RegulatoryApr 29, 2026, 04:07 PM
RCEL: RECELL GO Cleared in Australia & New Zealand for Commercialization
AI Summary
AVITA Medical, Inc. announced that its next-generation system, RECELL GO, has received regulatory clearance in Australia from the TGA and has been listed on New Zealand's WAND database by Medsafe. This clearance enables commercialization in both markets for burn and acute wound treatment. The company's distribution partner, Revolution Surgical, expects to initiate the commercial launch within weeks, expanding access to the standardized and efficient wound care technology.
Key Highlights
- RECELL GO received certification from Australia's Therapeutic Goods Administration (TGA).
- RECELL GO listed on New Zealand's Web Assisted Notification of Devices (WAND) database by Medsafe.
- Commercial launch in Australia and New Zealand expected within weeks by Revolution Surgical.
- RECELL GO automates and standardizes RECELL Spray-On Skin preparation for burn and trauma wounds.
- One RECELL Preparation Kit (RPK) can treat wounds up to 1,920 cm2.
- RECELL GO is now approved for use in the U.S., Europe, U.K., Australia, and New Zealand.