AVITA Medical Announces Modification of BARDA Contract to Advance Development of RECELL® System in Soft Tissue Reconstruction
22 March 2022 - 7:01AM
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 the
Biomedical Advanced Research and Development Authority (BARDA) has
modified its existing contract with the Company to support AVITA
Medical’s clinical trial in soft tissue reconstruction. BARDA is a
part of the Office of the Assistant Secretary for Preparedness and
Response (ASPR) at the U.S. Department of Health and Human Services
(HHS).
“We are extremely pleased that BARDA is supporting advanced
treatment options for soft tissue reconstruction,” said Dr. Mike
Perry, Chief Executive Officer of AVITA Medical. “The RECELL System
has already proven itself as a safe and effective tool for those
with burns, and we are committed to expanding its use to include
all acute wounds. We are pleased BARDA recognizes the potential it
holds for a broader group of patients experiencing trauma. BARDA
has been an outstanding partner, and we are excited to continue our
work to expand the indication for the RECELL System with their
support.”
Soft tissue reconstruction is of particular concern to BARDA and
AVITA Medical, as skin grafting, the current standard of care for
soft tissue reconstruction, requires the harvesting of donor skin
which can result in an additional wound to the patient. Significant
pain, delayed healing, risk of infection, the need for multiple
procedures, discoloration and scarring are associated with donor
site wounds. While skin grafting is commonly associated with burn
treatment, in 2017, approximately 80% of acute wounds that required
skin grafting were non-burn related injuries accounting for more
than 200,000 procedures in the U.S.i
AVITA Medical is currently completing a pivotal trial for the
use of the RECELL System for soft tissue reconstruction. Currently,
the RECELL System is indicated in the U.S. for treatment of acute
thermal burns. The clinical trial will compare the clinical
performance of conventional autografting to that of widely meshed
autografting with the RECELL System on acute non-burn
full-thickness skin defects, with the goal of demonstrating that
less donor skin is needed without compromising healing outcomes.
Topline data from the trial will be shared later this year.
AVITA Medical has had a long-term positive relationship with
BARDA since September 2015 and was of fundamental importance to the
Company being able to achieve premarket approval for the RECELL
System in late 2018.
This project has been funded in whole or in part with Federal
funds from the Office of the Assistant Secretary for Preparedness
and Response, Biomedical Advanced Research and Development
Authority, under Contract No. HHSO100201500028C
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. Media |
Investors |
Sam Brown, Inc. |
Westwicke Partners |
Christy Curran |
Caroline Corner |
Phone +1-615-414-8668 |
Phone +1-415-202-5678 |
christycurran@sambrown.com |
caroline.corner@westwicke.com |
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O.U.S. Media |
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Rudi Michelson |
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Phone +61 (0)3 9620 3333 |
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Mobile +61 (0)411 402 737 |
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rudim@monsoon.com.au |
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i 2017 Procedural Data. © 2019 DR/Decision Resources, LLC
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