AVITA Medical Announces Commencement of Manufacturing of RECELL® Device in Newly Acquired Facility in Preparation for Planne...
August 22 2018 - 11:21PM
Business Wire
AVITA Medical (ASX: AVH, OTCQX: AVMXY) today announced the
successful completion of multiple production runs for the RECELL
Device® within its newly acquired manufacturing facility in
Ventura, California. Effective July 1, 2018, AVITA Medical acquired
the facility from a Fortune 500 manufacturer that had previously
assembled the RECELL Device on a contract basis. The manufacturing
runs were performed after AVITA Medical’s takeover of the facility
and represent the first production activities undertaken by the
Company’s own manufacturing and quality control personnel.
Components currently being manufactured in the facility will be
used to supply clinical trial and international sales requirements
and to support the Company’s preparations for the expected U.S.
launch of the RECELL Device in the U.S.
“I am proud of the results achieved by our manufacturing,
quality control, regulatory and support teams who have successfully
transitioned the RECELL Device to in-house production within our
projected timelines,” said Dr. Michael Perry, Chief Executive
Officer. “The successful commencement of manufacturing of the
RECELL Device within our own facility is a major milestone and
ensures that we are prepared for the planned U.S. launch.”
Currently the RECELL Device is not approved for sale in the U.S.
and is limited by Federal Law to investigational use.
The RECELL Device is designed to enable medical professionals to
produce, at the point-of-care, a Regenerative Epidermal Suspension™
(RES™) using a small sample of the patient’s own skin. The
autologous suspension contains cells necessary to regenerate
epidermis and provides a new way to achieve permanent closure in
burns and other wounds while reducing the amount of skin harvested
at the time of surgery. Reduction in donor-site skin requirements
has important benefits from both clinical and health economic
perspectives. A U.S. Premarket Approval (PMA) application for the
treatment of burn injuries is currently under review by the U.S.
Food and Drug Administration (FDA). AVITA Medical expects
completion of the FDA review of the PMA during the third quarter of
calendar 2018, followed by U.S. approval and market launch.
ABOUT AVITA MEDICAL LIMITED
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.
Our medical devices work by preparing a Regenerative Epidermal
Suspension (RES), an autologous suspension comprised of the
patient’s own skin cells and wound healing factors that are
necessary to regenerate natural healthy skin. This is then applied
to the area to be treated.
In all countries outside of Europe, our portfolio is marketed
under the RECELL brand to promote skin healing in a wide range of
applications including burns, chronic wounds and aesthetics.
RECELL is TGA-registered in Australia, and CFDA-cleared in
China. In the United States, RECELL is not approved for sale and is
limited by federal law to investigational use.
In Europe, our portfolio of medical device products received
CE-mark approval as three tailored product presentations, with
three individual brand names. RECELL is designed for the treatment
of burns and plastic reconstructive procedures; ReGenerCell™ has
been formulated for chronic wounds including leg and foot ulcers;
and ReNovaCell™ is tailored for aesthetic applications including
the restoration of pigmentation.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This letter 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 letter 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 letter 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 letter. 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 letter speak only as of the date of this release, and we
undertake no obligation to update or revise any of these
statements.
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OUS MediaMonsoon CommunicationsSarah KemterPhone
+61 (0)3 9620 3333Mobile +61 (0)407 162
530sarahk@monsoon.com.auorUS MediaSyneos Health Public
RelationsDavid PolkPhone +1 (310) 309 1029Mobile +1 (805) 428
5775david.polk@syneoshealth.comorInvestors:Westwicke
PartnersCaroline CornerPhone +1 (415)
202-5678caroline.corner@westwicke.comorAVITA
Medical LtdDale A. SanderChief Financial OfficerPhone +1 (858)
663-6993dsander@avitamedical.com
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