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AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))) ("AVITA Medical", or the "Company"), a leading therapeutic acute wound care company, today announced it has received the CE Mark under the European Union Medical Device Regulation (EU MDR) for RECELL GO. This allows the Company to commercialize RECELL GO in Europe and in other markets that recognize the CE Mark.
"CE Mark for RECELL® GO is an important milestone for AVITA Medical and for patients," said Jim Corbett, Chief Executive Officer of AVITA Medical. "It enables us to bring this option to burn centers and clinicians in Europe to support their treatment of patients with acute wound injuries."
RECELL GO is a point-of-care 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% 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 commercialization of RECELL GO in select European countries, including Germany, Italy, and the United Kingdom, in collaboration with burn centers and clinical partners.
Posted In: RCEL
