Avita Medical has secured approval from the US Food and Drug Administration (FDA) for a premarket approval (PMA) supplement for its next-generation autologous cell harvesting device, the Recell GO System.
The Recell GO System is designed to treat burns and skin defects.
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It can treat thermal burn wounds and full-thickness skin defects by harnessing the regenerative properties of the skin of a patient.
Enhanced features introduced by the Recell GO System streamline the preparation of spray-on skin cells, reducing the training burden on medical staff and improving workflow efficiency.
The device ensures optimal cell yield and viability by controlling the Recell Enzyme incubation time. These advancements simplify the user interface, allowing medical teams to deliver consistent, quality care.
Avita Medical chief executive officer Jim Corbett said: “FDA approval of Recell GO marks a paradigm shift in the treatment of partial-thickness and full-thickness wounds.
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By GlobalData“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 is planning to launch the Recell GO System in leading US burn treatment centres next month, with a plan for a gradual rollout to other existing accounts throughout the year.
The system is intended to promote healing for the skin in a range of applications including full-thickness skin defects, burns, and vitiligo.
Last year, Avita Medical signed an agreement with PolyMedics Innovations whereby the latter will serve as the exclusive distributor for Recell in Germany, Austria, and Switzerland, with an option for future expansion into other European markets.
