Market Overview

AVITA Medical Announces Expanded Compassionate Use of RECELL® Device in Life-Threatening Burns


FDA approves expansion of program to include up to 108 patients and 26
U.S. burn centers

AVITA Medical (ASX: AVH,
today announced that the U.S. Food and Drug Administration (FDA) has
approved a significant increase in the number of patients who may be
treated in the U.S. using the RECELL® Autologous Cell Harvesting Device
under a Compassionate Use Investigational Device Exemption (IDE)
program. Under the expanded program, up to 108 patients with severe
burns may be treated using the RECELL Device, and up to 26 U.S. burn
centers may participate in the program.

The Compassionate Use program allows the treatment of eligible patients
with the RECELL Device in advance of FDA approval. Eligible patients are
those who have insufficient healthy skin available for conventional skin
grafting treatment of their injuries and whose treating physicians
believe there to be no suitable alternative treatment. Currently, 82
patients have already been treated under the Compassionate Use program.

Major U.S. burn centers that have treated patients with the RECELL
Device under the Compassionate Use program include Arizona Burn Center
at Maricopa Medical Center, Baton Rouge General Hospital, Grady Burn
Center – Grady Health System, Maine Medical Center - MaineHealth,
Massachusetts General Hospital, MedStar Washington Hospital Center,
Regional Medical Center / University of Tennessee, Wake Forest Baptist
Medical Center, Walter Reed National Military Medical Center, Riley
Hospital for Children (Indianapolis), St. Christopher's Hospital for
Children, Shriners Hospitals for Children – Boston, Sidney & Lois
Eskenazi Hospital, U.S. Army Institute for Surgical Research (San
Antonio), University of California San Diego Health System, and
University of South Alabama.

"The participation of these major U.S. burn centers in the Compassionate
Use program highlights the critical unmet need amongst patients with
life-threatening burns, and we are pleased to make the RECELL Device
available under this program," said Dr. Michael Perry, AVITA Medical's
Chief Executive Officer. "We are also encouraged by the fact that 24
U.S. burn centers have treated patients with the RECELL Device through a
combination of our clinical trials, Continued Access program, and
Compassionate Use program, giving the product candidate broad exposure
within the U.S. burn community. Combined with the over 7,000 patients
who have been treated with the RECELL Device globally, these programs
provide us a large body of experience regarding the potential clinical
benefits as well as the costs savings associated with use of the RECELL

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. PMA application for
the treatment of burn injuries is currently under review by the 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

Funding for the Compassionate Use program was provided by the Biomedical
Advanced Research and Development Authority (BARDA), under the Assistant
Secretary for Preparedness and Response, within the U.S. Department of
Health and Human Services, under ongoing USG Contract No.


ABOUT AVITA MEDICAL LIMITED Avita'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 Epithelial 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!