Soft tissue reconstruction includes skin grafting for soft tissue reconstruction, and requires the harvesting of donor skin which can result in an additional wound to the patient
Soft tissue reconstruction is of particular concern to BARDA and AVITA Medical. (Credit: Colin Behrens from Pixabay)
AVITA Medical, a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that the Biomedical Advanced Research and Development Authority (BARDA) has modified its existing contract with the Company to support AVITA Medical’s clinical trial in soft tissue reconstruction. BARDA is a part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).
“We are extremely pleased that BARDA is supporting advanced treatment options for soft tissue reconstruction,” said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. “The RECELL System has already proven itself as a safe and effective tool for those with burns, and we are committed to expanding its use to include all acute wounds. We are pleased BARDA recognizes the potential it holds for a broader group of patients experiencing trauma. BARDA has been an outstanding partner, and we are excited to continue our work to expand the indication for the RECELL System with their support.”
Soft tissue reconstruction is of particular concern to BARDA and AVITA Medical, as skin grafting, the current standard of care for soft tissue reconstruction, requires the harvesting of donor skin which can result 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.
AVITA Medical is currently completing a 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. The clinical trial will compare the clinical performance of conventional autografting to that of widely meshed autografting with the RECELL System on acute non-burn full-thickness skin defects, with the goal of demonstrating that less donor skin is needed without compromising healing outcomes. Topline data from the trial will be shared later this year.
AVITA Medical has had a long-term positive relationship with BARDA since September 2015 and was of fundamental importance to the Company being able to achieve premarket approval for the RECELL System in late 2018.
This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500028C
Source: Company Press Release