AVITA Medical Unlocks European Market with CE Mark for RECELL GO

Regulatory Breakthrough

AVITA Medical, a leader in therapeutic acute wound care, has achieved a significant regulatory milestone with the receipt of the CE Mark for its RECELL GO device. This certification, granted under the stringent European Union Medical Device Regulation, authorizes the company to market and sell RECELL GO across Europe and in other regions that recognize the CE Mark.

Innovative Technology for Wound Healing

RECELL GO is a point-of-care device that enables clinicians to prepare 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 acute wounds such as burns and surgical injuries to accelerate healing. This technology builds on the existing RECELL System, which is already in use across Europe and other international markets.

Clinical Impact and Market Potential

Recent clinical data presented at the 2025 European Burns Association Congress highlighted the efficacy of RECELL technology, showing a 36% reduction in hospital stays for adults with deep partial-thickness burns compared to traditional grafting methods. This underscores the potential for RECELL GO to improve patient outcomes while reducing healthcare costs.

Strategic European Rollout

With regulatory clearance secured, AVITA Medical plans to commence commercialization of RECELL GO in select European countries, including Germany, Italy, and the United Kingdom. The company intends to collaborate closely with burn centers and clinical partners to integrate this innovative treatment into standard care protocols.

Looking Ahead

AVITA Medical’s CE Mark approval for RECELL GO not only expands its product portfolio but also strengthens its position in the competitive acute wound care market. As the company moves forward with its European launch, investors and healthcare providers alike will be watching closely to see how quickly RECELL GO gains traction and impacts patient care.