There’s a new hope for the millions of people who suffer severe burns and abrasions every year. ReCell, a regenerative skin-cell solution, is the first treatment of its kind approved by the US Food and Drug Administration for growing back skin.
In the United States alone, roughly half a million people have to seek medical treatment for their burns each year. The most traditional form of treatment came in the form of skin grafts. However, those require more pain on the part of the patient, as doctors have to cut away and remove healthy skin elsewhere on the body to cover the burns.
ReCell is a creation of AVITA Medical, a global regenerative medicine company. According to CEO Michael Perry, the company wanted to give burn patients more treatment options -- especially ones that were less painful.
“Today’s approval of the RECELL System marks an important milestone for us and provides a new way to treat burns for the thousands of patients with significant unmet medical needs, said Perry in a statement. “We are grateful to those patients who participated in clinical trials of the RECELL System and to the clinical trial investigator teams whose dedication and scientific rigor made this approval possible. We also greatly appreciate our collaboration with BARDA and the support that they have provided to us throughout the development of the RECELL System.”
A race to restore and rebuild skin
ReCell is definitely not the only solution that’s been in the works. It’s simply the first one to gain FDA approval.
In 2009, MIT researchers made headlines when they proposed a similar spray-on skin. AVITA Medical competitor RenovaCare also created the SkinGun.
However, Avita’s technology beat its competitors to FDA approval -- and possibly to the market -- first.
ReCell reduces how much skin has to be removed over the burned surface before treatment, the company explained. It uses enzymes to break down those layers of skin from a piece of tissue. It then mixes those tissue cells into a liquid that’s applied to the skin using a simple, low-tech spray.
In most burn scenarios, skin grafts can require more skin than a patient anticipates. There’s also nerve damage along with damaging skin and muscle tissues.
Perry told media outlets that ReCell reduces the amount of healthy skin that gets damaged during a skin graft by 97 percent for a second-degree burn.
For doctors, ReCell could give them a new way to treat patients faster, easier, and safer than ever before. It takes just 30 minutes to process a patient’s skin, and because it’s the patient’s own skin from the area, there’s next-to-no possibility of rejection.
“Today’s approval of the RECELL System is a significant advancement in how we treat patients with burns,” said James H Holmes IV, MD, FACS, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina. “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.”
Next steps and going to market
Two separate clinical trials put ReCell to the test. Both trials were published in the Journal of Burn Care & Research. In the studies, ReCell reached 92 percent healing on burn sites after 8 weeks of treatment compared to just 85 percent for standard treatment processes like skin grafts.
“I have participated as an investigator in the two pivotal clinical trials of the RECELL System as well as the Compassionate Use and Continued Access programs,” said William Hickerson, MD, FACS, Firefighter Burn Center, Memphis, Tennessee, and University of Tennessee Health Science Center, Memphis, Tennessee. “Based on my personal experience treating patients with the RECELL System, and the strength of the entire body of clinical evidence supporting this innovative technology, today’s approval will improve the treatment of burn patients.”
The Biomedical Advanced Research and Development Authority (BARDA) also helped fund ReCell during its clinical trials. BARDA officials noted that ReCell could be an integral part of treating burn victims quickly and safely during times of national disasters and emergencies.
“While severe thermal burns happen every day, in a national security emergency an overwhelming number of people may need burn care quickly,” said BARDA Director Rick Bright, PhD. “Medical providers need easy-to-use treatments on hand to save more lives. Our goal is not only to support product development but also to integrate those products into routine care to build preparedness."
Currently, AVITA hasn’t listed a price for ReCell. However, Perry told NBC News it could be between $5,000 to $10,000 per unit. That cost would cover roughly 10 percent of a patient’s body. Deeper burns or burns covering a larger surface area would require more units.