- 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 Sulàyöm Innovation Campus in the Coyol Free Zone, Costa Rica.
The Sulàyöm 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 Sulàyöm mountain is regarded as the center of all creation. We chose to name our innovation campus Sulàyöm 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 Sulàyöm 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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Contacts
Raj Denhoy
Rdenhoy@establishmentlabs.com
+1 (415) 828-1044
