Real world experience found that the RECELL
System could save one US Burn Center up to USD $28MM annually
AVITA Medical (ASX: AVH, OTCQX: AVMXY) announced today that the
health economic model of the U.S. burn care pathway, developed in
collaboration with Biomedical Advanced Research and Development
Authority (BARDA) and IQVIA, has been published in the
peer-reviewed journal, Advances in Therapy. The model demonstrates
that utilizing AVITA Medical’s RECELL® System for the treatment of
in-patient burns is cost-saving or cost-neutral and results in
reduced length of hospital stay as compared to the standard of
care.
“This model is the outcome of an outstanding collaboration
between industry, government, medical, and health economics experts
to develop the first economic model of U.S. burn care, allowing for
robust evaluations of changes to practice including use of new
products such as the RECELL System,” said Andrew Quick, Chief
Technology Officer.
Utilizing this model, health economic data projects that use of
the RECELL System to treat in-patient burns could save a major U.S.
burn center up to USD $28 million annually compared to treatment
with the standard of care. These findings were recently presented
at the American Burn Association (ABA) 51st Annual Meeting by Kevin
Foster, MD, MBA, FACS, of the Arizona Burn Center. The model
calculated savings based on the demographic mix of patients treated
at that center in 2018.
Each year nearly half a million Americans suffer acute thermal
burns that require medical treatment, resulting in approximately
50,000 hospitalizations and more than 3,000 deaths. Use of
split-thickness skin grafts is considered standard treatment;
however, skin grafts are associated with significant pain, delayed
healing and hypertrophic scarring, each of which contributes to the
substantial costs incurred by the healthcare system.
“Use of this model will have broad implications for the U.S.
burn care community, allowing burn centers and hospitals to better
understand the fiscal aspects associated with the care of patients
with severe burn injuries,” said Erin Liberto, Chief Commercial
Officer. “On average, burn centers can save 14-17% of their costs
utilizing the RECELL System. The health economic data coupled with
our strong clinical data and reimbursement coverage present an
undisputable value proposition to hospital administration and
further enhance our ability to penetrate new accounts.”
The Advances in Therapy article titled, “Cost-Effectiveness of
the Use of Autologous Cell Harvested Device Compared to Standard of
Care for Treatment of Severe Burns in the United States,” may be
accessed online at https://doi.org/10.1007/s12325-019-00961-2. The
model employs sequential decision trees to depict the stages of
burn care, from initial burn assessment through treatment for
definitive closure of the burn wound, and predicts relative
differences between use of the RECELL System compared to the
standard of care. The model is based on data from the American Burn
Association’s National Burn Repository database, clinical trials,
and real-world use data. Actual costs of care come from three U.S.
burn centers, and when combined with Monte Carlo simulation of a
burn center patient population, the overall burn center budget
impact can be accurately predicted.
Authors of the publication include James H. Holmes IV, MD FACS,
Director, WFBMC Burn Center, Professor of Surgery, Wake Forest
University School of Medicine, Winston-Salem, North Carolina,
William Hickerson, MD, FACS, Memphis Medical Center, and Kevin
Foster, MD, MBA, FACS, Maricopa Integrated Health System at the
Arizona Burn Center.
Funding for the model 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. Funding provided by BARDA, under
Contract No. HHSO100201500028C.
ABOUT AVITA MEDICAL LIMITED
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 U.S. product, the RECELL® System, was
approved by the U.S. Food and Drug Administration (FDA) in
September 2018. The RECELL System is indicated for use in the
treatment of acute thermal burns in patients 18 years and older.
The RECELL System is used to prepare 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. Healthcare professionals should read the INSTRUCTIONS
FOR USE - RECELL® Autologous Cell Harvesting Device
(https://recellsystem.com/) for a full description of indications
for use and important safety information including
contraindications, warnings and precautions.
In international markets our products are marketed under the
RECELL System brand to promote skin healing in a wide range of
applications including burns, acute wounds, scars and vitiligo. The
RECELL System is TGA-registered in Australia and CFDA-cleared in
China.
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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version on businesswire.com: https://www.businesswire.com/news/home/20190515006093/en/
U.S. MediaSam Brown, Inc.Christy
CurranPhone +1-615.414.8668christycurran@sambrown.com
OUS MediaMonsoon CommunicationsSarah KemterPhone
+61 (0)3 9620 3333Mobile +61 (0)407 162
530sarahk@monsoon.com.au
Investors:Westwicke PartnersCaroline CornerPhone
+1-415-202-5678caroline.corner@westwicke.com
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