Avita acquired the facility last month from a manufacturer that previously assembled the Recell device on a contract basis. The components being made at the Ventura facility will be used to support the expected U.S. launch of Avita’s Recell product.
“I am proud of the results achieved by our manufacturing, quality control, regulatory and support teams who have successfully transitioned the Recell device to in-house production within our projected timelines,” CEO Michael Perry said in prepared remarks. “The successful commencement of manufacturing of the Recell device within our own facility is a major milestone and ensures that we are prepared for the planned U.S. launch.”
Using a small sample of a patient’s skin, Avita’s Recell device allows healthcare professionals to create an epidermal suspension that contains the cells required to regenerate epidermis. The technology is specifically designed to help produce permanent wound closure in burns while lessening the amount of skin that’s harvested, according to Avita.
The company said it expects the FDA to finalize its review of the Recell application during the third quarter of this year.