Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.

The U.S. Food and Drug Administration (FDA) has approved AVITA Medical, Inc.’s application for premarket approval (PMA) of its RECELL System for the treatment of vitiligo.

RECELL for repigmentation of stable depigmented vitiligo lesions is the first FDA-approved therapeutic device offering a one-time treatment at the point-of-care, the Company states. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.

The RECELL System is an autologous cell harvesting device that is used to prepare and deliver a regenerative cell suspension, Spray-On Skin Cells, using a small amount of a patient’s own skin. The Spray-On Skin Cells contain a combination of single living cells that stimulate healing and repigmentation throughout the wound bed. The preservation of melanocytes is important for restoring natural pigmentation to the recipient area. The suspension of Spray-On Skin Cells is suitable for application to skin resurfaced by an ablative laser. A portion of the suspension of Spray-On Skin Cells may also be applied to the donor site.

“RECELL represents first-in-class treatment for repigmentation through the delivery of normal, healthy skin cells,” says Jim Corbett, Chief Executive Officer of AVITA Medical, in a news release. “This is a breakthrough approval for AVITA Medical, significantly expanding the clinical applications for RECELL, and demonstrates our continued commitment to patient care. We look forward to offering a meaningful one-time treatment option for patients with stable vitiligo across the U.S.”

PMA approval was based upon results from the company’s pivotal trial evaluating the safety and effectiveness of the RECELL System for repigmentation of stable vitiligo lesions. The study compared repigmentation success rates with RECELL treatment in areas of skin resurfaced using ablative laser, versus standard of care (control) treatment in another area. Repigmentation was evaluated by an expert central review committee (CRC) at 6 and 12 months after treatment. The CRC reported 36% of RECELL treatments (versus 0% of control treatments) resulted in repigmentation of at least 80% of the treated area at 6 months, establishing super-superiority for the primary endpoint (p<0.025), with 100% durability of repigmentation at 12 months. At the same 6-month point, treating physicians reported RECELL treatment as a success for 68% of patients, and 80% of patients self-reported RECELL treatment as a success.

The PMA received prioritized review through the FDA’s Breakthrough Device program.