DFIB Cardiac Science (MM)

IRVINE, Calif., Aug. 25 /PRNewswire-FirstCall/ -- Cardiac Science Inc. (NASDAQ:DFIB), a leading U.S. manufacturer of life-saving automatic public-access defibrillators (AEDs), announced today that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market a biphasic version of the Company's AEDs in Japan. The biphasic AED product, a private-labeled OEM version of Cardiac Science's flagship Powerheart(R) AED, will be marketed in Japan under the CardioLife(R) brand name by Nihon Kohden Corporation, (Tokyo: JP: 6849), Japan's largest medical device manufacturer. "This is a major milestone for Cardiac Science, one that will allow us to begin realizing significant sales in Japan as we enter the fourth quarter of 2005 and into 2006 and beyond," said Raymond W. Cohen, Cardiac Science Chairman and CEO. "This biphasic submission has been under review by Japanese regulators for over two years, well beyond our initial expectation. As AED demand has grown in Japan, so has the demand for biphasic version AEDs. This regulatory delay has allowed one of our competitors with an approved biphasic version to make up ground in this market. As a result, our 2005 shipments to Japan dropped off substantially from strong second half 2004 levels. We are now able to get aggressively back on the playing field and continue making inroads into this important market. As mentioned in our recent investor conference call, Nihon Kohden reports that substantial demand exists for our biphasic AED product. The product is now ready for shipment and we are confident that with our biphasic version AED will allow us to regain our previous momentum," said Cohen. Tokyo-based Nihon Kohden, which has approximately 650 sales people in Japan, began selling Cardiac Science-manufactured AEDs in the second quarter of 2002 and quickly became the AED market share leader in Japan by selling approximately 10,000 Cardiac Science-manufactured AEDs to Japanese physicians and hospitals. In 2003 Japan's MHLW approved the use of AEDs by non-medical persons marking a significant shift in the Japanese ministry's view toward the use of AEDs, which formerly could only be legally used by physicians, paramedics and trained flight attendants in airplanes. Now any Japanese citizen or organization can deploy an AED after undergoing a course in AED operation. About the Japanese AED Market According to published market analysis, the Japanese AED market has the potential to be approximately 60,000 units per year by 2010 roughly 20 percent the size of the combined U.S. and European markets. Current buyers of AEDs in Japan include medical and dental clinics, hospitals, fitness centers, airports and airlines. Potential AED users in Japan include thousands of commercial buildings and government facilities as well as approximately 90,000 physician offices, 53,000 police, fire and emergency vehicles, 41,000 schools, 2,000 golf courses, Japan's extensive railway system and consumers. About Cardiac Science's Patented STAR(R) Biphasic AED Technology Among other things, AEDs employ technology that allows for an electric shock to be delivered to the heart using either a monophasic or biphasic defibrillation shock waveform. That is, current can travel in a single direction throughout the shock (monophasic), or the direction of the current can be reversed partway through the shock (biphasic). Studies have proven that biphasic waveforms are efficacious as compared to traditional monophasic waveforms using similar energy levels and may decrease damage to the heart. Cardiac Science's patented STAR(R) biphasic 'self-tracking active response' waveform customizes the defibrillation therapy for each patient by measuring each patient's ability to conduct electricity (impedance) and automatically customizing the waveform for that specific patient by varying duration, voltage and energy in order to optimize external defibrillation efficacy. Subsequent shocks progressively escalate to higher levels if additional shocks are needed to convert a sudden cardiac arrest victim to a normal rhythm. STAR biphasic has been proven in published multi-center clinical studies to have a first shock success rate of 100% using average energy levels of approximately 200 Joules. In clinical studies conducted using out-of-hospital data, STAR biphasic was able to successful restore normal patient rhythm in less than 55 seconds using only 2 shocks on average. About Nihon Kohden Nihon Kohden Corporation, (Tokyo: JP: 6849), Japan's largest medical device manufacturer manufactures a variety of diagnostic medical devices including patient monitoring systems, electrocardiograms, electroencephalograms, cardiac monitors and external defibrillators. About Cardiac Science Cardiac Science develops, manufactures and markets a complete line of Powerheart(R) brand, automatic public-access defibrillators (AEDs), and offers comprehensive AED/CPR training and AED program management services that facilitate successful deployments. Cardiac Science also manufactures its AED products on a private label basis for other leading medical companies such as Nihon Kohden (Japan), Quinton Cardiology Systems and GE Healthcare. For more information please visit http://www.cardiacscience.com/ or call 1.949.797.3800. This press release includes forward-looking statements. These statements may be identified by the use of forward-looking terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," or "will," or the negative thereof or other variations thereon or comparable terminology. Cardiac Science has based these forward-looking statements on the current expectations, assumptions, estimates and projections. While Cardiac Science believes the regulatory approval in Japan to be a benefit to the company and that it will allow sales in that region to improve in the coming periods , these expectations, assumptions, estimates and projections, while reasonable, are forward-looking statements and are only predictions and involve known and unknown risks and uncertainties, many of which are beyond our control. Certain factors, including those discussed in Cardiac Sciences' Annual Report on Form 10-K for the year ended December 31, 2004, under the heading "Risk Factors," may cause the actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments. Contact: Matt Clawson (Investors) Michael D. Gioffredi Len Hall (Media) Chief Marketing Officer Allen & Caron Inc Cardiac Science, Inc. (949) 474-4300 (949) 797-3800 DATASOURCE: Cardiac Science Inc. CONTACT: Investors, Matt Clawson, , or Media, Len Hall, , both of Allen & Caron Inc, +1-949-474-4300, for Cardiac Science, Inc.; or Michael D. Gioffredi, Chief Marketing Officer of Cardiac Science, Inc., +1-949-797-3800, Web site: http://www.cardiacscience.com/

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