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US backs Avita’s spray-on skin technology with big contract

• The Australian
• October 01, 2015 12:00AM

Australian medical device company Avita Medical has signed a “company-transforming” $54 million deal with the US government to supply its spray-on skin technology.

Avita chief executive Adam Kelliher said the deal had pushed the company on to a completely different plateau.

The company’s technology, ReCell, was developed by Australian doctor Fiona Wood and gained global attention when it was used to help people injured in the 2005 Bali bombings.
Avita, created to commercialise ReCell, revealed yesterday it had been awarded a contract with the Biomedical Advanced Research and Development Authority (BARDA) for use of its product under a US mass casualty preparedness program.

BARDA is a US agency that aims to ensure the US is prepared for public health emergencies.
“BARDA does not give out these awards lightly or easily,” Mr Kelliher said.
“There had very detailed due diligence involved ... it’s a massive endorsement.”
News of the deal saw shares in the company jump, closing 17 per cent higher at 8.2c.

Avita will receive $16.9m to support its ongoing US clinical regulatory program and to procure more than 5000 ReCell devices to be deployed in a mass casualty scenario involving burn injuries.
Mr Kelliher said there were two essential strands to the BARDA brief. One was to protect US citizens from chemical and biological disasters and nuclear warfare. The second was to keep the US at the forefront of medical innovation.

“They are always on the lookout for innovative breakthrough products,” he said. “Fundamental to this process is the fact that we are doing a burns trial in the US and at the same time we have compassionate use dispensation through the FDA. So there are a number of leading burns surgeons in the US who are using the product and have seen its success. Their views would’ve been important to BARDA.”
The Avita chief said “tentative” US talks began two years ago but had intensified over the past few months. He said other US government agencies had also looking at Avita, and “boxes have been ticked by several US government authorities”.

The deal will see BARDA fund a training package for burns surgeons and associated medics across the US. The government agency will support Avita through other initiatives.
“It is a massive support package for our direction of travel,” Mr Kelliher said.
The Australian company could also receive up to $37m when contract options are executed, supporting further clinical studies potentially required by the FDA as part of post-market surveillance, or to expand the use of ReCell to the paediatric population.
Mr Kelliher said the company operated in a competitive space but stood alone in its niche of providing epithelial closure of dreadful wounds. “The potential is that wherever a skin graph is being done our product ReCell should be done in conjunction with it. Once it is understood and used by capable people it has massive potential.

http://www.theaustralian.com.au/bus...ith-big-contract/story-e6frg8zx-1227551382348