AVITA Medical (ASX: AVH) has obtained US Food and Drug Administration (FDA) approval its for its unique RECELL GO system.
RECELL GO is a cell harvesting device that utilises the regenerative properties of a patient’s own skin to treat thermal burn wounds and full-thickness skin defects.
When choosing RECELL, clinicians and patients can realise several significant advantages over traditional skin grafting:
- Improved healing is achieved using significantly less donor skin
- Pain is reduced, closure is faster, and the aesthetic appearance at the RECELL-harvested donor site is improved
- Fewer procedures are required for definitive closure
- There's a reduction in the length of stay for burns covering less than 50% Total Body Surface Area (TBSA).
RECELL GO introduces enhanced features that streamline the preparation of Spray-On Skin Cells. This next-generation device significantly reduces the training burden on medical staff, improves workflow efficiency in the operating room, and controls the RECELL Enzyme incubation time to ensure optimal cell yield and viability. These advancements simplify the user interface, enabling medical teams to provide quality care readily and consistently to their patients.
"FDA approval of RECELL GO marks a paradigm shift in the treatment of partial-thickness and full- thickness wounds,” said Jim Corbett, CEO of AVITA Medical.
“By streamlining processes and enhancing operational efficiency with the use of RECELL GO, clinicians can now treat a greater number of patients and more broadly experience the proven benefits of RECELL technology. We believe that this transformative shift will empower more clinicians to achieve optimal outcomes for their patients, driving greater adoption, and fundamentally redefining wound care management. It's GO time for a new era in wound care."
In the United States, the company will launch RECELL GO in its top burn treatment centres in June, and other existing accounts will be converted to RECELL GO throughout the year.
In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns, full-thickness skin defects, and vitiligo. The RECELL System is TGA-registered in Australia, has received CE-mark approval in Europe and has PMDA approval in Japan.
