AVITA Medical submits FDA PMA application to expand indication

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Regenerative medicine company AVITA Medical (ASX:AVH) has announced the submission of a Premarket Approval (PMA) application to the US FDA for its RECELL System.

The company said the application, if approved, will expand the indication of RECELL to include the treatment of stable vitiligo.

“We are pleased to take the next step towards expanding the clinical application of RECELL into a treatment for vitiligo,” said AVITA Medical CEO Jim Corbett.

“RECELL offers first-in-class repigmentation of vitiligo lesions through the transplantation of melanocytes. Once approved, this indication will dramatically expand our reach in a huge market with limited treatment options. We anticipate a full launch of this treatment option in January 2025.”

The company said the application includes the recently released results of a pivotal trial for vitiligo.

The study compared repigmentation success rates in treating patients with segmental and non-segmental stable vitiligo. The study achieved its primary effectiveness endpoint of super-superiority.

The RECELL System earned FDA Breakthrough Device designation for its proposed indication of vitiligo. Under the program, AVITA Medical will receive prioritised review and interactive communication with the FDA throughout the premarket review phase.