Avita Medical Receives CMS Reimbursement for RECELL System in Acute Wound Care.

Avita Medical's RECELL System has received reimbursement from CMS for acute wound care. The system is a regenerative medicine device that enables a thin split-thickness skin sample to be processed and prepared into an autologous cellular suspension, called Spray-On Skin Cells. This suspension can be used to treat thermal burn wounds and full-thickness skin defects. The RECELL System is a commercial-stage device that has the potential to address unmet medical needs in burn injuries and skin repigmentation.

Effective October 1, 2025, hospitals across the U.S. will receive up to $4,875 in added reimbursement when using the RECELL System to treat non-burn full-thickness acute wounds resulting from trauma or surgery. This decision by the Centers for Medicare & Medicaid Services (CMS) is part of the New Technology Add-on Payment (NTAP) program, which recognizes the transformative nature of the RECELL System CMS New Technology Add-On Payment Expands Access to RECELL® for Patients with Non-Burn Acute Wounds^[1].

The RECELL System, developed by AVITA Medical, is a regenerative medicine device that processes a thin split-thickness skin sample into an autologous cellular suspension, known as Spray-On Skin Cells. This suspension can be used to treat thermal burn wounds and full-thickness skin defects, offering an innovative solution for improved clinical outcomes CMS New Technology Add-On Payment Expands Access to RECELL® for Patients with Non-Burn Acute Wounds^[1].

The NTAP designation will remain in effect through September 30, 2026, providing hospitals with supplemental reimbursement in addition to the standard CMS payment. This financial support is expected to lower barriers for hospitals, encouraging broader use of the RECELL System and potentially benefiting more patients CMS New Technology Add-On Payment Expands Access to RECELL® for Patients with Non-Burn Acute Wounds^[1].

The RECELL System has shown promising results in clinical trials. A multicenter, randomized-controlled trial published in the Journal of Trauma and Acute Care Surgery in 2024 demonstrated that the system, when used with a widely meshed autograft, achieved wound closure as effectively as standard skin grafting while requiring 27% less donor skin. The healing and safety outcomes were comparable between the two groups, indicating that RECELL can reduce donor site complications without compromising results CMS New Technology Add-On Payment Expands Access to RECELL® for Patients with Non-Burn Acute Wounds^[1].

AVITA Medical, a leading therapeutic acute wound care company, is at the forefront of wound healing solutions. The company's technologies, including the RECELL System, are designed to optimize wound healing and accelerate patient recovery. The RECELL System is approved by the U.S. Food and Drug Administration for the treatment of thermal burn and trauma wounds and has received regulatory clearances in Europe, Australia, and Japan CMS New Technology Add-On Payment Expands Access to RECELL® for Patients with Non-Burn Acute Wounds^[1].

The NTAP designation from CMS underscores the clinical value and innovation of the RECELL System. By providing financial support for its use, CMS is helping ensure that more patients can benefit from this transformative technology, which addresses unmet medical needs in burn injuries and skin repigmentation.