Thursday, August 23, 2018
AVITA Medical today announced the successful completion of multiple production runs for the RECELL Device® within its newly acquired manufacturing facility in Ventura, California. Effective July 1, 2018, AVITA Medical acquired the facility from a Fortune 500 manufacturer that had previously assembled the RECELL Device on a contract basis. The manufacturing runs were performed after AVITA Medical’s takeover of the facility and represent the first production activities undertaken by the Company’s own manufacturing and quality control personnel. Components currently being manufactured in the facility will be used to supply clinical trial and international sales requirements and to support the Company’s preparations for the expected U.S. launch of the RECELL Device in the U.S.
“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,” said Dr. Michael Perry, Chief Executive Officer. “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.”
Currently the RECELL Device is not approved for sale in the U.S. and is limited by Federal Law to investigational use.
The RECELL Device is designed to enable medical professionals to produce, at the point-of-care, a Regenerative Epidermal Suspension™ (RES™) using a small sample of the patient’s own skin. The autologous suspension contains cells necessary to regenerate epidermis and provides a new way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery. Reduction in donor-site skin requirements has important benefits from both clinical and health economic perspectives. A U.S. Premarket Approval (PMA) application for the treatment of burn injuries is currently under review by the U.S. Food and Drug Administration (FDA). AVITA Medical expects completion of the FDA review of the PMA during the third quarter of calendar 2018, followed by U.S. approval and market launch.
