AVITA Medical Completes Enrollment in Pivotal Trial Evaluating the RECELL® System for Soft-Tissue Reconstruction
January 06 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 it has
completed enrollment into its 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. Topline data will be shared later this year.
“Completing enrollment of the pivotal trial
assessing use of the RECELL® System for treatment of soft-tissue
reconstruction is an important milestone for AVITA
Medical and moreover, is synergistic with our current
commercial focus in burns. Ultimately, with FDA approval of this
indication, we expect to expand the use of
RECELL to include all acute wounds,” said Dr. Mike Perry,
Chief Executive Officer of AVITA Medical. “Early completion
of enrollment
in our soft tissue reconstruction trial underscores
the need and physician desire for new treatment options.”
Skin grafting is the standard of care for soft tissue
reconstruction, including post-trauma and post-surgical skin
reconstruction. Skin grafting requires the harvesting of donor
skin, resulting 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 The total addressable market
(“TAM”) for soft tissue repair is approximately $1 billion and more
than twice as large as the TAM for burns. Further, the existing
reimbursement codes utilized for burn treatment with the RECELL
System will apply to this indication.
“I’m very pleased to have participated in this clinical trial,
which we expect will confirm that less donor skin is needed for
soft-tissue injuries while not compromising healing outcomes
relative to conventional autografting,” said Dr. Steven E. Mapula,
Assistant Professor of Surgery TCU and Division Chief of Plastic
Surgery at John Peter Smith Hospital. “We believe the RECELL System
has the potential to become an important new treatment option for
those in need of soft-tissue reconstruction.”
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. 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. 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 |
_____________________i 2017 Procedural Data. © 2019 DR/Decision
Resources, LLC
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