VALENCIA, Calif. & MELBOURNE, Australia—Avita Medical, a global regenerative medicine company, announced today that key opinion leaders from five U.S. burn centers presented clinical results of the RECELL Autologous Cell Harvesting Device (RECELL System) at two US burn conferences, the 31st Annual Southern Region Burn CME Conference held in Mobile, AL and the Northeast Region Burn Conference held in Cambridge, MA. The burn surgeons also led two medical education symposiums on the use of the RECELL System at the conferences.
A health economic model calculating the cost savings advantages of treating burn patients with the RECELL System versus standard of care was presented by William Hickerson, MD, FACS, Firefighter Burn Center, Memphis, Tennessee, and University of Tennessee Health Science Center. In a presentation titled “Resource Use, Costs and Outcomes for Treatment of Severe Burns Using RECELL in the United States,” Hickerson reported that treating patients with the RECELL System alone, or in combination with widely spaced skin grafts, is projected to reduce his burn center’s costs by up to $21 million per year, compared to conventional treatment. Major drivers of the cost savings included a decrease in length of hospital stay and a reduction in the number of surgeries and related resources (blood transfusions and dressings).
A series of presentations detailing the results from two US pivotal clinical trials demonstrating the effectiveness and clinical benefits of the RECELL System were made at the Southern Region Burn Conference by James H Holmes IV, MD, FACS, Wake Forest Baptist Medical Center, and Jeffrey Carter, MD, FACS, Medical Director of University Medical Center New Orleans Burn Center and Associate Professor of Surgery at LSU Health New Orleans School of Medicine. The results were also presented by Dr. Jeffrey Wilson Shupp, MD, Director of The Burn Center at MedStar Washington Hospital Center, at the Northeast Conference.
Christopher Braxton, MD, University Medical Center New Orleans, presented “Treatment of High-Voltage Electrical Burn with Autologous Skin Cell Suspension: A Case Report,” a class of burn that falls outside of the approved FDA labeling and for which the patient was treated under the company’s Compassionate Use program. Braxton presented the case of a 57-year-old male with a 41 percent total body surface area (TBSA) burn following an explosive, high-voltage electrical injury on a movie set. The patient was treated with the RECELL system and his length of his hospital stay was only 1.02 days per percent TBSA versus the average 3.13 days per percent TBSA reported in the National Burn Repository Data.
The Southern Region Burn and the Northeast Region Burn Conferences are two in the series of regional conferences held in the US each year. The two medical symposiums held at the conferences were organized to assist in the training of US physicians who had not previously treated patients with the RECELL System in advance of FDA approval in clinical trials, or in the Compassionate Use program.
The RECELL System, just approved by the FDA in September 2018, is used to treat acute thermal burns by taking 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.
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 an adult patient’s entire back. Randomized, controlled trials have demonstrated that treatment of acute burn wounds with the RECELL System requires substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements reportedly provides key clinical benefits to patients and significant reductions in the cost of treatment.