The expansion will allow the trial to cover twice as many patients and extend it to patients to patients with larger, more serious defects than burns, the Cambridge, U.K.-based company said.
“Approval from the FDA for doubling the number of compassionate use cases is not only a significant achievement for Avita as we continue our pivotal U.S. trial of ReCell in burns, it provides an alternative treatment option for patients with no other skin-healing option. The ability to achieve definitive closure of extensive injuries in this patient population can have a life-saving impact,” CEO Adam Kelliher said in a press release.
The federal watchdog granted the initial compassionate use IDE for up to 12 subjects with life-threatening wounds, and with the expansion will allow for up to 24 patients to be treated.
The news sent stocks up nearly 12% to 7¢ (AUD 9¢), the highest it has been since August.
Last week, Avita said it won $53.9 million in contracts from the Biomedical Advanced Research and Development Authority for development and procurement of Avita’s ReCell autologous cell harvesting device.
The 5-year contract will provide an initial $16.9 million to support the company’s pursuit of FDA premarket approval for its ReCell device, and to procure more than 5,000 of the devices to establish an inventory to handle mass casualty scenarios that involve burn injuries, Avita Medical said.