RECELL® System Data to be Presented at the American Burn Association Annual Meeting
04 April 2022 - 10:00PM
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative
medicine company that is developing and commercializing a
technology platform that enables point-of-care autologous skin
restoration for multiple unmet needs, announced today that fifteen
presentations highlighting the clinical and cost-savings benefits
of the RECELL® Autologous Cell Harvesting Device (RECELL® System)
for the treatment of burn wounds will be shared at the American
Burn Association (ABA) Annual Meeting. The conference will be held
in Las Vegas, April 5-8, and will bring together more than 2,000
multi-disciplinary burn care professionals from across the globe to
discuss burn care and the latest research related to burn injuries.
“The depth and breadth of the RECELL System data being presented
at the American Burn Association Annual Meeting highlights the
impact this platform is having on the treatment protocol for burn
injuries,” said Dr. Mike Perry, Chief Executive Officer of AVITA
Medical. “Given the substantial and growing body of data supporting
the efficacy of the RECELL System for treatment of burn wounds,
coupled with the real-world treatment of more than 15,000 patients
globally, we look forward to building on this strong track record
to expand use of the RECELL System to encompass broader
indications, including soft-tissue repair and vitiligo, following
the completion of our clinical trials and approval by the FDA.”
RECELL® System PresentationsIn the U.S., the
RECELL® System is indicated for the treatment of acute thermal
burn wounds in patients 18 years of age and older or application in
combination with meshed autografting for acute full-thickness
thermal burn wounds in pediatric and adult patients.
Physician-initiated research beyond the FDA approved
indication is not sponsored by AVITA Medical and contains
independent data.
- Decreasing Preparation Time of Full-thickness Engineered
Constructs: Seeding Dermal Allografts with Non-cultured
Keratinocytes. Authors: Gallentine, Powell
- Early Post-operative Mobilization after treatment of burn
wounds with Autologous Skin Cell Suspension. Authors: Kelly,
Kahn
- Outcomes for 43 hand burns treated with 2:1 meshed and
epidermal autografts with abundant donors. Authors: Yoo,
Carter
- ASCS Treatment impact on length of stay data and costs for
patients with small burn. Authors: Carter, Carson, Rae, Saquib
Wibbenmeyer, Hickerson
- Partial thickness pediatric burn injuries treated with
autologous skin cell suspension. Author: Kopari
- Bromelain based enzymatic debridement followed by application
of autologous skin cell suspension for treatment of burns. Authors:
Williams, Bright
- Timing of autologous spray cell suspension: better early than
late. Author: Komak
- Use of autologous skin cell suspension (ASCS) for
full-thickness burn injuries reduces autograft procedures. Author:
Holmes
- Minimally invasive skin grafting with enzymatic debridement and
autologous skin cell suspension. Author: Kahn
- Autologous skin cell suspension application for toxic epidermal
necrolysis: a case report. Author: Pang
- Single stage application of autologous skin cell suspension in
deep partial thickness pediatric facial burns. Author: Lou
- Autologous skin cell suspension versus standard split thickness
autografting: a comparison of operative efficiency. Authors:
Sweitzer, Bell
- Catastrophic burn management: A case series using autologous
skin cell suspension. Author: Deeter
- Evaluation of dermal and epidermal replacement strategies for
the treatment of full-thickness wounds. Author: Hickerson
- Histologic changes of skin biopsies after autologous skin cell
suspension. Author: Lennard
The RECELL System is indicated in the U.S. for treatment of
acute thermal burns. The frequency of burn-related injuries and the
cost of treatment are high. The Centers for Disease Control and
Prevention (CDC) reported that 486,000 patients receive emergency
medical treatment for burns annually. Burn injuries result in
approximately 3,400 deaths each year, the third-leading cause of
accidental home injury deaths. Burns covering up to 90 percent of a
person’s body surface area, once considered fatal injuries, have
become survivable with appropriate treatment. Although
split-thickness autografts are the current standard treatment,
grafting is often associated with significant donor site pain,
delayed healing and scarring.
ABOUT AVITA MEDICAL, INC.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 RES® REGENERATIVE
EPIDERMAL SUSPENSION, 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 and a new ease-of-use design was approved in 2022.
The RECELL System is indicated for use in the treatment of acute
thermal burns. 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 10,000 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
STATEMENTSThis press release 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 press
release 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 press release 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 press
release. 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 press release
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, Inc.
FOR FURTHER INFORMATION:
U.S. MediaSam Brown, Inc.Christy CurranPhone
+1-615-414-8668christycurran@sambrown.comO.U.S.
MediaRudi Michelson Phone +61 (0)3 9620 3333 Mobile +61
(0)411 402 737 rudim@monsoon.com.au |
InvestorsICR WestwickeCaroline CornerPhone
+1-415-202-5678 caroline.corner@westwicke.com |
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