Initial Pre-Emergency Use Authorization Submission Made to U.S. FDA for Use of ReCell in a Mass Casu

Avita Medical received notification of the initial FDA review of the Pre-EUA (Emergency Use Authorization) submission to allow the emergency deployment of its ReCell device for a mass casualty event involving burn injuries.

The Biomedical Advanced Research and Development Authority (BARDA) filed the Pre-EUA submission, and the review is conducted at this pre-approval stage because, during exigent circumstances, the time available for the submission and review of an EUA request may be severely limited. For the contract with BARDA, this brings the company closer to establishing a national strategic stockpile of vendor-managed inventory of ReCell autologous cell harvesting devices, which once approved, will allow physicians to rapidly deliver a suspension of skin cells to various wounds, including burns. Under Avita's USD61.9m contract with BARDA, the initial order has a value of approximately USD8m, and BARDA could opt to purchase in advance of FDA market approval, which the company is also pursuing.

BARDA informed Avita that the pre-EUA submission has been reviewed by the FDA and that the agency has no 'additional comments or questions at this time.' BARDA said that a pre-EUA submission is not an indication of the FDA's views on the product's potential to be used under an EUA, nor that the sponsor has obtained or submitted all the information necessary for FDA to review a formal request for consideration of an EUA. BARDA explained that a pre-EUA submission is a mechanism to initiate early discussions with the FDA prior to an emergency only, and does not provide an independent legal basis for distributing or dispensing unapproved products or approved products for unapproved uses.

Avita will continue to update the required documentation to the FDA via communications with BARDA on an ongoing basis regarding any new information relevant to the ReCell device and its potential emergency use.

"Important boxes have been ticked, and it is very positive that the information supplied to date has satisfied FDA's initial review," Avita CEO Adam Kelliher said. "My team will keep supporting BARDA so that we can fulfill our contractual goal of delivering a significant number of ReCell devices for use in the event of a U.S. emergency."