AVITA Medical Submits Response to FDA, Resuming Review Clock for RECELL GO PMA Supplement
February 29 2024 - 4:02PM
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage
regenerative medicine company focused on first-in-class devices for
wound care management and skin restoration, today announced it has
submitted its response to the U.S. Food and Drug Administration
(FDA) for additional information requested in connection to its
premarket approval (PMA) supplement for RECELL GO™. This submission
resumes the substantive interactive review process under the
Breakthrough Devices Program.
The response addresses various questions and
incorporates data from in-house testing to support the PMA
supplement and fulfil the additional information request, which we
received in October of 2023. Upon receipt by the FDA, the
application of the PMA supplement resumes its 180-day real time
review, with 90 days remaining in the review period. Therefore, we
expect FDA approval on May 30, 2024, positioning us for a product
launch on May 31, 2024.
“RECELL GO will enhance our capabilities and reach
to continue our already impressive growth,” said Jim Corbett, Chief
Executive Officer of AVITA Medical. “RECELL GO reduces the training
burden on medical professionals and our field sales organization.
In doing so, we anticipate broader adoption of RECELL across
various applications, ultimately amplifying our impact and
transforming patient care."
The supplement follows the original PMA of its
RECELL Autologous Cell Harvesting Device and subsequent PMA
supplements.
About AVITA Medical, Inc.AVITA
Medical® is a commercial-stage regenerative medicine company
transforming the standard of care in wound care management and skin
restoration with innovative devices. At the forefront of our
platform is the RECELL® System, approved by the Food and Drug
Administration for the treatment of thermal burn wounds and
full-thickness skin defects, and for repigmentation of stable
depigmented vitiligo lesions. RECELL harnesses the regenerative
properties of a patient’s own skin to create Spray-On Skin™ Cells,
delivering a transformative solution at the point-of-care. This
breakthrough technology serves as the catalyst for a new treatment
paradigm enabling improved clinical outcomes. AVITA Medical also
holds the exclusive rights to market, sell, and distribute
PermeaDerm®, a biosynthetic wound matrix, in the United States.
In international markets, the RECELL System is
approved to promote skin healing in a wide range of applications
including burns, full-thickness skin defects, and vitiligo. 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.
Forward-Looking Statements
Statements in this press release may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements are subject to
significant risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Forward-looking statements generally may 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,” and similar words or expressions, and the use
of future dates. Forward-looking statements in this press release
include but are not limited to statements concerning our product
development activities and regulatory approval of our products.
These statements are made as of the date of this release, and the
Company undertakes no obligation to publicly update or revise any
of these statements, except as required by law. For additional
information and other important factors that may cause actual
results to differ materially from forward-looking statements,
please see the “Risk Factors” section of the Company’s latest
Annual Report on Form 10-K and other publicly available filings for
a discussion of these and other risks and uncertainties.
Investor & Media
Contact:Jessica EkebergPhone +1-661-904-9269
investor@avitamedical.commedia@avitamedical.com
Authorized for release by the Chief Financial
Officer of AVITA Medical, Inc.
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