• Approval will accelerate penetration of CardioCel® in the region
• CardioCel® is now in over 80 centers globally
•Milestone caps a very strong 12 months for CardioCel® and Admedus
Brisbane, Australia 19th June, 2015
Admedus Limited (ASX: AHZ) today announced that it has received an approval letter for CardioCel®, its proprietary bio-scaffold, in Singapore. This application was based on the submission for US Food and Drug Administration (FDA) approval, which includes indications for use in cardiovascular repairs, suture buttressing and vascular and vessel repairs in both adults and children.
CardioCel® has already been used in Singapore under a Special Access program since last year and this approval will accelerate market penetration in the region.
“The Singapore approval caps off a very productive 12 months for the Admedus team, which is translating into growing sales momentum for CardioCel®, the flagship product from our ADAPT® platform. In addition to our already strong base in Europe, we have gained several new approvals for the product while also expanding our presence in the US, where CardioCel® is now available in 40 centers.” said Admedus CEO, Mr Lee Rodne.
CardioCel® is now being used in over 80 treatmentcenters, including key institutions in Europe, USA, Canada, Hong Kong and Singapore. The Company is pursuing additional approvals in Asia and has also partnered with GenPharma Int’l Pvt. Ltd for distribution in North African and Middle East markets.
“CardioCel® is being increasingly utilised by leading surgical groups, and continues to show compelling results and patient outcomes with respect to its ease of use, high tensile strength, low immunogenicity and strong anti-calcification properties,” said Mr Rodne.
“Our sales team is marshalling these results to cement the strong clinical rationale for using this product and to actively support further global expansion. We are confident that this highly considered approach will successfully drive topline growth.”
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For more information, please contact:
Dr Julian Chick | Chief Operating Officer | Admedus Limited
Tel: 1300 550 310
Media:
Haley Price
+61 (0) 423 139 163
hprice@admedus.com
Media Europe & Asia
FTI Consulting
Simon Conway / Victoria Foster Mitchell
Tel: +44 (0) 20 3727 1000
admedus@fticonsulting.com
About Admedus Limited
Admedus (ASX: AHZ) is a diversified, global healthcare company. Our focus is on investing in and developing next generation technologies with world class partners, acquiring strategic assets to grow product and service offerings and expanding revenues from our existing, profitable medical sales and distribution business. The company has assets from research & development through clinical development as well as sales, marketing and distribution.
Admedus has commercialised its innovative tissue engineering technology for regenerative medicine in four continents. We also have a major interest in developing the next generation of vaccines with a Brisbane-based research group led by Professor Ian Frazer. The vaccine programmes target diseases with significant global potential, such as Herpes and Human Papillomavirus.
Further information on the company can be found on www.admedus.com
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