FDA Approves Severe Thermal Burn Skin Therapy Device

The US Food and Drug Administration (FDA) has approved a premarket approval application for spray-on skin cell device for adult patients with severe thermal burns.

The RECELL Autologous Cell Harvesting Device, from global regenerative medicine company AVITA Medical, has been approved for burn patients aged 18 years and older. As a direct-care system evidenced to treat burns in as little as 30 minutes, the RECELL system vies to limit the rate of required donor skin in severe thermal burn treatments.

The device, which uses a small amount of the patient’s own skin to prepare for the spray-on therapy, was approved on the strength of a pair of randomized, controlled clinical trials demonstrating the treatment of acute burn wounds. In the first trial, RECELL System was compared versus conventional split-thickness autografts in patients with deep second-degree burn injuries. Patients treated with the RECELL Systems were required to donate 97.5% less skin than standard-of-care, and reported statistically significant reduction in patient-reported pain, increases in satisfaction, and improved outcomes in donor scars. Though the patients needed to donate substantially less skin to treatment with the RECELL System, their burn sites achieved comparable definitive closure to standard-of-care.

FDA approval was based on the results of two randomized, controlled clinical trials comparing the treatment of burn patients with the RECELL System against the standard of care. The first controlled trial compared treatment with the RECELL System versus treatment with conventional split-thickness autografts in patients with deep partial-thickness (second-degree) burn injuries.

During the pivotal trial, the patient donor skin required to be harvested to treat burn sites with the RECELL System was 97.5% less than the amount harvested to treat burn sites using standard of care resulting in a statistically significant reduction in patient-reported pain, increased patient satisfaction and improved donor scar outcomes. Despite the statistically significant reduction in donor skin required to treat with the RECELL System, burn sites treated with RECELL achieved definitive closure comparable to the burn sites treated with standard of care.

William Hickerson, MD, of the Firefighter Burn Center in Memphis, TN, was an investigator on both pivotal clinical trials involving the device.

“Based on my personal experience treating patients with the RECELL System, and the strength of the entire body of clinical evidence supporting this innovative technology, today’s approval will improve the treatment of burn patients,” Hickerson said.

The device is approved for either lone second-degree burn treatment, in combination with autographing for the treatment of full-thickness burns. It functions by collecting and immersing skin samples into the company’s proprietary Enzyme solution, producing the spray-on skin cells. The Regenerative Epidermal Suspension includes keratinocytes, fibroblasts, and melanocytes, and is created in enough surplus to treat a wound up to 80 times the size of the donor skin sample.

James H. Holmes IV, MD, of the Wake Forest Baptist Medical Center in Winston-Salem, NC, said the RECELL System approval is a significant advancement in the treatment of burn patients.

“Dramatically reducing the amount of donor skin needed to treat second- and third-degree burns has important implications for pain, scarring and costs of care, while still providing comparable healing to the current standard of care,” Holmes said in a statement. “Additionally, the potential reduction in mortality is extremely promising.”