FDA Approves AVITA Medical's RECELL System for Vitiligo Skin Repigmentation

VALENCIA, Calif. and MELBOURNE, Australia — AVITA Medical, Inc., a leader in regenerative medicine, announced the U.S. Food and Drug Administration (FDA) has approved its RECELL® System for the treatment of vitiligo. This approval marks the first FDA-approved therapeutic device for repigmentation of stable depigmented vitiligo lesions, offering a one-time treatment at the point-of-care.

RECELL System Overview The RECELL System is an autologous cell harvesting device that prepares and delivers a regenerative cell suspension, known as Spray-On Skin™ Cells, using a small amount of the patient's own skin. This innovative treatment stimulates healing and repigmentation throughout the wound bed, with the preservation of melanocytes being crucial for restoring natural pigmentation.

Clinical Trial Results The FDA's approval was based on results from AVITA Medical's pivotal trial, which evaluated the safety and effectiveness of the RECELL System. The study demonstrated that 36% of RECELL treatments resulted in repigmentation of at least 80% of the treated area at 6 months, with 100% durability of repigmentation at 12 months. Additionally, 68% of patients were reported by treating physicians as successful cases, and 80% of patients self-reported the treatment as successful.

Impact on Vitiligo Treatment Vitiligo, affecting up to 2% of the global population, leads to the loss of pigmentation in patches of skin and significantly impacts patients' quality of life. The RECELL System's approval represents a major advancement in vitiligo care, offering a safe and effective treatment option for those suffering from stable vitiligo.

Regulatory Pathway The RECELL System received prioritized review through the FDA’s Breakthrough Device program, highlighting its potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions.

About AVITA Medical, Inc. AVITA Medical is at the forefront of developing and commercializing devices and autologous cellular therapies for skin restoration. The RECELL System, now approved for thermal burn wounds, full-thickness skin defects, and vitiligo repigmentation, harnesses the regenerative properties of a patient’s own skin to improve clinical outcomes. Internationally, the RECELL System is approved for a wide range of applications, including burns, soft tissue repair, vitiligo, and aesthetics.