- New manufacturing capacity allows Establishment Labs to provide
over half the current world demand for breast implants and supports
upcoming launches in China and the U.S.
- Global Learning Center expands training in next generation
technologies
- Establishment Labs also publishes 2022 Sustainability
Review
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 the grand opening of the Sulày�m Innovation Campus
in the Coyol Free Zone, Costa Rica.
The Sulày�m Campus will support Establishment Labs’ continued
global growth with additional capacity and capabilities in
manufacturing, R&D, digital media, training, and medical
education. The first phase of the project, which opens today,
includes approximately 100,000 square feet of manufacturing,
medical, research, and office space. The added manufacturing more
than doubles Establishment Labs’ capacity, allowing the company to
provide over half the current world demand for breast implants.
“To the Bribri, an indigenous tribe in Costa Rica, the Sulày�m
mountain is regarded as the center of all creation. We chose to
name our innovation campus Sulày�m as a reminder of our heritage
and of our unwavering commitment to women around the world,” said
Juan José Chacón-Quirós, CEO and Founder of Establishment Labs.
“Today, on the fifth anniversary of Establishment Labs’ public
listing, we are scaling-up our company to support the growing
demand for our products globally, including them being made
available in the U.S. and China; the creation of a new category
with Mia Femtech; and our commitment to expand access globally to
high quality breast reconstruction.”
The new facilities also include advanced R&D labs, new media
production and broadcasting studios, executive offices and meeting
facilities, and a Global Learning Center, which includes a surgical
theatre and procedure rooms for medical education and training. The
campus includes an additional 45,000 square feet of space that can
be used to further expand manufacturing or other capabilities. The
state-of-the-art facility is designed to be carbon neutral and uses
sustainable materials and other green design elements and
standards.
“Our new research labs will add to our technology and product
development programs, and we are adding significant new
capabilities in media and medical education,” Mr. Chacón-Quirós
continued. “The campus also underscores our commitment to our
communities by adding up to 1,000 new jobs over the next several
years and continuing our traditions of sustainability. Our goal was
to create a heart of creation and innovation, where our employees,
healthcare professionals, partners, and consumers from all over the
world can connect. This is what Sulày�m means to Establishment
Labs.”
The opening ceremony will include a Discovery Session showcasing
Establishment Labs innovations in science, technology, and product
development. The accompanying presentation will be made available
concurrent with the event in the investor portion of the
Establishment Labs investor website at
www.establishmentlabs.com.
Establishment Labs also announced the publication of its 2022
Sustainability Review. The Sustainability Review is published
annually and provides an assessment of the Company’s efforts in
support of environmental and social issues in its communities. The
current and previous editions of the annual review can be found on
the company’s website at:
https://establishmentlabs.com/corporate-sustainability/.
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 used to
improve outcomes in breast reconstruction following breast cancer
and it is the only regulatory-approved expander in the world with
an integrated port using radio-frequency technology that is MRI
conditional. 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/20230719115371/en/
Raj Denhoy Rdenhoy@establishmentlabs.com +1 (415) 828-1044
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