Avita Gets Expanded Compassionate Use for Burn Treatment Device

The FDA approved a large increase in the number of patients who may use Avita’s Recell autologous cell harvesting device, used for severe burns, under a compassionate use investigational device exemption (IDE) program.

With the approval, up to 108 patients suffering from severe and life-threatening burns may be treated with the Recell device and up to 26 U.S. burn centers may participate.

The compassionate use IDE program allows patients to be treated with the device before it receives FDA approval.