ASX ANNOUNCEMENT
ADMEDUS CARDIOCEL® GAINS SPECIAL ACCESS IN SINGAPORE
Four surgeons approved to use CardioCel® in Singapore
First CardioCel® use in Asia
Brisbane, Australia, 3 November, 2014
Admedus Limited (ASX: AHZ) today announced that CardioCel® has received approval from the Singapore Health Sciences Authority to enable four surgeons to use the product under an early access program.
CardioCel® is the Admedus Group’s lead regenerative tissue bio-implant used in repairing heart defects, including the repair of heart valves. CardioCel® has already received FDA 510k clearance and CE mark approval in the US and Europe respectively and is in use at cardiac centres throughout those markets. CardioCel® also recently received its Medical Device Licence in Canada and its use in Australia continues through the early access Authorised Prescriber Scheme.
"This is a very encouraging milestone for the Admedus Group, with surgeons in Singapore now granted approval to begin working with CardioCel® and establishing familiarity with this innovative medical device for the first time in Asia," said Mr Lee Rodne, Chief Executive Officer of Admedus. "The approval provides further endorsement of the benefits of CardioCel® and we hope it will pave the way to full marketing approval in this important health market."
The special access program will enable four surgeons from different leading cardiac hospitals to use the product in the repair of cardiovascular defects.
Admedus is currently seeking marketing approval for CardioCel® in multiple markets in Asia as part of its global strategy to launch the product in significant markets and continue to increase commercial revenues for the Admedus Group.
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