AVITA Medical Submits FDA PMA Supplement to Further Expand Indication to Soft Tissue Repair
December 12 2022 - 9:15AM
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative
medicine company leading the development and commercialization of
first-in-class devices and autologous cellular therapies for skin
restoration, announced today the submission of a Premarket Approval
(PMA) supplement application to the U.S. Food and Drug
Administration (FDA) for the company’s RECELL® System. The
supplement, if approved, will expand the indication of RECELL to
include soft tissue repair.
“The submission is a significant milestone in our effort to
expand the label of RECELL into the soft tissue repair market
opportunity,” said Jim Corbett, AVITA Medical Chief Executive
Officer. “Soft tissue repair encompasses a broad label of RECELL
applications and allows us to target all level 1 and level 2 trauma
centers in the U.S. Once approved, this indication expands our
current market opportunity by at least three times and is expected
to create a significant growth opportunity for us beginning July
2023.”
This PMA supplement includes the recently released results of
the pivotal trial for soft tissue repair. The study met both
co-primary endpoints, demonstrating that RECELL is statistically
significant in donor sparing and statistically non-inferior in
healing outcomes. For purposes of the clinical study, soft tissue
injuries included any full-thickness acute skin defect, such as
degloving or peeled back skin injuries, road rash, surgical wounds,
and flesh-eating disease.
The RECELL System earned FDA Breakthrough Device designation for
its proposed soft tissue repair indication. Under the program,
AVITA Medical will receive prioritized review and interactive
communication with the FDA throughout the premarket review phase.
The standard FDA review timeline for label expansion through a PMA
supplement is 180 days.
This PMA supplement application follows the original PMA
approval of the RECELL System in September 2018.
AVITA Medical’s clinical trial in soft tissue repair has been
funded in whole or in part with Federal funds from the
Administration for Strategic Preparedness and Response, Biomedical
Advanced Research and Development Authority, under contract no.
HHSO100201500028C.
Authorized for release by the Chief Financial Officer of AVITA
Medical, Inc.
ABOUT AVITA MEDICAL, INC.AVITA Medical® is a
regenerative medicine company leading the development and
commercialization of devices and autologous cellular therapies for
skin restoration. The RECELL® System technology platform, approved
by the FDA for the treatment of acute thermal burns in both adults
and children, harnesses the regenerative properties of a patient’s
own skin to create Spray-On Skin™ cells. Delivered at the
point-of-care, RECELL enables improved clinical outcomes and
validated cost savings. RECELL is the catalyst of a new treatment
paradigm and AVITA Medical is leveraging its proven and
differentiated capabilities to develop first-in-class cellular
therapies for multiple indications, including soft tissue repair
and repigmentation of stable vitiligo lesions.
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 approved for acute
partial-thickness 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. In February 2022, the FDA reviewed and approved the 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 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 15,000 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 approved under the
RECELL System brand to promote skin healing in a wide range of
applications including burns, soft tissue repair, vitiligo, and
aesthetics. The RECELL System is TGA-registered in Australia,
received CE-mark approval in Europe and has PMDA approval in
Japan.
To learn more, visit www.avitamedical.com.
FOR FURTHER INFORMATION:
Investors & MediaAVITA
Medical, Inc.Jessica EkebergPhone
+1-661-904-9269investor@avitamedical.com media@avitamedical.com
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