Medical education symposium is designed to
train U.S. physicians in use of RECELL System
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, today announced that a medical education
symposium on the use of the RECELL® Autologous Cell Harvesting
Device (RECELL® System) was held at the U.S. Midwest Region Burn
Conference in Minneapolis. The symposium was led by 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. Dr. Carter also presented at the
conference the results from two U.S. pivotal clinical trials
demonstrating the effectiveness and clinical benefits of the RECELL
System.
The U.S. Food and Drug Administration (FDA) recently approved
the RECELL System to treat acute thermal burns in patients 18 years
and older. The medical symposium was organized as the first step in
training 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. The Midwest Region Burn
Conference is one of the series of conferences sponsored by the
American Burn Association each year.
“The RECELL System allows us to navigate a new course of
recovery for people suffering acute burn injuries. The clinical
trials using the RECELL System have demonstrated a substantial
reduction in the burden of burn care where patients have
dramatically reduced donor sites and improved scarring,” said Dr.
Carter. “In my own experience at two active burn centers using the
RECELL System, patients have also demonstrated significantly
reduced length of stays and inspiring outcomes. These kinds of
results are exciting, and I am pleased to have the opportunity to
share with my peers this innovative product that has enabled us to
bring regenerative medicine out of the lab and to the bedside.”
The RECELL System is approved by the FDA to be used at the point
of care by licensed healthcare professionals to treat adult
patients with acute thermal burn wounds. 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 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.
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.
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/20181015005981/en/
US MediaSyneos Health Public RelationsChristian
Pflaumer, +1-212-229-8412Nicole Beckstrand,
+1-858-431-9611AVITAMedicalTeam@syneoshealth.comorOUS
MediaMonsoon CommunicationsSarah KemterPhone +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 Officer
Phonedsander@avitamedical.com
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