Heartstream receives FDA clearance to market ForeRunner automatic external defibrillator to treat victims of sudden cardiac arrest; Innovative technology designed to improve survival from the leading cause of death in the U.S.

SEATTLE, Wash.--(BUSINESS WIRE)--Sept. 12, 1996--Heartstream, Inc., (NASDAQ:HTST) announced today that the United States Food and Drug Administration (FDA) has given the Company clearance to market its ForeRunner automatic external defibrillator (AED) in the United States. The ForeRunner is an innovative, new defibrillator, designed to improve survival from sudden cardiac arrest (SCA) the leading cause of death in the United States by enabling a broad group of emergency first-response personnel -- those most likely to arrive in the first critical minutes -- to deliver life-saving defibrillation to victims of sudden cardiac arrest.

The ForeRunner incorporates a number of patented and proprietary technologies that make it easy to use, virtually maintenance free, small, lightweight, durable, and low cost. With these characteristics, the ForeRunner is the first defibrillator that is practical for many emergency medical responders.

Sudden cardiac arrest claims more than 350,000 lives each year largely because life-saving treatment - an electrical shock to the heart known as defibrillation -- does not reach victims within the first few critical minutes. Published studies indicate that survival rates from ventricular fibrillation, the primary cause of SCA, can exceed 70 percent if defibrillation is administered promptly. However, the chances of survival decrease by approximately 10% with each minute of delay. Presently, less than 25% of all emergency response vehicles and less than 1% of police cars are equipped with AEDs due in large part to existing devices being heavy, maintenance intensive, difficult to use, and expensive. As a result of this limited deployment of defibrillators and the resulting delays in treatment, the survival rate from SCA in the United States is presently less than 5%.

"We're delighted with today's decision by the FDA," said Alan J. Levy, Ph.D., president and chief executive officer of Heartstream. "The American Heart Association believes that an AED with characteristics suitable for widespread deployment will enable emergency response personnel to save thousands of lives every year. We look forward to working with communities across the country to make the widespread availability of this life-saving technology a reality."

About Sudden Cardiac Arrest

SCA can strike almost anyone, anywhere, at any time. Unlike a heart attack, in which blood flow to the heart muscle is temporarily blocked, the primary cause of sudden cardiac arrest is ventricular fibrillation, a life-threatening condition, in which the heart's normal electrical signals become disorganized and erratic, causing the heart to cease pumping blood. When the heart stops beating, the victim immediately loses consciousness, and -- without intervention -- will die within minutes. Definitive therapy, however, for SCA exists -- early defibrillation. It is not a lack of effective treatment, but the lack of warning and limited time for intervention that accounts for the high death rate following SCA.

The American Heart Association (AHA) and others have recommended widespread deployment of AEDs to improve survival rates from SCA. The AHA estimates that as many as 100,000 deaths could be prevented each year through the widespread deployment of defibrillators among trained responders such as EMTs, fire department personnel, police officers, flight attendants, and other authorized personnel who have a duty to respond to emergencies. Time to defibrillation could also be decreased if AEDs were available to trained and authorized first response personnel in places where large groups gather such as stadiums and arenas.

"Early defibrillation is the definitive treatment for sudden cardiac arrest caused by ventricular fibrillation," said Dr. Nisha Chandra, professor of medicine at the Johns Hopkins School of Medicine. "For every minute delay in reaching a victim with a defibrillator, however, their chance of survival decreases by approximately 10%. It is therefore important that communities provide defibrillators to those emergency responders most likely to be first on the scene of a sudden cardiac arrest."

About ForeRunner

Using proprietary technology, Heartstream has developed the ForeRunner, an innovative AED that is easy-to-use, easy to maintain, small, lightweight, durable, and low cost. This new defibrillator is designed to be deployed among a broad group of emergency response personnel (EMTs, fire department personnel, police officers, and other authorized responders), making the implementation of early response programs practical in communities, industrial settings, and other public and private facilities.

ForeRunner is expected to cost between $3,000 and $4,000 to put into service. Most current AEDs, in contrast, cost between $5,000 and $7,500. This low price will enable communities to widely deploy the ForeRunner throughout their existing medical response organizations.

ForeRunner combines a number of patented, patent-pending, and proprietary technologies that represent important advances in defibrillation technology and make it appropriate for widespread deployment. These advances include:

-- A highly accurate, computerized algorithm that automatically determines if a shock is appropriate, eliminating the need for the operator to be trained in interpreting an electrocardiogram (ECG). ForeRunner activates the shock button only when a life-threatening heart rhythm is identified.

-- The delivery of a defibrillatory shock in a biphasic waveform, which requires less energy than other AEDs to achieve comparable defibrillation efficacy, which enables the ForeRunner to be smaller, lighter, less costly, and more reliable.

-- The use of automated self-test technologies and a long-life battery cartridge, which allows the ForeRunner to be virtually maintenance free and contributes to its small size.

-- The use of innovative technology and materials resulting in a durable product the size of a hardcover book that weighs about four pounds, which is designed to withstand the variety of adverse conditions encountered in the emergency setting by providing resistance to water, mud, dust, and severe impact.

-- A simple, intuitive design, making the device easy to use and practical for broad deployment among authorized responders.

Heartstream, Inc. was founded in 1992 and employs approximately 75 people at its corporate headquarters in Seattle, Washington. Heartstream is publicly traded on NASDAQ under the symbol HTST. -0-

Note to producers and editors: For television, B-Roll is available with patients, medical professionals, and animation of the technology and close-ups of the device. For print media, color graphics are included in a press kit. For radio producers, an audio news release with interviews is also available.

CONTACT: Media Contact

Nigel Smith or Lloyd Benson

Schwartz Communications, Inc.

617/431-0770

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Company Contact

Keith Serzen or John Harris

Heartstream, Inc.

206/443-7630

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Investor Contact:

Gary Onn, Heartstream, 206/441-5133 or

Ruth Markowitz, Burns McClellan, Inc., 212/505-1919 ext. 20