Avita Medical updates results from clinical trial of RECELL System

AVITA Medical announced achievement of co-primary endpoints as a result of updated analysis of data from its clinical trial evaluating the safety and effectiveness of the RECELL System for soft tissue repair. The study design included two co-primary endpoints based on pairwise comparisons where each subject received both RECELL treatment and standard of care treatment (Control): one endpoint had a hypothesis of superiority for donor skin sparing and the other co-primary endpoint had a hypothesis of non-inferiority for healing. Both co-primary endpoints have been met: RECELL achieved statistically significant donor sparing over Control. RECELL achieved statistical non-inferiority for healing versus Control. AVITA Medical’s clinical trial in soft tissue repair has been funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500028C.