RECELL System clinical benefits and cost
savings featured in 26 presentations at four burn conferences in
early 2019
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, today announced that 26 abstracts highlighting
the clinical and cost savings benefits of the RECELL® Autologous
Cell Harvesting Device (RECELL® System) have been selected for
presentation at four burn conferences in early 2019. Nine of the
presentations will be made at the largest burn conference, the
American Burn Association (ABA) 51st Annual Meeting to be held in
Las Vegas April 2-5, 2019, including a Top-Five Abstract
presentation in plenary session. Each of the presentations will be
made by clinical investigators who will share their experiences and
observations treating patients with the RECELL System.
NINE PRESENTATIONS AT ABA MEETING
The nine presentations at the ABA meeting include the clinical
results and benefits of the RECELL System in the treatment of burns
in specific subgroups of patients and types of burn injuries,
including:
- Pediatric patients (selected as a
Top-Five Abstract to be presented in plenary session)
- Extensive burn injuries in an adult
population (life threatening burns greater than 50 percent total
body surface area or TBSA)
- Burn injuries of the hands
- Burn injuries of joints and
rehabilitation considerations
- Budget impact of use of the RECELL
System versus standard of care in treatment of severe burns at
Arizona Burn Center
- Post-operative wound management
following treatment with the RECELL System
- Treatment and healing of donor sites
with the RECELL System in patient with large TBSA burns
- Case study of 60% TBSA patient with
life-threatening burn injuries and limited donor skin
- A summary of ten years of clinical
experience using RECELL System in the point-of-care treatment of
burn injuries
The U.S. Food and Drug Administration (FDA) approved the RECELL
System in September 2018 for the treatment of acute thermal burns
in patients 18 years and older. Patients included in seven of the
ABA presentations were treated as part of the Compassionate Use and
Continued Access Investigational Device Exemption (IDE) programs
made available to more than 150 burn patients prior to the FDA
approval. Several of the presentations include classes of burns or
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.
“These abstracts build upon and greatly advance the pivotal
clinical trial results and health economic data presented at last
year’s ABA meeting,” said Dr. Michael Perry, AVITA Medical’s Chief
Executive Officer. “The presentations to be made this April at the
2019 ABA meeting highlight the positive clinical outcomes that burn
surgeons have observed in a broad range of patients and burn types.
The clinical results demonstrate that the RECELL System is a major
innovation in the treatment of burn patients as evidenced by the
prominent featuring of this product candidate at the ABA
conference. We appreciate the strong support we have received from
the medical professionals and patients participating in these
studies and thank them for their efforts in advancing the care of
burn patients.”
NINE ADDITIONAL PRESENTATIONS MADE AT TWO BURN CONFERENCES
LAST WEEK
During the North American Burn Society 37th Annual Conference
(NABS) held 20-23 January 2019 in Park City, Utah, eight
presentations were made supporting the clinical and economic
benefits of the RECELL System. Kevin Foster, MD, MBA, FACS, Arizona
Burn Center, made a series of presentations detailing the results
from two U.S. pivotal clinical trials which demonstrated the
effectiveness, safety and clinical benefits of the RECELL System,
and which were used as the primary basis for the FDA approval. Dr.
Foster also presented a case study of the successful treatment with
the RECELL System of a patient with a large soft-tissue defect
caused by necrotizing fasciitis, or flesh-eating bacteria. Other
presentations at the NABS conference included:
- An overview of the protocols for two
randomized controlled U.S. trials of the RECELL System in the
treatment of pediatric patients
- A case study of the successful
treatment of a 60% TBSA burn patient with the RECELL System in
combination with a biodegradable temporizing matrix
At the LA-ACS/SAL Annual Meeting held 18-20 January 2019 in New
Orleans, Louisiana, Blake Platt, MD, University Medical Center New
Orleans Burn Center and LSU Health New Orleans School of Medicine,
presented data demonstrating a reduction in length of stay for burn
patients treated with the RECELL System. Dr. Platt presented the
results of 18 patients treated in the Compassionate Use and
Continued Access programs who had a mean length of stay of 24 days
compared to the expected mean length of stay of 55 days based on
data from the American Burn Association National Burn Repository, a
greater than 50 percent reduction.
EIGHT PRESENTATIONS AT UPCOMING JOHN A BOSWICK BURN &
WOUND SYMPOSIUM
An additional eight presentations have been accepted for
presentation at the John A Boswick Burn & Wound Symposium to be
held 2-7 February 2019 in Maui. These describe the clinical and
cost savings benefits of treatment with the RECELL System, and the
presentations include:
- Pivotal trials in 2nd and 3rd degree
burns
- Health economic model demonstrating
cost savings benefit of the RECELL System
- Treatment with the RECELL System
combined with dermal substitutes
ABOUT THE RECELL SYSTEM
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. A small
skin sample is enzymatically and mechanically processed in the
RECELL System at the point of care to isolate the skin cells to
produce a suspension of Spray-On Skin Cells. The regenerative cell
suspension includes keratinocytes, fibroblasts, and melanocytes,
which play a critical role in wound healing. The suspension can be
sprayed directly on a second degree burn or with an expanded skin
graft on a third-degree burn, allowing for broad and even
distribution of live cells across the entire wound bed. The RECELL
System can be used to prepare enough suspension 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 an adult patient’s entire back. Randomized,
controlled trials have demonstrated that treatment of acute burn
wounds with the RECELL System requires 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.
Funding and technical support 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.
Programs discussed above which were funded under the BARDA contract
include the 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.
In international markets outside of Europe, 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,
CFDA-cleared in China, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190128005753/en/
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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