ReCell device gets fifth expanded FDA compassionate use

The FDA has approved expanding the number of patients with life-threatening injuries that can be treated by Avita Medical’s ReCell device under the Compassionate Use investigational device exemption program from 68 to 88. The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, where the patient has insufficient healthy skin available for standard skin grafting treatment, or where the medical staff believe there is no suitable alternative treatment.
Dr. Michael Perry, Chief Executive Officer, said: “We appreciate the FDA approval of the expansion of our Compassionate Use program, which highlights the critical unmet need among patients with life-threatening injuries such as severe burns. We thank the surgeons and other medical professionals treating these patients for their support of this program and for their continued dedication to these patients.”