A US Federal authority charged with supporting development of medical countermeasures for possible mass casualty events has agreed to fund Perth-based Avita Medical (ASX:AVH) a further $US7.96 million to support the regenerative medicine company in its plans for US market approval and product launch of ReCell.
The company, which makes Autologous Cell Harvesting Devices for treatment of burns, chronic wounds and certain aesthetic conditions, said the award supplements the contract executed last September with the Biomedical Advanced Research and Development Authority (BARDA), worth up to $US53.9m.
The initial contract with BARDA, an authority under the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services, includes procurement and various elements of support for late-stage development of ReCell.
The new contract addendum, worth up to $US7.96 million (AUD$11m), commences immediately, said the company, "giving further operational support to facilitate the overarching objective of BARDA for preparedness via securing effective treatment of burn injuries secondary to detonation of a nuclear device."
Avita said the additional funds will "bolster ongoing" work toward its filing of a PMA application, along with funding new initiatives toward gaining familiarity and acceptance of ReCell across US Burn Centers. It will also go towards the recruitment of new personnel at the company’s office in California.
“This welcome infusion of significant non-dilutive capital to fund our activities in the US, which we would otherwise have had to fund ourselves, greatly supports Avita Medical on its commercial journey,” said Avita CEO Adam Kelliher. “We are particularly excited about the health economics support, which we hope will enable us to show how innovative approaches such as ours can both help burn victims and save money as these are the key drivers to support our reimbursement efforts.”