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Allied Healthcare Group reports Queensland surgeon approved to use CardioCel®

Published: 19:00 07 Jul 2013 EDT

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Allied Healthcare Group (ASX: AHZ) could be on the cusp of increased revenues at it announced approval was received for the first surgeon to gain access to use CardioCel® under the Authorised Prescriber Scheme.

CardioCel® is a cardiovascular tissue product used to repair heart deformities including repairing and reconstructing heart valves.

Recently, CardioCel® and Allied Healthcare was awarded a $1.9 million matching grant for commercialisation of the product.

Dr Homayoun Jalali, a Brisbane-based paediatric and adult heart surgeon, was granted approval to use CardioCel® to treat and repair heart defects under the APS.

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 before the onset of full marketing approval.

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.

Allied Healthcare Group CEO Mr Lee Rodne said, “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.

“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® 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.

The company had a cash balance of $3.77 million at the end of the previous quarter, generating over $5.4 million in revenue, up 8% for the year to date.

 

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