DFIB Cardiac Science (MM)

University of Michigan to Compare Effectiveness of Cardiac Science Powerheart(R) CRM(TM) Bedside Monitor-Defibrillator With Traditional 'Code Blue' In-Hospital Emergency Response Protocol Poor In-Hospital Cardiac Arrest Mortality Rates Prompt New Clinical Study to Support New Standard of Care IRVINE, Calif., March 24 /PRNewswire-FirstCall/ -- Cardiac Science Inc. (NASDAQ:DFIB) announced today that physicians at the University of Michigan Cardiovascular Center have launched a prospective study designed to assess the effectiveness of the Company's patented fully-automatic hospital bedside monitor-defibrillator, the Powerheart(R) Cardiac Rhythm Module(TM) (CRM(TM)), against the traditional hospital "code blue" emergency response protocol. The CRM device is designed to continuously monitor at-risk cardiac patients around the clock and, when clinically appropriate, to deliver a potentially life-saving defibrillation shock without the need to wait for intervention by a nurse or physician. The two-phase study is being led by Kim A. Eagle, M.D., Albion Walter Hewlett Professor of Internal Medicine, Chief of Clinical Cardiology, and Clinical Director of the University of Michigan Cardiovascular Center. Other published studies suggest that tens of thousands of patients suffer sudden cardiac arrest (SCA) in acute care hospitals each year and that despite advances in care, mortality from these cardiac arrests exceeds 75 percent. Dr. Eagle said that the current resuscitation approaches employed by hospitals for patients who suffer life-threatening arrhythmias is often ineffective, and it is incumbent on the medical community to closely study technology solutions that have the possibility of proactively protecting at-risk cardiac patients. "Approaches to the management of sudden cardiac death in hospitals have changed surprisingly little over the past several decades, while at the same time, remarkably rapid response to this form of heart disease has become commonplace on airlines and in other public places," Dr. Eagle said. "Our clinical study will attempt to validate our hypothesis that bedside monitoring with automatic defibrillation is economically feasible and clinically effective in the hospital environment. If proven, it could result in thousands of saved lives per year and a revision in that standard of care for at-risk cardiac patients." The study will take place in the 10-bed Cardiac Intensive Care Unit (CICU) at the University of Michigan's University Hospital, where 42 cardiac arrests occurred in a recent one-year period. During Phase 1 of the study, defibrillation therapy in the CICU will continue to be administered manually under the guidance of a health care provider, per traditional hospital "code blue" protocols. Time-to-first defibrillation shock from the onset of the life-threatening ventricular tachyarrhythmias will be recorded, as will patient outcomes. During Phase 2, all patients in the CICU will be pre-attached to the Powerheart CRM operating in the fully automatic mode and will receive automatic defibrillation therapy without human intervention. The objective of the study will be to compare and contrast the response times and patient outcomes using current methodology against the Powerheart CRM. Current scientific literature reports that response times in hospitals are measured in minutes and are highly variable depending on staffing levels and time of day under the traditional "code blue" system. Typically less than 25 percent of patients who suffer SCA during their hospitalization survive to discharge from the hospital. Three additional clinical studies are currently underway to determine both clinical efficacy and cost-effectiveness of bedside CRM monitoring at other U.S. and international hospitals, including: * An economic and safety effectiveness study being performed at New York Methodist Hospital under the direction of Dr. Charles E. Oribabor, Director, Cardiac Surgery ICU at that institution; * On-going clinical and observational study at Maimonides Medical Center in Brooklyn, NY under the direction of Maimonides Director of Clinical Cardiology, Gerald Hollander M.D. Based on early positive results, the hospital elected to deploy more than 100 Powerheart CRM devices and has been accumulating data for more than two years and; * An outcomes study under the lead of Antonio Martinez-Rubio, M.D. in the Cardiology department at the Hospital de Sabadell in Barcelona, Spain. Past CRM Studies Reported in the Clinical Press In November 2004, a study published in the Journal Resuscitation authored by Henry Cusnir, M.D., et al, was conducted at Maimonides Medical Center in Brooklyn, N.Y. The study looked at staff response times to simulated cardiac arrest in monitored wards as compared to the Powerheart response in its fully- automatic mode. Staff verses Powerheart CRM response time was on average nearly 3 minutes verses 38 seconds. In October 2004, a study published in the Journal Resuscitation and authored by Andre Moreira Bento, M.D., et al, was conducted principally at the Instituto do Corocao, University of Sao Paulo Medical School in Sao Paulo, Brazil. The study monitored 55 cardiac patients located in special monitoring wards. During approximately 1,300 hours of monitoring, 18 episodes of life-threatening rhythm events were documented that required treatment through defibrillation. The mean response time to defibrillation shock delivered automatically by the Powerheart CRM was 33.4 seconds and the therapy was successful in converting the patient to a normal heart rhythm 94.4 percent of the time on the first shock (17/18) and 100 percent on the second shock (1/1). There were no patient complications reported. In February 2003, a European study authored by Antonio Martinez-Rubio, M.D. et al, was published in the Journal of the American College of Cardiology. The 117-patient study was conducted at 10 European medical centers in Germany, Spain, Italy and Finland. The patients included 51 at risk cardiac patients located in special monitoring wards (intensive or coronary care units or in an emergency room), and 66 patients who were undergoing electrophysiological testing or implantation of cardioverter- defibrillators (ICDs) because of suspected or documented ventricular tachyarrhythmias. During a total of 1,240 hours of testing, 1,988 heart rhythm events were documented and 115 of those needed treatment through defibrillation. The mean response time was 14.4 seconds and there were no complications reported. In June 2003, a study published in The American Journal of Cardiology authored by Thomas Mattioni, M.D., et al, conducted at the Arizona Heart Institute, Phoenix, AZ measured the ability of the Powerheart CRM to accurately discriminate superventricular (SVT) from life-threatening ventricular tachyarrhythmias (VT) in patients undergoing a conventional electrophysiology (EP) study in the electrophysiology lab. In a total of 98 patients the Powerheart CRM correctly identified 122 episodes of SVT for a resultant sensitivity of 100 percent and a specificity of 94 percent. The authors concluded that the Powerheart accurately discriminates SVT from VT and is expected to correctly deliver automatic shocks in the presence of spontaneous life-threatening arrhythmia and appropriately withhold therapy during SVT. About the Powerheart(R) Cardiac Rhythm Module(TM) (CRM(TM)) The Powerheart CRM is the only FDA-cleared therapeutic patient monitor that offers a complete therapeutic monitoring and defibrillation package in a single device -- continuous cardiac monitoring, synchronized cardioversion, non-invasive pacing as well as manual, semi-automatic or fully-automatic defibrillation. Designed for use in medically-supervised environments, the Powerheart CRM may be used to monitor patients during transport, as an emergency defibrillator or be prophylactically attached to an at-risk cardiac patient. Once programmed and attached to the patient via its disposable electrode pads, the CRM can operate without human intervention. It continuously monitors a patient's heart, detects the onset of life-threatening arrhythmias and can automatically deliver defibrillation therapy to patients suffering from spontaneous life-threatening ventricular tachyarrhythmias (sudden cardiac arrest). About Cardiac Science Cardiac Science develops, manufactures and markets a complete line of Powerheart(R) brand, automated public access defibrillators (AEDs), and offers comprehensive AED/CPR training and AED program management services that facilitate successful deployments. The company makes the Powerheart(R) CRM(TM), the only FDA-cleared therapeutic patient monitor that instantly and automatically treats hospitalized cardiac patients who suffer life-threatening heart rhythms. 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 news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, from time to time the company, or its representatives, have made or may make forward looking statements orally or in writing. The words "estimate," "potential," "intended," "expect," "anticipate," "believe," and similar expressions or words are intended to identify forward looking statements. Such forward-looking statements include, but are not limited to, the possibility that the Powerheart(R) CRM(TM) could create a new standard of care for in hospital cardiac patients. Cardiac Science cautions that these statements are subject to substantial risks and uncertainties and are qualified by important factors that could cause actual results to differ materially from those reflected by the forward-looking statements and should not be relied upon by investors when making an investment decision. Information on these and other factors is detailed in the Company's Form 10-K for the year ended December 31, 2004, and other documents filed by the Company with the Securities and Exchange Commission. Given these risks and uncertainties, investors are cautioned not to place undue reliance on such forward-looking statements. The Company does 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: Matt Clawson (Investors), , or Len Hall (Media), , 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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