Establishment Labs to Announce Fourth Quarter 2025 Financial Results on February 24
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irb approved pivotal studymedical
A pivotal study is a late-stage clinical trial intended to provide the decisive evidence regulators need to approve a medical product, and IRB approved means an independent ethics committee has reviewed and cleared the study to protect participants. Investors care because an IRB-approved pivotal study is like a final exam for a therapy: its results largely determine whether the product can reach the market, affecting potential revenue, regulatory risk, and company value.
mri conditionalmedical
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.
rfidtechnical
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.
tissue expandermedical
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.
iso13485:2016regulatory
ISO 13485:2016 is an international standard that specifies what a company must do to manage quality for medical devices and related services — think of it as a detailed recipe and checklist to make sure devices are designed, made and controlled consistently and safely. For investors, certification signals lower regulatory and operational risk, smoother market access and a reduced chance of costly recalls or compliance fines, which can protect revenue and company value.
fda 21 cfr 820regulatory
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.
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 December 31, 2025, before the market opens on Tuesday, February 24, 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 (U.S. and Canada) or +1 (201) 689-8037 (International) and use conference ID number 13758679. 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 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.
