Avita’s ReCell spray-on-skin nearing U.S approval

Avita Medical has announced exceptional results following the first FDA-approved treatment of a U.S burns patient with the company’s ReCell spray-on-skin treatment.

The patient, admitted to a burns hospital in North Carolina, presented with burns to both arms. Using the FDA protocol’s ‘blinded randomisation process’ one site was assigned treatment with ReCell, with the other treated using a split thickness skin graft, the traditional standard of care.

Avita reported that after seven days the ReCell graft site had 100 percent take and was completely re-epithelialised, meaning that the wound was completely covered with new skin without any open areas of blisters. The control site, on the other hand, had between 75 and 80 percent with 20 -25 percent of the area having unhealed interstices.

Importantly, the patient reported 0/10 pain at the ReCell site and 10/10 pain at the traditional control site. The treatment follows an exhaustive series of approvals applications and processes for Avita, including with the FDA (federal drugs administration) and the IRB (Institutional Review Board).

Avita Medical CEO Dr William Dolphin said that this was largely due to the fact that the fields of regenerative medicine and cell-based therapies are so new, leading the FDA and ethical review boards to take a very conservative approach.

“Nonetheless, the entire process has now been completed at five key investigational sites and we have achieved the substantial US milestone of commenced enrolment and application of ReCell,” Dolphin said.

Avita’s shares were up over 27 percent at the close of markets today.