Module Development and New Distribution Partnership Aim to Integrate
MTWA with Standard Stress Test Systems and Drive Broad Use
Cambridge Heart, Inc. (OTCBB: CAMH Stock News), today announced a strategy aimed at
increasing the sales and use of its proprietary Microvolt T-Wave
Alternans (MTWA) technology, which can predict a patient’s risk of
sudden cardiac arrest (SCA). The strategy calls for the Company to
partner with manufacturers of cardiac stress testing equipment to
develop an OEM MTWA Module that will be integrated into their systems,
and marketed to a much larger number of cardiologists and internal
medicine practitioners.
Historically, the Company’s marketing strategy was focused on providing
MTWA testing to those patients at highest risk for SCA and who were
likely candidates to receive implantable defibrillation devices (ICDs).
Although MTWA testing has clearly been demonstrated to be useful in
identifying those individuals who could benefit from ICD therapy,
clinical experience and a growing body of data suggests that MTWA
technology can and should be used to identify and manage the risk of SCA
in a much broader population of cardiac patients. The Company estimates
that there are approximately 10 to 12 million heart attack and heart
failure patients in the U.S., who can benefit from annual MTWA testing.
“To date, we have introduced our technology primarily through heart
rhythm specialists, but the broader group of at-risk cardiac patients,
who routinely undergo cardiac evaluations including stress testing, are
typically under the care of cardiologists and internal medicine
physicians,” said Ali Haghighi-Mood, Cambridge Heart’s CEO. “Our goal is
to get the MTWA test to the largest number of appropriate patients.”
The MTWA Module would allow an integrated stress and MTWA test, using
the Company’s proprietary sensors, to be performed on a partners’ stress
testing platform via customized software and patient interface. The
manufacturer would market the MTWA Module as an upgrade to their
existing installed base of stress systems, and as an optional feature to
new stress customers.
As the first step in the execution of this strategy, the Company has
signed a non-exclusive development and distribution agreement with a
leading U.S. stress manufacturer to develop a MTWA Module. Due to
competitive considerations, we do not plan to announce additional
details about the MTWA Module or the manufacturer’s platform until the
Module development is completed and the product is ready for launch. We
expect this will occur in 9 to 15 months based on development and
regulatory approval timelines.
Haghighi-Mood continued “In addition to ongoing efforts to position our
Heartwave II product line for a broader application through our direct
sales team, our new partnership and MTWA Module strategy make our
technology more readily accessible, economically attractive and
logistically simpler to integrate into the practice of those physicians
who are already providing cardiac stress or other non-invasive testing.
We look forward to sharing the partnership details and rolling out the
new MTWA product embodiment in the coming months.”
About CAMH Stock Profile 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.
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
first-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 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.
At Cambridge Heart: Vincenzo LiCausi, 978-654-7600 x 6645 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
