Healthcare Industry News: Microvolt T-Wave Alternans
News Release - May 13, 2008
CMS Reaffirms National Coverage Determination For Microvolt T-Wave Alternans
Patented Spectral Analytic Method RequiredTEWKSBURY, Mass.--(HSMN NewsFeed)--Cambridge Heart, Inc. (OTCBB: CAMH ), today announced the publication of the final decision memorandum regarding Medicare coverage of Microvolt T-Wave Alternans (MTWA) diagnostic testing. The Centers for Medicare & Medicaid Services (CMS) reaffirmed coverage of MTWA using the spectral analysis method and found insufficient evidence for coverage of MTWA using any other method.
The final decision memorandum is the result of CMS’s nine-month evaluation of the relevant clinical evidence available to the agency and consideration of public comments submitted on the request to expand coverage to include the Modified Moving Average (MMA) methodology. CMS issued a National Coverage Determination on March 21, 2006 that provides Medicare coverage for MTWA, only when the spectral analytic method is used.
“This CMS decision is important for Cambridge Heart because it reaffirms the unique clinical utility of our test,” said Ali Haghighi-Mood, Cambridge Heart Chief Executive Officer. “Furthermore, it is significant that other methodologies have thus far been unsuccessful in attempts to enter the MTWA testing market with a reimbursed offering. We see these attempts as validation of our marketplace and confirmation that MTWA will play an important role in the future of cardiac diagnostics.”
Dr. Haghighi-Mood noted that the CMS decision comes at an important time for Cambridge Heart. The Company recently launched a new placement program which aims to expand market penetration and foster clinical adoption of MTWA testing. “Risk stratification for sudden cardiac death remains one of the most significant challenges in medicine. While MTWA is a proven non-invasive tool for identifying those at risk, we believe it is under-utilized today and understand the need to make this technology more accessible to physicians and patients.”
The full decision memorandum can be viewed at: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=213
About Cambridge Heart, Inc.
Cambridge Heart (www.cambridgeheart.com) is engaged in the development and commercialization of products for the non-invasive diagnosis of cardiac disease, particularly the identification of those at risk of sudden cardiac arrest. The Company's products incorporate its proprietary Microvolt T-Wave Alternans measurement technologies, coupled with its patented Spectral Analytic Method and ultra-sensitive disposable electrode sensors. Only Spectral Analytic Method MTWA tests are reimbursed by Medicare under its National Coverage Policy that covers patients with a wide variety of cardiac symptoms. Other major insurers in the USA also have coverage policies for the test. The T-Wave Alternans test is included in the Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death jointly developed by the American College of Cardiology (ACC), The American Heart Association (AHA) and the European Society of Cardiology (ESC). The Company, founded in 1990, is based in Tewksbury, Massachusetts and is traded on the OTCBB under the symbol CAMH.
About the Cambridge Heart Microvolt T-Wave Alternans Test
The Cambridge Heart Microvolt T-Wave Alternans Test measures a specific extremely subtle pattern of beat-to-beat fluctuations in a person's electrocardiogram. This pattern of fluctuations is called T-wave alternans. These tiny variations in the electrocardiogram - measured at one millionth of a volt accuracy – are most commonly measured during a sub-maximal exercise stress test in the doctor’s office or hospital outpatient setting. The preparation for the test consists of placing proprietary sensors on the patient's chest. Extensive clinical research has shown that those patients who are at risk of ventricular tachyarrhythmia that test positive for Microvolt T-Wave Alternans are at increased risk for sudden cardiac death, while those who test negative are at reduced risk.
Statements contained in this press release 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 to achieve broad market acceptance of the Company's MTWA technology, failure of our sales and marketing partner 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 third-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/A 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
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