AVITA Medical , a global regenerative medicine company, today announced that the results from two U.S. pivotal clinical trials demonstrating the effectiveness and clinical benefits of the RECELL® Autologous Cell Harvesting Device (RECELL® System) were presented at the 46th Annual Eastern Great Lakes Burn Conference in Ann Arbor, Michigan. The results were presented by Jeffrey Carter, MD, FACS, Medical Director of University Medical Center New Orleans Burn Center & 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 U.S. Food and Drug Administration (FDA) approved on 20 September 2018 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 randomized, controlled clinical trials presented by Dr. Carter at the conference 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.
In his presentation, titled "Establishing the Safety and Effectiveness of RECELL as an Autograft-Sparing Technology for Definitive Closure of Burn Injuries," Dr. Carter provided an overview of the key shortcomings of the current standard of care, split-thickness autografts. These include the large donor skin requirements, donor site pain and complications, and extended hospitalization and treatment cost. In the first of the pivotal randomized, controlled clinical trials presented by Dr. Carter, use of the RECELL System in the treatment of deep partial-thickness (second-degree) burns demonstrated statistically significant reduction in donor skin requirements (97.5 percent reduction) and pain, increased patient satisfaction, and improved donor scar outcomes. In the second pivotal randomized, controlled clinical trial presented, use of the RECELL System in mixed and full-thickness (third-degree) burns met the trial's co-primary endpoints and demonstrated statistically significant reduction in donor skin requirements (32.0 percent reduction).
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 regenerative cell suspension includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in wound healing. 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 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.
Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device for a full description of important safety information, including contraindications, warnings, and precautions.
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