Market Overview

AVITA Medical Announces Presentation of RECELL® Device Effectiveness and Safety in Treatment of Thermal Burns at Premier U.S. Military Conference

Share:

Results from two U.S. pivotal trials featured in plenary session at U.S.
Defense Department Military Health System Research Symposium

AVITA Medical (ASX: AVH,
OTCQX: AVMXY)
today announced that results from two U.S. pivotal clinical trials
demonstrating the effectiveness and clinical benefits of the RECELL®
Autologous Cell Harvesting Device were presented in the plenary session
at the U.S. Defense Department Military Health System Research Symposium
(MHSRS) in Kissimmee, Florida. The results were presented by James H.
Holmes, IV, MD, FACS Wake Forest Baptist Medical Center, Winston-Salem
North Carolina.

"The RECELL Device addresses an unmet need in the treatment of burn
patients and provides the opportunity with a point-of-care technology to
reduce the amount of skin required for epidermal regeneration and
definitive closure of burns," said Dr. Holmes. "The trial results
demonstrate comparable burn wound healing between the RECELL Device and
standard skin grafts while utilizing significantly less skin and
resulting in improved healing of donor sites harvested for treatment
with the RECELL Device."

The MHSRS is the Department of Defense's premier scientific meeting and
provides a venue for presenting new scientific knowledge resulting from
military-unique research and development. The MHSRS is the only military
or civilian meeting that focuses specifically on the unique medical
needs of the Warfighter. MHSRS provides a collaborative setting for the
exchange of information between military providers with deployment
experience, research and academic scientists, international partners,
and industry on research and related health care initiatives falling
under the topic areas of Combat Casualty Care, Military Operational
Medicine, Clinical and Rehabilitative Medicine, Medical Simulation and
Information Sciences, Military Infectious Diseases, and the Radiation
Health Effects.

Key highlights of Dr. Holmes' presentation included:

  • The pivotal randomized, controlled clinical trial of the RECELL Device
    in the treatment of deep partial-thickness (second-degree) burns
    demonstrated statistically significant reduction in donor skin
    requirements (97.5 percent reduction) and pain, increased patient
    satisfaction and improved donor scar outcomes.
  • The pivotal randomized, controlled clinical trial in mixed and
    full-thickness (third-degree) burns met its co-primary endpoints and
    demonstrated statistically significant reduction in donor skin
    requirements (32.0 percent reduction).

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.

Funding for the two U.S. pivotal clinical trials 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.
HHSO100201500028C. In addition, funding for the trials was provided by
the U.S. Department of the Army, AFIRM 1 Contract #W81XWH-08-2-0032.

ABOUT AVITA MEDICAL LIMITED

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 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 www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

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!