Regenerative medicine company AVITA Medical (ASX:AVH) has announced topline results from its pivotal trial evaluating the safety and effectiveness of the RECELL System combined with meshed autograft for reduction of donor skin harvesting in soft tissue reconstruction.
The company is developing and commercialising a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs. It said 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,” said Dr Steven Mapula, an assistant professor of Surgery TCU and division chief of plastic surgery at John Peter Smith Hospital. “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. 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.
The company said the donor sparing endpoint was met, showing a superior ratio of treated injury area to donor site area with RECELL compared to control, but the healing endpoint did not reach pre-specified statistical non-inferiority. However, it added, the observed values for healing with RECELL were the same or slightly better than control.
“Our study has shown statistically superior donor sparing and comparable healing rates for RECELL treatment of soft tissue injuries and we are confident in moving forward with our plan for a PMA submission later this year,” said CEO Dr Mike Perry.
“The RECELL System has been used to effectively treat serious burn injuries and we anticipate that the RECELL System will be well-positioned to treat patients with soft-tissue injuries, pending FDA review and approval.”
The company said it also plans to submit detailed results from the trial for peer-reviewed publication.