Abstracts Highlighting RECELL Clinical and
Health Economic Benefits Included in Journal of Burn Care &
Research Supplement
AVITA Medical Limited (ASX: AVH, NASDAQ: RCEL), a regenerative
medicine company with a technology platform positioned to address
unmet medical needs in therapeutic skin restoration, announced
today the availability of RECELL® Autologous Cell Harvesting Device
(RECELL® System) abstracts in a supplement of the Journal of Burn
Care & Research highlighting data accepted for presentation at
the 52nd annual American Burn Association (ABA) Meeting prior to
its cancellation due to the COVID-19 pandemic.
“With the safety and health of all a top priority amid the
current COVID-19 pandemic, we are pleased the ABA is finding ways
for burn surgeons to digitally access scientific data that would
have been presented at its annual meeting,” said Dr. Mike Perry,
AVITA Medical’s Chief Executive Officer. “We are committed to our
role of advancing burn care, and the positive clinical outcomes and
health economic benefits of the RECELL System are reflected in the
breadth of data the ABA accepted. We look forward to continued
collaboration with burn surgeons who are increasingly using the
RECELL System across a range of burn sizes and look forward to
continuing to explore the potential to expand the use of RECELL to
benefit pediatric patients following the commencement of our
pivotal trial for pediatric scald injuries earlier this month.”
RECELL® System Data Abstracts Available in Journal of Burn
Care & Researchi:
Abstract Number
Abstract Title
Presenter
56
Reduced Length of Stay with Autologous
Skin Cell Suspension Reduces Burn Injuriesii
Jeffrey E. Carter, MD
Louisiana State University
University Medical Center New Orleans
96
Treatment of Donor Sites in Large TBSA
Burn Injuries with an Autologous Skin Cell Suspension Supports
Early Reharvestingiii
Kevin Foster, MD, MBA,
FACS
Arizona Burn Center Valleywise Medical
Center
525
Autologous Skin Cell Suspension May
Enhance Healing of Burn Wounds and Skin Graft Donor Sites in
Elderly Burn Patientsiv
Arhana Chattopadhyay
Stanford School of Medicine
550
Real World Treatment Trends for Patients
TBSA ≤20%: Evaluating Important Shifts in Care and Budget Impact of
ASCS Adoptionv
James H. Holmes, IV, MD
Wake Forest Baptist Medical Center
558
Relationship Between Patient
Characteristics and Number of Procedures as well as Length of Stay
for Patients Surviving Severe Burn Injuries: Analysis of the
American Burn Association National Burn Repositoryvi
Stacy Kowal, IQVIA Inc.
727
Use of a Biodegradable Dermal Matrix in
Conjunction with Meshed and Sprayed Autologous Cell Suspension with
a Vacuum Assisted Dressing Achieved Limb Salvage in a 73-Year Old
with Deep Full Thickness Burns Despite Exposed Tendon and
Bonevii
Joe Olivi, MD
Northwest Arkansas Medical Center
728
The Faces of Autologous Skin Cell
Suspension as Epidermal Graftsviii
Justin Van Hoorebeke, MD, MS
UCSF Fresno Community Regional
Medical Center
736
Autologous Skin Cell Suspension in
Combination with Meshed Autograft: A Case Report Demonstrating the
Efficacy in NSTIix
Nicole Kopari, MD
UCSF Fresno Community Regional Medical
Center
738
Post-Operative Wound Care Using
Silver-Based Dressing with Autologous Skin Cell Suspensionx
Jeffrey E. Carter, MD
Louisiana State University
University Medical Center New Orleans
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.
Authorized for release by the Chief Executive Officer of AVITA
Medical Limited.
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 8,000 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
(https://recellsystem.com/) for a full description of indications
for use and important safety information including
contraindications, warnings and precautions.
In international markets, 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 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.
This press release was authorized by the review committee of
AVITA Medical Limited.
i J Burn Care Res, Volume 41, Issue Supplement 1, March 2020,
American Burn Association 52nd Annual Meeting.
https://academic.oup.com/jbcr/issue/41/Supplement_1 Accessed
3/24/2020 ii J Burn Care Res, Volume 41, Issue Supplement_1, March
2020, Pages S37–S38, https://doi.org/10.1093/jbcr/iraa024.060 iii J
Burn Care Res, Volume 41, Issue Supplement_1, March 2020, Pages
S62-S63, https://doi.org/10.1093/jbcr/iraa024.099 iv J Burn Care
Res, Volume 41, Issue Supplement_1, March 2020, Pages S100–S101,
https://doi.org/10.1093/jbcr/iraa024.155 v J Burn Care Res, Volume
41, Issue Supplement_1, March 2020, Page S115,
https://doi.org/10.1093/jbcr/iraa024.178 vi J Burn Care Res, Volume
41, Issue Supplement_1, March 2020, Page S115,
https://doi.org/10.1093/jbcr/iraa024.178 vii J Burn Care Res,
Volume 41, Issue Supplement_1, March 2020, Page S195,
https://doi.org/10.1093/jbcr/iraa024.311 viii J Burn Care Res,
Volume 41, Issue Supplement_1, March 2020, Pages S195–S196,
https://doi.org/10.1093/jbcr/iraa024.312 ix J Burn Care Res, Volume
41, Issue Supplement_1, March 2020, Page S200,
https://doi.org/10.1093/jbcr/iraa024.319 x J Burn Care Res, Volume
41, Issue Supplement_1, March 2020, Page S201,
https://doi.org/10.1093/jbcr/iraa024.321
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U.S. Media Sam Brown, Inc. Christy Curran Phone
+1-615-414-8668 christycurran@sambrown.com
O.U.S. Media Rudi Michelson Phone +61 (0)3 9620 3333
Mobile +61 (0)411 402 737 rudim@monsoon.com.au
Investors Westwicke Partners Caroline Corner Phone
+1-415-202-5678 caroline.coner@westwicke.com
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