AHG’s CardioCel receives special access approval from TGA
Wednesday, 26 September, 2012
Allied Healthcare has had a win in the step to see its congenital heart defect treatment, CardioCel, approved for use across Australia.
A Brisbane surgeon has had an application to use Allied Healthcare (ASX:AHZ) CardioCel patch in procedures approved under the Therapeutic Goods Administration's Authorised Prescriber Scheme.
This scheme enables medical practitioners to apply for use of a product before it has received formal marketing approval, once the product has been reviewed by their hospital.
This represents the first approval of the patch by the TGA for use within Australia.
Professor Tom Karl of the Mater Hospital in Brisbane – one of the first surgeons to submit an application to use CardioCel in his procedures – secured the inaugural approval to use it in procedures to repair congenital heart defects in children.
The authorisation gives a precedent for current and future applications by surgeons under the scheme.
It will also allow Allied Healthcare and its regenerative tissue engineering division, Celxcel, to start receiving profit from sales of CardioCel, albeit not necessarily the same percentage as when the product receives full marketing approval.
Allied Healthcare CEO of regenerative medicine Bob Atwill expects more approvals under the scheme in the coming months.
“A number of other key cardiothoracic surgeons are in [the] process of making similar applications to the TGA as a result of CardioCel’s preclinical and clinical data showing its effectiveness in treating congenital heart defects,” he said.
The CardioCel patch is produced using Celxel's ADAPT tissue engineering technology, which has the advantage of reducing the risk of calcification compared to other tissue-based products.
CardioCel also has applications in procedures including heart valve reconstruction.
Besides its TGA application, Allied Healthcare is seeking a CE Mark for Cardiocel in Europe and FDA approval in the US.
Allied Healthcare (ASX:AHZ) shares were trading 23.81% higher at 2.6c as of 4:30pm on Wednesday.
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