- Business
- AVITA Medical, Inc. (ASX:AVH) develops and commercializes regenerative medicine technologies for wound care management and skin restoration, including its flagship RECELL System, a patented point-of-care device that produces Spray-On Skin Cells from a patient's own skin for treating thermal burns, full-thickness skin defects, trauma and surgical wounds; PermeaDerm, a biosynthetic wound matrix; and Cohealyx, a collagen-based dermal matrix, with the recently FDA-approved RECELL GO System enhancing application efficiency as a primary wound dressing. Founded in 1992 as Clinical Cell Culture in Perth, Australia, and now headquartered in Valencia, California, the company operates primarily in the United States across approximately 136 burn centers and high-value facilities targeting burns, trauma, vitiligo and aesthetics indications, while expanding internationally to Europe, Australia, New Zealand, Asia-Pacific and Canada. In recent developments, AVITA Medical received CE Mark approval in September 2025 for RECELL GO to enable launches in Germany, Italy and the United Kingdom; entered an exclusive distribution agreement with Revolution Surgical Pty Ltd in November 2024 to reintroduce RECELL products in Australia and New Zealand; restored U.S. reimbursement clarity through finalized Medicare payment rates under new Category I CPT codes across all regional contractors; and reported third-quarter 2025 commercial revenue of US$17.1 million with narrowed net losses, revised full-year revenue guidance to US$70-74 million, and ongoing cost efficiencies reducing operating expenses by 24 percent year-over-year.