AVITA Medical (ASX:AVH) has announced that the results from two US clinical trials demonstrating the effectiveness and clinical benefits of the RECELL Autologous Cell Harvesting Device were presented at the Annual Eastern Great Lakes Burn Conference in Michigan.
The results were presented by Dr Jeffrey Carter, medical director of University Medical Center New Orleans Burn Center and associate professor of Surgery at LSU Health New Orleans School of Medicine.
“The RECELL System technology provides a major advancement for burn care,” said Dr Carter. “Within these studies we demonstrated comparable healing and scar outcomes to standard of care using significantly less skin. My team is excited to learn of the recent FDA approval and we are looking forward to treating our patients outside of the clinical trials.”
The US FDA recently approved the RECELL System to treat acute 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 clinical trials presented by Dr Carter were used to support the FDA approval and 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 licensed healthcare professionals to treat adult patients with acute thermal burn wounds.
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 enzymatically and mechanically processed in the RECELL System at the point of care to isolate the skin cells to produce a suspension of Spray-On Skin Cells.
The suspension can be sprayed directly on a second-degree burn or with an expanded skin graft on a third-degree burn, allowing for broad and even distribution of live cells across the entire wound bed.
The company said the RECELL System can be used to prepare enough suspension 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.