AVITA Medical Announces Presentation at ABA Meeting Highlighting Results of Study Using RECELL System to Treat Third-Degree Burns in Pediatric Patients
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
Valencia, Calif., USA, and Melbourne, Australia,? 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.
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 splitthickness 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 Jeffrey Carter, MD, FACS University Medical Center New
Orleans Burn Center and LSU Health New Orleans School of Medicine. ?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 Fiona Wood, AM, Burns Service of Western Australia, Fiona
Stanley and Perth Children's Hospitals. ?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 partialthickness 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.