June 28, 2018
AVITA Medical today announced that it has entered into an agreement to acquire a manufacturing facility to support the planned U.S. launch of the RECELL Autologous Cell Harvesting Device in the treatment of burns.
The facility is currently operated by a Fortune 500 contract manufacturer that assembles the RECELL Device for AVITA Medical. AVITA Medical will take over operations of the 2,200 square meter (23,000 square foot) manufacturing plant, located in Ventura, California, effective July 1, 2018 and will retain key employees.
“Having direct control over the manufacturing of RECELL will ensure that we have the capacity to meet commercial demand, including the planned U.S. launch and the BARDA procurement, and provide us further control over our production processes and timelines,” said Dr. Michael Perry, Chief Executive Officer. “Acquiring this facility that has a track record of producing RECELL allows us to realize the benefits of inhouse production while maintaining the continuity of proven manufacturing and quality processes and systems.”
Housed within the Ventura facility is the segregated, vendor managed inventory warehouse that AVITA Medical constructed to meet the requirements of the RECELL Device procurement component of the contract with the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the US Department of Health and Human Services. BARDA has provided funding under ongoing USG Contract No. HHSO100201500028C.
The RECELL Device is an investigational medical device in the U.S. that 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). The Company expects completion of the FDA review of the PMA during the third quarter of calendar 2018, followed by U.S. approval and market launch. In April 2018 researchers from major burn centers throughout the U.S. made six presentations at the 50th Annual Meeting of the American Burn Association (ABA), in Chicago, describing the clinical and cost-savings advantages of the RECELL Device in the treatment of severe burns.