Healthcare Industry News: Microvolt T-Wave Alternans
News Release - February 11, 2010
Cambridge Heart Completes Development of New MTWA Module
510(K) Filed with the Food and Drug AdministrationTEWKSBURY, Mass.--(HSMN NewsFeed)--Cambridge Heart, Inc. (OTCBB- CAMH ), today announced that the Company has completed the development phase of its Microvolt T-Wave Alternans (MTWA) OEM Module, and has submitted a 510(k) application for regulatory approval with the U.S. Food and Drug Administration (FDA). The module is the centerpiece of the Company’s new business model that involves partnering with leading stress test equipment manufacturers to broaden the distribution and use of MTWA technology.
“We are very pleased with our progress and pace in achieving this important milestone,” said Ali Haghighi-Mood, Cambridge Heart’s President and CEO. “With the completion of the development work and our FDA regulatory submission, we are one step closer to making our Microvolt T-Wave Alternans technology available to more physicians and their patients.”
The MTWA test, administered in much the same way as a stress test, is a non-invasive diagnostic tool that can identify the presence of a subtle alternating pattern in the ECG which has been shown to be a significant risk factor for sudden cardiac arrest.
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. 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.
Source: Cambridge Heart
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
