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CST: 22/08/2019 00:52:43   

China FDA Approval for Oscar 2 Blood Pressure Monitor with CardieX’s "SphygmoCor® Inside" Technology

120 Days ago

SYDNEY, Australia, April 23, 2019 (GLOBE NEWSWIRE) -- CardieX Limited (Australian Stock Exchange listed: CDX) announces approval by the Chinese Food and Drug Administration (CFDA) of the Oscar 2 with “SphygmoCor® InsideAmbulatory Blood Pressure Monitor (ABPM), a product collaboration between CardieX wholly owned group company AtCor Medical (AtCor) and leading US blood pressure device manufacturer SunTech Medical Inc.

CFDA approval allows Oscar 2 ABPM with SphygmoCor® to be utilised by 20,000+ physicians, hospitals, clinics throughout China where ABPM is the most effective method of detection, diagnosis, monitoring and management of hypertension - a leading cause of more than 12% of annual adult deaths worldwide. Hypertension is a major and growing health disorder in China with over half the adult population currently affected. In China, a US$50M annual market opportunity.

Highlights

  • China FDA (CFDA) approval for Oscar 2 with “SphygmoCor® Inside” received; a market leading Ambulatory Blood Pressure Monitor (ABPM) for use in China for monitoring of central blood pressure.
     
  • Total addressable new CardieX revenue and market opportunity for sales of Oscar 2 with SphygmoCor® in China approximately $USD50 million annually - Potential for over 20,000 physicians, hospitals and clinics
     
  • Oscar 2 with SphygmoCor® is a successful existing collaboration between leading US based blood pressure monitor manufacturer and distribution company SunTech Medical, and CardieX wholly owned group company AtCor Medical.

  • CardieX’s SphymoCor® technology is the global gold standard in central blood pressure and arterial stiffness assessment, with over 1400 published studies and 4000+ global deployments.

  • Oscar 2 with SphygmoCor® will be the only available ABPM solution in China currently with “SphygmoCor inside” and provides a unique market differentiation for ABPM devices in this significant medical device segment.
     
  • CFDA approval in China expands existing collaboration between SunTech and CardieX for sales and distribution of Oscar 2 with SphygmoCor®. Device already FDA approved for sale in USA and is CE marked for sale in European Economic Area.

For more information please contact:
NWR Communication - Peter Taylor or Anne Leslie
peter@nwrcommunications.com.au
anne@nwrcommunications.com.au

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