AVITA Medical Announces Expanded Compassionate Use of RECELL Device in Life-Threatening Burns

AVITA Medical (ASX:AVH, OTCQX:AVMXY) today announced that the U.S. Food and Drug Administration (FDA) has approved a significant increase in the number of patients who may be treated in the U.S. using the RECELL® Autologous Cell Harvesting Device under a Compassionate Use Investigational Device Exemption (IDE) program.

As quoted in the press release:

The Compassionate Use program allows the treatment of eligible patients with the RECELL Device in advance of FDA approval. Eligible patients are those who have insufficient healthy skin available for conventional skin grafting treatment of their injuries and whose treating physicians believe there to be no suitable alternative treatment. Currently, 82 patients have already been treated under the Compassionate Use program.

Major U.S. burn centers that have treated patients with the RECELL Device under the Compassionate Use program include Arizona Burn Center at Maricopa Medical Center, Baton Rouge General Hospital, Grady Burn Center – Grady Health System, Maine Medical Center – MaineHealth, Massachusetts General Hospital, MedStar Washington Hospital Center, Regional Medical Center / University of Tennessee, Wake Forest Baptist Medical Center, Walter Reed National Military Medical Center, Riley Hospital for Children (Indianapolis), St. Christopher’s Hospital for Children, Shriners Hospitals for Children – Boston, Sidney & Lois Eskenazi Hospital, U.S. Army Institute for Surgical Research (San Antonio), University of California San Diego Health System, and University of South Alabama.

Click here to read the full press release.