Establishment Labs Announces CE Mark Approval for Minimally Invasive Surgical Tools
30 May 2023 - 10:00PM
Business Wire
Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global
medical technology company dedicated to improving women’s health
and wellness, principally in breast aesthetics and reconstruction,
today announced it has received CE marking under the European
Medical Device Regulation for the Motiva Injector®, the Motiva®
Inflatable Balloon, and the Motiva® Channel Dissector.
“The approval in Europe of our minimally invasive tools is an
important step in the evolution of plastic surgery,” said Juan José
Chacón-Quirós, Founder and Chief Executive Officer. “Innovations
that improve both the experience and outcome of a medical procedure
can expand markets. This minimally invasive technology platform can
help change perceptions and overcome reservations — opening
aesthetics to the many women who would not consider a traditional
surgery. We are also extremely gratified that all Motiva implants
and tools have now received certification under the new European
MDR standard.”
The Motiva Channel Dissector, Balloon, and Injector are designed
to be used in Establishment Labs’ next generation minimally
invasive aesthetic procedures. Establishment Labs has now completed
a full transition of all currently marketed Motiva implants and
tools as well as the Company’s quality management systems to be in
compliance with the new European Medical Device Regulation
(MDR).
“Medicine is often advanced with the development of innovative
technology platforms that enhance the skill of the practitioner,”
added Professor Marcos Sforza, plastic surgeon, lecturer, and
researcher based in London, England. “These tools provide new
capabilities that allow procedures to be performed more safely and
predictably, resulting in better outcomes for our patients.”
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical technology
company dedicated to improving women’s health and wellness through
the power of science, engineering, and technology. The Company
offers a portfolio of Femtech solutions for breast health, breast
aesthetics and breast reconstruction. The over three million
Motiva® devices Establishment Labs has delivered to plastic and
reconstructive surgeons since 2010 have created a new standard for
safety and patient satisfaction in the over 85 countries in which
they are available. The Motiva Flora® tissue expander is the only
regulatory-approved expander in the world with an integrated port
that is MRI conditional and is used to improve outcomes in breast
reconstruction following breast cancer. Mia Femtech™, Establishment
Lab’s unique minimally invasive experience for breast harmony, is
the Company’s most recent breakthrough innovation. These solutions
are supported by over 200 patent applications in 25 separate patent
families worldwide and over 50 scientific studies and publications
in peer reviewed journals. Establishment Labs manufactures at two
facilities in Costa Rica compliant with all applicable regulatory
standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP
program. In 2018, the Company received an investigational device
exemption (IDE) from the FDA for Motiva Implants® and began a
clinical trial to support regulatory approval in the United States.
Please visit our website for additional information at
www.establishmentlabs.com.
Establishment Labs' implants and tools are currently not
approved for commercial distribution in the United States. The
Company’s Motiva implants are undergoing clinical investigation
pursuant to U.S. FDA regulations for investigational medical
devices.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). You can find many (but not all) of
these statements by looking for words such as “approximates,”
“believes,” “expects,” “anticipates,” “estimates,” “intends,”
“plans,” “intends to,” “would,” “will,” “may” or other similar
expressions in this press release. Any statements that refer to
projections of our future financial or operating performance,
anticipated trends in our business, our goals, strategies, focus
and plans, including related product development and
commercialization and regulatory approvals, and other
characterizations of future events or circumstances, including
statements expressing general optimism about future operating
results, related to the company’s performance are forward-looking
statements. We claim the protection of the safe harbor contained in
the Private Securities Litigation Reform Act of 1995. We caution
investors that any forward-looking statements presented in this
report, or that we may make orally or in writing from time to time,
are expressions of our beliefs and expectations based on currently
available information at the time such statements are made. Such
statements are based on assumptions, and the actual outcome will be
affected by known and unknown risks, trends, uncertainties, and
factors that are beyond our control. Although we believe that our
assumptions are reasonable, we cannot guarantee future performance,
and some will inevitably prove to be incorrect. As a result, our
actual future results and the timing of events may differ from our
expectations, and those differences may be material. Factors, among
others, that could cause actual results and events to differ
materially from those described in any forward-looking statements
include risks and uncertainties relating to: our ability to
successfully, timely and cost-effectively develop, seek and obtain
regulatory clearance for and commercialize our product offerings;
the rate of adoption of our products by healthcare providers or
other customers; the success of our marketing initiatives; the safe
and effective use of our products; our ability to protect our
intellectual property; our future expansion plans and capital
allocation; our ability to expand upon and/or secure sources of
credit or capital; our ability to develop and maintain
relationships with qualified suppliers to avoid a significant
interruption in our supply chains; our ability to attract and
retain key personnel; our ability to scale our operations to meet
market demands; the effect on our business of existing and new
regulatory requirements; and other economic and competitive
factors. These and other factors that could cause or contribute to
actual results differing materially from our expectations include,
among others, those risks and uncertainties discussed in the
company’s quarterly report and annual reports, and other filings
made by the company with the Securities and Exchange Commission.
The risks included in those documents are not exhaustive, and
additional factors could adversely affect our business and
financial performance. We operate in a very competitive and rapidly
changing environment. New risk factors emerge from time to time,
and it is not possible for us to predict all such risk factors, nor
can we assess the impact of all such risk factors on our business
or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in
any forward-looking statements. We are not undertaking any
obligation to update any forward-looking statements. Accordingly,
investors should use caution in relying on past forward-looking
statements, which are based on known results and trends at the time
they are made, to anticipate future results or trends.
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version on businesswire.com: https://www.businesswire.com/news/home/20230530005218/en/
Investor/Media Contact Raj Denhoy 415-828-1044
rdenhoy@establishmentlabs.com
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