Avita Medical has received clearance from the US Food and Drug Administration (FDA) for its premarket approval (PMA) application for the RECELL System to treat vitiligo.
Designed to offer a one-time treatment at the point of care, the therapeutic device is intended for the repigmentation of stable depigmented vitiligo lesions.
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RECELL is an autologous cell harvesting device used for the preparation and delivery of a regenerative cell suspension, spray-on skin cells, utilising a patient’s own skin.
The spray-on skin cells include a combination of single living cells, which stimulate healing and repigmentation across the wound bed.
Its suspension can be used for skin resurfaced by an ablative laser. A portion of the suspension can also be applied to the donor site.
Avita Medical CEO Jim Corbett said: “RECELL represents first-in-class treatment for repigmentation through the delivery of normal, healthy skin cells.
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By GlobalData“This is a breakthrough approval for Avita Medical, significantly expanding the clinical applications for RECELL and demonstrating our continued commitment to patient care. We look forward to offering a meaningful one-time treatment option for patients with stable vitiligo across the US.”
The FDA has approved the device based on data from the company’s study, which assessed its safety and effectiveness for stable vitiligo lesions repigmentation.
It compared repigmentation success rates with RECELL treatment in skin areas resurfaced with the help of ablative laser, against standard of care (control) treatment in another area.
An expert central review committee (CRC) assessed the repigmentation at six and 12 months after treatment.
The CRC found that 36% of RECELL treatments led to at least 80% repigmentation of the treated area at six months, while control treatments showed no such improvement, establishing super-superiority for the primary endpoint.
Furthermore, it reported 100% durability of repigmentation at 12 months.
