• CardioCel® issued Medical Device Licence in Canada
• Canada becomes the latest market in the global launch of CardioCel®, following sales in Europe and the US Brisbane, Australia, 20 October, 2014
Admedus Limited (ASX: AHZ) today announced that CardioCel® has been granted a Medical Device Licence in Canada by Health Canada.
CardioCel® is the Admedus Group’s lead regenerative tissue bio-implant used in repairing heart defects, including the repair of heart valves.
Canada becomes the latest market approval for CardioCel®, with the product already having received CE Mark in Europe and 510k clearance in the US. The product’s use in Australia continues under the early access Authorised Prescriber Scheme (APS).
CardioCel® is being used by heart surgeons to treat patients at centres across Australia, Europe and the US.
“The Canadian approval is another important step in the global launch of CardioCel® and will add revenue growth for the Admedus Group,” said Mr Lee Rodne, Chief Executive Officer of Admedus.
The launch of CardioCel® in Canada is part of a continuing global strategy to gain product regulatory approval in major markets and directly secure key centers and surgeons as customers. The marketing of CardioCel® in Canada will be undertaken by the Admedus North American sales team.
Today’s announcement sees CardioCel® available for immediate sale and use by heart surgeons throughout Canada.
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For more information, please contact: Dr Julian Chick | Chief Operating Officer | Admedus Limited Tel: +61 3 9620 5454
Media:
Hayley Price
+61 (0) 423 139 163
hprice@admedus.com
Media relations Europe & Asia
Consilium Strategic Communications
Emma Thompson / Jessica Hodgson / Ivar Milligan
+44 (0)20 3709 5700
admedus@consilium-comms.com
About CardioCel®
CardioCel® is a type of cardiovascular scaffold that can be used to repair congenital heart deformities and more complex heart defects. It is engineered via Admedus’ proprietary ADAPT™ tissue engineering process to produce a durable, collagen scaffold with handling properties preferred by surgeons that avoids calcification, while supporting native cell infiltration, growth and differentiation.
About Admedus Limited
Admedus (ASX: AHZ) is a diversified healthcare company focused on investing in and developing next generation technologies with world class partners, acquiring strategic assets to grow its product and service offerings and expanding revenues from its 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 is in the process of commercialising its innovative tissue engineering technology for regenerative medicine. Admedus also has 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 disease with significant global potential such as Herpes and Human Papillomavirus.
Further information on the company can be found on www.admedus.com
About Admedus Regen
Admedus Regen started as a research program in 2001 focusing on tissue engineering and regenerative medicine based around the proprietary ADAPT® Tissue Engineering Process. The lead programme, CardioCel® is approved in Europe and in the US, and is being used in Australia under the Authorised Prescriber Scheme. CardioCel® is a cardiovascular scaffold used to repair paediatric and adult heart deformities. These deformities range from routine hole in the heart operations to major vessel outflow tract repairs. The CardioCel® scaffold may also be used to repair leaking heart valves in paediatric and adult patients. CardioCel® has been shown to allow tissue regeneration once implanted. Some researchers postulate that stem cells play an active role in tissue regeneration*, suggesting that CardioCel® facilitates endogenous stem cells and other cells to regenerate and repair damaged tissue.
The division is based on the patented ADAPT® Tissue Engineering Process as a platform technology to produce implantable tissue scaffolds for use in various soft tissue repair applications and for the production of replacement tissue heart valves.
The ADAPT® technology is used to process xenograft tissues to produce unique, implantable tissue scaffolds that are compatible with the human body. The technology has a number of advantages over current tissue treatment processes on the market, most notably the reduction of calcification post-implantation and has the potential to replace many of the products that surgeons currently use for soft tissue repair.
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