Burn surgeon presents health economic model
projecting burn center will save up to USD $21 million per year
treating patients with the RECELL System compared to conventional
treatment
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, today announced that key opinion leaders from
five U.S. burn centers presented clinical results of the RECELL®
Autologous Cell Harvesting Device (RECELL® System) at two U.S. burn
conferences, the 31st Annual Southern Region Burn CME Conference
held in Mobile, AL and the Northeast Region Burn Conference held in
Cambridge, MA. In addition, the burn surgeons led two medical
education symposiums on the use of the RECELL System at the
conferences.
A health economic model calculating the cost savings advantages
of treating burn patients with the RECELL System versus standard of
care was presented by William Hickerson, MD, FACS, Firefighter Burn
Center, Memphis, Tennessee, and University of Tennessee Health
Science Center. In a presentation titled “Resource Use, Costs and
Outcomes for Treatment of Severe Burns Using RECELL in the United
States,” Dr. Hickerson reported that treating patients with the
RECELL System alone, or in combination with widely spaced skin
grafts, is projected to reduce his burn center’s costs by up to USD
$21 million per year compared to conventional treatment. Major
drivers of the cost savings included a decrease in length of
hospital stay and a reduction in the number of surgeries and
related resources (blood transfusions and dressings).
A series of presentations detailing the results from two U.S.
pivotal clinical trials demonstrating the effectiveness and
clinical benefits of the RECELL System were made at the Southern
Region Burn Conference by James H Holmes IV, MD, FACS, Wake Forest
Baptist Medical Center, and Jeffrey Carter, MD, FACS, Medical
Director of University Medical Center New Orleans Burn Center and
Associate Professor of Surgery at LSU Health New Orleans School of
Medicine. The results were also presented by Dr. Jeffrey Wilson
Shupp, MD, Director of The Burn Center at MedStar Washington
Hospital Center, at the Northeast Conference.
Christopher Braxton, MD, University Medical Center New Orleans,
presented “Treatment of High-Voltage Electrical Burn with
Autologous Skin Cell Suspension: A Case Report,” a class of burn
that falls outside of the approved FDA labeling and for which the
patient was treated under the Company’s Compassionate Use program.
Dr. Braxton presented the case of a 57-year-old male with a 41
percent total body surface area (TBSA) burn following an explosive,
high-voltage electrical injury on a movie set. The patient was
treated with the RECELL System and his length of his hospital stay
was only 1.02 days per percent TBSA versus the average 3.13 days
per percent TBSA reported in the National Burn Repository Data.
The Southern Region Burn and the Northeast Region Burn
Conferences are two in the series of regional conferences held in
the U.S. each year. The two medical symposiums held at the
conferences were organized to assist in the training of U.S.
physicians who had not previously treated patients with the RECELL
System in advance of FDA approval in clinical trials or in the
Compassionate Use program.
ABOUT THE RECELL SYSTEM
The U.S. Food and Drug Administration (FDA) approved the RECELL
System in September 2018 to treat acute thermal burns in patients
18 years and older. 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. 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 an adult patient’s
entire back. Randomized, controlled trials have demonstrated that
treatment of acute burn wounds with the RECELL System requires
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.
Funding for the development of the RECELL System 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. Programs discussed above which were
funded under the BARDA contract include the two randomized,
controlled clinical trials, the Compassionate Use program, and
development of the health economic model demonstrating the cost
savings associated with the RECELL System.
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 indicated for use in the
treatment of acute thermal burns in patients 18 years and older.
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. 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.
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.
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/20181112005857/en/
US MediaSyneos Health Public RelationsChristian
PflaumerPhone +1-212-229-8412Nicole BeckstrandPhone
+1-858-431-9611AVITAMedicalTeam@syneoshealth.comorOUS
MediaMonsoon CommunicationsSarah KemterPhone +61 (0)3
9620 3333Mobile +61 (0)407 162
530sarahk@monsoon.com.auorInvestors: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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