Market Overview

AVITA Medical Announces Commencement of Manufacturing of RECELL® Device in Newly Acquired Facility in Preparation for Planned U.S. Launch


AVITA Medical (ASX: AVH,
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

"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.


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.

In 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.

To learn more, visit


This letter includes forward-looking statements. These
forward-looking statements generally can be identified by the use of
words such as "anticipate," "expect," "intend," "could," "may," "will,"
"believe," "estimate," "look forward," "forecast," "goal," "target,"
"project," "continue," "outlook," "guidance," "future," other words of
similar meaning and the use of future dates. Forward-looking statements
in this letter include, but are not limited to, statements concerning,
among other things, our ongoing clinical trials and product development
activities, regulatory approval of our products, the potential for
future growth in our business, and our ability to achieve our key
strategic, operational and financial goal. Forward-looking statements by
their nature address matters that are, to different degrees, uncertain.
Each forward-looking statement contained in this letter is subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statement. Applicable
risks and uncertainties include, among others, the timing of regulatory
approvals of our products; physician acceptance, endorsement, and use of
our products; failure to achieve the anticipated benefits from approval
of our products; the effect of regulatory actions; product liability
claims; risks associated with international operations and expansion;
and other business effects, including the effects of industry, economic
or political conditions outside of the company's control. Investors
should not place considerable reliance on the forward-looking statements
contained in this letter. Investors are encouraged to read our publicly
available filings for a discussion of these and other risks and
uncertainties. The forward-looking statements in this letter speak only
as of the date of this release, and we undertake no obligation to update
or revise any of these statements.

View Comments and Join the Discussion!