Cardiac Science Receives Regulatory Approval to Market Powerheart in Australia; Company Announces Australian Distribution Partner and $333,000 Order of Powerhearts.
Business Editors, Health/Medical Writers
IRVINE, Calif.--(BW HealthWire)--Dec. 27, 2000
Cardiac Science Inc., (Nasdaq:DFIB), today announced that it has been granted approval by the Australian Therapeutic Goods Administration The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. to allow Cardiac Science to begin marketing its unique fully automatic Powerheart(R) hospital bedside defibrillator-monitor in Australia.
Cardiac Science also announced it entered into an exclusive distribution agreement for Australia and sold 50 of its Powerheart defibrillator-monitors along with disposable 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. electrodes and related accessories resulting in $333,500 in revenue.
"With over 1,200 hospitals in Australia This is a list of major hospitals in Australia. New South Wales
Public hospitals in New South Wales are organised into eight Area Health Services plus The Children's Hospital at Westmead. , we believe there is a substantial market for Powerheart," said Ray Jarvis Leon Raeminton Jarvis (born February 2, 1949 in Chesapeake, Virginia) is a retired American football wide receiver in the National Football League for the Atlanta Falcons, Buffalo Bills, Detroit Lions, and the New England Patriots. He played college football at Norfolk State University. , sales and marketing manager for Cardiac Science's new Australian New Australian
Austral an Australian name for a recent immigrant, esp. one from Europe distribution partner, CS Australia Pty Ltd PTY LTD Propriety Limited (company structure in Australia) of Melbourne, Australia. "Our marketing plan is to offer Powerheart to Australian hospitals without the hospital incurring any capital equipment cost for the Powerheart device itself. Since hospitals will incur only the cost of prophylactically-attached disposable electrodes that are replaced daily, we believe we can significantly accelerate the adoption rate of Powerheart in Australia while generating a healthy return for our distribution company."
Cardiovascular disease Cardiovascular disease
Disease that affects the heart and blood vessels.
Mentioned in: Lipoproteins Test
cardiovascular disease is Australia's largest health problem with over 52,000 deaths in 1998 alone. Moreover, each year it is estimated that over 30,000 Australians undergo heart surgery that put them at risk of developing life-threatening heart rhythms. Australia has a population of approximately 18 million and spends approximately $27 billion, or 8.5 percent of its gross domestic product on healthcare services of which 70 percent of this expenditure is publicly funded.
About Australian Therapeutic Goods Administration
Australian Therapeutic Goods Administration ("TGA See TARGA.
TGA - Targa Graphics Adaptor "), the Australian medical products regulatory authority, acts independently of the U.S. Food and Drug Administration. FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. approval alone does not qualify a medical device for importation into Australia. Before medical devices can be legally supplied in Australia, a device is subject to rigorous review and must be registered in the Australian Register of Therapeutic Goods. Manufacturers are required to provide evidence to establish quality, safety and efficacy of their device, as well as the standard of manufacture of the goods, for review by TGA prior to approval.
About Cardiac Science
Cardiac Science develops and markets life-saving external cardiac 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 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 shocks within as little as 10 seconds and without human intervention to re-establish the heart's normal rhythm. Its core proprietary defibrillation and electrode technology platform 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 recurring revenue stream from the sale of proprietary disposable defibrillator electrodes.
On Nov. 27, 2000 Cardiac Science announced that it offered to acquire all of the outstanding common stock of Spacelabs Medical Inc. (Nasdaq:SLMD SLMD Subscriber Line Module Digital ) for $15 per share. Cardiac Science is aggressively pursuing all avenues in its effort to acquire Spacelabs in a negotiated transaction.
Cardiac Science began marketing its first commercial product, the Powerheart in early 2000. For more information on Cardiac Science, please visit its Internet site at www.cardiacscience.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 include, but are not limited to: the size of the market for Powerheart in Australia; the life-saving potential of Cardiac Science's technology; the Company's ability to integrate its technology into patient monitors, develop new products and improve patient-care; a potential transaction between Cardiac Science Inc. and Spacelabs Medical, Inc. that may or may not occur. 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 Form 10-K
A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.
See 10-K. for the year ending December 31, 1999 and other documents filed with the Securities and Exchange Commission.