avita medical (ASX:AVH) announced FDA approval of its new RECELL GO mini disposable cartridge.

spray on skin

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

This platform involves harvesting the patient’s own tissue. One square centimeter of skin can be used to treat an 80 square centimeter wound. The sample is converted into a “spray-on skin” and applied directly to the wound. While normal wounds only heal from the edges, the RECELL method promotes healing from within the wound as well.

Wounds treated with RECELL heal within one to two weeks, compared to the expected three to six weeks for normal healing.

RECELL GO is a platform extension. This device has a disposable cartridge and is designed for multiple use, whereas the original RECELL device had a disposable component for spray-on skin treatment and application.

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 (approximately 3 square feet).

RECELL GO mini uses the same processing equipment as the standard system, but the cartridges are smaller and waste is minimized.

next step

“The FDA’s approval of RECELL GO mini strengthens our ability to provide clinicians with a fit-for-purpose solution that meets the diverse needs of patients with full-thickness wounds,” said Avita Medical’s CEO. ), said Jim Corbett. He noted that the small size of the device could facilitate widespread adoption of the RECELL platform.

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

The stock is trading 5.25% higher at $4.01.