Dive Brief:

• Avita Medical said FDA approved a significant increase in the number of burn patients who may be treated using its Recell Autologous Cell Harvesting Device under the compassionate use investigational device exemption (IDE) program.
• FDA’s approval expands use of Avita’s treatment to include up to 108 patients and 26 U.S. burn centers.
• Patients who are eligible for the treatment have insufficient healthy skin available for conventional skin grafting treatment of their injuries, and their treating physicians believe there to be no suitable alternative treatment.

Dive Insight:

The Recell device enables medical professionals to produce a regenerative epidermal suspension using a small sample of the patient’s skin and wound healing factors necessary to regenerate epidermis. This is then applied to the area to be treated.

The suspension offers a way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery.

The compassionate use program allows the treatment of eligible U.S. patients with the Recell device in advance of FDA approval. Eight-two patients have already been treated with the device under the compassionate use program at more than 15 major U.S. burn centers.

“The participation of these major U.S. burn centers in the compassionate use program highlights the critical unmet need amongst patients with life-threatening burns, and we are pleased to make the Recell device available under this program,” said Michael Perry, Avita Medical’s CEO.

Through a combination of the company’s clinical trials and other programs, 24 U.S. burn centers have treated patients with the device, the company said. Globally, more than 7,000 patients have been treated to date.

Avita said a U.S. PMA application for the treatment of burn injuries is currently under review by the FDA. The company expects completion of the FDA review of the PMA during the third quarter of 2018, followed by U.S. approval and market launch.

Avita said Recell is TGA-registered in Australia and CFDA-cleared in China. In Europe, the company has received CE-mark approval for three products: Recell for the treatment of burns and plastic reconstructive procedures; ReGenerCell for chronic wounds including leg and foot ulcers, and ReNovaCell for aesthetic applications including the restoration of pigmentation.