AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Pivotal Study Evaluating RECELL System for Soft Tissue Reconstruction
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine company focused on the development and commercialization of innovative therapies leveraging the healing properties of a patient’s own skin, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application to conduct a pivotal 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 (a type of injury where the skin is ripped from the underlying tissue), crush wounds (a break in the external surface of the body), 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 Dr. Michael Perry, Chief Executive Officer of AVITA Medical. “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. 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