AVITA Medical Announces TGA Certification in Australia and Medsafe WAND Listing in New Zealand for RECELL GO
- RECELL GO® receives regulatory clearance in Australia and New Zealand, enabling commercialization across both markets
- RECELL GO is AVITA Medical's next-generation system that automates and standardizes the preparation of RECELL® Spray-On Skin™ for the treatment of burn and trauma wounds
VALENCIA, Calif., April 29, 2026 (GLOBE NEWSWIRE) -- AVITA Medical®, Inc. (NASDAQ:RCEL, ASX: AVH)), a leading therapeutic acute wound care company delivering transformative solutions, today announced that RECELL GO, its next-generation system for preparing RECELL Spray-On Skin, has received certification from Australia's Therapeutic Goods Administration ("TGA") and has been listed on New Zealand's Web Assisted Notification of Devices ("WAND") database by Medsafe, enabling commercialization in both markets for burn and acute wound treatment.
AVITA Medical's exclusive distribution partner in Australia and New Zealand, Revolution Surgical Pty Ltd ("Revolution Surgical"), expects to initiate commercial launch within the coming weeks.
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, commented: "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."
"The TGA certification and WAND listing of RECELL GO represents an important step in expanding access to RECELL," said Cary Vance, Interim Chief Executive Officer of AVITA Medical. "With RECELL GO, we are bringing greater standardization and efficiency to the preparation process, and together with our partner Revolution Surgical, we look forward to supporting adoption across Australia and New Zealand."
About RECELL GO
RECELL GO combines a reusable, AC-powered RECELL Processing Device ("RPD") with a single-use RECELL Preparation Kit ("RPK"), with one RPK capable of treating wounds up to 1,920 cm2.
In Australia, RECELL has historically been prepared using a manual process. RECELL GO precisely regulates enzyme incubation times and processing conditions, helping to optimize cell yield and viability while reducing operator variability, training burden, and operating room complexity.
RECELL works by using 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 can promote faster wound healing while reducing the need for large skin grafts – lowering donor-site pain and scarring – and shortening hospital stays.
RECELL was originally developed in Australia by renowned burn surgeon Professor Fiona Wood, who was recently awarded the Lifetime Achievement Award by the American Burn Association ("ABA") at the ABA's 2026 Annual Meeting. RECELL GO represents the evolution of that innovation into a standardized, device-enabled system that is now approved for use in the U.S., Europe, the U.K., Australia and New Zealand.
About AVITA Medical, Inc.
AVITA Medical® is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies are designed to optimize wound healing, effectively accelerating the time to patient recovery. At the forefront of our platform is RECELL®, approved by the FDA for the treatment of thermal burn and trauma wounds. RECELL harnesses the healing properties of a patient's own skin to create Spray-On Skin™, offering an innovative solution for improved clinical outcomes at the point-of-care. In the U.S., AVITA Medical also holds the exclusive rights to market, sell, and distribute Cohealyx®, an AVITA Medical-branded collagen-based dermal matrix, and the exclusive rights to manufacture, market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix.
In international markets, RECELL is approved to promote skin healing in a wide range of applications, including thermal burn and trauma wounds. RECELL and RECELL GO® are CE-marked in Europe and have TGA certification in Australia and are listed with Medsafe in New Zealand; RECELL is PMDA-approved in Japan.
To learn more, visit www.avitamedical.com.
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Investor & Media Contact:
Ben Atkins
Phone +1-805 341 1571
investor@avitamedical.com | media@avitamedical.com
Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.
©2026 AVITA Medical. AVITA Medical®, Cohealyx®, RECELL®, RECELL GO®, and Spray-On Skin™ are trademarks of AVITA Medical. PermeaDerm® is a registered trademark of Stedical Scientific, Inc. All other trademarks are the properties of their respective owners.
