The decision accelerates the timeline for ReCell’s approval, which Avita had expected to occur in the 3rd quarter of 2017, the company said.
“The FDA’s decision that we meet the criteria tallies with our view that ReCell is a unique offering for helping burns victims, and as such, approval would be preferable sooner than later,” research & technology vice president Andrew Quick said in prepared remarks. “So we are very excited that we can now advance discussions with the agency to determine exactly how this changes our timeframes.”
Avita said it will work with the FDA’s Center for Biologics Evaluation & Research on a data development plan for its pre-market approval application for ReCell. Enrollment in a 30-patient investigational device exemption trial is nearly complete at 26 subjects, the company said.
The FDA in October doubled to 24 the number of facilities eligible to use ReCell under a compassionate use exemption, Avita said.
In September, Avita said it won $53.9 million in contracts from the Biomedical Advanced Research & Development Authority for the ReCell device.