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.
Follow us:
Twitter: @Admedus
Facebook: www.facebook.com/pages/Admedus
For more information, please contact:
Dr Julian Chick | Chief Operating Officer | Admedus Limited
Tel: +61 3 9620 5454
Media:
Haley Price
+61 (0) 423 139 163
hprice@admedus.com
Media 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 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 heart valves. 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 the product facilitates endogenous stem cells and other cells to regenerate and repair damaged tissue.
CardioCel® is the Admedus Group’s lead regenerative tissue bio-implant used in repairing heart defects, including the repair of heart valves. It is engineered via the Admedus Group’s 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. Our focus is 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. We also have a major interest in developing the next generation of vaccines with a Brisbane-based research group lead 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, the US and Canada and is being used in Australia under the Authorised Prescriber Scheme.
Admedus Regen 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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• 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.
Follow us:
Twitter: @Admedus
Facebook: www.facebook.com/pages/Admedus
For more information, please contact:
Dr Julian Chick | Chief Operating Officer | Admedus Limited
Tel: +61 3 9620 5454
Media:
Haley Price
+61 (0) 423 139 163
hprice@admedus.com
Media 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 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 heart valves. 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 the product facilitates endogenous stem cells and other cells to regenerate and repair damaged tissue.
CardioCel® is the Admedus Group’s lead regenerative tissue bio-implant used in repairing heart defects, including the repair of heart valves. It is engineered via the Admedus Group’s 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. Our focus is 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. We also have a major interest in developing the next generation of vaccines with a Brisbane-based research group lead 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, the US and Canada and is being used in Australia under the Authorised Prescriber Scheme.
Admedus Regen 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.
Help employers find you! Check out all the jobs and post your resume.