Avita Medical (ASX:AVH) said today the FDA approved an expansion to the number of patients treatable by its ReCell device under the compassionate use investigational device exemption program by 20 individuals.
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, the company said.
With the expansion, which is the fifth for the company, up to 88 patients with life-threatening injuries can be treated with the ReCell device.
Patients eligible for treatment with the device are those who have insufficient healthy skin available for standard skin grafting treatment, or those whose treating physicians believe there to be no suitable alternative treatment, according to the company.
A total of 64 patients have been treated with the device under compassionate use, Avita said, with two abstracts related to cases from the compassionate use program having been accepted for presentation at the American Burn Association’s 50th annual meeting.
“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,” CEO Dr. Michael Perry said in a prepared statement.
Avita said it submitted a PMA application for the ReCell device last September, and hopes for the review of the application to be completed during the second or third quarters this year.