21.09.2010 10:06:00
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Cardiac Science Launches Cambridge Heart’s Microvolt T-Wave Alternans (MTWA) Technology in Stress Test Systems
Cambridge Heart, Inc. (OTCBB: CAMH), a developer of noninvasive diagnostic tests for cardiac disease, today announced the launch of its Microvolt T-Wave Alternans (MTWA) technology as an integrated part of industry-leading cardiac stress test systems manufactured and distributed by Cardiac Science Corporation (Nasdaq: CSCX). The MTWA technology, which can predict a patient’s risk of sudden cardiac arrest (SCA), is now being offered to new and existing users of Cardiac Science’s Quinton Q-Stress cardiac stress systems.
"This is an important milestone for Cambridge Heart and a significant advancement of our new strategy to increase MTWA adoption through partnerships with cardiac diagnostic test manufacturers,” said Ali Haghighi-Mood President and CEO of Cambridge Heart Inc. "The partnership with Cardiac Science, one of the world’s leading manufacturers of cardiac stress test equipment, allows our technology to be marketed to a much broader number of cardiologists and internal medicine practices.”
An estimated 10 to 12 million heart attack and heart failure patients in the U.S. alone could benefit from MTWA testing on an annual basis.
"MTWA for Q-Stress combines the industry’s leading cardiac stress testing system with Cambridge Heart’s unique testing system for SCA risk, creating the most comprehensive cardiac risk profiling system in the industry,” said Tony Titus, Cardiac Science Vice President of Marketing. "The MTWA test is a clinically proven reimbursable test and can be performed during standard stress test sessions. It is the only test of its kind that Medicare will reimburse.”
In an effort to make the MTWA testing more accessible, Cambridge Heart is developing OEM modules that can be integrated as an add-on to new and existing cardiac stress testing systems, cardiac monitoring devices or other devices that assess the status or risk in cardiac patients. Since the announcement of the partnership with Cardiac Science in June 2009, Cambridge Heart successfully developed and tested the OEM module, filed for and received 510K clearance from the U.S. Food and Drug Administration, completed the physical integration and sales force training within the timeframe originally projected.
"Our MTWA technology, which has proven its value as an indicator of SCA risk, can now be delivered via a modularized, software-based embodiment that makes it readily accessible, economically attractive and logistically simpler to integrate into a range of diagnostic cardiology equipment,” Haghighi-Mood added.
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 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. Material deviations from our current operating plan, including lower than expected sales to Cardiac Science and 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 fund operations and 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.
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