Cardiac Science - 500 Beiträge pro Seite

[francoir]

Cardiac Science Receives FDA 510(k) Approval to Market Its New-Generation Powerheart(R) Bedside Monitor-Defibrillator
Offers Vigilant Surveillance, Can Deliver Lifesaving Defibrillation Without Human Intervention

IRVINE, Calif., Dec. 3 /PRNewswire/ -- Cardiac Science Inc (Nasdaq: DFIB - news) today announced that the U.S. Food and Drug Administration has granted the Company 510(k) clearance to market its new second-generation Powerheart® Cardiac Rhythm Module(TM) in medically supervised environments such as hospitals, medical and dental surgery centers, physician offices, clinics and nursing homes. The new Powerheart is considerably smaller in size, lower in cost and more flexible than its predecessor.

The Powerheart is the only FDA-cleared external device that can automatically monitor and treat patients at risk of sudden cardiac arrest (SCA), a life-threatening condition reported by The New England Journal of Medicine to strike an estimated 370,000 to 750,000 hospitalized patients each year. SCA, the single largest cause of death of Americans, resulted in approximately 465,000 deaths in 1998, according to the Center for Disease Control.

President and CEO Raymond W. Cohen stated, ``In-hospital cardiac arrest is a major unsolved health problem that affects a measurable percent of the approximately 5 million cardiac patients who spend upwards of five days each in U.S. hospitals annually. A chronic shortage of nurses contributes to delays in response which, in turn, result in unrecoverable hospital costs and low, 15-20 percent survival rates from SCA. As a result, medical facilities are seeking ways to increase vigilance, mitigate risk and reduce costs. We foresee escalating Powerheart adoption due to these factors and the growing recognition that our technology represents a safe and cost-effective solution for patients at risk of suffering life-threatening abnormal heart rhythms.``

Cardiac Science`s patented Powerheart technology was developed to create a new standard of care for in-hospital resuscitation, replacing current procedures that traditionally require intervention by highly trained personnel with crash-cart defibrillators, which can result in significant delays in treatment and poor patient outcomes. Since a person`s chance of survival decreases by 10 percent for each minute that passes, it is widely recognized that reducing the time interval to first defibrillation shock after the onset of lethal abnormal heart rhythms is necessary to achieve the highest survival rates. Various clinical studies have reported the current rate of survival of patients who suffer in-hospital SCA to be between 0 and 29 percent.

About the Powerheart® Cardiac Rhythm Module(TM)

Cardiac Science`s patented second-generation Powerheart continuously monitors a patient`s heart activity externally for life-threatening abnormal heart rhythms and can administer life-saving defibrillation therapy in seconds without the need to wait for intervention from a nurse, physician or attendant.

The new Powerheart device is approximately one-fourth the size and one- third the cost of its predecessor and can either stand-alone, be attached to standard third-party-manufactured bedside patient monitors, or be used during the transport of patients within a medical center. Other features of the new device include patented biphasic defibrillation technology, non-invasive temporary external cardiac pacing and proprietary, disposable defibrillation electrode pads designed to be comfortably worn by patients 24 hours a day.

The Powerheart is marketed in the U.S. under a recurring revenue business model whereby the Company places Powerhearts in a customer`s facility with no up-front capital equipment charge to the hospital in exchange for an agreement to purchase a specific number of the Company`s proprietary, disposable defibrillation electrodes on a monthly or quarterly basis.

About Cardiac Science

Cardiac Science develops, manufactures and markets life-saving automated external cardiac defibrillator devices and proprietary disposable defibrillator electrode pads that monitor and treat patients who suffer life- threatening heart rhythms. The Company recently completed its acquisitions of both Stockholm-based Artema Medical AB, a European manufacturer of patient monitors and external defibrillator devices, and Minneapolis-based Survivalink Corp, a leading manufacturer of automated external defibrillators (AEDs). The Company`s patented Powerheart® hospital bedside defibrillator, Artema®- brand products and easy-to-use portable Survivalink®-brand Automated External Defibrillators (AEDs) are marketed in the United States by its 36-person direct sales force and by international distributors in over 40 countries around the world. For more information please visit www.cardiacscience.com .

[francoir]

Cardiac Science Granted Three Additional U.S. Patents Covering Automatic Defibrillator Technology
Company Holds 62 Patents in Its Expanding Intellectual Property Portfolio With 10 More Pending

IRVINE, Calif., Dec. 6 /PRNewswire/ -- Cardiac Science, Inc (Nasdaq: DFIB - news) today announced it has been granted three additional U.S. patents related to its innovative Automatic External Defibrillator products. The new patents strengthen the Company`s expanding intellectual property portfolio, which now numbers 62 issued patents with another 10 patents filed and pending. All are related to its automatic defibrillation technology platform and its various applications.

The patents cover the various embodiments of the Company`s proprietary Powerheart® technology, the only external hospital monitor that provides continuous monitoring of a patient`s heart rhythm, instantly recognize a life-threatening rhythm and deliver a shock without the need for help from a hospital attendant. A portable and wearable version of the Powerheart, called the Personal Wearable Defibrillator, is currently under development.

In addition, Cardiac Science has a wide range of patents covering the technology found in its Automated External Defibrillators (AEDs) including its RescueReady® technology which features one button operation, pre-connected disposable electrode pads and self-test capabilities. Other patents cover the Company`s proprietary RHYTHMx ECD(TM) tachyarrhythmia detection software technology, biphasic defibrillation waveform technology and disposable defibrillator electrodes.

Chief Technology Officer Kenneth Olson said this wide range of patents, along with those recently acquired in the Survivalink merger, have allowed Cardiac Science to gain a distinct competitive advantage in the marketplace. According to Frost and Sullivan, the annual worldwide AED market is expected to grow from $140 million listed in 2000 to $650 million in 2006.

``Cardiac Science`s intellectual property portfolio has positioned the Company to be a leader in an exploding but very competitive market,`` Olson said. ``Our intelligent automatic defibrillation devices are distinct from others offered in the hospital market and the fast growing public access defibrillation marketplace.``

The newest patents include Patent No. 6,301,502 titled ``Defibrillation System`` issued on October 9, 2001 which covers a defibrillation system that collects and downloads patient information to a central database. No. 6,304,780 titled ``External Defibrillation System with Diagnostic Module`` issued on October 16, 2001 covers the concept of an external module used to perform diagnostic testing of a defibrillator. No. 6,321,113 titled ``Automatic External Defibrillator First Responder and Clinical Data Outcome Management System`` issued on November 20, 2001 covers proprietary methods for rapidly downloading of information stored in the memory of the device to a base station and transmission to another location without need to remove the AED from service. Cardiac Science has 10 additional patents pending which have been filed related to its automatic defibrillation technology platform and applications.

[francoir]

Cardiac Science Announces Additional Hospitals Installing Powerheart(R) Units; First Order for Powerheart CRM
Installations Continue to Increase as Hospitals Seek to Improve Patient Survival and Establish a New Standard of Care for Cardiac Patients

IRVINE, Calif., Dec. 12 /PRNewswire/ -- Cardiac Science Inc. (Nasdaq: DFIB - news) today announced that a number of new hospitals and medical centers around the nation have recently agreed to deploy Powerheart® bedside monitor defibrillators, effectively setting a new standard of care at each institution by providing immediate response to patients who suffer an in-hospital cardiac arrest.

U.S. hospitals deploying Powerheart include Jackson Memorial Hospital/University of Miami, St. Joseph`s Hospital in Ft. Wayne, Indiana, Bromenn Regional Medical Center in Bloomington, Illinois and Sutter Roseville Medical Center in Roseville, CA. In addition, the Company received its first Powerheart® Cardiac Rhythm Module(TM) (``CRM``) order from Hospital of St. Raphael in New Haven, CT. The CRM device was recently cleared to market by the U.S. Food and Drug Administration. The orders involved an aggregate of 128 Powerheart units, which are being placed in these institutions in exchange for minimum purchase contracts for proprietary disposable monitoring/therapy electrodes that are attached to at-risk patients and which require replacement every 24 hours.

According to a recent study in The New England Journal of Medicine [N Engl J Med, 344(17): 1304-13, April 26, 2001] it is estimated that each year well over 350,000 hospital patients in the United States experience a sudden cardiac arrest (SCA) caused by abnormal heart rhythms with survival to discharge from the hospital of between 0 and 29 percent. The current approach to in-hospital resuscitation requires intervention by highly trained personnel resulting in significant delays in treatment.

Earlier, The American Heart Association concluded that intervals of no more than three minutes from the onset of lethal abnormal heart rhythms to first defibrillation shock are necessary to achieve the highest survival rates. Powerheart is the only hospital monitor that provides continuous monitoring of a patient`s heart rhythm, instantly recognizes a life- threatening rhythm and delivers a shock in as little as 10 seconds without the need to wait for help from a nurse, physician or hospital attendant.

``The Powerheart technology continues to gain traction in hospitals,`` said Raymond W. Cohen, Cardiac Science President and CEO, ``and our direct sales organization continues to build on this momentum and interest in improving the response to sudden cardiac arrest in medical facilities. We continue to be encouraged by the market`s growing awareness and acceptance of our technology and expect Powerheart placements to accelerate throughout 2002.

``The medical community is realizing that sudden cardiac arrest is a leading cause of death in hospitals,`` continued Cohen, ``and is recognizing that Powerheart is the most effective solution to this problem. When deployed, Powerheart save lives, while mitigating risks, reducing costs and establishing a new standard of care for cardiac patients.``

[francoir]

U.S. Government Legislation, Regulations Driving Rapid Expansion of AED Market
Federal Office of Management and Budget Urges `Lifesaving Action` Be Taken by Regulators

IRVINE, Calif., Dec. 19 /PRNewswire/ -- New government legislation that mandates the use of Automated External Defibrillators (AEDs) and provides funding for their deployment is on the rise. The legislation aimed at increasing the chances of survival of cardiac arrest victims, the number one killer of Americans accounting for over 465,000 deaths each year, is effectively expanding the AED market and leading to an acceleration in AED orders for public and government workplaces all around the nation, according to Cardiac Science Inc. (Nasdaq: DFIB - news), manufacturer of the Survivalink® AED.

Even the federal Office of Management and Budget (OMB) has jumped into the regulatory fray by issuing a highly unusual ``prompt letter`` that encouraged the Occupational Safety and Health Administration (OSHA) to quickly initiate new regulations that would mandate placing AEDs in the nation`s workplaces. OSHA responded this week by issuing a Technical Information Bulletin and information resource outlining the potential benefits of workplace AED Programs.

According to a letter from Assistant Secretary of Labor John Henshaw, who administers OSHA, employers should be made more aware of this important lifesaving technology and that the Agency will distribute this information to more than 125 trade, professional and union organizations as well as feature the benefits of AEDs on their website. These documents can be accessed via the Internet at http://www.osha.gov/media/oshnews/dec01/trade-20011217A.html . These guidelines are to convey the benefits of making AEDs available in the workplace and to point employers towards the resources necessary to develop such programs.

A host of AED-related bills, currently being introduced at the federal level and in state governments across the nation, will likely have a positive impact on Frost and Sullivan`s annual AED market projections that currently range from $140 million in 2000 to $650 million in 2006. The first of the bills, the Cardiac Arrest Survival Act, which directed the placement of AEDs in federal buildings around the nation, was signed by President Clinton in November 2000. A companion bill, the Rural Access to Emergency Devices Act, authorized $25 million in federal funds to help rural communities purchase AEDs and to provide training in how to use them.

More recently, the Community Access to Emergency Defibrillation Act of 2001 was introduced into the House of Representatives this month. Authored by Lois Capps, D-Calif and John Shimkus, R-Ill., the bill earmarks $55 million a year for five years for communities to buy AEDs and establish access to defibrillation programs. A companion and identical bill was introduced in the Senate by Edward M. Kennedy, D-Mass. and William Frist, R-Tenn.

Representatives Capps and Shimkus have also introduced in the House a bill the provides guidance and resources to schools for public access to defibrillation programs -- the Automatic Defibrillators in Adams Memory Act.

Cardiac Science, Inc. President and CEO Raymond W. Cohen said the education of the public and the exposure to the concept of public access defibrillators has been given an enormous boost by the recent spate of governmental actions in this area.

``From a commercial standpoint, this regulatory activity expands our market and is obviously good news,`` said Cohen. ``We are also encouraged that legislators at the state and Federal level have come to recognize the fact that public access defibrillation is among the most important public health topics of this decade. We applaud these and future actions aimed at improving public safety.``

[francoir]

Monday January 14, 1:00 am Eastern Time
Press Release
SOURCE: Cardiac Science, Inc.

Cardiac Science Signs OEM Agreement With Nihon Kohden of Japan to Supply Automated External Defibrillators
Japan`s Largest Medical Company to Sell Cardiac Science AEDs in the Japanese Market and International Markets Worldwide

IRVINE, Calif. and TOKYO, Jan. 14 /PRNewswire-FirstCall/ -- Cardiac Science Inc. (Nasdaq: DFIB - news) and Nihon Kohden Corporation, (Tokyo: JP: 6849), Japan`s largest medical device manufacturer, today announced a strategic OEM distribution agreement under which Nihon Kohden will market Cardiac Science`s complete line of Automated External Defibrillators (AEDs) under Nihon Kohden`s tradename in Japan and other international markets. Nihon Kohden also obtained exclusive distribution rights to market the Cardiac Science Powerheart® CRM(TM) fully-automatic bedside defibrillator-monitor and proprietary disposable defibrillation electrode pads in the Japanese market.

Initial shipments of AEDs to Nihon Kohden are expected to begin early in the second quarter of this year. Cardiac Science`s AEDs are approved for sale in Japan and, to date, have been sold to Japan Airlines (Tokyo: JP: 9201) and a number of medical facilities throughout Japan. Commercial shipments of Powerhearts are anticipated to commence subsequent to regulatory clearance by the Japanese Ministry of Health and Welfare.

``We are keenly focused on gaining a significant share of the fast-growing AED market in the U.S., Japan, and other countries worldwide. To that end, our strategy is to align ourselves with strong strategic distribution partners who have the market presence to gain and control a dominant share of their respective AED markets and also have the vision to help us achieve our longer-term goal of making our unique Powerheart technology a new standard of care for hospitalized cardiac patients,`` said Raymond W. Cohen, Cardiac Science`s president and CEO. ``Given the competitive advantages of our AED product and the magnitude of Nihon Kohden`s distribution capabilities, we anticipate, in 2002 and beyond, greatly accelerating our revenue from the emerging Japanese AED market.``

About Automated External Defibrillators

AEDs are portable easy-to-use devices that deliver a life-saving electric defibrillation shock to the heart to halt sudden cardiac arrest -- rapid and chaotic heart activity -- and restore a normal heart rhythm. AEDs are used by first responders such as police, fire and ambulance personnel, and are also being deployed for use by the public at places where people gather, play and work. Currently, a person who suffers sudden cardiac arrest outside of a hospital has only around a 5 percent chance of surviving. Clinical studies have revealed that survival rates between 30 to 75 percent are possible when an AED is readily available and used to shock a victim within 3 minutes from the onset of cardiac arrest.

About the Japanese AED market

According to market analysis published by Frost & Sullivan, it is estimated that the worldwide market for AEDs will expand fivefold to more than 300,000 units a year by 2006, accounting for more than $650 million in annual revenue. The potential Japanese AED market is estimated to be as much as 20 percent the size of the combined U.S. and European markets. Potential AED users in Japan include approximately 89,000 medical and dental clinics, 53,000 police, fire and emergency vehicles, thousands of commercial buildings and government facilities as well as 41,000 schools and 2,000 golf courses.

In October 2001, Cardiac Science announced that JAL agreed to purchase 130 of its Survivalink®-brand AEDs for deployment on its fleet of commercial airliners. JAL is the first non-medical organization to purchase AEDs and the first Japanese airline to deploy AED`s on its aircraft and train its flight attendants and crew. Approximately 40 Cardiac Science AEDs were sold by a Japanese distributor to medical clinics throughout Japan in Q4 2001.

Beginning in December 2001, a new interpretation of current Japanese legislation allows trained flight personnel to use an AED to defibrillate a person after placing a call to a doctor. Prior to this new interpretation, only licensed physicians or paramedics under a physician`s direct supervision were allowed to use a defibrillator. Legislative initiatives, led by Japanese emergency physicians and cardiologists, are currently pending to expand AED use to include trained laypersons throughout Japan. As an important step in this process, the Japanese language version of the revised American Heart Associations CPR and Emergency Cardiac Care Guidelines 2000 were formally introduced in December. These new global standards establish specific response time goals for immediate defibrillation for the treatment of people who suffer sudden cardiac arrest.

About Nihon Kohden Corporation

Nihon Kohden, based in Tokyo, Japan, develops, manufactures and distributes a variety of diagnostic medical devices including patient monitoring systems, electrocardiograms (EKGs), electroencephalograms (EEGs), cardiac monitors and external defibrillators and has annual revenue in excess of $500 million.

Nihon Kohden currently holds about 50 percent of the Japanese domestic defibrillator market, which includes traditional hospital crash-cart defibrillators and ambulance defibrillators. Approximately $20 million of standard external defibrillators were sold in Japan in 2000. Nihon Kohden products are marketed in Japan by its approximately 650-person direct sales force and by distributors in more than 100 countries worldwide.