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Allied Healthcare Group Ltd : Allied Healthcare Group submits CE Mark application for the CardioCel® cardiovascular patch

06/04/2012 | 10:52pm US/Eastern

ASX ANNOUNCEMENT

Allied Healthcare Group submits CE Mark application for the CardioCel®

cardiovascular patch

Brisbane, Australia, 5th of June 2012

Allied Healthcare Group (ASX: AHZ) announced today that it has submitted to its European Notified Body a CE mark application for marketing authorisation of its tissue matrix product CardioCel®. This application is part of the Allied strategy to bring its regenerative medicine products to market in the major global markets. As CardioCel® is manufactured using animal derived material, this submission will be evaluated by Allied's Notified Body, as well as the Medicines and Healthcare Regulatory Agency (MHRA) in the United Kingdom.
"This is another step towards the commercialisation of the CardioCel® and ADAPT® technology and part of the company strategy to bringing products to market in the regenerative medicine multi-billion dollar markets" stated Lee Rodne Allied Healthcare Group Managing Director. "The next 12 to 18 months will be exciting for our regenerative medicine franchise as it seeks approval in numerous jurisdictions".
Over the past 10 years the ADAPT® technology and its use to prepare tissue for surgical repair, has been tested in a significant number of animal studies as well as a Phase II study. This dossier consists of the extensive data package generated around this technology and the CardioCel® cardiovascular patch.
"The CE Mark submission is a key value driver for the Allied Healthcare Group. 2013 is shaping up to be a very exciting year launching our first product from the ADAPT® TEP platform technology into major cardiovascular marketplaces" said Allied Healthcare Group Executive and CEO of the regenerative franchise Bob Atwill.
The importance of this application is that Europe is one of the major markets for regenerative medicine products. If successful, this provides the potential for significant revenue for the Allied Healthcare Group. The initial use of the product will be in cardiac surgical repair, such as congenital heart disease, which is one of the major causes of death in infants. The ADAPT® platform technology also has the potential to have a significant impact on the global market for structural heart defect repair, estimated at over $3Bn* with Europe one of the major markets.
Allied Healthcare Group is expecting to file for US marketing approval for the CardioCel®
product later this year.
In addition to the initial cardiovascular products, Allied Healthcare Group is also evaluating how its ADAPT® TEP platform technology can be used in pelvic floor reconstructions, hernia repairs, orthopaedics and as a biological scaffold to grow and deliver stem cells.

ABN 35 088 221 078

Level 1, 197 Adelaide Terrace

Perth Western Australia 6000

PO Box 6879 East Perth

Western Australia 6892

T +61 (0)8 9266 0100

F +61 (0)8 9266 0199

E info@alliedhealthcaregroup.com.au

www.alliedhealthcaregroup.com.au
For more information, please contact:
Dr Julian Chick, Chief Operating Officer Allied Healthcare Group Tel: +61 3 9620 5454
Bob Atwill, Allied Healthcare Group Executive and CEO, Celxcel Tel: +61 448 778 880
Media:
Paul Dekkers
Buchan Consulting
+61 2 9237 2800 pdekkers@buchanwe.com.au
* Natixis Bleichroeder LLC estimates
About Allied Healthcare Group Limited
Allied Healthcare Group Limited (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.
Allied Healthcare Group is in the process of commercializing its innovative tissue engineering technology for regenerative medicine and is a major investor in Brisbane based Coridon Pty Ltd, led by Professor Ian Frazer developing next generation vaccines for global markets.
Further information on the Company can be found on www.alliedhealthcaregroup.com.au.
About Celxcel
Celxcel, a regenerative tissue engineering technology company founded in 2001 focusing on tissue engineering and regenerative medicine based around the proprietary ADAPT® Tissue Engineering Process (TEP). Celxcel's lead program has successfully completed a number of animal studies and a Phase II human clinical trial for its lead product CardioCel®. CardioCel® is a cardiovascular patch used to repair paediatric heart deformities. These deformities range from routine "Hole in the Heart" operations to major vessel outflow tract repairs. The CardioCel® patch may also be used to repair leaking heart valves in paediatric patients.
Celxcel uses its patented ADAPT® Tissue Engineering Process (TEP) as a platform technology to produce implantable tissue patches for use in various soft tissue repair applications and for the production of replacement tissue heart valves. The ADAPT® technology is used to process animal derived tissues to produce unique implantable tissue patches 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. This technology has the potential for medical professionals to use regenerative products instead of synthetic products currently used in soft tissue repair.

ABN 35 088 221 078

Level 1, 197 Adelaide Terrace

Perth Western Australia 6000

PO Box 6879 East Perth

Western Australia 6892

T +61 (0)8 9266 0100

F +61 (0)8 9266 0199

E info@alliedhealthcaregroup.com.au

www.alliedhealthcaregroup.com.au
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