China FDA Approval for Oscar 2 Blood Pressure Monitor with CardieX’s "SphygmoCor® Inside" Technology
April 23 2019 - 8:21PM
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
Lesliepeter@nwrcommunications.com.auanne@nwrcommunications.com.au
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