Strong market response to the RECELL System
approval in advance of U.S. launch with 36 burn centers actively
reviewing the product or placing commercial orders
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, today announced that it has commenced the U.S.
national market launch of the RECELL® Autologous Cell Harvesting
Device (RECELL® System) for the treatment of acute thermal burns in
patients 18 years and older. The U.S. sales team of Regenerative
Tissue Specialists and Clinical Training Specialists that joined
AVITA Medical in November 2018 has been trained and fully deployed
across the U.S. in support of the nationwide launch of the RECELL
System.
In advance of the national launch, AVITA Medical has been
actively fulfilling orders in response to strong market demand.
Clinical evidence, years of successful patient outcomes and
favorable health economic results have created ideal market
conditions for the RECELL System. AVITA’s new commercial team is
now in active discussions with nearly half of the total number of
burn centers across the U.S. The Company also announced the
successful commercial results that have been achieved in advance of
the national market launch:
- 36 burns centers have begun the
purchase authorization process with their hospital
administration.
- 25 burn centers have been trained and
certified in the use of the RECELL System.
- 12 accounts have already placed orders
and have received commercial shipments.
“We are pleased that in advance of our market launch and without
any direct promotional effort the clinical and economic benefits of
the RECELL System have generated strong interest and sales orders,”
said Erin Liberto, Chief Commercial Officer. “Based on the
pre-promotion demand, we are excited to see the response now that
our full sales team of 20 has been deployed.”
AVITA Medical’s U.S. commercial team brings extensive surgical
and operating room experience to support the RECELL market
adoption. Each member of the sales team has burn care experience
with an average of 16 years of experience in the field, and 100
percent of the team members have previously launched a new product.
The team’s Clinical Training Specialists are all credentialed
clinicians with first-hand burn experience, and the Regenerative
Tissue Specialists are adept at effectively navigating hospital
approval processes. With the continued scientific and clinical
support of a distinguished Medical Affairs staff, the AVITA team is
well positioned to drive the market success of the RECELL
System.
“I could not be more pleased with the quality of individuals and
the collective focus they have all devoted to the RECELL System
launch,” said Terry Bromley, Vice President of Commercial
Operations. “We are very delighted with the enthusiasm our highly
experienced sales team has expressed for the RECELL System, and how
quickly this team of professionals has prepared for the U.S.
launch.”
Key commercial achievements after the U.S. Food and Drug
Administration (FDA) approved the RECELL System in September 2018
include:
- American Burn Association (ABA) issued
reimbursement coding guidelines within one week of approval.
- Commercial product availability within
two weeks of approval.
- First commercial sale within two days
of product availability.
- Entire U.S. sales team in place within
eight weeks of approval.
- National sales launch commenced in
January 2019.
Healthcare professionals should read the INSTRUCTIONS FOR USE -
RECELL® Autologous Cell Harvesting Device
(https://recellsystem.com/) for a full description of important
safety information including contraindications, warnings and
precautions.
ABOUT THE RECELL SYSTEM
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 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 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 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,
CFDA-cleared in China, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190107006119/en/
Media:Monsoon CommunicationsSarah KemterPhone +61
(0)3 9620 3333Mobile +61 (0)407 162 530sarahk@monsoon.com.au
Investors:Westwicke PartnersCaroline CornerPhone
+1-415-202-5678caroline.corner@westwicke.com
AVITA Medical LtdDale A. SanderChief Financial
OfficerPhone +1-661-367-9178dsander@avitamedical.com
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