AVITA Medical has announced that the pivotal clinical trial of its RECELL System for soft tissue repair has achieved the co-primary endpoints in updated data analysis.
The trial was designed to assess the RECELL System’s effectiveness and safety for soft tissue repair.
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It included two co-primary endpoints; one had a hypothesis of superiority for donor skin-sparing while the other had a hypothesis of non-inferiority for healing.
The company stated that these endpoints were based on pairwise comparisons, where each participant in the study received treatment with the RECELL system as well as the standard of care treatment (control).
Findings from the study demonstrated that the RECELL system achieved statistically significant donor sparing over control (p<0.001) and non-inferiority for healing versus control (p<0.025).
These findings will support the company’s application for premarket approval (PMA) from the US Food and Drug Administration (FDA).
AVITA Medical CEO Jim Corbett said: “These results reinforce the potential for RECELL to become a new standard of care for soft tissue repair.
“We look forward to sharing the soft tissue repair outcomes with the FDA via our PMA submission expected in December 2022.”
The RECELL System allows healthcare providers to produce a suspension of Spray-On Skin Cells using a small sample of the patient’s own skin to treat acute thermal burns.
It has been designed to be used at the point of care setting alone or with autografts depending on the depth of the burn injury.
AVITA Medical previously announced that the donor-sparing endpoint had achieved superiority.
The clinical trial of the RECELL System in soft tissue repair is backed with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.
