TEWKSBURY, Mass.--(BUSINESS WIRE)--Cambridge Heart, Inc. (OTCBB: CAMH), today announced that it has received clearance from the U.S. Food and Drug Administration to begin marketing its Microvolt T-Wave Alternans (MTWA) OEM module. The MTWA OEM module is designed to work with existing cardiac stress test platforms distributed by other manufacturers. This FDA 510(k) clearance allows Cambridge Heart to begin marketing the MTWA OEM module integrated with the Q-Stress line of stress systems manufactured by Cardiac Science Corporation, Inc. (NASDAQ:CSCX). The non-invasive MTWA test measures small heartbeat irregularities that indicate a patient’s heightened risk for sudden cardiac arrest.
In June 2009, Cambridge Heart and Cardiac Science entered into a five-year development and distribution partnership, whereby Cardiac Science will market the MTWA OEM module to its existing base of installed stress systems as an upgrade, and to new stress customers as an optional feature. Development of the MTWA OEM module was completed in early February 2010. Sales training and pre-launch activities will take place between now and an expected launch date later this year.
“The development of MTWA as an add-on module for our stress systems allows us to bring new technology to our customers and extend our leadership in the stress segment,” said Dave Marver, Cardiac Science President & CEO. “This initiative is consistent with our goal to help our physician customers by offering simple, cost-effective, and efficient devices that improve public health.”
Ali Haghighi-Mood, Cambridge Heart’s President and CEO said, “We are pleased to have reached this important milestone in a relatively short period of time. Obtaining the FDA clearance is a big step as we implement our new business model that aims to market the MTWA technology via partnerships with the leading stress test manufacturers. Most immediately, the clearance allows us to focus our activities on working with Cardiac Science, training its sales force and distributors and engaging in other activities in advance of the product launch.”
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. 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 gaining FDA clearance for the MTWA Module, 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.
