Summary: AVITA Medical announced FDA approval for its RECELL GO System, an advanced device for harvesting autologous skin cells to treat burn wounds and skin defects. The system simplifies preparation, reduces training requirements, and enhances workflow efficiency.

Key Takeaways:

  1. The RECELL GO System uses less donor skin, reducing pain and improving healing and aesthetic outcomes.
  2. The device decreases the need for multiple procedures and shortens hospital stays for burns covering less than 50% TBSA.
  3. It will be launched in top U.S. burn treatment centers in June, with broader distribution throughout the year.

AVITA Medical Inc, a commercial-stage regenerative medicine company focused on devices for wound care management and skin restoration, announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for the RECELL GO System, its next-generation autologous cell harvesting device. The RECELL GO System is designed to harnesses the regenerative properties of a patient’s own skin to treat thermal burn wounds and full-thickness skin defects.

According to the company, RECELL offers clinicians and patients the following 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)

The system reportedly introduces enhanced features that streamline the preparation of Spray-On Skin Cells. According to AVITA Medical, 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 reportedly 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, chief executive officer 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.”

According to a press release from AVITA Medical, it will launch RECELL GO in its top burn treatment centers in the United States in June, and other existing accounts will be converted to RECELL GO throughout the year. New accounts will receive RECELL GO with their first order, eliminating the need for conversion, says the company.

The supplement follows the original PMA of RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.