IRADIMED CORP

This Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 (this "Quarterly Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by words and phrases such as “believe,” “anticipate,” “expect,” “may,” “will,” “should,” “predict,” “could,” “would,” “intend,” “estimates,” “projects,” “plans,” “outlook,” “continue,” “potential,” and similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements include, without limitation, statements about the Company’s future financial and operating results, plans, objectives, and intentions, as well as other statements that are not based on historical fact.

All forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to:

•our ability to obtain or maintain regulatory approvals and comply with applicable regulations, including 510(k) clearances for our products and product candidates, the outcome of inspections conducted by the U.S. Food and Drug Administration (the “FDA”) or other regulatory bodies, additional actions by or requests from the FDA or other regulatory bodies, and unanticipated costs or delays associated with the resolution of such matters;

•our reliance on a limited number of products and our ability to identify and pursue development of additional products;

•our ability to retain key management, marketing, and scientific personnel and to attract and retain additional qualified personnel;

•our expectations regarding the sales and marketing of our products and services;

•our expectations regarding the integrity of our supply chain;

•the potential for adverse application of applicable laws and regulations on our operations;

•our expectations for market acceptance of our new products;

•the potential for exposure to product liability claims and our marketed products to be withdrawn due to recalls or adverse events;

•our ability to prepare, file, prosecute, maintain, defend against infringement of, and enforce patent claims and other intellectual property rights in our products;

•the implementation of our business strategies;

•our financial performance and how it may be interpreted by securities analysts and investors;

•our ability to compete with existing competitors and new market entrants;

•difficulties or delays in developing, manufacturing, or marketing our products and services;

•changes in laws or in their interpretation or application, and the risk of non-compliance;

•cost-containment efforts of our customers, purchasing groups, third-party payers, and governmental organizations;

•costs associated with protecting our trade secrets and enforcing our patent, copyright, and trademark rights, including the risk of successful challenges to the validity of such rights;

•costs or claims resulting from errors or defects in our manufacturing that may injure persons or damage property, including costs from remediation efforts or recalls;

•the results or timing of commercial disputes, patent infringement claims, other legal proceedings, or government investigations;

•interruptions in our ability to manufacture our products, or the unavailability or increased cost of key components or raw materials;

•the risk that third parties may fail to meet their contractual obligations, which could disrupt our operations or adversely affect our financial results;

•the effects of government-mandated healthcare reform;

•the impact on our operations and financial results of public health emergencies, including natural disasters, and policies and actions by governments or other third parties;

•breaches or failures of our or our vendors’ or customers’ information technology systems, including by cyberattack, data leakage, or unauthorized access;

•the risks associated with the integration of Artificial Intelligence (“AI”) or Machine Learning (“ML”) into our products or business, including algorithmic errors or bias, uncertain regulatory requirements applicable to AI-enabled medical devices, data privacy and security concerns arising from the use of AI or ML, and potential liability arising from AI-driven product decisions or recommendations;

•the loss of one or more key customers or suppliers, or a default by any such party;

•unfavorable changes to the terms of key customer or supplier relationships;

•weakening of economic conditions that could adversely affect demand for our products;

•changes in tax rates, interest rates, or inflationary pressures on the U.S. and global economies;

•geopolitical risks, including international conflicts and political instability, which could lead to increased market volatility;

•the impact of tariffs, trade restrictions, export controls, and changes in trade policy, which could increase the cost of components and raw materials used in our products, disrupt our supply chain, limit our ability to sell products in international markets, or otherwise adversely affect our business and results of operations; and

•other risks detailed in our filings with the U.S. Securities and Exchange Commission (the “SEC”).

You should consider the forward-looking statements contained in this Quarterly Report in light of the risk factors and other information set forth under “Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Part II, Item 1A. Risk Factors” in this Quarterly Report, as well as “Part I, Item 1A. Risk Factors” and “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “2025 Annual Report”), and in our other filings with the SEC. Our filings with the SEC are available at http://www.sec.gov. We caution you not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report. We undertake no obligation to publicly update or revise any forward-looking statement contained in this Quarterly Report, whether as a result of new information, future developments, or otherwise, except as required by applicable law.

Unless otherwise indicated, references in this Quarterly Report to “IRADIMED,” the “Company,” “we,” “our,” and “us” refer to IRADIMED CORPORATION. References to the “U.S.” mean the United States of America.