fda it's on!!, page-2

"ADMEDUS’s CARDIOCEL® CLEARED FOR SALE IN THE US
? CardioCel® now able to be marketed in the US
? Adds to EU approval in 2013
? Platform for growth in revenue for Admedus
Brisbane, Australia, 10th February 2014
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 Admedus Ltd.
“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 in Florida.
This program has been supported with a grant from Commercialisation Australia,
funded by the Australian government. "