Avita Medical (ASX:AVH) has announced the US FDA has approved a significant increase in the number of patients who may be treated in the country with its RECELL Autologous Cell Harvesting Device under a FDA Compassionate Use Investigational Device Exemption (IDE) program.
RECELL is a regenerative medical device designed to facilitate skin regeneration while reducing the amount of skin harvested at the time of surgery.
According to the company, under the expanded protocol, up to 88 patients with life-threatening injuries, including severe burns, may be treated with RECELL.
This is the fifth expansion to the Compassionate Use protocol for RECELL approved by the FDA and expands by 20 the number of patients who may be treated. Eligible patients are those who have insufficient healthy skin available for standard skin grafting treatment of their injuries and whose treating physicians believe there to be no suitable alternative treatment.
“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,” said Dr Michael Perry, Avita Medical’s CEO. “We thank the surgeons and other medical professional treating these patients for their support of this program and for their continued dedication to these patients.”