AVITA Medical Gains TGA Approval and NZ Listing for RECELL GO System
AVITA Medical’s RECELL GO received TGA certification in Australia and WAND listing in New Zealand, enabling commercialization of its automated Spray-On Skin system for burn and acute wound treatment. Revolution Surgical plans to launch RECELL GO within weeks, with each kit treating wounds up to 1,920 cm2.
1. Regulatory Certifications
RECELL GO secured certification from Australia’s Therapeutic Goods Administration and listing on New Zealand’s WAND database, permitting sales in both markets. These approvals mark the first device-enabled iteration of Spray-On Skin technology cleared in the Asia-Pacific region.
2. Commercial Launch Plans
AVITA Medical’s exclusive partner Revolution Surgical will initiate commercial rollout within weeks, targeting burn centers and acute wound clinics across Australia and New Zealand. The launch strategy emphasizes rapid adoption through training programs and streamlined device integration.
3. Product Features and Benefits
RECELL GO automates enzyme incubation and cell preparation, reducing operator variability and operating room complexity. Each single-use preparation kit treats wounds up to 1,920 cm2, potentially accelerating healing, reducing graft size requirements and shortening hospital stays.