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CAMH News Cambridge Heart Announces 2007 Guidance

BEDFORD, Mass.--(BUSINESS WIRE)--Cambridge Heart, Inc. (OTCBB-CAMH) today announced revenue and gross margin guidance for 2007. Based on a more favorable reimbursement environment, a growing body of positive clinical literature, and continued increases in its direct sales force and clinical specialist group, the Company expects total revenue for 2007 to range between $12 and $14 million. The Company expects that gross margin, as a percentage of revenue, will be in the range of 60-65% for 2007. The installed base of Microvolt T-Wave Alternans (MTWA) systems at the end of 2006 was approximately 650. The Company estimates that half of these systems are actively being used, with the remainder being primarily older HearTwave I systems, which have varying levels of utilization. Of the Company’s total Alternans revenue for 2006, approximately 70% was derived from the sale of HearTwave II systems and 30% from the sale of disposable sensors.

“As we enter 2007, we are optimistic about our near-term, as well as long-term, opportunities to drive our Microvolt T-Wave Alternans business,” said Robert Khederian, Chairman and Interim Chief Executive Officer. “While we accomplished a great deal in 2006 and completed the year with solid momentum and continued quarter over quarter revenue increases, we are still in the very early phases of the commercial adoption of our technology.”

“Cambridge Heart has gained enough visibility on its business to warrant our providing forward-looking guidance. 2007 will be our first full year with significant private payer and Medicare reimbursement for MTWA testing, which we believe is a significant advance in identifying the most appropriate patients to receive implantable defibrillator therapy” Mr. Khederian added.

“Along with the National Coverage Decision from CMS for Medicare patients, private payer coverage for our diagnostic test has expanded from approximately 16% of covered lives in the beginning of 2006 to approximately 52% as we enter 2007. As a result, and with the expectation that we will continue to expand private payer coverage for our MTWA testing, we see significant growth opportunities for 2007 and beyond. We believe it is helpful to outline some of our key initiatives for the upcoming year,” said Mark Florence, Vice President, Marketing and Sales.

• To increase the adoption of MTWA technology in the 9,000 U.S. cardiology and electrophysiology practices, the Company expects to increase its sales force significantly by the end of 2007. The Company ended 2006 with 11 sales representatives, an increase from 3 at the beginning of 2006, and intends to increase the number of sales representatives to 28 by the end of 2007. The Company believes this expansion will also allow it to begin educating the 58,000 U.S. internal medicine physicians about the benefits of MTWA testing. The Company estimates that MTWA testing could be appropriate for at least 10 to 12 million patients in the U.S.
• To support the anticipated growth of the installed base and focus on increasing sensor utilization, the Company intends to expand its clinical application specialist group in parallel with the expansion of the sales force. The clinical applications specialists are critical in training each site, and assisting with implementing the clinical pathway used to select the appropriate patients for MTWA testing. The Company also intends to continue working with practices that have the HearTwave I system to upgrade them to the easier-to-use HearTwave II system.

“We believe our primary challenge in 2007 and beyond is execution, and the management team is fully prepared for the challenge and opportunities that exist ahead,” concluded Mr. Khederian.

About Cambridge Heart

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 Bedford, 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 about anticipated revenue growth and gross margin as a percentage of revenue for 2007, the Company’s plans to increase the number of sales representatives and clinical applications specialists in 2007, the Company’s belief that there are significant growth opportunities for the Company in 2007, and all other statements 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, the Company uses 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, inability to hire and retain qualified sales representatives and 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 the Company’s technology, adverse results in future clinical studies of the Company’s technology, failure to obtain or maintain patent protection for the Company’s technology and other factors identified in the Company’s most recent Annual Report on Form 10-K under "Factors Which May Affect Future Results", which is on file with the SEC. In addition, any forward-looking statements represent the Company’s estimates only as of today and should not be relied upon as representing the Company’s estimates as of any subsequent date. While the Company may elect to update forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, even if the Company’s estimates change.