Valencia, Calif., USA, and Melbourne, Australia, 28 June 2018 — AVITA Medical (ASX: AVH, OTCQX:
AVMXY) 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.
The acquisition of the manufacturing facility is to occur with Avita Medical taking an exclusive lease of the
relevant facilities. Avita Medical will not own the facilities, rather Avita Medical will pay a commercial rent
for the exclusive right under the lease for those facilities. The initial lease term is for 39 months with
options for 3 additional 3-year terms at prevailing standard market rates.
Avita Medical will now own and assume responsibility for all processing equipment used in the production
of the RECELL Device (excluding outsourced components). The building ownership (lessor), Hartco Ventura,
remains the same as under the previous lessee.
Under the agreement, manufacturing and warehouse equipment within the facility was tranfered to AVTIA
Medical at no cost. The opportunity to acquire the facility arose because the contract manufacturer elected
to consolidate its facilities.
The contract manufacturer has manufactured the RECELL device at this facility since 2004 following GMP
standards and has maintained ISO 13485 registration. The facility is FDA registered and its most recent FDA
inspection was in February 2018 which resulted in no form 483 citations. Avita has retained key personnel
and will continue to manufacture RECELL to GMP standards at the facility.
“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
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.
ABOUT AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet
medical needs in burns, chronic wounds, and aesthetics indications. 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. The medical devices work by preparing a REGENERATIVE
EPITHELIAL SUSPENSION™, an autologous suspension comprised of the patient’s skin cells and wound healing
factors necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto
the areas of the patient requiring treatment.
In the United States, the RECELL Device is an investigational device limited by federal law to investigational
use. In September 2017, AVITA Medical submitted to the U.S. Food and Drug Administration (FDA) a
Premarket Approval (PMA) application for the RECELL Device for the treatment of burn injuries.
In all countries outside of Europe, our portfolio is marketed under the RECELL Device brand to promote skin
healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL Device is
TGA-registered in Australia, and CFDA-cleared in China.
In Europe, our portfolio of medical device products received CE-mark approval as three tailored product
presentations, with three individual brand names. The RECELL Autologous Cell Harvesting Device is designed
for the treatment of burns and plastic reconstructive procedures; REGENERCELL™ Autologous Cell Harvesting
Device has been formulated for chronic wounds including leg and foot ulcers; and RENOVACELL™ Autologous
Cell Harvesting Device is tailored for aesthetic applications including the restoration of pigmentation.
To learn more, visit www.avitamedical.com.