AVITA Medical Announces Temporary Interruption of Sales of Products in EU
March 03 2019 - 6:27PM
Business Wire
-Sales temporarily interrupted while closing
administrative and procedural open items related to EU certificates
and unrelated to product performance
-No impact on U.S. market
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, today announced that sales of the RECELL® Device
in the EU have been temporarily interrupted. The sales interruption
occurred after the notified body responsible for EU certificates
reported open items related to administrative and procedural
non-conformities. These open items are limited to product
distributed within the EU and are not related to product quality,
performance or safety. This action has no impact on the sale of
products outside of the EU. The Company does not actively promote
the products in the EU and its activity in the region is limited to
filling purchase requests as they are received, therefore the
financial impact to AVITA of this temporary interruption is
immaterial as EU sales of products have averaged approximately
A$40,000 per month during Fiscal 2019.
“It is important to note that this interruption is unrelated to
the performance and safety of our products and does not impact the
U.S. market,” said Dr. Mike Perry, Chief Executive Office of AVITA
Medical. “We will work closely with the authorities to close this
administrative request as soon as possible, and no later than the
3rd quarter of calendar 2019. We do not actively promote in the EU
at this time but do want to ensure that our products are available
as soon as possible to those institutions who request it and to
patients who can benefit from their use.”
AVITA Medical received U.S. Food and Drug Administration (FDA)
approval of the RECELL® Autologous Cell Harvesting Device (RECELL®
System) for the treatment of acute thermal burns in patients 18
years and older in September 2018.
ABOUT AVITA MEDICAL LIMITED
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 REGENERATIVE EPIDERMAL SUSPENSION™
(RES™), 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 in patients 18 years and older.
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 7,000 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, acute wounds, scars and vitiligo. The
RECELL System is TGA-registered in Australia and CFDA-cleared in
China.
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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U.S. Media Sam Brown Inc. Christy CurranPhone
+1-615.414.8668chrristycurran@sambrown.com
OUS MediaMonsoon CommunicationsSarah KemterPhone
+61 (0)3 9620 3333Mobile +61 (0)407 162
530sarahk@monsoon.com.au
Investors:Westwicke PartnersCaroline CornerPhone
+1-415-202-5678caroline.corner@westwicke.com
AVITA Medical LtdDale A. SanderChief Financial
OfficerPhone +1-661-367-9178dsander@avitamedical.com
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