AVITA Medical, a regenerative medicine company focused on skin restoration, has received the US Food and Drug Administration (FDA) approval for its RECELL System to treat vitiligo.
RECELL is an autologous cell harvesting device that prepares and delivers a regenerative cell suspension, Spray-On Skin Cells, using a small part of the patient’s own skin.
The Spray-On Skin Cells comprises a combination of single living cells that stimulate healing and re-pigmentation all the way through the wound bed.
Clinicians can use the RECELL device to prepare and deliver autologous skin cells from pigmented skin to stable depigmented areas, for a safe and effective treatment for vitiligo.
The RECELL is the first FDA-approved therapeutic device for the repigmentation of depigmented vitiligo lesions at the point of care, said the regenerative medicine company.
AVITA Medical chief executive officer Jim Corbett said: “RECELL represents first-in-class treatment for repigmentation through the delivery of normal, healthy skin cells.
“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.”
The FDA approval was supported by results from the company’s clinical trial that assessed the safety and effectiveness of the RECELL System for the repigmentation of stable vitiligo lesions.
In the study, successful repigmentation with RECELL treatment in areas of skin resurfaced using an ablative laser was compared to standard of care (SoC) treatment in another area.
The repigmentation rates were evaluated by an expert central review committee (CRC) at 6 and 12 months after treatment with RECELL and SoC treatment.
According to the CRC report, 36% of patients treated with RECELL had at least 80% repigmentation at 6 months, with 100% durability at 12 months, the primary endpoint.
In addition, treating physicians reported that RECELL treatment is a success for 68% of patients, and 80% of patients self-reported RECELL treatment as a success.
In November last year, AVITA Medical received the FDA Breakthrough Device designation for the RECELL System.
