AVITA Medical (ASX:AVH) has achieved a significant milestone with the granting of the CE Mark under the European Union Medical Device Regulation (EU MDR) for its next-generation wound care device, RECELL GO.
The certification clears the way for commercialisation across Europe and in other markets that recognise the CE Mark, expanding the company’s global footprint.
Chief Executive Officer Jim Corbett described the approval as a significant step forward. “CE Mark for RECELL GO is an important milestone for AVITA Medical and for patients. It enables us to bring this option to burn centres and clinicians in Europe to support their treatment of patients with acute wound injuries,” he said.
RECELL GO is a point-of-care device that allows healthcare professionals to create a suspension of a patient’s own skin cells, known as Spray-On Skin Cells, from a small sample of healthy skin. These cells are then applied to wounds to accelerate healing. The system builds on AVITA’s established RECELL System, which is already in use in European hospitals.
Evidence of the technology’s impact continues to grow. At the 2025 European Burns Association Congress, researchers reported that adult patients with deep partial-thickness burns treated with RECELL experienced a 36 per cent reduction in hospital stays compared with traditional grafting. The findings highlight the device’s potential to improve patient outcomes while reducing healthcare system costs.
With approval now secured, AVITA will begin commercial rollout of RECELL GO in key European markets, including Germany, Italy, and the United Kingdom, working closely with burn centres and clinical partners.
In the US, RECELL is approved by the Food and Drug Administration for treating burn and trauma wounds. The company also holds exclusive US rights to PermeaDerm, a biosynthetic wound matrix, and Cohealyx, a collagen-based dermal matrix. Internationally, RECELL is approved for a range of wound-healing applications in Europe, Australia, and Japan, with RECELL GO now set to broaden the company’s reach across the European Union.