Admedus gains Singapore approval for CardioCel

THE ROADHOUSE PHARMACY: Admedus Limited (ASX: AHZ) has received approval from the Singapore Health Sciences Authority to enable four surgeons to use the company’s CardioCel® product under an early access program.

Admedus explained CardioCel is a 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,” Admedus chief executive officer Lee Rodne said in the company’s announcement to the Australian Securities Exchange.

“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.”

Admedus said 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.

Email: info.au@admedus.com

Website: www.admedus.com