AVITA Medical, a regenerative medicine company specialising in wound care devices, has announced that the US Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for the RECELL GO mini.
The new addition to the RECELL GO system is a mini disposable cartridge designed to treat smaller wounds up to 480cm2, compared to the standard cartridge’s capacity of 1,920cm2.
AVITA Medical has designed the RECELL GO mini for the full-thickness skin defect market, including smaller wounds.
As part of the RECELL GO platform, the mini uses the same multi-use processing device but features a modified cartridge optimised for smaller skin samples.
This design reduces resource use and minimises waste, providing an entry point for clinicians not previously using the RECELL GO platform for smaller wounds and improving accessibility in trauma and burn centres.
AVITA Medical CEO Jim Corbett said: “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.
“By introducing a treatment option specifically for smaller wounds, we are expanding the accessibility of RECELL to a wider range of patients.”
The company anticipates that the RECELL GO mini will drive growth within the broader RECELL GO platform, further advancing AVITA Medical’s strategy to impact patient care.
The rollout will commence in Q1 2025, targeting trauma and burn centres that treat smaller wounds.
The PMA supplement for RECELL GO mini follows the original PMA of the RECELL Autologous Cell Harvesting Device and its subsequent PMA supplements, marking a significant step in the company’s growth strategy.
AVITA Medical aims to advance wound care and skin restoration with advanced devices.
Its flagship product, the US Food and Drug Administration (FDA)-approved RECELL System, treats thermal burn wounds, full-thickness skin defects, and stable vitiligo lesions.
In the US, the regenerative medicine company also markets PermeaDerm, a biosynthetic wound matrix, and Cohealyx, a collagen-based dermal matrix that was approved recently by the FDA.
Internationally, RECELL is approved for burns, skin defects, and vitiligo.
