Avita Medical (ASX:AVH) 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 the repigmentation of vitiligo lesions. In 2023, it was approved for full-thickness skin defects (i.e., wounds of the epidermis and dermis, exposing bone, fat, or muscle).
The platform involves harvesting the patient’s own tissues. 1 square centimeter of skin can be used to treat an 80 square centimeter wound. The sample is made into “Spray-On Skin”, which is then applied directly to the wounds. A normal wound only heals at the edges, but the RECELL method also stimulates healing from the inside of the wound.
A wound treated with RECELL could heal in 1 to 2 weeks, as opposed to the 3 to 6 weeks expected for typical healing.
RECELL GO is an extension of the platform. The device features disposable cartridges and is designed to be multi-use, whereas the original RECELL device featured single-use components for the treatment and application of Spray-On Skin.
Mini GO
Avita’s new Mini GO is for smaller wounds, up to 480 square centimeters, while RECELL GO can treat wounds up to 1,920 square centimeters (about 3 square feet).
RECELL GO mini uses the same processing device as the standard system, but with a smaller cartridge, minimizing waste.
Next steps
“The FDA approval of RECELL GO mini strengthens our ability to provide clinicians with tailored solutions that meet the diverse needs of patients with full-thickness wounds,” said Jim Corbett, CEO of Avita Medical. He noted that the reduced size of the device could lead to wider adoption of the RECELL platform.
Avita plans to launch the RECELL GO mini in trauma and burn centers in the first quarter of 2025.
Shares are trading up 5.25% at $4.01.
