AVITA Medical Announces First U.S. Sales of RECELL® System and Commencement of Commercial Shipping

Multiple U.S. burn centers incorporating RECELL System into their
practices in advance of national U.S. market launch

a global regenerative medicine company, today announced that it has
received the first commercial sales orders from U.S. burn centers for
the RECELL® Autologous Cell Harvesting Device (RECELL® System) and has
commenced commercial shipment of the product. The U.S. Food and Drug
Administration (FDA) approved on 20 September 2018 the RECELL System to
treat acute thermal burns in patients 18 years and older.

We are pleased to have fulfilled multiple orders for the RECELL System
in such a short period of time following FDA approval and in advance of
our national U.S. market launch,” said Erin Liberto, Chief Commercial
Officer. “Our immediate commercial focus is completing the recruitment
and training of our U.S. field force. However, we are in a unique
position as many large burn centers already have substantial experience
using our product through our clinical trials and Compassionate Use and
Continued Access Programs. Moreover, some burn centers have indicated
their desire to adopt the RECELL System in advance of our national
market launch. In general, we expect most burn centers will adhere to
the standard process for novel devices of initially evaluating the
product and thereafter advancing it through their Hospital’s Value
Analysis Committee prior to purchasing for regular use. This process can
sometimes be a lengthy one and may take 6 months or more to complete.
That said, we are excited to see some of the larger burn centers
accelerate this process and commence incorporating the RECELL System
into their practice.”

Of the 134 burns centers in the U.S., 24 already have experience using
the RECELL System through participation in clinical trials and the
Compassionate Use and Continued Access programs. Notably, these 24 burn
centers are estimated to treat over 30 percent of the U.S. burn patients

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 used to support the FDA
approval 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.


US Media
Syneos Health Public Relations
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Nicole Beckstrand, +1-858-431-9611

Monsoon Communications
Sarah Kemter
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Caroline Corner, +1-415-202-5678
Medical Ltd

Dale A. Sander, +1-661-367-9178
Financial Officer


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