The Food and Drug Administration has approved Avita Medical Ltd.’s Recell System for treating severe burns, the biotechnology company said Friday.
Avita Medical is based in Melbourne, Australia but has its U.S. headquarters in Valencia.
The approval was based on two clinical trials.
“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,” Chief Executive Dr. Michael Perry said in a statement.
The company plans to launch the product in the U.S. in the fourth quarter of this year. It estimates there is a $200 million market for the treatment.
Shares of Avita Medical (AVMXY) rose a fraction of a cent, or 28 percent, on Friday on over-the-counter markets.