|[February 09, 2014]
Admedus's CardioCel® Cleared for Sale in the US
BRISBANE, Australia --(Business Wire)--
Admedus (ASX:AHZ) today announced it has received FDA clearance to
market CardioCel® in the US. CardioCel® is the
group's lead regenerative tissue product to repair and treat a range of
cardiovascular and vascular defects. The Company will now look to
complement its existing product launch in Europe with preparation for
initial sales in the US.
The intended use of CardioCel® in the US is in pericardial
closure and for the repair of cardiac and vascular defects in both
adults and paediatrics.
"This is a significant milestone for the Company as we expand into
global markets and further develop our range of regenerative tissue
products for commercialisation and sale." said Mr. Lee Rodne, CEO of
"CardioCel® is an important addition to the surgeon's armoury
in the treatment of congenital heart disease, as well as for the repair
of heart valves and other cardiac defects" he said.
Admedus is able to sell CardioCel® in both Europe and the US
and will pursue market approvals in Asia and other jurisdictions.
"Admedus is looking forward to an exciting 2014/15 as we launch CardioCel®
globally and continue to grow our sales revenue and cardiovascular teams
in these regions" said Mr Rodne.
CardioCel® is engineered by the group's ADAPT®
tissue engineering process to be a durable, pure collagen scaffold that
avoids calcification, supports native cell infiltration, growth and
differentiation and which promotes a regenerative healing process.
CardioCel® has shown benefits over existing products in that
it does not calcify like other tissue products and has shown to
facilitate autologous tissue regeneration once surgically implanted,
while retaining strength and natural elasticity. CardioCel®
is a ready to use, off the shelf product that has the potential to
prevent follow up surgeries for patients because of its
anti-calcification and regenerative properties.
Admedus will be attending the 14th Annual International
Symposium on Congenital Heart Disease on the 14th of February
This program has been supported with a grant from Commercialisation
Australia, funded by the Australian government.
For more information, please contact:
Dr. Julian Chick,
Chief Operating Officer Admedus Limited Tel: +61 3 9620 5454
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