AVITA Medical achieves co-primary endpoints in updated RECELL trial

VALENCIA, Calif. and MELBOURNE, Australia, Nov. 09, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today 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 (p<0.001).
• RECELL achieved statistical non-inferiority for healing versus Control (p<0.025).

“These results reinforce the potential for RECELL to become a new standard of care for soft tissue repair,” said Jim Corbett, AVITA Medical Chief Executive Officer. “We look forward to sharing the soft tissue repair outcomes with the FDA via our PMA submission expected in December 2022.”

Previously, the company announced that the donor sparing endpoint had achieved superiority and that the healing endpoint had just missed non-inferiority. Subsequently, further re-verification resulted in corrections to the healing data, ultimately leading to a conclusion of non-inferiority for healing.

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.