US$53.9m for Avita to support mass burn injuries
Shares in Avita Medical (ASX:AVH) leapt over 30% today as the regenerative medicine company was awarded a contract with the US Biomedical Advanced Research and Development Authority (BARDA) worth up to $53.9 million. The five-year contract supports late-stage clinical development and procurement of Avita’s ReCell autologous cell harvesting device under a mass casualty preparedness program.
BARDA, a federal agency assigned to ensure the United States is prepared for public health emergencies, recently revealed that it was seeking to fund development of autograft-sparing products that can enhance the capacity to provide definitive care for thermal burn injuries. Avita responded to the solicitation by proposing the use of ReCell — a single-use device that allows medical professionals to quickly make a Regenerative Epithelial Suspension (RES), which can be immediately applied to a burn. In terms of autograft-sparing capability, RES can be created using only small skin samples, reducing the need for skin donor sites.
BARDA’s contract commits funding of $16.9 million to support Avita’s ongoing US clinical regulatory program towards FDA premarket approval (PMA) and to procure more than 5000 ReCell devices to establish an inventory so the product can help deal with a mass casualty scenario involving burn injuries. Avita also has the potential to receive up to $37 million when contract options are executed, which provides 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. Total procurement under the contract would cover more than 25,000 devices.
“Securing this contract from a US federal agency is a momentous milestone,” said Avita CEO Adam Kelliher. “US authorities have conducted a detailed evaluation of our technology and this contract further validates the opportunity afforded by our unique regenerative medicine.
“Further, this deal highlights the importance of preparedness for mass casualties. We look forward to meeting BARDA’s criteria for large-scale product delivery.”
Avita Medical (ASX:AVH) shares were trading 32.86% higher at $0.093 as of around 11.30 am on Wednesday.
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