Presentation describing treatment of pediatric
patients with RECELL System selected as “Best of the Best
Abstract”
Developer of RECELL System, Professor Fiona
Wood, to present long-term clinical outcomes of over 3,500 patients
treated with RECELL
AVITA Medical (ASX: AVH, OTCQX: AVMXY) announced today the
schedule for ten presentations describing clinical and cost-savings
advantages of the RECELL® Autologous Cell Harvesting Device
(RECELL® System) in the treatment of severe burns. The
presentations at the American Burn Association (ABA) 51st Annual
Meeting to be held from April 2 - 5, 2019 in Las Vegas will
highlight positive results obtained with treatment using the RECELL
System in a broad range of patient populations and burn types. One
of the RECELL System presentations describing the treatment of
pediatric patients was selected as a “Best of the Best Abstract”
out of more than 500 submissions.
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. Two
randomized, controlled clinical trials demonstrated that treatment
of acute burn wounds with the RECELL System required substantially
less donor skin than required with conventional treatment 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. 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.
“With more than 10 years of clinical experience with the RECELL
System, our long-term effectiveness and safety data underscore how
we are changing the treatment paradigm for burn patients,” said Dr.
Michael Perry, AVITA Medical Chief Executive Officer. “Following
our recent FDA approval, our goal is to partner with burn
specialists across the country to help facilitate optimal outcomes
for burn patients using this novel therapy.”
Podium Presentations
Session Date, Time, Location(all
times PDT)
Session Description
Presenter
Friday, April 5, 2019
8:36 – 8:54 a.m.
Amazon G
*BEST OF THE BEST ABSTRACTS*
“Evaluation of Pediatric Population
Treated for Burn Injuries Using an Autologous Skin Cell
Suspension.”
Jeffrey Carter, MD, FACS
University Medical Center New Orleans Burn
Center and LSU Health New Orleans School of Medicine
Friday, April 5, 2019
10:30 – 10:45 a.m.
Amazon A
Abstract 107
“Post-Operative Wound Management Following the Use of
an Autologous Cell Harvesting Device in the Treatment of Patients
with Life-Threatening Injuries: A Single Center’s Experience.”
Christopher Craig, PA-C, MMS
Wake Forest Baptist Health
Friday, April 5, 2019
11:15 – 11:30 a.m.
Amazon A
Abstract 109
“Evaluation of Autologous Skin Cell Suspension for
Healing of Burn Injuries of the Hand.”
Joseph
Molnar, MD, PhD, FACS
Wake Forest Baptist Health
Friday, April 5, 2019
11:30 – 11:45 a.m.
Amazon A
Abstract 111
“10 Years of Clinical Experience Using Point of Care
Non Cultured Autologous Skin Cell Suspension.”
Professor Fiona Wood, AM
Burns Service of Western Australia, Fiona
Stanley Hospital, Princess Margaret Hospital for Children
Friday, April 5, 2019
11:45 a.m. – 12:00 p.m.
Amazon L
Abstract 104
“This is How We Do It: Rehabilitation Following the
Use of an Autologous Cell Harvesting Device.”
Dana
Nakamura, OTR/L
Wake Forest Baptist Health
Poster Presentations
Session Date, Time, Location(all
times PDT)
Session Title, Description
Presenter
Wednesday, April 3, 2019
12:30 - 1:45 p.m.
Exhibit Hall – Rio Pavilion Abstract
339
“The Use of an Autologous Cell Harvesting and
Processing Device in Two Burn Patients at an Urban Pediatric Burn
Center.”
Paul Glat, MD, FACS
St. Christopher's Hospital for
Children
Wednesday, April 3, 2019
12:30 - 1:45 p.m.
Exhibit Hall – Rio Pavilion Abstract
340
“Autologous Regenerative Epidermal Suspension (RES™):
A Case Study.”
Kristina Chang, BA
Massachusetts General Hospital
Thursday, April 4, 2019
12:30 - 1:45 p.m.
Exhibit Hall – Rio Pavilion Abstract
498
“Healing of Donor Sites with an Autologous Skin Cell
Suspension for Large TBSA Burn Injuries: A Prospective Evaluation.”
Kevin Foster, MD, MBA, FACS
Arizona Burn Center
Thursday, April 4, 2019
12:30 - 1:45 p.m.
Exhibit Hall – Rio Pavilion Abstract
381
“Budget Impact of Autologous Cell Harvesting Device
(ACHD) Use versus Standard of Care (SOC) for Treatment of Severe
Burns: A Case Study”
Kevin Foster, MD, MBA,
FACS
Arizona Burn Center
Thursday, April 4, 2019
12:30 - 1:45 p.m.
Exhibit Hall – Rio Pavilion Abstract
509
“Evaluation of Autologous Skin Cell Suspension for
Definitive Closure of Extensive Burn Injuries in Adult Population.”
William Hickerson, MD, FACS,
Firefighter Burn Center and University of Tennessee Health Science
Center
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.
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 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
(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, 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/20190310005056/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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