Ann: Pivotal Soft Tissue Trial Receives US FDA IDE Approval, page-13

Recell effectiveness is significantly over-hyped compared with actual results of Avita's own references

Holmes JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018

"Both treatments were clinically effective in healing >97% of the treated burns by week 4. The incidence of definitive closure, as defined as ≥95% re-epithelialization, was 97.6% (81/83) for the ReCell-generated ASCS treated site and 100% (83/83) for the control STSG–treated site (Figure 3). The difference in proportions between the two groups was −2.4% (95% CI: −8.4% to 2.3%). Therefore, the healing of ASCS-treated sites was statistically comparable to those sites treated with a 2:1 meshed STSG, thus substantiating the noninferiority primary effectiveness endpoint."

"Additionally, subject-reported pain at the treatment site during the first 16 weeks was not significantly different between the ASCS and control sites (Figure 4A). Similarly, long-term results at 16, 24, and 52 weeks showed no difference in subject satisfaction with appearance (Figure 4B) or in scarring (Figure 4C) at the ASCS-treated sites compared with the control sites. Following treatment site healing, no late-term wound breakdown was reported."