AVITA Medical Submits FDA PMA Supplement for RECELL GO
June 29 2023 - 6:21PM
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, today announced its submission of a premarket approval
(PMA) supplement to the U.S. Food and Drug Administration (FDA) for
RECELL GO™. The supplement follows the original PMA of its RECELL
Autologous Cell Harvesting Device and subsequent PMA supplements.
With its innovative capabilities, RECELL GO revolutionizes the
current, manually operated RECELL device by eliminating the need
for manual management of skin samples. RECELL GO will utilize
single-use processing cartridges integrated into a durable AC
powered processing device. The automated workflow streamlines the
critical steps of enzyme incubation, buffer rinse, mechanical
disaggregation, and filtering, transforming the production process
of Spray-On Skin™ Cells.
“This step is pivotal to advancing our platform and strategic
growth plans,” said Jim Corbett, Chief Executive Officer of AVITA
Medical. “The submission is a testament to our unwavering
commitment to innovation and dedication to patient care. Upon
approval, RECELL GO will serve as the catalyst that accelerates our
growth trajectory. By significantly reducing the burden on medical
professionals, we anticipate increased adoption of RECELL across
our indications, amplifying our impact and transforming the lives
of patients.”
As previously announced, RECELL GO maintains the FDA
Breakthrough Device designation from predecessor devices. Under the
Breakthrough Device program, the submission will receive
prioritized, interactive review with an expected January 2024
approval.
Authorized for release by the Chief Executive 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 thermal burn wounds and
full-thickness skin defects and for repigmentation of stable
depigmented vitiligo lesions, 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.
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.
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.
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 statements. Applicable risks and uncertainties
include, among others, the timing and realization 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.
FOR FURTHER INFORMATION:
Investors & MediaAVITA Medical,
Inc.Jessica EkebergPhone +1-661-904-9269
investor@avitamedical.commedia@avitamedical.com |
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From Apr 2024 to May 2024
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From May 2023 to May 2024