AVITA Medical (ASX:AVH), a regenerative medicine company focused on the development and commercialisation therapies based on the healing properties of a patient’s own skin, has announced that the US FDA has approved its Investigational Device Exemption (IDE) application to conduct a trial evaluating the safety and effectiveness of the RECELL Autologous Cell Harvesting Device (RECELL System) in combination with meshed autografting for the treatment of acute full-thickness skin defects, such as degloving, abrasions, lacerations, and surgical wounds.
“FDA approval of our IDE for a soft tissue reconstruction pivotal clinical trial is an important next step in expanding the potential indications of our RECELL System technology platform. We are pleased with the strong interest expressed by the clinical community in participating in this study and we look forward to working with physicians and their patients upon study commencement,” said CEO Dr Michael Perry.
“Many burn specialists who have experience treating burn patients with the RECELL System also treat patients with trauma injuries in their clinics. The treatment protocols for burns and trauma are well-aligned and as such, we anticipate a positive transfer of clinical experience to benefit this patient population during the clinical trial.
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, said Avita.
"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," it said.
“Based on the compelling safety and effectiveness of the RECELL System in treating burn wounds, we believe our innovative technology is ideally positioned to be evaluated as a treatment to heal trauma- and surgery-related wounds,” said AVITA chief technology officer Andy Quick. “With a clear opportunity to improve the standard-of-care, we look forward to sharing results upon completion of this pivotal trial.”
AVITA said it will initiate a prospective, multi-centre, randomised controlled study to compare the clinical performance of conventional skin grafting with and without the use of the RECELL System on acute non-burn full-thickness skin defects. Each patient will have a control wound treated with conventional skin grafting and a wound treated with expanded skin grafting in combination with the RECELL System.
Healing will be evaluated by a qualified clinician blinded to the treatment allocation. Additional long-term safety and effectiveness data collected over the course of the 52-week study will include blinded evaluation of scar outcomes and patient treatment preference.