Avita Medical (ASX:AVH) said today it won expanded coverage under the FDA’s compassionate use investigational device exemption program for its Recell autologous cell harvesting device.
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, Avita said.
With the expansion, Avita will be able to enroll a total of 108 patients with severe burns to be treated with the device at up to 26 US burn centers, the Valencia, Calif.-based company said. Currently, a total of 82 patients have been treated with the device, Avita said.
“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. 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. Combined with the over 7,000 patients who have been treated with the Recell device globally, these programs provide us a large body of experience regarding the potential clinical benefits as well as the costs savings associated with use of the Recell device,” CEO Dr. Michael Perry said in a prepared statement.
In June, Avita Medical released results from a pivotal clinical trial of its ReCell autologous cell harvesting device in treating deep partial-thickness second-degree burns.
