CMS New Technology Add-On Payment Expands Access to RECELL® for Patients with Non-Burn Acute Wounds

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AVITA Medical (NASDAQ: RCEL) announced that hospitals will now be eligible for New Technology Add-on Payment (NTAP) reimbursement from CMS when using RECELL to treat non-burn trauma and surgical full-thickness wounds. Starting October 1, 2025, hospitals can receive up to $4,875 in additional reimbursement per case through September 30, 2026.

The NTAP designation was granted under CMS's alternative pathway for FDA Breakthrough Devices. A clinical trial published in the Journal of Trauma and Acute Care Surgery demonstrated that RECELL achieved comparable wound closure while requiring 27% less donor skin compared to standard skin grafting. The technology prepares Spray-On Skin™ cells from a small sample of the patient's healthy skin.

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• Hospitals may receive up to $4,875 in added reimbursement when using RECELL to treat non-burn full-thickness acute wounds resulting from trauma or surgery

• Effective October 1, the add-on payment eases financial barriers, supporting broader use of RECELL
  
  

VALENCIA, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- AVITA Medical^®, Inc. (ASX: AVH, NASDAQ: RCEL), a leading therapeutic acute wound care company, today announced that beginning October 1, 2025, hospitals across the U.S. will be eligible for New Technology Add-on Payment (NTAP) reimbursement from the Centers for Medicare & Medicaid Services (CMS) when RECELL is used to treat acute, non-burn trauma and surgical full-thickness wounds.

This designation will remain in effect through September 30, 2026, providing hospitals with supplemental reimbursement of up to $4,875 per case in addition to the standard CMS payment. The NTAP was granted under CMS’ alternative NTAP pathway, which recognizes the transformative nature of products that have received Breakthrough Device designation from the U.S. Food and Drug Administration.

“With only a select number of technologies reaching this milestone each year, CMS’s NTAP decision underscores the clinical value and innovation of RECELL,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “By lowering financial barriers for hospitals, CMS is helping ensure that more patients can benefit from RECELL, which treats acute wounds effectively while requiring less donor skin and easing the challenges of recovery.”

Skin grafting is the standard of care for full-thickness acute wounds resulting from trauma or surgery. However, skin grafting requires the harvesting of a significant amount of donor skin, resulting in a larger wound to the patient. Significant pain, delayed healing, risk of infection, the potential need for multiple procedures, discoloration, and scarring are associated with donor site wounds.

RECELL is used by healthcare professionals to prepare a suspension of Spray-On Skin™ cells from a small sample of the patient’s own healthy skin. A multicenter, randomized-controlled trial published in the Journal of Trauma and Acute Care Surgery (2024) demonstrated that RECELL, when used with a widely meshed autograft, achieved wound closure just as effectively as standard skin grafting while requiring 27% less donor skin. Healing and safety outcomes were comparable between the two groups, showing that RECELL can reduce donor site complications without compromising results.

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 the RECELL System, approved by the U.S. Food and Drug Administration 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 Cells, offering an innovative solution for improved clinical outcomes at the point-of-care. In the U.S., AVITA Medical also holds the rights to manufacture and exclusive rights to market, sell, and distribute PermeaDerm^®, a biosynthetic wound matrix, and the exclusive rights to market, sell, and distribute Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix.

In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including thermal burn and trauma wounds, with regulatory clearances in Europe, and excluding RECELL GO, in Australia and Japan.

To learn more, visit www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

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 “could,” “expect,” “may,” “will,” “would,” and similar words or expressions, and the use of future dates. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation: industry market conditions; failure to obtain and/or maintain regulatory approvals and comply with applicable regulations; market reaction to growth or product initiatives; market penetration of our products; changes in the legal or regulatory environments; and other business effects, including economic or political conditions outside of the Company’s control. Any forward-looking statements made herein are made as of the date of this 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.

FAQ

What is the new CMS reimbursement amount for RECELL (NASDAQ: RCEL) treatment?

Starting October 1, 2025, hospitals can receive up to $4,875 in additional reimbursement per case through the New Technology Add-on Payment (NTAP) program.

How long will AVITA Medical's RECELL NTAP designation last?

The NTAP designation will remain in effect from October 1, 2025, through September 30, 2026.

What are the clinical benefits of RECELL compared to standard skin grafting?

RECELL achieves comparable wound closure while requiring 27% less donor skin than standard skin grafting, with similar healing and safety outcomes.

What types of wounds can be treated with RECELL under the new NTAP coverage?

The NTAP coverage applies to acute, non-burn trauma and surgical full-thickness wounds.

How does RECELL's Spray-On Skin technology work?

RECELL is used by healthcare professionals to prepare a suspension of Spray-On Skin™ cells from a small sample of the patient's own healthy skin.