Avita Medical shares jump on FDA approval of burn treatment
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The news: Shares in Avita Medical have surged after the US-based regenerative medicine company said it had received a nod from the US Food and Drug Administration (FDA) for its premarket approval (PMA) supplement for the Recell Go System.
The numbers: Avita shares jumped nearly 13% to $3.02 in early trading on the ASX after the announcement. The stock has been under pressure as the company’s commercial revenue has slowed in recent months, with first quarter net loss doubling to USD18.7 million ($28.3 million) amid rising sales and marketing expenses.
The context: The Recell Go device harnesses the regenerative properties of a patient's own skin to treat thermal burn wounds and full-thickness skin defects.
Following the FDA approval, it will now be launched in top burn treatment centres in the US in June, while other existing accounts will be converted to the new device throughout the year, the company said.
What they said: "FDA approval of Recell Go marks a paradigm shift in the treatment of partial-thickness and full thickness wounds," chief executive Jim Corbett said.
"We believe that this transformative shift will empower more clinicians to achieve optimal outcomes for their patients, driving greater adoption, and fundamentally redefining wound care management."
The source: ASX announcement
