Avita Medical Ltd received approval from the U.S. Food and Drug Administration to treat more burn victims with its investigational cell harvesting device Recell under a special program.
The Australia and U.S.-listed biotech company said that under the FDA's Compassionate Use Investigational Device Exemption program it can now treat up to 108 patients with severe burns using Recell, and up to 26 U.S. burn centers may participate in the program.
The device has not been approved by the FDA yet.
The compassionate use program allows the device to be used, ahead of a formal approval, on eligible patients, such as those who don't have enough healthy skin for conventional skin grafting.
The company has been treating patients under the program since April 2014. Under the initial approval, up to 12 patients with life-threatening wounds were treated at various burn centers across the U.S., the company had said in its April 2014 release.
Since then, 82 patients have already been treated under the compassionate use program.
Funding for the program is being provided by the Biomedical Advanced Research and Development Authority, or BARDA, which operates under the U.S. Department of Health and Human Services.
"We are also encouraged by the fact that 24 U.S. burn centers have treated patients with the Recell device through a combination of our clinical trials, Continued Access program, and Compassionate Use program, giving the product candidate broad exposure within the U.S. burn community," CEO Michael Perry said.
Recell uses a small skin sample from a burn patient to produce a regenerative suspension that helps close wounds. In June, Avita announced the acquisition of a manufacturing facility to support the launch of the device. The company has reported positive data from three late stage trials of the device.
Currently, Recell is not approved for sale in the U.S. and is limited by federal law for investigational use only. The FDA is expected to complete its premarket review of Recell in the third quarter of 2018, Avita said.