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