Ray and Sergio; DFIB news
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, 2005 /PRNewswire-FirstCall via COMTEX/ --
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."
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This could be big with China. |
