Strong market response to the RECELL System
approval in advance of U.S. launch with 32 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 completed hiring of
the U.S. sales team to support the U.S. market launch of the
RECELL® System for the treatment of acute thermal burns. The full
direct sales team of 20 healthcare professionals has joined AVITA
and are in the process of completing a rigorous training program,
including on-site training within burn centers, in preparation for
the market launch of the RECELL System. The Company also announced
that in advance of the market launch a total of 32 U.S. burns
centers are in active review of the RECELL System or have commenced
ordering and are taking deliveries of the product.
The U.S. sales team includes Regenerative Tissue Specialists
(RTS) who are based throughout the U.S. and will lead the
qualification, account management, and relationship development
within each burn center. Each RTS is highly experienced in the burn
care market and well versed in the clinical aspects of patient
care. Also incorporated in the sales team are Clinical Training
Specialists (CTS) who will train surgeons and nurses and assist
burn centers in their use of the RECELL System. Each CTS is a
Registered Nurse and joins AVITA with an accomplished background in
burn care and institutional relationships. The efforts of the RTS
and CTS teams to train and certify doctors and nurses will be
augmented by AVITA’s Medical Affairs team, a group that is highly
experienced in the burn space and were responsible for training the
24 burn centers who participated in the clinical trials and
Compassionate Use program for the RECELL System.
“We are quite pleased with how quickly we were able to recruit a
highly experienced, specialized field force,” said Erin Liberto,
Chief Commercial Officer. “Industry awareness and credibility
resulting from the strong clinical results and economic benefits of
the RECELL System led to the fast recruitment and enables us to
proceed quickly to the U.S. national sales launch during the first
week of January 2019. In general, we expect most U.S. burn centers
will follow a fairly standard process of evaluating the RECELL
System and then taking it through their hospital’s Value Analysis
Committees prior to purchasing the product. This process can
sometimes be a lengthy one taking six months to complete, although
we are already seeing a number of burn centers move more
rapidly.”
In advance of the national sales launch of the RECELL System a
large number of burn centers have proactively initiated the process
with AVITA to enable them to commence purchasing the product. Of
the 134 burn centers in the U.S., 32 have already commenced an
evaluation of RECELL or have proceeded to the formal purchasing
approval process required to order the product. Seven of these burn
centers have completed their internal processes, ordered the RECELL
System, and have received commercial shipments.
“We are excited about the market response to date considering
that prior to our sales launch we have purely been reacting to the
market interest and meeting the demand driven by our clinical
results and key opinion leader support as opposed to creating
demand,” said Dr. Michael Perry, Chief Executive Officer. “We are
in a unique position as many large burn centers already have
significant experience with the product through our clinical trials
and Compassionate Use program, and we are pleased that a good
number of burn centers have adopted the product in advance of the
formal market launch.”
Key commercial achievements subsequent to the FDA approval on 20
September 2018 include:
- Customer Service Line went live within
two days of approval
- Commercial Product availability within
two weeks of approval
- First commercial sale within two days
of product availability
- Entire U.S. field force in place within
eight weeks of approval
ABOUT THE RECELL SYSTEM
The U.S. Food and Drug Administration (FDA) approved the RECELL
System in September 2018 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. 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.
Funding for the development of the RECELL System was provided by
the Biomedical Advanced Research and Development Authority (BARDA),
under the Assistant Secretary for Preparedness and Response, within
the U.S. Department of Health and Human Services, under ongoing USG
Contract No. HHSO100201500028C. Programs discussed above which were
funded under the BARDA contract include the two randomized,
controlled clinical trials, the Compassionate Use program, and
development of the health economic model demonstrating the cost
savings associated with the RECELL System.
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 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,
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/20181115006113/en/
US MediaSyneos Health Public RelationsChristian
Pflaumer, +1-212-229-8412orNicole 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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