AVITA Medical announced that the Food and Drug Administration (FDA) has approved the Premarket Approval (PMA) application to market the RECELL Autologous Cell Harvesting Device to treat thermal burns in patients aged ≥18 years.
The RECELL System is intended for use at the point of care by trained healthcare professionals. It can be used alone for treating partial-thickness burns, or in combination with autografting to treat full-thickness burns.
A small sample of the patient’s own skin is immersed in the Company’s proprietary Enzyme solution in the RECELL System, which separates the skin cells to produce Spray-On Skin Cells in as little as 30 minutes. The resulting Regenerative Epidermal Suspension (RES) includes keratinocytes, fibroblasts, and melanocytes, which are involved in wound healing. The RES is then sprayed directly on the burn wound, covering the entire wound bed. The RECELL System can prepare enough RES to treat a wound up to 80 times the size of the donor’s skin sample.
The FDA approval was supported by 2 randomized controlled trials that showed acute burn wounds (second- and third-degree) treated with the RECELL System required substantially less donor skin than that required with standard-of-care split-thickness autografts, to close burn wounds. In 1 trial, the patient donor skin required to treat second-degree burn sites with the RECELL System was 97.5% less than the amount harvested using standard-of-care. This led to a statistically significant reduction in patient-reported pain, increased patient satisfaction, and improved donor scar outcomes. In addition, the burn sites treated with RECELL System achieved definitive closure comparable to burn sites vs burn sites treated with standard-of-care.
The second trial demonstrated that the patient donor skin required to treat third-degree burn sites with the RECELL System was 32% less than that required with standard-of-care (P<.001). At Week 8 post-treatment, 92% of the burn sites treated with RECELL System achieved complete healing vs 85% of sites treated with standard-of-care, demonstrating non-inferiority.
“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. Additionally, the potential reduction in mortality is extremely promising,” stated James H Holmes IV, MD, FACS, Wake Forest Baptist Medical Center, Winston-Salem, NC.
AVITA Medical anticipates a formal launch in the 4th quarter of 2018.
For more information visit AvitaMedical.com.