Avita Medical has received approval from the US Food and Drug Administration (FDA) for its Recell system for the treatment of full-thickness skin defects.
The regulator has approved the company’s premarket approval supplement application for the system.
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Avita Medical CEO Jim Corbett said: “This is a landmark approval representing an inflection point for Avita Medical.
“The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”
The indication has been expanded to cover a wide range of full-thickness skin defects, including wound injuries after surgical excision, resection and traumatic avulsion.
This move is expected to help the company significantly expand its market potential at least five times.
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By GlobalDataIn 2018, the company first received approval from the FDA for the Recell system to treat severe burns.
It is an autologous cell-harvesting device that uses a small amount of a patient’s skin to prepare, produce and deliver a regenerative cell suspension called Spray-On Skin cells.
The Spray-On Skin cells comprise a combination of single living cells, which stimulate healing and re-pigmentation throughout the wound bed to enable a definitive closure.
According to the findings of the pivotal trial conducted by the company, Recell showcased good healing rates for soft tissue repair and reconstruction.
Corbett added: “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 on 1 July 2023.”
