AVITA Medical Unlocks ANZ Sales of Automated Wound Care System RECELL GO
AVITA Medical has secured dual regulatory clearance for RECELL GO in Australia and New Zealand, unlocking commercialisation pathways for its next-generation wound care system across the ANZ region. The company received certification from Australia’s Therapeutic Goods Administration and listing on New Zealand’s Web Assisted Notification of Devices database by Medsafe, with distribution partner Revolution Surgical Pty Ltd expected to initiate commercial launch within the coming weeks.
AVITA Medical secures regulatory clearance for RECELL GO in Australia and New Zealand
The regulatory milestone enables AVITA Medical (ASX: AVH) to commercialise RECELL GO for burn and acute wound treatment across both markets. The system represents an evolution of the company’s existing RECELL technology, automating preparation processes that have historically been performed manually in Australia.
Revolution Surgical holds exclusive distribution rights for the ANZ region and is positioned to drive adoption through established clinical networks. The partnership model allows AVITA Medical to access both markets without direct sales infrastructure investment, leveraging existing distributor relationships for accelerated market penetration.
The regulatory clearance adds to RECELL GO’s expanding global footprint. The system is CE-marked in Europe, TGA-certified in Australia, Medsafe-listed in New Zealand, and FDA-approved in the United States.
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What is RECELL GO and how does it work?
RECELL GO combines a reusable, AC-powered RECELL Processing Device with a single-use RECELL Preparation Kit. One Preparation Kit can treat wounds up to 1,920 cm².
The system uses a small sample of a patient’s own healthy skin to prepare a suspension of skin cells that is sprayed onto the wound. This approach promotes faster wound healing, reduces the need for large skin grafts, lowers donor-site pain and scarring, and can shorten hospital stays.
In Australia, RECELL has historically been prepared using a manual process. RECELL GO automates this by precisely regulating enzyme incubation times and processing conditions. This helps optimise cell yield and viability while reducing operator variability, training burden, and operating room complexity.
The automation addresses key clinical adoption barriers by standardising outcomes and reducing the technical expertise required for preparation. This matters to investors because it improves the commercial viability of the technology by making it more accessible to a broader range of clinical settings.
| Feature | Manual RECELL Preparation | RECELL GO System |
|---|---|---|
| Preparation method | Manual | Automated |
| Enzyme incubation | Operator-dependent | Precisely regulated |
| Training burden | Higher | Reduced |
| Cell yield consistency | Variable | Optimised |
Australian origins of RECELL technology
RECELL was originally developed in Australia by Professor Fiona Wood, Director of the Burns Service of Western Australia and Director of the Burn Injury Research Unit at the University of Western Australia. Professor Wood was recently awarded the Lifetime Achievement Award by the American Burn Association at the ABA’s 2026 Annual Meeting.
RECELL GO represents the evolution of the original Australian innovation into a standardised, device-enabled system. The technology has progressed from manual preparation methods to an automated platform approved for use across multiple jurisdictions.
Professor Fiona Wood
“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.”
Global regulatory footprint
The ANZ clearance adds to RECELL GO’s multi-jurisdictional regulatory approvals:
- RECELL GO: CE-marked in Europe, TGA-certified in Australia, Medsafe-listed in New Zealand, FDA-approved in the United States
- RECELL (original): Approved in the United States, Europe, the United Kingdom, Australia, New Zealand, and PMDA-approved in Japan
- U.S. FDA indications: Thermal burn and trauma wounds
The expanding regulatory footprint demonstrates the company’s ability to execute on multi-jurisdictional approval pathways. Each clearance unlocks incremental revenue channels while de-risking the commercialisation strategy through geographic diversification.
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Strategic outlook and commercialisation pathway
Revolution Surgical will drive adoption across Australia and New Zealand through established clinical relationships. The distributor model reduces AVITA Medical’s capital requirements for market entry while accelerating time-to-revenue in both markets.
Cary Vance, Interim Chief Executive Officer
“The TGA certification and WAND listing of RECELL GO represents an important step in expanding access to RECELL. 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.”
AVITA Medical positions itself as a leading therapeutic acute wound care company delivering transformative solutions. Beyond RECELL GO, the company holds exclusive U.S. rights to market Cohealyx, a collagen-based dermal matrix, and exclusive rights to manufacture, market, sell, and distribute PermeaDerm, a biosynthetic wound matrix. This broader portfolio provides multiple revenue streams within the acute wound care segment.
The ANZ regulatory clearance represents a meaningful expansion of market access for the company’s next-generation technology. With an established distribution partner and a system designed to reduce clinical adoption barriers, RECELL GO is positioned to capture market share in the ANZ burn and acute wound treatment segments.
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