US-based regenerative medicine company AVITA Medical has received the US Food and Drug Administration (FDA) premarket approval (PMA) for its RECELL GO System.
RECELL GO is the company’s next-generation autologous cell harvesting device that harnesses a patient’s skin to treat his thermal burn wounds and full-thickness skin defects.
The system is said to provide clinicians and patients with several significant advantages over traditional skin grafting, including improved healing using significantly less donor skin.
It also enables reduced pain, faster wound closure, improved aesthetic appearance at the RECELL-harvested donor site, and fewer procedures for definitive closure.
The RECELL GO system also showed a reduction in the length of stay for burns covering less than 50% of Total Body Surface Area (TBSA), said the medical device company.
AVITA Medical CEO Jim Corbett said: “FDA approval of RECELL GO marks a paradigm shift in the treatment of partial-thickness and full-thickness wounds.
“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.”
AVITA said that its RECELL GO system comes with enhanced features that simplify the preparation of Spray-On Skin Cells.
The device 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.
Its advancements will help simplify the user interface, to help medical teams provide quality care consistently to their patients, said the company.
AVITA intends to launch RECELL GO at its top burn treatment centres in the US, this month and convert other existing accounts to RECELL GO through this year.
