- Facility will support Establishment Labs’ planned growth, including launches of Motiva® Flora® and of Motiva MIA®as well as geographic expansion into China and the United States.
- Builds on Establishment Labs’ world class manufacturing operations in Costa Rica; annual capacity will more than double to approximately 1,900,000 Motiva implants/year when fully operational.
- Will expand research & development resources and add new capabilities for digital media, training, and medical education.
- State of the art facility is designed to be carbon neutral and will use sustainable materials and other green design elements and standards.
SANTA BARBARA, Calif., June 23, 2021 — Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today held the groundbreaking ceremony forits new SulayIöm Innovation Campus in Costa Rica. When complete, the new facilities will total approximately 145,000 square feet (13,500 square meters) and will support the company’s continued global growth with additional capacity and capabilities inmanufacturing, R&D, digital media, training, and medicaleducation.
“The groundbreaking on our Sulayöm Innovation Campus is a critical next step in our growth, as Motiva Implants continue to gain recognition as a new standard in breast aesthetics,” said Juan José Chacón-Quirós, CEO and Founder of Establishment Labs. “The name Sulayöm comes from Bribri, an indigenous Costa Rican language, and is translated to mean, ‘The place in the mountains at the center of the world.’ This new, state of the art facility will give us the manufacturing capacity to support our planned global growth over the next several years, from entering the U.S. and China to our market expansion initiatives in minimally invasive breast aesthetics and breast reconstruction. We are also expanding our research labs for new development programs and enhancing our digital media outreach, training, and medical education capabilities. The campus underscores our commitment to a sustainable future and will continue our traditions of being carbon neutral and utilizing sustainable materials and methods. After just a decade of commercial sales with Motiva, we now look forward to expanding our capacity so that we can supply more than half of the current worldwide market.”
The new campus will be completed in two phases with the first phase expected to cost approximately $35 million, the majority of which the company intends to finance with a local credit partner. Construction on the new building will begin following finalization and execution of certain contractual arrangements. The new facilities will add up to 1,000 new jobs over the next several yearsand will be located in the Coyol Free Zone in Costa Rica.
About Establishment Labs
Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in more than 80 countries through exclusive distributors or the company’s direct salesforce. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant® clinical trial in the United States in April 2018. In addition to Motiva Implants®, Establishment Labs’ product and technologies portfolio includes the Divina® 3D Simulation System and other products and services. Please visit our website for additional information at www.establishmentlabs.com.
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. 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 planned growth and product differentiation, our future expansion plans and capital allocation, construction and infrastructure development projects yet to be undertaken, our ability to reach agreements to expand upon our credit arrangements and/or secure other sources of credit or capital, our ability to meet financial covenants contained in our credit facilities, legal agreements yet to be executed, the market acceptance of our products, the effects of manufacturing or assembly realignments, availability of raw materials and specialized labor or increases in their costs, our ability to identify and develop relationships with a sufficient number of qualified suppliers to avoid a significant interruption in our supply chains, our ability to attract and retain key personnel, compliance with environmental, health and safety laws and/or building codes and standards, our ability to scale our operations and realize expected associated revenues and cost savings, and our ability to avoid damage to our facilities or other force majeure events that could disrupt our operations and expansion plans. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, 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 that could cause or contribute to these differences include, among others, those risks and uncertainties discussed in the company’s annual report on Form 10-K filed on March 15, 2021, quarterly reports on Form 10-Q, 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.