Professor Fiona Wood, co-inventor of the RECELL
System, described her experience treating more than 3,500 patients
using RECELL and resulting benefits, including reduced time to
healing and decreased length of hospitalization
The publication of the RECELL System pivotal
trial in the treatment of second-degree burns was selected as a top
journal publication for 2018
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, announced that interim results describing
clinical outcomes for pediatric patients treated using the RECELL®
System were presented at the American Burn Association (ABA) 51st
Annual Meeting in Las Vegas by Jeffrey Carter, MD, FACS University
Medical Center New Orleans Burn Center and LSU Health New Orleans
School of Medicine. Patients enrolled in the Investigational Device
Exemption (IDE), Compassionate Use and Continued Access studies had
mixed-depth and full-thickness (third-degree) burns and were
treated with the combination of Spray-On Skin™ Cells prepared using
the RECELL system and widely meshed autografts. Patients in the
studies experienced excellent healing outcomes, with 98% of wounds
healed four weeks after treatment. Dr. Carter’s presentation
describing the treatment of pediatric patients was selected as a
“Best of the Best Abstract” out of more than 500 abstract
submissions to the ABA meeting.
Another one of the ten presentations related to the RECELL
System at the ABA meeting was a long-term review of patient
outcomes by the co-inventor of the technology, Professor Fiona
Wood, AM, Burns Service of Western Australia, Fiona Stanley and
Perth Children’s Hospitals. Professor Wood described her experience
treating more than 3,500 patients with burns and other cutaneous
injuries. In addition, the 2018 publication of the RECELL System
pivotal trial in second-degree burns in the Journal of Burn Care
& Research was recognized during the “The Year in Review: The
Top Journal Publications” session of the ABA meeting.
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 was approved by the U.S. Food and Drug Administration (FDA)
in September 2018 for the treatment of acute thermal burns in
patients 18 years and older. The pediatric presentation includes a
class of patients that fall outside of the currently approved U.S.
product labeling. Healthcare professionals should read the
INSTRUCTIONS FOR USE – RECELL® Autologous Cell Harvesting Device
(https://recellsystem.com/) for a full description of indications
for use and important safety information, including
contraindications, warnings and precautions.
Best of the Best Abstract – Pediatric Burn Care
Dr. Carter presented data showing that 98% of
mixed-depth/full-thickness burn Injuries in pediatric patients
treated using Spray-On Skin Cells in combination with widely spaced
meshed autografts were healed within four weeks of treatment. The
presentation, titled “Evaluation of a Pediatric Population Treated
for Burn Injuries Using an Autologous Skin Cell Suspension: Interim
Analysis,” described the interim outcomes for 23 pediatric patients
with a median age of 6.7 years old (ranging from 0.8 to 16.0)
treated under FDA-IDE approved Compassionate Use and Continued
Access programs. In patients with extensive burn injuries, lack of
available donor skin is a major limitation achieving permanent
closure; and the longer a wound remains open, the more susceptible
a patient is to infection. In the U.S., one-third of burn injuries
occur in children, and the availability of donor skin for
traditional meshed autografts is even more limited in pediatric
patients with extensive injuries. The use of the RECELL System, a
donor skin sparing technology that enables rapid definitive closure
of burn wounds, has the potential to improve patient outcomes.
In this study of pediatric patients which included those with
life-threatening thermal burn injuries, Spray-On Skin Cells
prepared using the RECELL System were applied in combination with
widely meshed split-thickness autografts to achieve definitive
closure using minimal donor skin. A total of 107 burn injuries were
treated in the study, and 98% achieved definitive healing within
four weeks of treatment. Importantly, for patients with greater
than 50% total body surface area (TBSA) burns, treatment with the
combination of Spray-On Skin Cells and widely meshed
split-thickness autografts achieved the same high rate of healing
at week four as patients with smaller burns (burns equal to or less
than 50% TBSA) treated with the same combination. In addition, in
the study the donor sites on all patients were treated with
Spray-On Skin Cells, and 62.5% of the donor sites were healed
within a week of treatment, and 100% were completely healed within
two weeks of treatment.
“This interim analysis supports the use of the RECELL System as
a viable option for treatment in these deeper burn injuries in
pediatric patients,” said Dr. Carter. “In this vulnerable patient
population, we observed excellent clinical outcomes with 98% of
wounds healing within four weeks of treatment, and with the
majority of burn sites having cosmetic outcomes rated as
satisfactory or equivalent compared to uninjured skin. The early
healing of donor sites contributed to a decrease between harvest
times for patients with limited donor skin availability.”
Co-Inventor of the RECELL System Describes More than Ten
Years of Experience with the RECELL System
Professor Wood described her long-term experience treating more
than 3,500 patients using the RECELL System in a presentation
titled “10 years of clinical experience using point of care non
cultured autologous skin cell suspension harvested using the RECELL
System.” Professor Wood, the co-inventor of the technology forming
the basis for the RECELL System, provided an analysis of the
long-term impact of the integration of the RECELL System as the
standard of care in a health system providing burn care to a
population of 2.6 million in Western Australia. For more than a
decade, the RECELL System was used in the treatment of more than
3,500 patients, 90% of which had acute burn injuries, 9% were
treated for scar revision, and 1% had other wounds. More than 700
of these patients were pediatric patients, with approximately 50%
suffering scald injuries.
“Our use of cell-based therapies which ultimately evolved into
the RECELL System was driven by our desire to reduce the time to
healing and improve the outcomes for our burn patients. The quality
of life must be worth the pain of survival,“ said Professor Wood.
“Treatment using the RECELL System was associated with a reduction
in the number of surgical procedures, earlier intervention, and
reduction in time to healing and length of stay. The RECELL System
facilitated early intervention and wound healing as a solo
treatment in partial-thickness injuries, and in combination with
traditional techniques in deeper injuries with limited donor sites.
Using a cumulative outcome index, intervention within one week of
injury was associated with significantly improved outcome at three
months which was maintained at one-year post injury.”
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 Spray-On Skin™ Cells, 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 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 (https://avitamedical.com) for a
full description of indications for use and important safety
information, including contraindications, warnings and
precautions.
Funding and technical support for the development of the RECELL
System is 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 funded under the BARDA contract include two randomized,
controlled pivotal clinical trials, the Compassionate Use and
Continued Access programs, development of the health economic model
demonstrating the cost savings associated with the RECELL System,
and two randomized, controlled clinical trials in pediatric burn
patients.
In international markets, AVITA Medical’s products are marketed
under the RECELL System brand to promote skin healing in a wide
range of applications including burns, acute wounds, scars and
vitiligo. The RECELL System is TGA-registered in Australia and
CFDA-cleared in China.
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/20190407005041/en/
U.S. MediaSam Brown, Inc.Christy CurranPhone:
+1-615-414-8668christycurran@sambrown.com
O.U.S. MediaMonsoon 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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