AVITA Medical (ASX:AVH) has secured regulatory clearance in Australia and a WAND listing in New Zealand for RECELL GO, its next-generation system for preparing RECELL Spray On Skin.
The approvals enable commercial launch in both markets through AVITA’s exclusive distributor Revolution Surgical, which “expects to initiate commercial launch within the coming weeks.”
RECELL GO pairs a reusable AC-powered RECELL Processing Device with a single-use RECELL Preparation Kit and automates steps that were previously handled manually in Australia. The system “precisely regulates enzyme incubation times and processing conditions, helping to optimise cell yield and viability while reducing operator variability, training burden, and operating room complexity.” One RPK can treat wounds up to 1,920 cm2 providing a large treatment area from a single preparation.
The technology builds on work by Australian burn surgeon Professor Fiona Wood, who originally developed RECELL. Professor Wood said, “RECELL GO represents the evolution of a technology we developed in Australia, building on our original approach by eliminating manual preparation steps and reducing the burden on clinical teams. Its certification is significant in expanding RECELL access for burn and trauma patients across Australia and New Zealand.”
AVITA positions RECELL and RECELL GO as point-of-care therapies that use a small sample of a patient’s own healthy skin to create a suspension of skin cells that is sprayed onto wounds to promote faster healing, reduce the need for large grafts, and shorten hospital stays.
Cary Vance, Interim CEO of AVITA, said, “The TGA certification and WAND listing of RECELL GO represents an important step in expanding access to RECELL,” and added, “With RECELL GO we are bringing greater standardisation and efficiency to the preparation process and together with our partner Revolution Surgical, we look forward to supporting adoption across Australia and New Zealand.”