Avita Medical Limited has achieved both co-primary endpoints in its pivotal clinical trial which will soon be submitted for U.S. market approval of its ReCell device to treat severe burns. The company also released supportive results from a previous burns trial in a dual data release. The 30-patient trial was conducted at seven leading U.S. burn centers between 2015 and early 2017.
The first co-primary effectiveness endpoint gauged superiority of donor skin expansion, to resolve whether using ReCell could lead to less donor skin being needed. This difference in donor skin expansion with ReCell was found to be significant and resulted in use of an average of just over 30% less donor skin than the Control and a commensurate reduction in donor site size. The second co-primary effectiveness endpoint explored the incidence of healing within 8 weeks, which was similar in wounds that received ReCell compared to those that received control treatment. Healing with ReCell was found to be statistically non-inferior relative to conventional treatment.
These data will be submitted to the U.S. Food and Drug Administration as part of an application to support Premarket Approval (PMA) for the ReCell Autologous Cell Harvesting device. The Company is now focused on fulfilling requirements for remaining non-clinical data needed for the PMA submission, which is on track for mid-2017. Based on expected timelines, approval could occur by Q2 2018.