Multiple U.S. burn centers incorporating RECELL
System into their practices in advance of national U.S. market
launch
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, today announced that it has received the first
commercial sales orders from U.S. burn centers for the RECELL®
Autologous Cell Harvesting Device (RECELL® System) and has
commenced commercial shipment of the product. 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.
“We are pleased to have fulfilled multiple orders for the RECELL
System in such a short period of time following FDA approval and in
advance of our national U.S. market launch,” said Erin Liberto,
Chief Commercial Officer. “Our immediate commercial focus is
completing the recruitment and training of our U.S. field force.
However, we are in a unique position as many large burn centers
already have substantial experience using our product through our
clinical trials and Compassionate Use and Continued Access
Programs. Moreover, some burn centers have indicated their desire
to adopt the RECELL System in advance of our national market
launch. In general, we expect most burn centers will adhere to the
standard process for novel devices of initially evaluating the
product and thereafter advancing it through their Hospital’s Value
Analysis Committee prior to purchasing for regular use. This
process can sometimes be a lengthy one and may take 6 months or
more to complete. That said, we are excited to see some of the
larger burn centers accelerate this process and commence
incorporating the RECELL System into their practice.”
Of the 134 burns centers in the U.S., 24 already have experience
using the RECELL System through participation in clinical trials
and the Compassionate Use and Continued Access programs. Notably,
these 24 burn centers are estimated to treat over 30 percent of the
U.S. burn patients annually.
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 used to support
the FDA approval 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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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
Officerdsander@avitamedical.com
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