FDA Approves AVITA Medical’s RECELL GO System

AVITA Medical Inc. has won U.S. Food and Drug Administration (FDA) premarket approval (PMA) for the RECELL GO System, a next-generation autologous cell harvesting device that harnesses the regenerative properties of a patient’s own skin to treat thermal burn wounds and full-thickness skin defects.

The company claims RECELL provides clinicians and patients with several advantages over traditional skin grafting, including improved healing, using significantly less donor skin;¹ reduced pain, faster closure, and an improved aesthetic appearance at the RECELL-harvested donor site;² fewer procedures required for definitive closure;³ and reduced hospitalization for burns covering less than 50% of the total body surface area.^2,3,4

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,” AVITA Medical CEO Jim Corbett said. “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 has already launched RECELL GO in top U.S. burn treatment centers, 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.

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

AVITA Medical is a commercial-stage regenerative medicine company developing wound care management solutions and skin restoration devices. At the forefront of its platform is the RECELL System, approved by the FDA for treating thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin Cells, delivering a solution at the point-of-care. This technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm, a biosynthetic wound matrix, in the United States.

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.

References
¹ Instructions for Use. RECELL Autologous Cell Harvesting Device.
² Holmes JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018;39(5):694-702.
³ Kowal S, Kruger E, Bilir P, et al. Cost effectiveness of the use of autologous cell harvesting device compared to standard of care for treatment of severe burns in the United States. Adv Ther. Published online May 7, 2019. doi:10.1007/s12325-019-00961-2.
⁴ Holmes JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018;39(5):694-702.

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