Regenerative medicine company AVITA Medical (ASX:AVH) has announced that the US FDA has approved its premarket approval (PMA) supplement for the RECELL GO System.
The system is the company's autologous cell harvesting device that harnesses the regenerative properties of a patient’s skin to treat thermal burn wounds and full-thickness skin defects.
The company said RECELL GO introduces enhanced features that streamline the preparation of Spray-On Skin Cells. It said the 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.
"FDA approval of RECELL GO marks a paradigm shift in the treatment of partial-thickness and full-thickness wounds,” said AVITA Medical CEO Jim Corbett.
“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."
The company said it would launch RECELL GO in the US in its burn treatment centres in June. Other existing accounts will be converted to RECELL GO throughout the year, and new accounts will receive RECELL GO with their first order, eliminating the need for conversion.