New FDA submission for use of ReCell in mass casualty scenario

Company News

Avita Medical (ASX:AVH), a regenerative medicine company focused on the treatment of wounds and skin defects, has 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.

According to the company, 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.

The process 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 US$61.9 million contract with BARDA, the initial order has a value of approximately US$8 million, 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."

“Important boxes have been ticked, and it is very positive that the information supplied to date has satisfied FDA’s initial review,” said Avita CEO Adam Kelliher.  “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.”

EUA is a provision whereby the FDA may authorise use of an investigational device when there are no adequate, approved, and available alternatives only after the Health and Human services (HHS) Secretary has made a declaration of emergency or threat justifying authorisation of emergency use.

Avita also said its program to get a US Pre-Market Approval (PMA) from the FDA is on track, with all data collected from its pivotal clinical trial involving seven leading US burns centres. The Company says it expects to submit its PMA application in mid-2017, with an anticipated FDA decision mid-2018. The FDA has approved ReCell for cases of Compassionate Use, where it is needed for life-saving events, and has granted Continued Access to the device for those medical professionals who participated in the clinical trial.