Rollout of the device will begin with trauma and burn centres that currently treat smaller wounds, in Q1 2025. Image credit: GlobeNewswire.

The US Food and Drug Administration (FDA) has approved a premarket approval (PMA) supplement for Avita Medical’s RECELL GO mini, a line extension of the existing RECELL GO system.

RECELL GO mini is designed to treat smaller wounds, with the mini disposable cartridge able to cover wounds up to 480 square metres. The US company’s standard cartridge treats an area of 1,920 square metres.

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The news was released after Nasdaq closed on 23 December, meaning shares in Avita have yet to react.

Avita’s RECELL platform harnesses the regenerative properties of a small piece of the patient’s own skin to create what the company calls Spray-On Skin Cells. These different cell types, including keratinocytes, dermal fibroblast, and melanocytes, are applied to the wound to promote healing and regimentation. The company says that RECELL offers an early point-of-care treatment of thermal burn wounds and full-thickness skin defects.

Avita’s RECELL GO, which streamlines the Spray-On Skin Cell preparation, was approved by the FDA in May 2024. The GO device was approved as a supplement of the original system called RECELL Autologous Cell Harvesting Device, approved in December 2023.

Avita stated that the latest line extension in the form of the RECELL GO mini offers an entry point for clinicians who may not have previously used the RECELL GO platform for smaller wounds. Rollout of the device will begin with trauma and burn centres that currently treat smaller wounds, in Q1 2025.

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Avita’s CEO Jim Corbett said: “By introducing a treatment option specifically for smaller wounds, we are expanding the accessibility of RECELL to a wider range of patients. We believe this addition will drive greater adoption across trauma centers, where smaller wounds are common, and support our broader growth strategy.”

The wound care management market was estimated to be worth $33.3bn in 2024 and is forecast to grow to over $48bn by 2033. Tissue engineered skin substitutes is predicted to contribute $3bn to the market by 2033. Allergan is currently the company with the leading market share in the tissue engineered skin substitutes sector, according to analysis by GlobalData.