Avita Medical (ASX:AVH) announced FDA approval for its new RECELL GO mini disposable cartridge.
Spray on the 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 the dermis exposing bone, fat, or muscle).
The platform involves harvesting the patient’s own tissue. 1 square centimeter of skin can be used to treat a wound of 80 square centimeters. The sample is transformed into “Spray-On Skin” which is then applied directly to wounds. A normal wound heals only at the edges, but the RECELL method stimulates healing from the inside of the wound as well.
A wound treated with RECELL can 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 single-use cartridges and is intended for multiple 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 centimeters, while the RECELL GO can treat wounds up to 1,920 square centimeters (about 3 square feet).
RECELL GO mini uses the same processing unit as the standard system, but with a smaller cartridge, which minimizes waste.
Next steps
“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 smaller size of the device could lead to wider adoption of the RECELL platform.
Avita expects to launch the RECELL GO mini in trauma and burn centers in the first quarter of 2025.
Shares traded 5.25% higher at $4.01.
