China Health Authority Grants Cardiac Science Approval to Sell Its Latest Line of Powerheart(R) AEDs
28 6월 2005 - 3:30PM
PR Newswire (US)
China Health Authority Grants Cardiac Science Approval to Sell Its
Latest Line of Powerheart(R) AEDs Approved Products Include
Powerheart and GE-Branded AEDs and Powerheart CRM Bedside Therapy
Monitor IRVINE, Calif., June 28 /PRNewswire-FirstCall/ -- Cardiac
Science Inc. (NASDAQ:DFIB) announced today that it has received
regulatory approval from the People's Republic of China State Food
and Drug Administration (SFDA) to sell its latest line of automatic
external defibrillators (AEDs), including its Powerheart(R) brand
public-access AEDs and the Powerheart(R) CRM(R), a unique bedside
monitor that automatically treats hospitalized cardiac patients who
suffer life-threatening heart rhythms. The SFDA action provides
clearance for Cardiac Science to begin shipments of its G3 series
AEDs into China under its Powerheart and FirstSave(R) brands as
well as under GE Healthcare's Responder(R) brand name which Cardiac
Science manufactures on a private label basis for GE. Cardiac
Science branded AEDs operate in the Chinese language and are sold
through its local Chinese distribution partners. The GE Responder
brand AEDs are marketed in China by GE Healthcare. Initially, AEDs
are expected to be deployed principally in medical and emergency
rescue settings and used by hospitals, physicians and paramedics on
fire vehicles and ambulances. Historically, as new markets have
developed, medical and first responder segments have been the first
to deploy AEDs, followed by more widespread adoption for
installation in government institutions, transportation,
corporations, and other public places where citizens congregate.
More than 100 Powerheart CRMs are currently in use in Chinese
hospitals. Cardiac Science has gained a solid market share position
in emerging AED markets around the world with international sales
now accounting for approximately 40 percent of the Company's
revenue said Chairman and Chief Executive Officer Raymond W. Cohen.
"People all over the world are recognizing that AEDs offer an
effective and inexpensive way to protect citizens against sudden
cardiac arrest," Cohen said. "While the U.S. market continues to
lead the way in the awareness and adoption of AEDs we believe the
international market now accounts for over 20 percent of worldwide
AED sales. China, which represents a large potential market for us,
joins an extensive list of countries where our latest generation
Powerheart AED G3 line is approved for sale including other
Asia/Pacific countries like South Korea, Thailand, New Zealand and
Australia and dozens of countries in Europe, South America and the
Middle East. We plan to pursue our business aggressively in these
countries and take advantage of the opportunities these regulatory
approvals present us." About Cardiac Science Cardiac Science
develops manufactures and markets a complete line of Powerheart(R)
brand, automatic public-access defibrillators, commonly known as
AEDs, and offers comprehensive AED/CPR training and AED program
management services that facilitate successful deployments. The
Company makes the Powerheart(R) CRM(R), 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 Corporation (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 Regulatory Approval in China for its AEDs and CRMs will
generate revenue for Cardiac Science from its distributors or GE
Healthcare. 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: Rene Caron (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, Rene
Caron, , or media, Len Hall, , both of Allen & Caron Inc., for
Cardiac Science, Inc., +1-949-474-4300; Michael D. Gioffredi, Chief
Marketing Officer of Cardiac Science, Inc., +1-949-797-3800, Web
site: http://www.cardiacscience.com/
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