ANTERIS TECHNOLOGIES LTD ADMEDUS LIMITED ABN 35 088 221 078
REGISTERED OFFICE:
26 Harris Road Malaga Western Australia 6090
ASX RELEASE
F +61 (0)8 9266 0199
E info.au@admedus.com
www.admedus.com
CardioCel® now approved for valve and annular repair in Europe
European label now more in line with US label, where CardioCel is already approved for valve repair and reconstructions
CardioCel now in over 120 centres globally
Label expansion part of the global strategy to position CardioCel as the leading bio- scaffold
Admedus (ASX:AHZ) has today announced that it has received notification from the European Medicines Agency (EMA) that CardioCel has been granted a broader label indication for its use in Europe. The new, expanded indication for CardioCel means the product is approved for use in the repair and reconstruction of heart valves, in addition to congenital heart defects, and is more in line with the US label.
The expanded indication is a significant step in establishing CardioCel as the regenerative tissue product of choice for repairing and reconstructing heart valves and is part of the Group's global strategy to drive sales growth. CardioCel is now used in over 120 centres globally.
'This is an important label expansion and will help us to increase the use of CardioCel in Europe, particularly in adult patients. We're very excited to expand our work with surgeons and key heart centres in Europe and around the world on improving patient outcomes in treating heart valve disease by repairing and reconstructing heart valves with CardioCel.' said Admedus CEO Mr Lee Rodne.
Admedus is currently undertaking a post-approval clinical study with leading heart centres to further bolster the clinical data available for CardioCel to demonstrate the benefits to patients in whole valve reconstructions over bio-prosthetic valve replacement.
CardioCel is on market in Europe, USA, Canada, Hong Kong, Singapore and Malaysia and continues to be accessed in the Australian market through early access programs. Admedus is also working with its partner Genpharm in the Middle Eastern and Northern Africa (MENA) region for additional regulatory approvals as well as exploring new markets in Asia.
CardioCel was initially launched in Europe at the end of 2013 and has been implanted in over 3000 patients. This recent label extension will enable surgeons to use CardioCel to repair congenital heart defects, heart valve repairs and augmentations, as well as whole heart valve reconstructions. The European heart valve market is estimated to be worth over $1 billon.
Follow us:
Twitter: @Admedus
Facebook: www.facebook.com/pages/Admedus
Dr Julian Chick | Chief Operating Officer | Admedus Limited Tel: +61 (0)8 9266 0100
Shevaun Cooper | PR Manager | Admedus Limited
Tel: +61 (0) 417 985 599 | Email: scooper@admedus.com
FTI Consulting
Simon Conway / Victoria Foster Mitchell Tel: +44 (0) 20 3727 1000
admedus@fticonsulting.com
Admedus (ASX: AHZ) is a specialist 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 disease with significant global potential, such as Herpes and Human Papillomavirus.
Further information on the company can be found on www.admedus.com
CardioCel is a type of cardiovascular bio-scaffold that can be used to repair congenital heart deformities and more complex heart defects. It is used to repair diseased paediatric and adult hearts. These repairs 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. CardioCel is a registered trademark.
|
distributed by
|
