Study to evaluate treatment with the RECELL
System within 72-hours of a pediatric scald burn injury
AVITA Medical Limited (ASX: AVH) (NASDAQ: RCEL), a regenerative
medicine company with a technology platform positioned to address
unmet medical needs in therapeutic skin restoration, announced
today the initiation of a pivotal trial for the treatment of
pediatric scald injuries with enrollment of the first patient at
the Arizona Burn Center at Valleywise Medical Health Center in
Phoenix, AZ. This study seeks to demonstrate that treatment with
the RECELL System of partial-thickness burn injuries within
72-hours can safely and effectively increase the incidence of
healing at day 10 when compared to a standard wound dressing.
“The immediate treatment of scald injuries in pediatric patients
represents a shift in thinking as surgeons currently favor a
delayed approach to avoid the additional trauma associated with
conventional skin grafting. With the commencement of this pivotal
trial, we intend to demonstrate that treatment with the RECELL
System within the first three days of a pediatric burn improves
healing and decreases the need for autografting,” said Dr. Mike
Perry, AVITA Medical Chief Executive Officer. “Building on the
success surgeons have had in treating burns in adult patients, we
look forward to potentially expanding the use of the RECELL System
to benefit pediatric patients with burns and are pleased to
progress toward this with the commencement of this pivotal
trial.”
In the U.S., it is estimated that 30-percent of burn patients
are within the ages of one to 15 years old, and approximately
45-percent of the pediatric burn injuries are from scald burnsi.
The standard of care for pediatric patients with second-degree
burns, such as scald burns, is to apply dressings and assess the
injury over time to determine if skin grafting is required. Skin
grafting results in scar formation in the area treated and involves
the harvesting of substantial amounts of donor skin, resulting in
an additional wound to the patient. Significant pain, delayed
healing, risk of infection, the need for multiple procedures,
discoloration and scarring are all associated with skin graft donor
site wounds.
“Second-degree burn injuries among children are often the result
of an accident, such as a child grabbing and tipping over a pot of
boiling water, causing a scald burn of varying depths across the
body. We typically dress the injury, then watch it for 10-14 days
to determine if the wound requires autografting,” said Dr. Kevin
Foster, Director of the Arizona Burn Center at Valleywise Health
Medical Center. “We are eager to evaluate the RECELL System as an
early treatment option as it may speed up the healing process as
well as reduce the frequency with which we turn to conventional
autografting for treatment of pediatric scalds.”
The primary endpoint of this prospective multi-center trial is
to demonstrate that treatment of partial-thickness burn injuries
with the RECELL System increases the incidence of healing at day 10
compared with a standardized wound dressing. Additionally, the
effects of both treatments on time to healing, the incidence of
conventional autografting, pain, itching, scarring, health-related
quality of life and resource utilization will be investigated.
Enrollment of 160 pediatric patients, ages one to 16 years old, is
planned. This study utilizes an adaptive design with an interim
analysis.
Healing will be evaluated by a clinician blinded to the
treatment allocation. Additional data collected over the course of
the 52-week study will include blinded evaluation of scar outcomes,
evaluation of disease-specific quality of life, and healthcare
resource utilization.
BARDA Funding Supports Development of RECELL System
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.
Authorized for release by the Chief Executive Officer of AVITA
Medical Limited.
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 8,000 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, chronic wounds and aesthetics. The
RECELL System is TGA-registered in Australia and received CE-mark
approval in Europe. 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.
This press release was authorized by the review committee of
AVITA Medical Limited.
i American Burn Association NBR Advisory Committee, National
Burn Repository 2016 Report
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