AVITA Medical has received the CE Mark under the European Union Medical Device Regulation (EU MDR) for RECELL GO. This allows the company to commercialise RECELL GO in Europe and in other markets that recognise the CE Mark.

“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,” said Jim Corbett, Chief Executive Officer (CEO), AVITA Medical. “

RECELL GO is a Point-of-Care (PoC) device used by healthcare professionals to prepare a suspension of a patient’s own skin cells (Spray-On Skin Cells) from a small sample of healthy skin. The cells are applied to promote healing in burns and traumatic or surgical wounds. RECELL GO builds on the RECELL System already in use across Europe.

Data recently presented at the 2025 European Burns Association Congress demonstrated that adults with deep partial-thickness (second-degree) burns treated with RECELL experienced a 36 percent reduction in hospital stays compared with traditional grafting, underscoring the clinical value of the RECELL technology.

With the CE Mark secured, AVITA Medical will begin commercialisation of RECELL GO in select European countries, including Germany, Italy and the United Kingdom, in collaboration with burn centres and clinical partners.