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March 26, 2002
FOR: ZOLL Medical Corporation
INVESTOR CONTACT: A. Ernest Whiton
Chief Financial Officer
ZOLL Medical Corporation
PRESS CONTACT: Robert Minicucci
Corporate Communications Manager
ZOLL Medical Corporation
+1 (978) 421-9832
FOR IMMEDIATE RELEASE
ZOLL Receives FDA Marketing Clearance For New Automated External Defibrillator
Burlington, MA Tuesday, March 26, 2002 – -- ZOLL Medical Corporation (Nasdaq: ZOLL), a manufacturer of non-invasive cardiac resuscitation devices, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance for its new automated external defibrillator (AED), the ZOLL AED Plus. This new product is the first ZOLL device to target the large and growing first responder and public access defibrillator market. It is also the first AED to feature a combination of simple, step-by-step illustrations and audio coaching – making a stressful and challenging medical crisis a more manageable and controlled rescue for laypersons assisting victims of sudden cardiac arrest. The ZOLL AED Plus helps the rescuer more calmly think through the appropriate steps, and administer necessary life-saving treatment as defined by the American Heart Association guidelines.
Richard A. Packer, President and Chief Executive Officer of ZOLL observed, "This is a significant milestone for our company. We’re pleased that the ZOLL AED Plus will now be available to the first responder and public access market, where it will help rescuers all over the world provide lifesaving treatment to victims of sudden cardiac arrest. We believe this defibrillator is so easy to use it will increase the availability of AEDs, the confidence of rescuers, and it will help assure that not a moment is lost in the rescue process."
Mr. Packer added, "We see tremendous potential for ZOLL in the first responder and expanding AED public access markets and look to expand our support services and technical capabilities to further assist first responders and other trained rescuers. We expect to use our strength and experience in state-of-the-art cardiac resuscitation devices to penetrate this market, where the unique features of the AED Plus will have an immediate and sustained impact in the public access marketplace.”
Mr. Packer concluded, “We will begin taking orders for the ZOLL AED Plus immediately in the United States and expect to begin shipments during our third fiscal quarter. Initial shipments of demonstration units have begun for our international customers.”
The ZOLL AED Plus Product
Time is critical for victims of sudden cardiac arrest – the chance of survival decreases 10 percent every minute defibrillation is delayed. The ZOLL AED Plus is designed to help rescuers respond more rapidly and effectively. The AED Plus is notable for several unique features. It is the first to feature a single electrode pad that is easy to position on the victim’s body (unlike other AEDs which have two pads). It is the first AED to run on off-the-shelf, affordable, consumer batteries. The AED Plus also incorporates ZOLL’s proprietary Rectilinear Biphasic™ waveform, the only biphasic waveform the FDA has cleared and labeled as clinically superior to monophasic defibrillators for conversion of ventricular fibrillation in high-impedance patients and for cardioversion of atrial fibrillation.
The Rapidly Growing First Responder and Public Access Market
The first responder and public access market includes professionals like emergency medical technicians (EMTs), law enforcement and fire personnel, as well as trained laypersons like security guards, health club employees, flight attendants, lifeguards, and office managers.
Frost and Sullivan has estimated the AED market in 2001 was $173 million dollars, with expectations of an annual growth rate of 28 percent for the next five years, reaching over $600 million in revenues. They have also estimated annual unit sales of AEDs at over 300,000 units by 2006. The AED market continues to gain momentum with several important developments, including the Occupational Safety and Health Administration (OSHA) endorsement of defibrillator placement in the workplace, the Community Access to Early Defibrillation Act with annual funding for the purchase of defibrillators and related training (which is currently pending approval in Congress), and the enactment of the 1999 Cardiac Arrest Survival Act, mandating all government agencies to establish a plan for placement of defibrillators in Federal buildings.
AEDs are used to treat sudden cardiac arrest resulting from ventricular fibrillation (VF), a spontaneous, mostly fatal interruption of normal heartbeat and a leading cause of death in the United States. The American Heart Association (AHA) estimates that nearly 120,000 of the approximately 300,000 people who die from sudden cardiac arrest could be saved with public access defibrillation. According to the AHA, “Public access defibrillation, which places AEDs in the hands of trained laypersons, has the potential to be the single greatest advance in the treatment of VF cardiac arrest since the development of CPR.”
ZOLL Medical Corporation, headquartered in Burlington, MA, designs, manufactures and markets an integrated line of proprietary, non-invasive resuscitation devices and disposable electrodes. Used by health care professionals to provide both types of cardiac resuscitation – pacing and defibrillation – these products are essential in the emergency treatment of cardiac arrest victims, both inside and outside the hospital. ZOLL also designs and markets software that automates collection and management of both clinical and non-clinical data for emergency medical service providers. ZOLL has operations in the United States, Canada, United Kingdom, Germany, France, the Netherlands, and Australia, and business partners in all of the world’s major markets. For more information about ZOLL and its products, visit the ZOLL web site at www.zoll.com.
Certain statements contained in this press release, including statements regarding the anticipated development of the Company's business, the intent, belief or current expectations of the Company, its directors or its officers, primarily with respect to the Company's business model and future operating performance of the Company, including expectations regarding results in future periods, operating performance, contributions to results from the Company’s new Public Access Defibrillation product, the payoff that may be realized from investments and the Company’s future profitability, its ability to establish a new sales force in foreign markets, its expectations regarding future purchasing activity, and other statements contained herein regarding matters that are not historical facts, are “forward-looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those factors discussed in the section entitled “Risk Factors” in the Company's Annual Report on Form 10-Q filed on February 13, 2002, as well as uncertainties regarding the market, acceptance and profitability of the ZOLL AED Plus and M Series CCT, the length and severity of the current economic slowdown and its impact on capital spending budgets, the reduction in overall capital equipment expenditures in the hospital and pre-hospital market, the potential disruption in the transportation industry on the Company’s supply chain and product distribution channels, and the desire or ability of other parties to purchase the Company's products.
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