Point-of-care regenerative medicine technology
approved to treat second- and third-degree burns using Spray-On
Skin™ Cells product
U.S. market launch planned for 4th calendar
quarter 2018. Target market for burns approximates USD $200
million
AVITA Medical (ASX: AVH) (OTCQX: AVMXY), a global regenerative
medicine company, today announced that the U.S. Food and Drug
Administration (FDA) approved the Company’s Premarket Approval
(PMA) application to market the RECELL® Autologous Cell Harvesting
Device (RECELL® System) to treat severe 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
supporting 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.
“Patients are at the center of everything we do at AVITA
Medical, and we are pleased to be able to provide an innovative
solution for the treatment of severe burn injuries,” said Dr.
Michael Perry, Chief Executive Officer. “Today’s approval of the
RECELL System marks an important milestone for us and provides a
new way to treat burns for the thousands of patients with
significant unmet medical needs. We are grateful to those patients
who participated in clinical trials of the RECELL System and to the
clinical trial investigator teams whose dedication and scientific
rigor made this approval possible. We also greatly appreciate our
collaboration with BARDA and the support that they have provided to
us throughout the development of the RECELL System.”
The RECELL System is approved to be used at the point of care by
trained healthcare professionals to treat adult patients with
severe 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 collected and immersed in the Company’s proprietary
Enzyme solution in the RECELL System to separate the skin cells to
produce Spray-On Skin Cells. The resultant Regenerative Epidermal
Suspension™ (RES™) includes keratinocytes, fibroblasts, and
melanocytes, which play a critical role in wound healing. The
suspension is then sprayed directly onto the prepared burn wound,
providing a broad and even distribution of live cells across the
entire wound bed. The RECELL System can be used to prepare enough
RES™ 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.
“Today’s approval of the RECELL System is a significant
advancement in how we treat patients with burns,” said James H
Holmes IV, MD, FACS, Wake Forest Baptist Medical Center,
Winston-Salem, North Carolina. “Dramatically reducing the amount of
donor skin needed to treat second- and third-degree burns has
important implications for pain, scarring and costs of care, while
still providing comparable healing to the current standard of care.
Additionally, the potential reduction in mortality is extremely
promising.”
FDA Approval Supported by the Results from Two Randomized,
Controlled Clinical Trials
FDA approval was based on the results of two randomized,
controlled clinical trials comparing the treatment of burn patients
with the RECELL System against the standard of care. The first
controlled trial compared treatment with the RECELL System versus
treatment with conventional split-thickness autografts in patients
with deep partial-thickness (second-degree) burn injuries. During
the pivotal trial, the patient donor skin required to be harvested
to treat burn sites with the RECELL System was 97.5% less than the
amount harvested to treat burn sites using standard of care
resulting in a statistically significant reduction in
patient-reported pain, increased patient satisfaction and improved
donor scar outcomes. Despite the statistically significant
reduction in donor skin required to treat with the RECELL System,
burn sites treated with RECELL achieved definitive closure
comparable to the burn sites treated with standard of care. Results
from the second-degree burn pivotal trial were published online on
May 24, 2018 in the Journal of Burn Care & Research (JBCR),
followed by publication in the September/October 2018 issue (Volume
39, Issue 5) of JBCR. The results have also been presented at
multiple scientific conferences, including the Top Five Abstract
plenary session of the American Burn Association (ABA) 50th Annual
Meeting held in April 2018.
The second randomized, controlled pivotal clinical trial
evaluated treatment of deep full-thickness (third-degree) burns
with the RECELL System combined with split-thickness autografts,
versus treatment with standard of care. During the pivotal trial,
the patient donor skin required to be harvested to treat burn sites
with the RECELL System was 32 percent less than the amount
harvested to treat burn sites with the standard of care
(p<0.001). Despite the statistically significant reduction in
donor skin required to treat with the RECELL System, burn sites
treated with the RECELL System achieved definitive closure
comparable to the burn sites treated with standard of care. At
eight weeks post treatment, 92 percent of the burn sites treated
with the RECELL System achieved complete healing versus 85 percent
for the sites treated with the standard of care, demonstrating
non-inferiority. Results from the pivotal trial in third-degree
burns have been presented at multiple scientific conferences,
including the ABA Meeting in April 2018.
In addition to the two pivotal trials, the RECELL System has
been used in the treatment of over 90 burn patients under a
Compassionate Use program, and over 65 patients under a Continued
Access program. Both programs were approved by the FDA and allowed
the treatment of patients with severe burns while the PMA was under
review. In addition, more than 7,000 patients worldwide have been
treated to date with the RECELL System.
“I have participated as an investigator in the two pivotal
clinical trials of the RECELL System as well as the Compassionate
Use and Continued Access programs,” said William Hickerson, MD,
FACS, Firefighter Burn Center, Memphis, Tennessee, and University
of Tennessee Health Science Center, Memphis, Tennessee. “Based on
my personal experience treating patients with the RECELL System,
and the strength of the entire body of clinical evidence supporting
this innovative technology, today’s approval will improve the
treatment of burn patients.”
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.
Economic Model Demonstrates Significantly Reduced Treatment
Costs for RECELL System
The frequency of burn-related injuries and the cost of treatment
are high. The Centers for Disease Control and Prevention (CDC)
reported that 486,000 patients receive emergency medical treatment
for burns annually. Burn injuries result in approximately 3,400
deaths each year, the third-leading cause of accidental home injury
deaths. Burns covering up to 90 percent of a person’s body surface
area, once considered fatal injuries, have become survivable with
appropriate treatment. Although split-thickness autografts are the
current standard treatment, grafting is associated with significant
donor site pain, delayed healing and scarring.
IQVIA, with support from AVITA Medical and the Biomedical
Advanced Research and Development Authority (BARDA), developed a
Burn Care Pathway Health Economic Model to determine cost savings
to burn centers as a result of using the RECELL System compared to
the current standard of care to treat second- and third-degree
burns of varying sizes. The validated model demonstrates that using
the RECELL System alone in second-degree burns or in combination
with autografts in third-degree burns reduces hospital costs and
length of stay, regardless of comorbidities, lowering the cost of
treatment by 44 percent or more for patients with large burns. In
addition, the model concluded that in a 200-bed burn center, the
use of the RECELL System would reduce annual total treatment costs
by USD $13 million.
BARDA Funding Supports Development of RECELL System
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. Since 2015, BARDA has committed USD
$50 million towards specific development initiatives including the
two randomized, controlled clinical trials, the Compassionate Use
and Continued Access programs, the PMA and related activities,
development of the health economic model demonstrating the cost
savings associated with the RECELL System, and two randomized,
controlled clinical trials which will evaluate the RECELL System in
the pediatric population. Procurement of the RECELL System by BARDA
under a vendor-managed inventory system would be triggered in the
future to bolster preparedness by providing availability for use in
a national disaster. In addition, part of the funding for the
pivotal clinical trials was provided by the U.S. Department of the
Army, AFIRM 1 Contract #W81XWH-08-2-0032.
“While severe thermal burns happen every day, in a national
security emergency an overwhelming number of people may need burn
care quickly,” said BARDA Director Rick Bright, PhD. “Medical
providers need easy-to-use treatments on hand to save more lives.
Our goal is not only to support product development but also to
integrate those products into routine care to build
preparedness.”
U.S. Market Launch
In anticipation of approval, AVITA Medical has undertaken
substantial efforts to prepare for the U.S. market launch. These
initiatives include the recruitment of sales and marketing
leadership highly experienced in regenerative medicine and the
treatment of burns, completion and assimilation of extensive direct
market research, and establishment of pricing and reimbursement
strategies and support infrastructure. With the receipt of FDA
approval, the Company will finalize its product packaging and
promotional materials to reflect the final approval details and
will complete the recruitment and hiring of its field sales team.
The Company expects to formally launch the RECELL System in the
U.S. in the fourth calendar quarter of 2018. The Company estimates
that inpatient treatment of burns in the U.S., the initial target
for the RECELL System, is an approximately USD $200 million
market.
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 comprising 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 Kemter, +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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