AVITA Medical Secures CE Mark for RECELL GO, Expanding Burn Treatment Access Across Europe
Key Insights
AVITA Medical received CE Mark approval for RECELL GO (search) under EU Medical Device Regulation, enabling commercialization across Europe and other CE Mark-recognizing markets.
The point-of-care device creates Spray-On Skin Cells from patients' own healthy skin samples to promote healing in burns (search) and traumatic wounds (search).
Clinical data from the 2025 European Burns (search) Association Congress showed RECELL treatment reduced hospital stays by 36% compared to traditional grafting for deep partial-thickness burns (search).
AVITA Medical has achieved a significant regulatory milestone with the receipt of CE Mark approval for RECELL GO (search) under the European Union Medical Device Regulation (EU MDR), opening the door for commercialization across Europe and other markets that recognize the CE Mark. The approval represents a major expansion opportunity for the Valencia, California-based therapeutic acute wound care company.
"CE Mark for RECELL GO (search) 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."
Point-of-Care Innovation for Wound Healing
RECELL GO (search) is a point-of-care device that enables healthcare professionals to prepare a suspension of a patient's own skin cells, known as Spray-On Skin Cells, from a small sample of healthy skin. The technology harnesses the healing properties of autologous skin cells, which are then applied to promote healing in burns (search) and traumatic or surgical wounds (search). The device builds upon the existing RECELL System (search) already in clinical use across Europe.
The RECELL technology represents an innovative approach to wound care by utilizing the patient's own cellular material, potentially reducing complications associated with traditional grafting procedures while accelerating the healing process.
Clinical Evidence Demonstrates Significant Benefits
Recent clinical data presented at the 2025 European Burns (search) Association Congress provided compelling evidence for the RECELL technology's clinical value. The data demonstrated that adults with deep partial-thickness (second-degree) burns treated with RECELL experienced a 36% reduction in hospital stays compared with traditional grafting methods.
This substantial reduction in hospitalization time underscores the potential clinical and economic benefits of the RECELL technology, offering improved patient outcomes while potentially reducing healthcare system burden.
Strategic European Market Entry
With the CE Mark secured, AVITA Medical plans to begin commercialization of RECELL GO (search) in select European countries, including Germany, Italy, and the United Kingdom. The company will pursue this expansion in collaboration with burn centers and clinical partners, leveraging established relationships within the European healthcare system.
The strategic approach to market entry reflects the company's commitment to ensuring proper clinical support and training for healthcare providers adopting the technology.
Expanding Treatment Portfolio
AVITA Medical's technology platform extends beyond RECELL GO (search), with the original RECELL System (search) already approved by the U.S. Food and Drug Administration for treating thermal burn and trauma wounds. In international markets, the RECELL System has received regulatory clearances in Europe, Australia, and Japan for promoting skin healing across a wide range of applications including thermal burn and trauma wounds.
The company also maintains exclusive rights in the U.S. market for PermeaDerm (search), a biosynthetic wound matrix, and Cohealyx (search), a collagen-based dermal matrix, further strengthening its position in the acute wound care market.