A Melbourne-based regenerative medicine company is hailing expanded US approval for its spray-on skin solution for treating wounds and burns as a huge market opportunity.
Avita Medical on Thursday said that the US Food and Drug Administration had approved its RECELL system for treating full-thickness skin defects, such as from degloving, necrotising soft-tissue infections or skin cancer.
"This is a landmark approval representing an inflection point for Avita Medical," said CEO Jim Corbett.
"The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings."
An alternative to painful skin grafts, the RECELL system uses a small amount of the patient's own skin to create a regenerative cell suspension that stimulates healing. It has been used in the US to treat severe burns since 2018.
Avita said that it had already doubled its field sales team in anticipation of the expanded FDA approval, which enlarges its market opportunity by at least five times. A full commercial rollout is set to begin on July 1.
At 11.38am AEST, Avita shares were up 13.1 per cent to a four-week high of $4.85.