Avita gains key US approval

The medtech company jointly established by Perth burns surgeon Fiona Wood has achieved a landmark regulatory approval in the US for its spray-on skin technology.

Avita Medical said the US Food and Drug Administration (FDA) had approved its premarket approval supplement for the use of its RECELL system to treat full-thickness skin defects. 

“This is a landmark approval representing an inflection point for Avita Medical,” US-based chief executive Jim Corbett said.

“The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”   

The approval means RECELL can be used for a broad range of skin defects, such as wound injuries and surgical excision.

The company said this would dramatically expand its market opportunity by at least five times.

“We had a high level of confidence in the FDA’s approval timeline of RECELL for the treatment of skin defects,” Mr Corbett said.

“In anticipation of the expanded indication, we more than doubled our field sales organisation in the first few months of the year.

“Our sales team is now ready, trained, and fully prepared for the commercial launch, which will commence July 1 2023.”

The RECELL system was first approved in the US for the treatment of severe burns in 2018.

Shares in ASX-listed Avita were trading 10 per cent higher at $4.72 today after peaking in early trade at $5.14.