AVITA Medical, Inc. announced that it has completed enrollment into its pivotal trial for the use of the RECELL® System for soft-tissue reconstruction. Currently, the RECELL System is indicated in the U.S. for treatment of acute thermal burns. Topline data will be shared later this year.

Skin grafting is the standard of care for soft tissue reconstruction, including post-trauma and post-surgical skin reconstruction. Skin grafting 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, discoloration and scarring are associated with donor site wounds.

While skin grafting is commonly associated with burn treatment, in 2017, approximately 80% of acute wounds that required skin grafting were non-burn related injuries accounting for more than 200,000 procedures in the U.S.i The total addressable market (“TAM”) for soft tissue repair is approximately $1 billion and more than twice as large as the TAM for burns. Further, the existing reimbursement codes utilized for burn treatment with the RECELL System will apply to this indication.