FDA approves ReCell System to treat burns.- AVITA Medical

AVITA Medical announced that the FDA approved the Company�s Premarket Approval (PMA) application to market the ReCell Autologous Cell Harvesting Device (ReCell System) to treat severe thermal burns in patients 18 years and older. The ReCell System uses a small amount of a patient�s own skin to prepare Spray-On Skin Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns.

The two randomized, controlled clinical trials supporting the FDA approval demonstrated that treatment of acute burn wounds with the ReCell System required substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment. The ReCell System is approved to be used at the point of care by trained healthcare professionals to treat adult patients with severe thermal burns.

The ReCell System can be used alone in the treatment of partial thickness burns, or in combination with autografting for the treatment of full-thickness burns. A small skin sample is collected and immersed in the Company�s proprietary Enzyme solution in the ReCell System to separate the skin cells to produce Spray-On Skin Cells. The resultant Regenerative Epidermal Suspension� (RES ) includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in wound healing. The suspension is then sprayed directly on to the prepared burn wound, providing a broad and even distribution of live cells across the entire wound bed. The ReCell System can be used to prepare enough RES to treat a wound up to 80 times the size of the donor skin sample, so a skin sample approximately the size of a credit card can be used to treat a wound that covers a patient�s entire back.