AVITA Medical submits to US FDA with the goal of expanding indication for RECELL

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Regenerative medicine company AVITA Medical (ASX:AVH) has submitted to the US FDA for premarket approval (PMA) supplement application for its RECELL System.

The company said that if approved, the supplement will expand the indication of RECELL to include soft tissue repair.

“The submission is a significant milestone in our effort to expand the label of RECELL into the soft tissue repair market opportunity,” said AVITA Medical CEO Jim Corbett.

"Soft tissue repair encompasses a broad label of RECELL applications and allows us to target all level 1 and level 2 trauma centres in the US. Once approved, this indication expands our current market opportunity by at least three times and is expected to create a significant growth opportunity for us beginning July 2023.”

This PMA supplement includes the recently released results of the pivotal trial for soft tissue repair. The study met both co-primary endpoints, demonstrating that RECELL is statistically significant in donor-sparing and statistically non-inferior in healing outcomes.

The company said that for the clinical study, soft tissue injuries included any full-thickness acute skin defect, such as degloving or peeled-back skin injuries, road rash, surgical wounds, and flesh-eating disease.

The RECELL System earned FDA Breakthrough Device designation for its proposed soft tissue repair indication. Under the program, AVITA Medical will receive prioritised review and interactive communication with the FDA during the premarket review phase. The standard FDA review timeline for label expansion through a PMA supplement is 180 days.

This PMA supplement application follows the original PMA approval of the RECELL System in September 2018.