Cambridge Heart Raises Revenue Guidance Conference Call to be held on March 22, 2007, at 8:30 AM ETBEDFORD, Mass., Mar 21, 2007 (BUSINESS WIRE) -- Cambridge Heart, Inc. (OTCBB:CAMH), today announced a three-year
exclusive sales and marketing agreement with St. Jude Medical, Inc.
(NYSE:STJ), under which St. Jude Medical will be responsible for
marketing Cambridge Heart's HearTwave II(R) Microvolt T-Wave Alternans
System and sensors to cardiologists and electrophysiologists in North
America. Cambridge Heart's sales force will continue to market the
HearTwave II to internal medicine and primary care practices.
Alternans testing is designed to allow physicians to identify patients
who are at increased risk of Sudden Cardiac Death (SCD).
"Our partnership with St. Jude Medical is a landmark event for
Cambridge Heart, our employees, and our shareholders," stated Robert
P. Khederian, Chairman and Interim CEO of Cambridge Heart, Inc. "Our
entire organization should be commended for their hard work and
achievements leading up to this co-marketing partnership."
"Industry reports estimate 10 million to 12 million individuals in
the U.S. have underlying heart disease and are at significantly higher
risk for Sudden Cardiac Death than the general population.
Unfortunately, there are many high-risk patients who are not receiving
the therapy they need, and our HearTwave II System allows physicians
to identify, non-invasively, those who will most likely benefit from
ICD therapy," commented Laurence Blumberg, M.D., Vice President of
Business Development, a founder, and a Director of the Company. "Our
alliance with St. Jude Medical, a leader in the $10 billion cardiac
rhythm management market, is a critical step in expanding patient and
physician awareness and the need for alternans testing."
St. Jude Medical has purchased $12.5 million of preferred stock in
Cambridge Heart, which is convertible into common stock at $2.99 per
share. St. Jude Medical will market and sell the system to
cardiologists and electrophysiologists in North America, and Cambridge
Heart will manage the installation of systems, the training of new
customers, and the servicing of the equipment. Additional agreement
details were not disclosed. Banc of America Securities LLC acted as
financial advisor to Cambridge Heart.
"We are excited about the opportunity this partnership offers our
physician customers and the patients they serve," stated Michael T.
Rousseau, president of St. Jude Medical's U.S. Division. "The ability
to provide physicians with a non-invasive, cost-effective test to help
identify patients that will benefit from ICD therapy is very
As a result of the agreement, Cambridge Heart today is raising its
2007 revenue guidance to $14 million to $16 million from the prior
guidance of $12 million to $14 million. Cambridge Heart's net loss for
2007 is expected to increase as compared to the Company's prior plan.
Clinical support, manufacturing, general, and administration costs are
expected to increase as Cambridge Heart builds its infrastructure to
support St. Jude Medical's sales efforts. Additionally, there will be
a material impact on the Cambridge Heart's balance sheet, as the
Company will carry much higher inventory levels than it has
Based upon the $12.5 million investment from St. Jude Medical,
Cambridge Heart does not foresee a need to raise additional capital in
the near-term. Therefore, Cambridge Heart intends to withdraw its
universal shelf registration statement currently on file with the
Securities and Exchange Commission.
Conference Call Information
Cambridge Heart will hold a conference call at 8:30 AM ET on
Thursday, March 22, 2007, to discuss the sales and marketing agreement
with St. Jude Medical. The call will be hosted by Mr. Robert
Khederian, the Company's Chairman and Interim CEO, Dr. Ali
Haghighi-Mood, Chief Operating and Chief Technology Officer, and Dr.
Laurence Blumberg, Vice President of Business Development. Interested
parties may participate by dialing (800) 299-8538 (outside the U.S.
(617) 786-2902), passcode 70539889. Interested parties may listen to a
recording of the conference call at any time during the 48 hours
immediately following the call by dialing (888) 286-8010 (outside the
U.S. (617) 801-6888) and enter the passcode 27449450. This playback
will begin approximately two hours after the call ends. The conference
call also will be available by webcast on the Company's web site at
About The Non-Invasive HearTwave(R) II Microvolt T-Wave Alternans
Cambridge Heart's HearTwave II Microvolt T-Wave Alternans System
measures a specific and extremely subtle pattern of beat-to-beat
fluctuations in a person's electrocardiogram. This pattern of
fluctuations is called T-wave Alternans. These tiny variations in the
electrocardiogram, measured at one millionth of a volt accuracy, are
measured most commonly during a sub-maximal exercise stress test in
the doctor's office or hospital outpatient setting. Extensive clinical
research has shown patients with a positive or non-negative microvolt
T-wave Alternans test are at increased risk for sudden cardiac death,
while those who test negative are at reduced risk.
Sudden Cardiac Death
According to the American Heart Association, sudden cardiac death
(SCD), or cardiac arrest, is the sudden, abrupt loss of heart function
in a person who may or may not have diagnosed heart disease. The time
and mode of death are unexpected. It occurs instantly or shortly after
symptoms appear. The most common reason for patients to die suddenly
is cardiovascular disease, in particular, coronary heart disease.
About half of all deaths from coronary heart disease are sudden and
unexpected, regardless of the underlying disease. Thus, half of all
deaths due to atherosclerosis (arteries lined with fatty deposits) are
sudden. So are half of deaths due to degeneration of the heart muscle
or to cardiac enlargement in patients with high blood pressure. Sudden
cardiac death is a major health problem, causing about 330,000 deaths
each year among U.S. adults before reaching a hospital or emergency
The term "massive heart attack" is often mistakenly used in the
media to describe sudden death. The term "heart attack" or myocardial
infarction refers to death of heart muscle tissue due to the loss of
blood supply, not necessarily resulting in the death of the heart
attack victim. While a heart attack may cause cardiac arrest and
sudden cardiac death, the terms aren't synonymous.
About Cambridge Heart, Inc.
Cambridge Heart (www.cambridgeheart.com) is engaged in the
development and commercialization of products for the non-invasive
diagnosis of cardiac disease, particularly the identification of those
at risk of sudden cardiac arrest, and can be used to stratify patients
to ICD therapy, a $6 billion market. The Company believes 10 million
to 12 million Americans with underlying heart disease are at risk and
should receive Alternans measurement. The Company's products
incorporate its proprietary Microvolt T-Wave Alternans measurement
technologies, coupled with its patented Spectral Analytic Method and
ultra-sensitive disposable electrode sensors. The Company, founded in
1990, is based in Bedford, Massachusetts, and is traded on the OTCBB
under the symbol CAMH.
Only Spectral Analytic Method MTWA tests are reimbursed by
Medicare under its National Coverage Policy that covers patients with
a wide variety of cardiac symptoms. Other major insurers in the U.S.
also have coverage policies for the test. The T-Wave Alternans test is
included in the Guideline for Management of Patients with Ventricular
Arrhythmias and the Prevention of Sudden Cardiac Death jointly
developed by the American College of Cardiology (ACC), The American
Heart Association (AHA), and the European Society of Cardiology (ESC).
Statements contained in this press release about the anticipated
revenue growth and other effects of the Company's agreement with St.
Jude Medical on Cambridge Heart's financial results, and all other
statements that are not purely historical are forward-looking
statements for purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995. In some cases, the
Company uses 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 partner 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 under
"Factors Which May Affect Future Results", which is on file with the
SEC and available at www.EDGAR.com. In addition, any forward-looking
statements represent the Company's estimates only as of today and
should not be relied upon as representing our estimates as of any
subsequent date. While the Company may elect to update forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so except as may be legally necessary,
even if the Company's estimates should change.
SOURCE: Cambridge Heart, Inc.
Cambridge Heart, Inc.
Laurence Blumberg, MD, 781-271-1200
Vice President, Business Development
Burns McClellan, Inc.