Avita receives FDA approval for spray-on skin device

Avita Medical (ASX:AVH) has announced FDA approval for its new RECELL GO mini disposable cartridge.

Spray-on skin

The original RECELL platform received FDA approval in 2018 for severe burns. In 2022, the platform was approved for repigmentation of vitiligo lesions. In 2023, it was approved for full-thickness skin defects (ie, injuries to both the epidermis and dermis, exposing bone, fat or muscle).

The platform involves harvesting the patient's own tissue. 1 square centimetre of skin can be used to treat an 80 square centimetre wound. The sample is transformed into "Spray-On Skin", which is then applied directly to wounds. A normal wound heals just from the edges, but the RECELL method also stimulates healing from within the wound.

A wound treated with RECELL could heal within 1-2 weeks, as opposed to the 3-6 weeks expected for typical healing.

RECELL GO is an extension of the platform. The device has disposable cartridges and is designed to be multi-use, whereas the original RECELL device had single-use components for processing and applying Spray-On Skin. 

Mini GO

Avita's new Mini GO is for smaller wounds, up to 480 square centimetres, whereas RECELL GO can treat wounds up to 1,920 square centimetres (about 3 square feet).

RECELL GO mini uses the same processing device as the standard system, but with a smaller cartridge, minimising waste.

Next steps

“The FDA approval of RECELL GO mini strengthens our ability to provide clinicians with fit-for-purpose solutions that meet the diverse needs of patients with full-thickness wounds,” said Jim Corbett, CEO of Avita Medical. He noted that the device’s smaller size could drive wider adoption of the RECELL platform.

Avita expects to launch the RECELL GO mini in trauma and burn centres during the first quarter of 2025.

Shares are trading 5.25% higher at $4.01.