Tuesday, December 20, 2022
AVITA Medical, Inc., a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, announced today the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its RECELL® System. 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 Jim Corbett, AVITA Medical Chief Executive Officer. “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.”
This PMA application includes the recently released results of the pivotal trial for vitiligo. The study achieved its primary effectiveness endpoint of super-superiority (p<0.025). The study compared repigmentation success rates in treating patients with segmental and non-segmental stable vitiligo.
The RECELL System earned FDA Breakthrough Device designation for its proposed indication of vitiligo. Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase. The standard FDA review timeline for a PMA application is 180 days.
This PMA application follows the original PMA approval of the RECELL System in September 2018.
