Avita Medical touts new burn treatment
Spray-on skin treatment to hit U.S. market soon, after FDA approval
Avita Medical, a regenerative medicine company with U.S. offices in Valencia, has received approval by the FDA for its product that would transform the way burns are treated, according to developers.
The company’s ReCell System is a spray-on skin treatment that can be used alone for partial-thickness burns or in combination with autografting for fullthickness wounds in as little as 30 minutes.
With a green light from the FDA, Avita is now preparing to launch the product in the U.S. within the coming months.
How it works
Before application, a small skin sample is collected and immersed into an enzyme solution to separate the skin cells to produce the spray.
The resultant is then sprayed directly onto the burn wound, where the cells in the solution help start a new layer of healthy skin.
The current standard of treatment is skin grafts, but the method calls for scarring, significant pain and delayed healing as the healthy skin is cut to layer over the burns.
With the ReCell System, however, “97.5-percent less skin is used to treat a burn area than with skin grafts in the case of seconddegree burns. You would need a
skin sample the size of a credit card to treat an entire patient’s back,” said Dale Sander, Avita Medical spokesperson.
Two clinical trials have shown a faster recovery after using less skin than standard grafts. So far, more than 7,000 patients worldwide have been treated with the ReCell System.
Dr. Michael Perry, CEP of Avita Medical, said in a statement that the approval marked a significant milestone for the company and “provides a new way to treat burns for thousands of patients with significant unmet medical needs.”
ReCell in the burns treatment market
The frequency of burn-related injuries and the cost of treatment is high.
The Centers for Disease Control and Prevention reported that 486,000 patients receive emergency medical treatment for burns annually and about 3,400 people die of burn injuries each year.
“While severe thermal burns happen every day, in a national security emergency an overwhelming number of people may need burn care quickly,” said Rick Bright, Ph.D., director of Biomedical Advanced Research and Development Authority, which helped pay for its development.
Avita’s target market is estimated to be around $200 million per year, according to Sander.
A health economic model showed that the product would reduce annual total treatment costs by $13 million in a 200bed burn center.
Avita is now finalizing its product packaging and promotional materials, hiring its field sales team and training medical professionals.
Sanders said while 24 out of the 134 burn centers in the U.S. have already had experience with the product through clinical studies, more are expected to order in advance as ReCell System is scheduled to launch by the end of 2018 formally.