Additional data presented at ABA Annual meeting
include results demonstrating that donor sites treated using the
RECELL System could be reharvested in as little as seven days after
treatment
Patients with burns covering more than 50% of
their bodies treated using the RECELL System in combination with
widely meshed autografts healed as quickly as patients with smaller
burn injuries with the same treatment
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, announced health economic data projecting that
use of the RECELL System to treat patients with severe burns could
save a major U.S. burn center up to USD $28 million annually
compared to treatment with the standard of care. The health
economic results were presented at the American Burn Association
(ABA) 51st Annual Meeting in Las Vegas by Kevin Foster, MD, MBA,
FACS, of the Arizona Burn Center, and were calculated based on the
demographic mix of patients treated at that institution in
2018.
An additional presentation at the ABA meeting, awarded best in
category at the conference, highlighted preliminary study results
demonstrating that donor sites treated with the Spray-On Skin™
Cells prepared using the RECELL System could be reharvested in as
little as seven days after treatment. Also presented were data
showing that patients with extensive burns, greater than 50% total
body surface area (TBSA), treated with Spray-On Skin Cells in
combination with widely meshed autografts healed as quickly as
patients with smaller burn injuries provided the same treatment
combination. Patients from both the donor site and large TBSA
presentations were treated under Compassionate Use and Continued
Access programs, which allowed treatment of patients with
life-threatening burns in advance of the September 2018 approval to
market the RECELL System in the U.S.
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. Two
randomized, controlled clinical trials demonstrated that treatment
of acute burn wounds using the RECELL System required substantially
less donor skin than conventional treatment 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. The RECELL System was approved by the U.S. Food
and Drug Administration (FDA) in September 2018 for the treatment
of acute thermal burns in patients 18 years and older. The donor
site and large TBSA presentations include classes of burns or
injuries that are unapproved indications that fall outside of the
currently approved U.S. product labeling. 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.
RECELL Projected to Reduce Cost of Treating Severe Burns at
Major Center by USD $28 Million Annually
The results of the health economic model were highlighted by Dr.
Foster in a presentation titled “Budget impact of autologous cell
harvesting device (ACHD) use versus standard of care (SOC) for
treatment of severe burns: A case study for the Arizona Burn
Center” and demonstrated:
- The Arizona Burn Center would save
approximately USD $28 million (16%) per year using the RECELL
System versus the current standard of care (net of the cost of the
RECELL System)
- The largest driver of the predicted
cost savings is reduction in length of stay per patient, comprising
70% of the savings
- Also contributing to the estimated cost
savings is an approximate 67% less autografting procedures, with
reduction in operating room time contributing another 13% to the
estimated cost savings
The Arizona Burn Center is part of the Maricopa Integrated
Health System (MIHS), a major public teaching hospital and safety
net system of care based in Phoenix.
“We now have a tool to economically assess any new intervention
into the burn market, which can be used in our hospitals to
determine fiscal responsibility of new treatments,” said Dr.
Foster. “Based on the characteristics of our burn center and the
patients we treated in 2018, use of the RECELL System is estimated
to produce significant cost savings of about 16% of our total
center costs, or approximately $28 million per year. Key drivers of
projected cost savings were decreased length of hospital stay,
fewer autograft surgeries, reduced donor site size and associated
wound care, and reduced rehabilitation needs.”
To investigate the value proposition and potential
transformative impact of Biomedical Advanced Research and
Development Authority (BARDA) investments in burn care such as the
RECELL System, an evaluation and modeling tool which emulated the
cost effectiveness in routine care was developed by IQVIA™, BARDA
and AVITA Medical. The BEACON model evaluates how practice
patterns, interventions and patient characteristics interact across
all phases of care (wound assessment, debridement/excision,
temporary coverage and permanent closure) to understand how patient
and burn center outcomes change given the incorporation of a new
burn care treatment, such as the RECELL System. Results from the
model demonstrate that the RECELL System would reduce treatment
costs for patients with burns ranging from 10 percent to 40 percent
TBSA were presented last year at the 2018 ABA Annual Meeting and at
a series of other burn and health economic meetings. As described
in this week’s presentation, the patient characteristics for the
Arizona Burn Center (for example, age, burn depth, TBSA) were input
into the BEACON model based on the 800 patients with 10% TBSA and
greater burns treated in 2018 at the institution.
“Our ability to run this economic model based on the specific
demographics of an individual burn center is a great resource to
them as they evaluate the potential benefits of the RECELL System,”
said Dr. Michael Perry, Chief Executive Officer. “We thank Dr.
Foster, IQVIA, BARDA and others who have participated in the
development of the BEACON model. The cost savings benefits of the
RECELL System demonstrated by the model complement the clinical
benefits which are also being prominently featured in a series of
ten presentations at the ABA meeting this week.”
Funding and technical support for the development of the RECELL
System is 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 funded under the BARDA contract include two randomized,
controlled pivotal clinical trials, the Compassionate Use and
Continued Access programs, development of the health economic model
demonstrating the cost savings associated with the RECELL System,
and two randomized, controlled clinical trials in pediatric burn
patients.
Healing of Donor Sites after Treatment Using the RECELL
System
Another presentation by Dr, Foster, “Healing of Donor Sites with
Autologous Skin Cell Suspension Enables Early Reharvesting for
Large TBSA Burn Injuries: A Prospective Evaluation,” described the
treatment of donor sites in patients with large TBSA burn injuries.
In large TBSA injuries the patient may not have enough donor skin
available to allow for immediate treatment of the entire area of
burn injuries with traditional autografting techniques. In severely
burned patients with extensive injuries, surgeons often must wait
until the donor sites have healed so that they can reharvest from
the site, resulting in delays in treatment and healing and the need
for multiple procedures and extended hospital time.
In the prospective observational study of 73 subjects with
life-threatening thermal burn injuries treated under the
Compassionate Use program, 426 donor sites wounds were treated with
Spray-On Skin™ Cells prepared using the RECELL System. The mean
TBSA of the patients in the study was 54% with burns ranging from
20% to 91% TBSA. Two weeks after treatment, 91% of the donor sites
had healed in this compromised patient population, and 98% had
healed by week eight. Donor sites treated using the RECELL System
were able to be reharvested as early as seven days after treatment.
No infection or delayed healing were reported for donor sites
treated with Spray-On Skin™ Cells.
“The ability to reharvest additional donor skin from a site in
as little one week after treatment with the RECELL system is
extremely beneficial in this population of patients with extensive
life-threatening injuries and limited available donor skin,” said
Dr. Foster. “Treatment of donor sites using the RECELL System may
provide improved healing rates as well as pain reduction and
additional exploration of the potential benefits of the RECELL
System should be undertaken.”
Treatment of Patients with Burns Greater than 50%
TBSA
William Hickerson, MD, FACS, Firefighter Burn Center and
University of Tennessee Health Science Center, presented data
showing that the use of the RECELL System in combination with
meshed autografts achieves definitive closure for patients with
burn injuries greater than 50% TBSA and achieved comparable
outcomes to patients with less severe injuries in a presentation
titled “Evaluation of Autologous Skin Cell Suspension (ASCS) for
Definitive Closure of Extensive Burn Injuries in an Adult
Population.” In patients with extensive burn injuries, lack of
available donor skin is a major limitation in achieving permanent
closure, and the longer a wound remains open the more susceptible a
patient is to infection. The use of the RECELL System, a donor skin
sparing technology that enables rapid definitive closure, has the
potential to improve patient outcomes. The purpose of this study
was to evaluate clinical outcomes for patients with
life-threatening, greater than 50% TBSA burn injuries, in which the
RECELL System was used in combination with widely meshed
split-thickness autografts.
In this study of 35 patients with life-threatening thermal burn
injuries, the RECELL System was used in combination with widely
meshed split-thickness autografts to achieve definitive closure
using minimal donor skin. For patients with greater than 50% TBSA
burns, 150 burn wounds were treated with the combination of
Spray-On Skin™ Cells and widely meshed split-thickness autografts,
with 95% of the wounds achieving complete wound closure two months
after treatment. For patients with equal to or less than 50% TBSA
burns, 53 burn wounds were treated with the same combination and
the rate of healing was similar to the large TBSA patients, with
92% of wounds achieving full healing two months after treatment
“The RECELL System combined with widely meshed split-thickness
autografts achieved definitive closure and achieved healing
outcomes for patients with life-threatening injuries greater than
50% TBSA, largely equivalent to those with less severe injuries
equal to or less than 50% TBSA,” said Dr. Hickerson. “There were no
device-related adverse events and long-term durability was
excellent.”
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 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://avitamedical.com) for a
full description of indications for use and important safety
information, including contraindications, warnings and
precautions.
In international markets, AVITA Medical’s 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190404005858/en/
U.S. MediaSam Brown, Inc.Christy CurranPhone:
+1-615-414-8668christycurran@sambrown.com
O.U.S. MediaMonsoon CommunicationsSarah
KemterPhone: +61 (0)3 9620 3333Mobile: +61 (0)407 162
530sarahk@monsoon.com.au
InvestorsWestwicke PartnersCaroline CornerPhone:
+1-415-202-5678caroline.corner@westwicke.com
AVITA Medical LtdDale A. SanderChief Financial
OfficerPhone: +1-661-367-9178dsander@avitamedical.com
AVITA Medical (ASX:AVH)
Historical Stock Chart
From Mar 2024 to Apr 2024
AVITA Medical (ASX:AVH)
Historical Stock Chart
From Apr 2023 to Apr 2024