FDA Clears Cambridge Heart's Alternans Test as the First Non-Invasive Cardiac Diagnostic Tool to Identify Patients At Risk of Sudden Cardiac Events.

BEDFORD, Mass.--(BW HealthWire)--April 13, 1999--

Company's Alternans Test Will Accelerate Preventative Treatment for

Patients at Risk of Cardiac Arrest, the Nation's Leading Cause Of

Death

Cambridge Heart, Inc. (NASDAQ/NMS:CAMH) announced today that the United States Food & Drug Administration (FDA) has given the Company clearance to market its non-invasive cardiac diagnostic test, called an Alternans Test, to identify certain patients at risk of sudden life threatening arrhythmias (cardiac arrest) and resultant sudden cardiac death (SCD). With this clearance, the new test will fill a major gap in current cardiac disease diagnosis. Cardiac arrest claims more than 300,000 lives a year in the United States and is the nation's leading cause of death.

Patients considered at risk of heart disease currently go through a series of non-invasive exercise stress tests that can identify ischemic heart disease--the clogging or narrowing of arteries--but not risk of arrhythmia. As a result, only a small fraction of patients at risk of ventricular arrhythmia--even those with a serious, documented heart condition--presently receive invasive but definitive electrophysiology (EP) testing and go on to preventative treatment. The lack of an effective non-invasive test to evaluate the millions of patients at risk of SCD has slowed the delivery of potentially life-saving therapies.

New Test Detects Tiny Fluctuations in Heartbeat

The Cambridge Heart Alternans system works like a "super stress test" and measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. T-wave alternans is not visible on electrocardiograms used in conjunction with ordinary exercise stress tests. These tiny heartbeat variations--measured at one millionth of a volt--are detected during a typical treadmill or bicycle exercise stress test by specially designed, high-resolution electrodes placed on a patient's chest. Extensive clinical research has shown that patients with symptoms of or at risk of life-threatening arrhythmias, who test positive for T-wave alternans, are at significant risk of subsequent sudden cardiac events including sudden death.

Most patients considered at risk of heart disease have an exercise stress test: approximately nine million stress tests are conducted each year in the United States. The stress test can identify patients at risk of ischemic heart disease but is not able to detect patients with arrhythmic heart disease or "electrical problems" that can lead to SCD. By recognizing the presence of T-wave alternans, the Cambridge Heart Alternans Test is the first non-invasive diagnostic tool cleared by the FDA able to stratify those patients at elevated risk of life-threatening arrhythmias. The procedure is easily conducted in a physician's office or a hospital stress laboratory.

Currently, ventricular arrhythmias in high-risk patients are evaluated through the EP test. The EP test is a one to three hour procedure in which pacemaking catheters are threaded into a major artery, typically the femoral artery in the groin, and then into the heart. Tens of millions of Americans are at risk of sudden cardiac death and more than nine million have the traditional stress test. However, due largely to the inability of current non-invasive tests to detect risk of ventricular arrhythmias, and the risks and costs associated with invasive testing, only approximately 70,000 high-risk individuals are referred for diagnostic EP testing every year.

According to David S. Rosenbaum, M.D., associate professor of Medicine, Biomedical Engineering, Physiology & Biophysics at Case Western Reserve University and Chief of the Cardiac Arrhythmia Service at Cleveland Veterans Affairs Medical Center, "Sudden cardiac arrest kills more than 300,000 Americans annually. Controlled studies conclusively demonstrate that broader use of an implantable cardioverter defibrillator (ICD) would make a dramatic dent in this number. The question that we have all struggled with is: Who do we treat? The T-wave alternans test may now help answer this question and create a bigger life-saving net for patients at risk."

The post-diagnosis treatment protocol for patients at elevated risk of ventricular arrhythmia can begin with a regimen of anti-arrhythmic drugs or beta blockers to treat underlying heart disease. For the highest risk patients, increasingly, the preferred treatment modality is the surgical placement of an implantable cardioverter defibrillator (ICD) that automatically defibrillates the heart back into normal rhythm.

Based on today's clearance, the Alternans Test may be used to help stratify patients whom clinicians know or suspect are at elevated risk of SCD. This includes patients with a prior history of arrhythmias, who present with symptoms such as palpitations, syncope (fainting) or lightheadedness or who have other specific conditions placing them at elevated risk.

T-Wave Alternans and Sudden Cardiac Death: Extensive Clinical Data

In a clinical research study conducted at Massachusetts General Hospital and published in the New England Journal of Medicine (1994: 330:235-241), 66 high-risk patients were followed for 20 months. Results indicated that 81% of those testing positive for T-wave alternans died or suffered a life-threatening arrhythmia, compared to only 6% of patients testing negative for T-wave alternans. In a recently published paper in the Journal of Cardiovascular Electrophysiology, (1998: 9:1258-1268), 95 patients were assessed comparing T-wave alternans testing with a battery of other non-invasive tests. In the study, which included 18-month follow-up through to ICD firing, T-wave alternans was found to be the most significant predictor of ventricular arrhythmia. In a recent multi-center clinical trial of the Alternans Test, long-term event follow-up data on 337 patients indicated a 14-fold increase in the risk of life-threatening arrhythmias or death in patients testing positive for T-wave alternans. The results of this study were presented at the American College of Cardiology meeting on March 9 in New Orleans.

"We are clearly pleased with this news," said Jeffrey M. Arnold, president, chairman, and CEO of Cambridge Heart. "This is a major step forward in the fight against sudden cardiac death. The availability of a non-invasive test to predict life-threatening arrhythmias in high-risk patients will lead to earlier intervention with preventative therapies. We look forward to working with the cardiology community in the months ahead to ensure appropriate clinical use of the Alternans Test."

About the Cambridge Heart Alternans Test

The Cambridge Heart Alternans "super stress test" is a fully featured diagnostic system that includes a cart-mounted computer with proprietary software, integral ECG system, display, keyboard and output devices that can be configured for both hospital and office settings. The system is designed to support a broad range of standard and physician-customized protocols for the conduct of cardiac stress tests and is compatible with both standard electrodes and Cambridge Heart's Hi-resolution electrodes for the detection of T-wave alternans. The system is capable of controlling both treadmill and bicycle ergometers, devices used to exercise the patient during the test.

Starting at under $30,000, the system is only marginally more expensive than standard stress test systems. A stress test with the Cambridge Heart test utilizing T-wave alternans technology will cost approximately $350 per procedure. Incrementally, the test is expected to cost $100 more than the traditional exercise stress test.

About Cambridge Heart

Cambridge Heart is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. Using innovative technologies, the Company is addressing such key problems in cardiac diagnosis as the identification of those at risk of sudden cardiac arrest, the early detection of coronary artery disease, and the prompt and accurate diagnosis of heart attack. The Company, started in 1992, is based in Bedford, Mass. and is traded on the NASDAQ/NMS under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com.

Indications for Use

As cleared by the FDA, the Cambridge Heart CH 2000 System is intended for use as follows:

"For the measurement of T-wave alternans and recording of electrocardiograms and vector cardiograms at rest and during ECG stress testing. The presence of T-wave alternans in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death). The CH 2000 should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests."

Statements made in this news release that are not historical facts include forward-looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are included in Cambridge Heart's Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.

Note to producers and editors: For television, a VNR and B-Roll package is available, which includes an interview and B-Roll of sudden cardiac arrest survivor Charles Schwartz; and an interview and B-Roll of David S. Rosenbaum, M.D., associate professor of Medicine, Biomedical Engineering, Physiology & Biophysics at Case Western Reserve University and Chief of the Cardiac Arrhythmia Service at Cleveland Veterans Affairs Medical Center. For print media, a color photo of a patient taking an Alternans Test is available on Business Wire.

-0-

FEED DATE:       Wednesday  April 14, 1999
FEED TIME:       1:30 PM - 1:45 PM Eastern
COORDINATES:     C-Band / Telstar 5 / Transponder 16 / Audio 6.2 & 6.8
DOWNLINK FREQ:   4020 MHz (Horizontal)

RE-FEED DATE:    Thursday  April 15, 1999
RE-FEED TIME:    1:30 PM - 1:45 PM Eastern
COORDINATES:     Ku-Band /SBS-6 / Transponder 3 / Audio 6.2 & 6.8
DOWNLINK FREQ:   11.774 MHz (Horizontal)

-0-