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Brisbane, Australia, 8 July 2013 -- Allied Healthcare Group (ASX: AHZ) today announced that Dr Homayoun Jalali, a Brisbane-based paediatric and adult heart surgeon, has been granted approval to use CardioCel® to treat and repair heart defects under the Authorised Prescriber Scheme.
Dr Jalali is the sixth surgeon to obtain access to use CardioCel® under early access schemes which allows Australian surgeons to apply to use the product prior to full marketing approval.
“This is a key step for Allied as it represents the first adult surgeon to gain access to use CardioCel® under the Authorised Prescriber Scheme, and has the potential to increase market potential and revenue for the Company considerably,” said Allied Healthcare Group CEO Mr Lee Rodne.
“CardioCel® offers considerable ease of use for surgeons, as it can be used straight out of the box, and we are encouraged to see growing support for the product both locally and internationally. CardioCel® is also proven to deliver key benefits to patients compared to current marketed tissue repair products.”
CardioCel® is a cardiovascular tissue product used to repair heart deformities including repairing and reconstructing heart valves.
Ten years of preclinical and clinical studies have shown CardioCel® patches have no evidence of cytotoxicity or calcification at the site of repair for four years post-surgery. CardioCel® has also shown superior cell survival and regenerative properties when compared with existing gold standard patches implanted with stem cells.
Allied Healthcare Group has filed for marketing approval for CardioCel® with both the European Regulatory Authority (EMA) and the US FDA.
Videos on CardioCel® can be viewed at: http://www.alliedhealthcaregroup.com.au/video
For more information, please contact:
Dr Julian Chick, Chief Operating Officer Allied Healthcare Group Tel: +61 3 9620 5454
Media:
Shevaun Cooper
Buchan Consulting
+61 39866 4722
scooper@buchanwe.com.au
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 commercialising its innovative tissue engineering technology for regenerative medicine. Allied also has 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 like Herpes and Human Papilloma virus.
Further information on the Company can be found on www.alliedhealthcaregroup.com.au.
Allied’s Regenerative Medicine Division
Allied’s regenerative tissue engineering technology started as a research program in in 2001 focusing on tissue engineering and regenerative medicine based around the proprietary ADAPT® Tissue Engineering Process. The lead programme CardioCel® has successfully completed a number of animal studies and a Phase II human clinical trial. 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. 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 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.
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