AVITA Medical Announces FDA Approval of New RECELL® System with Improved Ease of Use
February 17 2022 - 4:01PM
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
United States Food and Drug Administration (FDA) has reviewed and
approved the premarket approval application (PMA) supplement for
RECELL® Autologous Cell Harvesting Device, an enhanced RECELL
System aimed at providing clinicians a more efficient user
experience and simplified workflow. The RECELL® System is a device
that enables healthcare professionals to produce a suspension of
Spray-On Skin™ Cells using a small sample of the patient’s own skin
for the treatment of acute thermal burns.
“To ensure RECELL continues to meet the needs of our customers,
we initiated a program to explore how we could improve the device,
and then addressed those matters with this new system,” said Dr.
Mike Perry, Chief Executive Officer of AVITA Medical. “Based upon
research and human factors testing, we are confident that the new
RECELL System will be positively received by the burn community.
The enhancements will provide a range of benefits to clinicians
using the device and in turn, patients will benefit as the
procedure becomes more efficient.”
Until now, the RECELL System – which launched in the United
States nearly two years ago – consisted of multiple individually
packaged sterile components requiring transfer into the sterile
field and required clinicians to rely on multiple people to assist
during the process. AVITA Medical researchers spoke with surgeons,
physician assistants and registered nurses – both experienced and
new users of the device – to study how procedures with the RECELL
System are being conducted in real-world scenarios and how they can
be improved.
While the intended use of the device as a whole remains
unchanged, the RECELL System has been modified to reduce set-up
steps by approximately one-third and to enable use of the device
with reduced support personnel. In a survey, 94% of users believe
that the new RECELL System will allow them to prepare for a
procedure faster than with the current RECELL System and more than
80% of users anticipate a faster learning curve for a newly trained
user to become proficient with the system.i
The launch of the new RECELL System in the United States will
begin in Q2 2022. For more information about the RECELL System,
please visit www.RECELLSystem.com.
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
STATEMENTS
This 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. |
ICR Westwicke |
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 |
|
Rudi Michelson |
|
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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