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FDA Notification Allows Cardiac Science to Market Its Powerheart Defibrillator for Out-of-Hospital Applications in the United States.


Business Editors and Health/Medical Writers

BIOWIRE2K

IRVINE, Calif.--(BW HealthWire)--Feb. 27, 2001

Notification by FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 Intended to Allow Use of Automatic Defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a  

in Outpatient Surgery Centers, Nursing Homes and at Home When

Prescribed by a Physician

Cardiac Science Inc. (Nasdaq:DFIB), today announced that it has received notification from the U.S. Food and Drug Administration that allows Cardiac Science to market its fully automatic Powerheart(R) defibrillator-monitor for out-of-hospital application in the United States.

"This notification by the FDA clears the way for Cardiac Science to significantly expand its U.S. market opportunity for Powerheart beyond hospitals to include various outpatient facilities," said Raymond W. Cohen cohen
 or kohen

(Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male.
, president and chief executive officer of Cardiac Science.

"Physicians will now have the opportunity to attach Powerheart to patients undergoing outpatient or office-based surgical procedures who are deemed to be at risk for developing cardiac arrhythmias.

"Moreover, we see enormous potential for Powerheart to be prescribed for use at home on patients who are at temporary risk of developing life-threatening heart rhythms while recovering from cardiac surgery, angioplasty procedures or undergoing adjustment of anti-arrhythmic medications, or treatment for congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. ."

The Powerheart AECD AECD Automatic external cardioverter-defibrillator A device that monitors cardiac rhythm and automatically defibrillates (R) is a non-invasive external defibrillator designed to be attached prophylactically to monitor cardiac patients for detection of life threatening heart rhythms. If a person suffers cardiac arrest cardiac arrest
n.
Abbr. CA A sudden cessation of cardiac function, resulting in loss of effective circulation.


Cardiac arrest
A condition in which the heart stops functioning.
, Powerheart delivers a life-saving defibrillation Defibrillation Definition

Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm.
 shock within seconds, and without human intervention to restore a normal heart rhythm.

"During the last few months we have hired eight direct salespeople strategically located in major cities around the U.S. to address this new market opportunity," said Michael Gioffredi, vice president, sales and marketing. "We anticipate penetration of the market in the coming months and expect to realize revenue from this segment in the third quarter of 2001."

About Out-Patient Facilities

According to Ambulatory Surgery ambulatory surgery
n.
Surgery performed on a person who is admitted to and discharged from a hospital on the same day.


ambulatory surgery,
n
, Medical & Healthcare Marketplace Guide, there are 2,726 Freestanding Outpatient Surgery Centers in the United States and approximately 200,000 physician practices performing surgical procedures.

About Sudden Cardiac Arrest

Sudden Cardiac Arrest (SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. ) continues to be a major health care problem making it the leading cause of death in the United States and Europe.

SCA is an abrupt disruption of the heart's function causing lack of blood flow to vital organs and resulting in loss of blood pressure, lack of pulse and loss of consciousness. The usual mechanism of SCA is when the heart's built-in electrical system malfunctions causing the ventricles Ventricles
The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues.
 to quiver or fibrillate fib·ril·late
v.
1. To undergo or to cause to undergo fibrillation.

2. To make or to become fibrillar.

adj.
Being fibrillated.
.

The heart's chaotic rhythm can no longer pump oxygenated blood Oxygenated blood
Blood carrying oxygen through the body.

Mentioned in: Patent Ductus Arteriosus
 effectively throughout the body, and most importantly, to the brain. For each minute that passes, a patient's chance of survival declines approximately 10 percent.

Outcomes related to the occurrence of SCA depend on several factors, but a wealth of information from numerous studies suggests that survival rates are inversely proportional to the duration of the life-threatening arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of . In fact, evidence derived from patients with implantable cardioverter defibrillators (ICDs) show that even small increases in the duration of cardiac arrest may be detrimental.

About Cardiac Science

Cardiac Science develops and markets life-saving external cardiac defibrillator devices and proprietary software that monitors a patient's cardiac activity, instantly detects the onset of a life-threatening heart rhythm and automatically delivers defibrillation without human intervention.

The company's proprietary technology has multiple applications, including use in external and wearable defibrillators and with standard patient monitors widely used in hospitals throughout the world. The growth of the company's installed base provides a potential recurring revenue stream from the sale of proprietary disposable defibrillator electrodes.

Cardiac Science began marketing its first commercial product, the Powerheart, in early 2000 and generated approximately $4.2 million in revenue based on the sale of 734 Powerhearts and related accessories. For more information on Cardiac Science, visit its Internet site at www.cardiacscience.com.

On Jan. 10, 2001 Cardiac Science announced that it offered to acquire all of the outstanding common stock of Artema Medical AB, a Scandinavian manufacturer of defibrillators, patient monitors and a proprietary expiratory ex·pi·ra·to·ry
adj.
Of, relating to, or involving the expiration of air from the lungs.



expiratory

relating to or employed in the expiration of air from the lungs.
 gas measurement module. Artema is publicly listed on the OM Stockholm Exchange O-List (Symbol:ARTM ARTM Analysis & Reporting Training Module
ARTM Availability Reporting and Tracking Module (replaced by STASS FY96)
ARTM Acquisition Reform Training Modules
). In 2000, Artema reported $26.5 million in revenue and was profitable.

Artema's products are sold via distributors in Europe, Asia and the Middle East. In consideration for the transaction, Artema shareholders will receive $20 million in Cardiac Science stock. Cardiac Science expects the transaction to close in May 2001.

On Feb. 14, 2001, Cardiac Science announced that it signed a definitive merger agreement to acquire Survivalink Corp., a privately held Minneapolis-based company that is a leading provider of Automated External Defibrillators automated external defibrillator Emergency medicine A portable device designed for use by first-response personnel for out-of-hospital emergency treatment of Pts suffering from cardiac arrest. See First-response personnel.  (AEDs). In 2000, Survivalink reported it sold more than 6,000 AEDs, grew its revenue by more than 40 percent to $17.1 million and was profitable.

Survivalink has more than 50 patents issued on its AED AED - Automated Engineering Design  technology. As consideration in the transaction, Cardiac Science will pay $35.5 million in cash and $35.5 million in restricted common stock to Survivalink shareholders for a total purchase price of $71 million. The offer is subject to approval by Cardiac Science and Survivalink shareholders and is expected to close in June 2001.

For more information on Survivalink, visit its Internet site at www.survivalink.com.

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. Such forward looking statements, including statements the company's timetable for penetrating the outpatient surgery and physician office market and generating revenues from such efforts, the life saving potential of the company's technology, and the timetable for completing the Artema Medical AB and Survivalink Corp. acquisitions, are based on current expectations that involve numerous risks and uncertainties. Actual results could differ materially from those anticipated in such forward looking statements as a result of various known and unknown factors including, without limitation, future economic, competitive, regulatory, and market conditions, future business decisions, market acceptance of the company's products, and those factors discussed in the company's Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ending Dec. 31, 1999 and in other documents filed by the Company with the Securities and Exchange Commission. In light of the significant uncertainties inherent in such forward-looking statements, the inclusion of such statements should not be regarded as a representation by the company or any other person that the company's objectives and plans will be achieved. Words such as "believes," "anticipates," "expects," "intends," "may," and similar expressions are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. The company undertakes no obligation to revise any of these forward-looking statements, and such statements should not be relied upon by investors when making an investment decision.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Feb 27, 2001
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