Regenerative medicine company AVITA Medical (ASX:AVH) has announced that the US FDA has approved its application for the 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.
Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.
“RECELL represents first-in-class treatment for repigmentation through the delivery of normal, healthy skin cells,” said CEO Jim Corbett.
“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 US.”
The RECELL System is an autologous cell harvesting device used to prepare and deliver a regenerative cell suspension, Spray-On Skin Cells, using a small amount of a patient’s 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.