Cardiac Science (NASDAQ:DFIB)
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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/