AVITA Medical Announces Medical Education Symposium and Presentation of RECELL® System Pivotal Trial Results at U.S. Midwest Region Burn Conference

Medical education symposium is designed to train U.S. physicians in
use of RECELL System

VALENCIA, Calif. & MELBOURNE, Australia–(BUSINESS WIRE)–AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine
company, today announced that a medical education symposium on the use
of the RECELL® Autologous Cell Harvesting Device (RECELL® System) was
held at the U.S. Midwest Region Burn Conference in Minneapolis. The
symposium was led by Jeffrey Carter, MD, FACS, Medical Director of
University Medical Center New Orleans Burn Center and Associate
Professor of Surgery at LSU Health New Orleans School of Medicine. Dr.
Carter also presented at the conference the results from two U.S.
pivotal clinical trials demonstrating the effectiveness and clinical
benefits of the RECELL System.

The U.S. Food and Drug Administration (FDA) recently approved the RECELL
System to treat acute thermal burns in patients 18 years and older. The
medical symposium was organized as the first step in training U.S.
physicians who had not previously treated patients with the RECELL
System in advance of FDA approval in clinical trials or in the
Compassionate Use program. The Midwest Region Burn Conference is one of
the series of conferences sponsored by the American Burn Association
each year.

The RECELL System allows us to navigate a new course of recovery for
people suffering acute burn injuries. The clinical trials using the
RECELL System have demonstrated a substantial reduction in the burden of
burn care where patients have dramatically reduced donor sites and
improved scarring,” said Dr. Carter. “In my own experience at two active
burn centers using the RECELL System, patients have also demonstrated
significantly reduced length of stays and inspiring outcomes. These
kinds of results are exciting, and I am pleased to have the opportunity
to share with my peers this innovative product that has enabled us to
bring regenerative medicine out of the lab and to the bedside.”

The RECELL System is approved by the FDA to be used at the point of care
by licensed healthcare professionals to treat adult patients with acute
thermal burn wounds. The RECELL System uses a small amount of a
patient’s own skin to prepare Spray-On Skin™ Cells at the point of care
in as little as 30 minutes, providing a new way to treat thermal burns.

The RECELL System can be used alone in the treatment of
partial-thickness burns, or in combination with autografting for the
treatment of full-thickness burns. A small skin sample is enzymatically
and mechanically processed in the RECELL System at the point of care to
isolate the skin cells to produce a suspension of Spray-On Skin Cells.
The regenerative cell suspension includes keratinocytes, fibroblasts,
and melanocytes, which play a critical role in wound healing. The
suspension can be sprayed directly on a second degree burn or with an
expanded skin graft on a third-degree burn, allowing for broad and even
distribution of live cells across the entire wound bed. The RECELL
System can be used to prepare enough suspension to treat a wound up to
80 times the size of the donor skin sample, so a skin sample
approximately the size of a credit card can be used to treat a wound
that covers a patient’s entire back.

The two randomized, controlled clinical trials presented by Dr. Carter
at the conference were used to support the FDA approval and demonstrated
that treatment of acute burn wounds with the RECELL System required
substantially less donor skin than required with conventional
split-thickness autografts to achieve closure of burn wounds. Reduction
in donor skin requirements provides key clinical benefits to patients
and significant reductions in the cost of treatment.

Healthcare professionals should read the INSTRUCTIONS FOR USE – RECELL®
Autologous Cell Harvesting Device for a full description of important
safety information including contraindications, warnings and precautions.


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
EPIDERMAL SUSPENSION(RES™), an autologous suspension
comprised of the patient’s skin cells necessary to regenerate natural
healthy epidermis. This autologous suspension is then sprayed onto the
areas of the patient requiring treatment.

AVITA Medical’s first FDA approved product, the RECELL® System, produces
Spray-On Skin™ Cells using a small amount of a patient’s own skin,
providing a new way to treat severe burns, while significantly reducing
the amount of donor skin required. The RECELL System is designed to be
used at the point of care alone or in combination with autografts
depending on the depth of the burn injury. Compelling data from
randomized, controlled clinical trials conducted at major U.S. burn
centers and real-world use in more than 7,000 patients globally,
reinforce that the RECELL System is a significant advancement over the
current standard of care for burn patients and offers benefits in
clinical outcomes and cost savings.

In international markets outside of Europe, our portfolio is marketed
under the RECELL System brand to promote skin healing in a wide range of
applications including burns, chronic wounds and aesthetics. The RECELL
System 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.


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.


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