AVITA Medical 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.
“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 Andy Quick, Chief Technology Officer of AVITA Medical. “With a clear opportunity to improve the standard-of-care, we look forward to sharing results upon completion of this pivotal trial.”AVITA Medical will initiate a prospective, multi-center, randomized 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. The study’s two primary effectiveness endpoints are:
- Incidence of healing by eight weeks post treatment
- Donor skin sparing, evaluated by comparing the ratios of donor skin required to treat the wounds
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.
The pivotal studies leading to the RECELL System’s FDA premarket approval (PMA) for the treatment of acute thermal burns demonstrated that the RECELL System treated burns using 97.5[ii] percent less donor skin when used alone in second-degree burns, and 32 percent less donor skin when used with autograft for third-degree burns.[iii] Despite the statistically significant reduction in donor skin required to treat burn patients with the RECELL System, burn wounds treated with the RECELL System achieved healing comparable to the burn wounds treated with standard of care. Donor site outcomes from the clinical trial for second-degree burns also revealed a statistically significant reduction in patient-reported pain, increased patient satisfaction and improved scar outcomes.[ii]
[i] 2017 Procedural Data. © 2019 DR/Decision Resources, LLC
[ii] Holmes JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018
[iii] Holmes JH, Molnar JA, Shupp JW, et al. Demonstration of the safety and effectiveness of the RECELL System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries. Burns. 2019;45:772-782.