 16,
2012-- Cambridge Heart, Inc. (OTCBB: CAMH), a developer of
non-invasive diagnostic tests for cardiac disease, today announced that its Microvolt T-Wave Alternans™ (MTWA) test
received reimbursement coverage from Japan’s Ministry of Health, Labor and
Welfare (MHLW). Effective April 1, 2012, the MTWA Test will be reimbursed for
patients who are considered at risk for lethal arrhythmias including, but not
limited to, patients with a history of heart attack, cardiomyopathy and Brugada
syndrome.
Commenting on the decision, Dr. Takanori
Ikeda, Professor of Medicine at Toho University Medical Center, said, “We are
very pleased with the reimbursement decision on MTWA testing. A large body of
clinical evidence supports the predictive value of the test which can now be
used more broadly to help identify and manage the risk of life-threatening
arrhythmias.”
Cambridge Heart markets its MTWA technology
in Japan through its partnership with Fukuda Denshi Corporation, one of Japan’s
leading and most active medical device and technology companies, which has
already established an MTWA user base in the country , noted Ali Haghighi-Mood,
Cambridge Heart President and CEO.
“This decision highlights the valuable role
that MTWA can play in managing a patient’s risk for sudden cardiac arrest,”
Haghighi-Mood said. “Gaining reimbursement coverage in Japan, which enjoys one
of the most advanced healthcare systems in the world, is an important milestone
for our MTWA technology and another indicator that the value of MTWA testing is
being recognized around the world. We look forward to working closely and
strategically with our distribution partner in Japan to further expand that
market and maximize the value of the relationship.”
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. 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.
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 these forward-looking statements.
Factors that may cause or contribute
to such differences include failure to obtain or maintain adequate levels of
government and third-party reimbursement for use of our MTWA test and other
factors 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.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.
Source: Cambridge Heart, Inc. , www.cambridgeheart.com
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