AVITA Medical Announces Presentation of RECELL® Device Effectiveness & Safety in Treatment of Thermal Burns at Premier U.S. ...
August 22 2018 - 12:35AM
Business Wire
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.
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OUS MediaMonsoon CommunicationsSarah KemterPhone
+61 (0)3 9620 3333Mobile +61 (0)407 162
530sarahk@monsoon.com.auorUS MediaSyneos Health Public
RelationsDavid PolkPhone +1 (310) 309 1029Mobile +1 (805) 428
5775david.polk@syneoshealth.comorInvestors:Westwicke
PartnersCaroline CornerPhone +1 (415)
202-5678caroline.corner@westwicke.comorAVITA
Medical LtdDale A. SanderChief Financial OfficerPhone +1 (661)
367-9178dsander@avitamedical.com
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