Establishment Labs® to Announce First Quarter 2026 Financial Results on May 6

Key Terms

minimally invasive medical

Medical procedures described as minimally invasive use small cuts, flexible tubes or tiny cameras to treat or diagnose problems with far less cutting than traditional surgery — like using a keyhole instead of tearing down a wall. Investors care because these approaches can shorten hospital stays, lower complication rates and change equipment and reimbursement needs, which can speed adoption and reshape market demand for devices, supplies and services.

irb medical

An Institutional Review Board (IRB) is an independent committee that reviews and approves medical and behavioral research involving people to ensure safety, informed consent, and ethical treatment—think of it as a safety inspector for studies. For investors, IRB decisions matter because their approval or requests for changes can speed up, delay, or halt clinical trials and other studies, directly affecting timelines, costs, and the value of companies developing treatments.

tissue expander medical

A tissue expander is a temporary medical implant, often like a small balloon placed under the skin and gradually filled with fluid to gently stretch tissue and create extra space for later reconstructive surgery. Investors track them because their approval status, safety record, manufacturing supply and insurance reimbursement directly affect a medical device maker’s sales, regulatory risk and potential legal exposure — factors that influence a company’s revenue and valuation.

mri conditional medical

MRI conditional is a regulatory label for a medical device or implant that means it can safely enter an MRI scanner only when certain, clearly specified conditions are met (such as scanner strength, device orientation or imaging settings). Like a gadget that works only underwater to a set depth, the label matters to investors because it affects clinical adoption, product competitiveness, regulatory clearance and potential liability: broad or restrictive conditions can materially influence sales and market access.

rfid technical

RFID, or Radio Frequency Identification, is a technology that uses radio waves to automatically identify and track objects, animals, or people. It involves small tags or chips that emit signals when scanned, similar to a barcode but without needing direct line-of-sight. For investors, RFID enhances supply chain efficiency and inventory management, potentially reducing costs and improving business operations.

biosensor medical

A biosensor is a device that detects biological signals—such as proteins, DNA, or metabolites—and converts them into readable electronic or visual data, like a smoke detector that senses a problem and triggers a readable alert. For investors it matters because biosensors can enable faster, cheaper, and more frequent medical tests or environmental monitoring, creating sales, recurring consumable demand, and potential regulatory milestones that can materially affect a company’s revenue and valuation.

iso13485:2024 regulatory

ISO 13485:2024 is the latest version of an internationally recognized standard for quality management systems specifically for medical device makers and their suppliers. Think of it as a detailed recipe and checklist that helps companies design, produce and monitor devices so they are safe, consistent and meet regulator requirements; for investors, certification signals lower regulatory and operational risk, smoother market access and potentially fewer costly recalls or compliance problems.

fda 21 cfr 820 regulatory

FDA 21 CFR 820 is the U.S. regulatory rule that sets required quality-management practices for medical device makers, covering design, manufacturing, testing, record-keeping and corrective actions. For investors it matters because compliance is like a building code for devices: it affects a maker’s ability to sell products, avoid recalls or fines, and predict manufacturing costs and reliability, all of which influence revenue risk and company valuation.

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NEW YORK--(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, plans to announce its financial results for the quarter ended March 31, 2026, before the market opens on Wednesday, May 6, 2026, and will host a conference call at 8:30 am ET that day to discuss those results.

To participate in the conference call, Dial: 877-407-8037 (US & Canada) +1 201-689-8037 (international). The call will also be available via live or archived webcast on the “Investor Relations” section of the Establishment Labs website at www.establishmentlabs.com.

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 100 countries. With five 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 primary breast augmentation and primary 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 ISO13485:2024 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 27, 2026, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260423747289/en/

Investor/Media Contact:
Malavika William
mwilliam@establishmentlabs.com

Source: Establishment Labs Holdings Inc.