TEWKSBURY, Mass., Oct 05, 2011 (BUSINESS WIRE) -- Cambridge Heart, Inc. /quotes/zigman/163657 CAMH 0.00% , a developer of non-invasive diagnostic tests for cardiac disease, today announced that it has concluded a review of data generated at several clinical sites including those that participated in the Company's MTWA-CAD feasibility study. The data suggests that MTWA is a statistically significant predictor of ischemic events. In addition, the data revealed instances where the Company's MTWA test identified underlying coronary artery disease that was not identified by other standard diagnostic modalities.
Commenting on the data, Dr. Richard Cohen, Chairman of the Company's Scientific Advisory Board and Whitaker Professor in Biomedical Engineering at the Massachusetts Institute of Technology, stated "The results of the review are very promising, suggesting that Microvolt T-Wave Alternans(TM) (MTWA) is predictive of ischemic events in cardiac patients undergoing routine stress testing. I am looking forward to working with the Company and the rest of the Scientific Advisory Board to design a prospective trial in order to formally test the hypothesis that the detection of obstructive coronary artery disease can be enhanced when MTWA is used in conjunction with other diagnostic modalities."
The feasibility study provided the Company with the information required to design a multi-center, prospective clinical trial intended to provide the basis for regulatory approval. Accordingly, the Company has decided to conclude the enrollment in its MTWA-CAD study, and commence the design of the prospective clinical trial.
Cambridge Heart's President and CEO Dr. Ali Haghighi-Mood stated, "The data suggest that our proprietary technology can play a role in identifying patients at risk for ischemic events, in addition to those at risk of Sudden Cardiac Arrest (SCA)." Dr. Haghighi-Mood added, "The population of patients at moderate or high risk of coronary artery disease is estimated at between 30 to 40 million in the U.S., thus this population represents an attractive commercial opportunity for the Company. Our objective is to improve the detection of coronary artery disease by having MTWA measured in conjunction with other read-out modalities such as ECG, ultrasound imaging or nuclear imaging during stress testing. We intend to pursue the additional clinical trial required for regulatory approval as aggressively as possible."
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(R) 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. 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. Forward-looking statements include statements about the Company's plans with respect to future clinical trials and regulatory approvals pertaining to the Company's MTWA test. 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 funding necessary to fund operations and to develop or enhance our technology, adverse results in future clinical studies of our technology, material deviations from our current operating plan, lower than expected sales by Cardiac Science of its Q-Stress System, failure to obtain or maintain adequate levels of government and third-party reimbursement for use of our MTWA test, customer delays in making final buying decisions, decreased demand for our products, 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.
SOURCE: Cambridge Heart, Inc.
At Cambridge Heart:
Vincenzo LiCausi, 978-654-7600 x 6645
Chief Financial Officer
Edna Kaplan, 781-639-1910
Wolfe Axelrod Weinberger Associates, LLC
Stephen D. Axelrod, CFA, 212-370-4500
Diana Bittner, 212-370-4500