Regenerative medicine company AVITA Medical (ASX:AVH) has completed enrolment in its pivotal trial for the use of the RECELL System for soft tissue reconstruction.
The RECELL System is currently indicated in the US for the treatment of acute thermal burns. The company said topline data from the new trial will be shared later this year.
“Completing enrollment of the pivotal trial assessing use of the RECELL System for treatment of soft tissue reconstruction is an important milestone for AVITA Medical and moreover, is synergistic with our current commercial focus in burns. Ultimately, with FDA approval of this indication, we expect to expand the use of RECELL to include all acute wounds,” said Dr Mike Perry, CEO of AVITA Medical.
“Early completion of enrollment in our soft tissue reconstruction trial underscores the need and physician desire for new treatment options.”
Skin grafting is the standard of care for soft tissue reconstruction, including post-trauma and post-surgical skin reconstruction. It requires the harvesting of donor skin, resulting in an additional wound to the patient. Significant pain, delayed healing, risk of infection, the need for multiple procedures, discolouration and scarring are associated with donor site wounds.
While skin grafting is commonly associated with burn treatment, in 2017, approximately 80 per cent of acute wounds that required skin grafting were non-burn related injuries accounting for more than 200,000 procedures in the US.
“I’m very pleased to have participated in this clinical trial, which we expect will confirm that less donor skin is needed for soft-tissue injuries while not compromising healing outcomes relative to conventional autografting,” said Dr Steven E. Mapula, assistant professor of surgery TCU and division chief of plastic surgery at John Peter Smith Hospital. “We believe the RECELL System has the potential to become an important new treatment option for those in need of soft-tissue reconstruction.”