AVITA (RCEL) said late Thursday the US Food and Drug Administration granted 510(k) clearance for the Cohealyx collagen-based dermal matrix, expanding the company's capabilities in the treatment of full-thickness wounds.
The company said it co-developed the product with Regenity Biosciences.
AVITA said it intends to develop clinical data for Cohealyx early next year and expects to launch full commercialization efforts in the US at the start of Q2.
"We also anticipate Cohealyx will generate significant revenue as we penetrate the full-thickness skin defect market," the company said.
AVITA shares were up 2.3% in after-hours activity.
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