AVITA Medical, Inc. (ASX: AVH) has completed enrolment into its pivotal trial for the use of the RECELL System for soft-tissue reconstruction.
AVITA is a regenerative medicine company that is developing and commercialising a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs.
Currently, the RECELL System is indicated in the US for treatment of acute thermal burns. Topline data will be shared later this year.
Completing enrolment 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, AVITA’s CEO.
“Early completion of enrolment 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. 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 US.
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.
“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 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.”