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, announced publication of its 2025 Post-Market Surveillance (PMS) Report. The report is being released ahead of the annual meeting of the American Society of Plastic Surgeons held October 9-12 in New Orleans.

“Publishing our PMS report every year since the launch of Motiva in 2010 shows our dedication to accountability and transparency,” said Peter Caldini, Establishment Labs Chief Executive Officer. “No other company in our industry publishes this level of information on an annual basis, and I would encourage them to do so. What is most important is the consistency of our post-market surveillance data across diverse sources, all of which show less than 1% device-related complications with Motiva implants leading to reoperations. These results are the basis for our continued success worldwide, our strong start in the United States since FDA approval, and our confidence in our 2025 financial guidance and strong growth in 2026.”

Establishment Labs’ Post-Market Surveillance Report is published each year and includes data on the real-world performance of Motiva implants. The report includes a comprehensive review of outcomes with Motiva implants from peer-reviewed publications, global registries, the company’s warranty and claims data, and studies supporting regulatory approvals, including data from the US FDA study. The PMS report has been released annually since the commercial launch of Motiva implants in 2010. Establishment Labs’ PMS Report can be found on the company’s website: https://establishmentlabs.com/science-based-innovation/pms-report/.

“The consistency of outcomes over fifteen years, across all regions of the world, and from many different sources is not a coincidence, it is the result of purpose-driven design,” added Roberto de Mezerville, Chief Technology Officer at Establishment Labs. “Our technologies were engineered to perform better by incorporating the latest advancements in science and technology, and the data continues to validate that we’ve established a new benchmark in the industry. Notably, the performance remains consistent regardless of placement technique, subglandular or submuscular, and incision site. Today there are more than two million women worldwide with Motiva, and we expect an approximate 400,000 to join them next year. We are not just shaping the future of this industry, we are redefining what women can expect from science, design, and innovation with minimally invasive and tissue-preserving technologies.”

About Establishment Labs

Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women’s health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The Company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 90 countries. With over four million Motiva^® devices delivered to plastic and reconstructive surgeons since 2010, the Company’s products have created a new standard for safety and patient satisfaction. The company’s minimally invasive platform consists of Mia Femtech^®, a unique minimally invasive experience for breast harmonization, and Preservé™, a breast tissue preserving and minimally invasive technology for breast augmentation, revision augmentation and mastopexy augmentation. GEM® is a next generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB approved pivotal study. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Zensor™ is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company’s first biosensor Zenº™, currently part of an IRB approved pivotal study to measure core breast temperature. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical 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. Please visit our website for additional information at www.establishmentlabs.com

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 annual report on Form 10-K filed on February 28, 2025 and in the company's quarterly report on Form 10-Q filed on August 7, 2025, which risks and uncertainties may be updated in the future in 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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