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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This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “anticipate,” “could,” “expect,” “may,” and similar words or expressions, and the use of future dates. Forward-looking statements include, but are not limited to, statements relating to the timing and realization of regulatory approvals of our products; anticipated market share growth and revenue generation; failure to achieve the anticipated benefits from approval of our products; risks associated with international operations and expansion; and other business effects, including the effects of industry, as well as other economic or political conditions outside of the Company’s control. These statements are made as of the date of this press release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.

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.

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