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.
Avita Medical CEO Dr Michael Perry said: “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.
“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.
AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin.
Our medical devices work by preparing a Regenerative Epidermal Suspension (RES), an autologous suspension comprised of the patient’s own skin cells and wound healing factors that are necessary to regenerate natural healthy skin. This is then applied to the area to be treated.
n all countries outside of Europe, our portfolio is marketed under the RECELL brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics.
RECELL is TGA-registered in Australia, and CFDA-cleared in China. In the United States, RECELL is not approved for sale and is limited by federal law to investigational use.
In Europe, our portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. RECELL is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell™ has been formulated for chronic wounds including leg and foot ulcers; and ReNovaCell™ is tailored for aesthetic applications including the restoration of pigmentation.
Source: Company Press Release
