RECELL System Approved to Treat Full-Thickness Skin Defects

The Food and Drug Administration (FDA) has expanded the approval of the RECELL^® System to include treatment of full-thickness skin defects, including wound injuries after traumatic avulsion, surgical excision, or resection.

The RECELL System is a single-use, autologous cell harvesting device intended for use at the point of care by a trained health care professional. The device allows for the collection of a small skin sample that is used to produce a suspension of Spray-On Skin™ Cells. The cell suspension contains a combination of keratinocytes, fibroblasts, and melanocytes and is directly applied to the wound.

The expanded indication was supported by data from a randomized, controlled trial that evaluated the safety and effectiveness of RECELL combined with meshed autograft for reduction of donor skin harvesting in soft tissue reconstruction (ClinicalTrials.gov Identifier: NCT04091672).

Findings showed that RECELL met both primary endpoints, demonstrating statistically significant donor skin sparing (ie, less skin required to repair and close the wound) compared with conventional skin grafting (control) (P <.001), as well as achieving statistical noninferiority for healing vs the control (P <.025).

“The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings,” said Jim Corbett, AVITA Medical Chief Executive Officer. The FDA first approved the RECELL System in 2018 for the treatment of severe burns. In 2021, the approval was extended to pediatric patients.