Avita Medical, Inc., a UK-based company that is developing a technology platform for point-of-care autologous skin restoration, announces topline results from its randomized, controlled trial evaluating the safety and effectiveness of the Recell system, combined with meshed autograft for reduction of donor skin harvesting in soft-tissue reconstruction. Injuries considered for the clinical trial included any full-thickness acute skin defect, such as degloving or peeled back skin injuries, road rash, surgical wounds, and flesh-eating disease.
“Soft-tissue injuries can be challenging to treat, and I am very pleased with the outcomes using Recell—especially the use of less donor skin when treating a variety of injuries,” says Steven E. Mapula, MD, assistant professor of surgery at Texas Christian University and division chief of plastic surgery at John Peter Smith Hospital in Fort Worth. “Following FDA approval, I look forward to utilizing Recell broadly to help patients with a wide variety of soft-tissue injuries.”
The study design included co-primary endpoints, based on pairwise comparisons where each subject received both Recell used in combination with widely meshed skin grafting and the Control treatment of conventional skin grafting; 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. Preliminary review of adverse events shows consistency with our years of prior RECELL experience, reinforcing the product’s compelling safety profile.
The primary study outcomes are as follows:
- The donor sparing endpoint was met, showing a superior ratio of treated injury area to donor site area (p<0.001) with Recell versus the control.
- The healing endpoint did not reach pre-specified statistical non-inferiority, however, observed values for healing with Recell were the same or slightly better than the control.
“Our study has shown statistically superior donor sparing and comparable healing rates for Recall treatment of soft tissue injuries and we are confident in moving forward with our plan for a PMA submission later this year,” says Mike Perry, PhD, CEO of Avita Medical. “The Recell system has been used to effectively treat serious burn injuries and we anticipate that the Recelll system will be well-positioned to treat patients with soft-tissue injuries, pending FDA review and approval.”