Fiona Wood-founded Avita Medical has received a $US16.9 million ($A24.1 million) commitment from a US government agency to fund a trial of its ReCell device.
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Fiona Wood-founded Avita Medical has received a $US16.9 million ($A24.1 million) commitment from a US government agency to fund a trial of its ReCell device.
Fiona Wood-founded Avita Medical has received a $US16.9 million ($A24.1 million) commitment from a US government agency to fund a trial of its ReCell device.
The Biomedical Advanced Research and Development Authority has committed the funds to support late-stage clinical development of Avita’s ReCell autologous cell harvesting device, which treats thermal burn injuries, and will procure an initial 5,000 units.
The devices are being procured under a US mass casualty preparedness program.
The contract, which will run for five years, will fund the clinical regulatory program towards FDA premarket approval.
“Under the contract, Avita also has the potential to receive up to $US37 million when contract options are executed which provide support for further clinical studies potentially required by the FDA as part of post-market surveillance, or as needed to expand the use of ReCell to the paediatric population,” Avita said in a statement.
“Total procurement under the contract would cover more than 25,000 devices.”
Avita chief executive Adam Kelliher said the Barda agreement was a transformational opportunity for the company.
“Securing this contract from a US federal agency is a momentous milestone. US authorities have conducted a detailed evaluation of our technology and this contract further validates the opportunity afforded by our unique regenerative medicine,” Mr Kelliher said.
“Further, this deal highlights the importance of preparedness for mass casualties.”
The ReCell technology first gained prominence as a treatment for burns victims after the 2002 bombing attack in Bali, and was deployed recently at the Taiwan waterpark disaster.
The device allows medical professionals to quickly make a ‘regenerative epithelial suspension’, which can immediately be applied to a burn.
One benefit of the device is that it could reduce the need for skin donors.
Shares in Avita were 17.1 per cent higher to 8.2 cents at the close of trade.
Rank | Company | Revenue | |
---|---|---|---|
th | ![]() | Avita Medical | $87.8m |