AVITA Medical Announces Commencement of Randomized Controlled Clinical Study of RECELL® System in Treatment of Children with...
October 24 2018 - 8:51PM
Business Wire
Clinical study is being conducted in Brisbane,
Australia, in collaboration with the Queensland University of
Technology and Lady Cilento Children’s Hospital
AVITA Medical (ASX: AVH) (OTCQX: AVMXY), a global regenerative
medicine company, today announced that the commencement of a
randomized, controlled clinical study of the RECELL® Autologous
Cell Harvesting Device (RECELL® System) in the treatment of
significant superficial partial- and mid-thickness pediatric burns,
including scald injuries. The clinical trial is being conducted by
the Queensland University of Technology (QUT) in collaboration with
the Pegg Leditschke Children’s Burns Centre at Lady Cilento
Children’s Hospital in Brisbane, QLD. Treatment of children in the
trial has commenced. The pediatric clinical trial is being led Dr.
Bronwyn Griffin, Child Health Research Centre, QUT, and Professor
Roy M. Kimble, Lady Cilento Children’s Hospital - Department of
Paediatric Surgery.
The protocol for the clinical trial was presented last week at
the Australian & New Zealand Burn Association Annual Scientific
Meeting in Brisbane by Dr. Anjana Bairagi, Honorary Research Fellow
(Paediatric Surgery) at the Children’s Burns Centre at Lady Cilento
Children’s Hospital. The current standard of care for children with
partial-thickness burns is cleaning of the wound followed by a
dressing application. Limitations of the standard of care include
delay in healing of the burn injury, scarring, and pain. The
clinical trial will include approximately 90 patients under 18
years old. Patients will be randomized into one of three groups and
will be treated either with the RECELL System and Biobrane®
dressing, the Biobrane dressing alone, or standard care (silver
impregnated silicone lined dressing). The primary endpoint will be
days to re-epithelization of the burn injury. Secondary endpoints
include pain, patient satisfaction and scarring.
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.
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/20181024006062/en/
US MediaSyneos Health Public RelationsChristian
Pflaumer, +1-212-229-8412Nicole Beckstrand,
+1-858-431-9611AVITAMedicalTeam@syneoshealth.comorOUS
MediaMonsoon CommunicationsSarah Kemter, +61 (0)3 9620
3333Mobile: +61 (0)407 162
530sarahk@monsoon.com.auorInvestors:Westwicke
PartnersCaroline Corner,
+1-415-202-5678caroline.corner@westwicke.comorAVITA Medical
LtdDale A. Sander, +1-661-367-9178Chief Financial
Officerdsander@avitamedical.com
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