Clinical results demonstrate point-of-care
regenerative medicine technology benefits in treatment of second-
and third-degree burns using Spray-On Skin™ Cells
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, today announced that the results from two U.S.
pivotal clinical trials demonstrating the effectiveness and
clinical benefits of the RECELL® Autologous Cell Harvesting Device
(RECELL® System) were presented at the 46th Annual Eastern Great
Lakes Burn Conference in Ann Arbor, Michigan. The results were
presented by Jeffrey Carter, MD, FACS, Medical Director of
University Medical Center New Orleans Burn Center & Associate
Professor of Surgery at LSU Health New Orleans School of
Medicine.
“The RECELL System technology provides a major advancement for
burn care,” said Dr. Carter. “Within these studies we demonstrated
comparable healing and scar outcomes to standard of care using
significantly less skin. My team is excited to learn of the recent
FDA approval and we are looking forward to treating our patients
outside of the clinical trials.”
The U.S. Food and Drug Administration (FDA) approved on 20
September 2018 the RECELL System 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. The two randomized, controlled clinical trials
presented by Dr. Carter at the conference were used to support the
FDA approval and demonstrated that treatment of acute burn wounds
with the RECELL System required 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.
In his presentation, titled “Establishing the Safety and
Effectiveness of RECELL as an Autograft-Sparing Technology for
Definitive Closure of Burn Injuries,” Dr. Carter provided an
overview of the key shortcomings of the current standard of care,
split-thickness autografts. These include the large donor skin
requirements, donor site pain and complications, and extended
hospitalization and treatment cost. In the first of the pivotal
randomized, controlled clinical trials presented by Dr. Carter, use
of the RECELL System in the treatment of deep partial-thickness
(second-degree) burns demonstrated statistically significant
reduction in donor skin requirements (97.5 percent reduction) and
pain, increased patient satisfaction, and improved donor scar
outcomes. In the second pivotal randomized, controlled clinical
trial presented, use of the RECELL System in mixed and
full-thickness (third-degree) burns met the trial’s co-primary
endpoints and demonstrated statistically significant reduction in
donor skin requirements (32.0 percent reduction).
The RECELL System is approved to be used at the point of care by
licensed healthcare professionals to treat adult patients with
acute thermal burn wounds. The RECELL System can be used alone in
the treatment of partial-thickness burns, or in combination with
autografting for the treatment of full-thickness 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 a patient’s entire back.
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.
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 FDA-approved product, 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.
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/20180926006138/en/
US Media:Syneos Health Public RelationsChristian
PflaumerPhone: +1-212-229-8412orNicole BeckstrandPhone:
+1-858-431-9611AVITAMedicalTeam@syneoshealth.comorOUS
Media:Monsoon 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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