Pilot Trial to Determine Whether MTWA Technology Identifies Patients with Undetected Coronary Artery Disease
TEWKSBURY, Mass.--(BUSINESS WIRE)-- Cambridge Heart, Inc. (OTCBB: CAMH), today announced the first patient enrollments in the MTWA-CAD study (Evaluation of Microvolt T-Wave Alternans Testing for the Detection of Active Ischemia in Patients with Known or Suspected Coronary Artery Disease).
The study is designed to determine if Cambridge Heart’s MTWA testing can enhance current diagnostic methods for detecting ischemia in patients with underlying coronary artery disease. Ischemia is defined as inadequate blood supply to the coronary arteries, which can lead to myocardial infarction or what is commonly referred to as a "heart attack."
"Today, we use MTWA to determine if a patient is at increased risk for potentially fatal arrhythmias, but the test may also have value in detecting underlying coronary artery disease," said, Dr. Edward Kosinski, a cardiologist at Cardiology Physicians in Bridgeport, CT and the Medical Director of Connecticut Clinical Research LLC, where the first patients have been enrolled. “This study will help us to determine if MTWA can detect blood flow problems as well as electrical problems in the heart.”
The MTWA-CAD trial is a pilot study expected to enroll up to 200 patients. The Company estimates that the enrollments will be completed by mid-2011.
"This study is an important first step in determining if MTWA can help identify hidden ischemia in patients with suspected coronary artery disease,” said Ali Haghighi-Mood, Cambridge Heart's Chief Executive Officer. “If proven, we believe it could set a new standard for cardiac stress testing."
An estimated 40 million cardiac stress tests in various modalities are performed annually in the United States. Cambridge Heart filed a patent application related to ischemia in December of 2009.
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.
Statements contained in this press release 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, 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. Forward-looking statements include statements about the Company’s expected launch of the MTWA Module, the Company’s expected reductions in operating expenses, and the Company’s belief that existing resources and currently projected financial results are sufficient to fund operations through December 31, 2010. Actual results may differ materially from those indicated by these forward-looking statements. Material deviations from our current operating plan, including a delay in launching the MTWA Module with Cardiac Science, lower than expected sales to Cardiac Science, lower than expected sales of our Heartwave II System, may cause or contribute to such differences. Other 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
Edna Kaplan, 781-639-1910
Allen & Caron
Matt H. Clawson, 949-474-4300
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