FDA Green Lights First Spray-on-Skin Product for Burns

Friday, September 21, 2018 | FDA Approval/Clearance


The US Food and Drug Administration granted premarket approval to Avita Medical’s Recell, a spray-on-skin that treats second- and third-degree burns in patients aged older than 18 years.

The U.S. market launch for the Recell Autologous Cell Harvesting Device (RECELL® System) is planned for 4th quarter 2018.  The System uses a small amount of a patient’s own skin to prepare Spray-On Skin™ Cells at the point of care in about 30 minutes.

“Today’s approval of the Recell System is a significant advancement in how we treat patients with burns,” says James H Holmes IV, MD, FACS, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, in a news release. “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.”

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 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 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 onto 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.

 

 

 

 

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