What changed in this filing

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Item 1. Business

2024-03-01 compared with 2023-03-02 · 78 added, 65 removed, 479 unchanged (23% of the section changed)

IRADIMED CORPORATION (“IRADIMED”, the “Company,” “we,” “us,” “our”) develops, manufactures, markets and distributes Magnetic Resonance Imaging (“MRI”) compatible medical devices and related accessories, disposables and services relating to them.

IRADIMED CORPORATION (“IRadimed”, the “Company,” “we,” “us,” “our” or similar terms) develops, manufactures, markets and distributes Magnetic Resonance Imaging (“MRI”) compatible medical devices and related accessories, disposables and services relating to them.

We were incorporated in Oklahoma in July 1992 and reincorporated in Delaware in April 2014.

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The features of the IRADIMED 3880 include:

wireless ECG with dynamic gradient filtering;

wireless SpO2 using Masimo® algorithms;

wireless Electrocardiogram (“ECG”) with dynamic gradient filtering;

wireless blood oxygen saturation monitoring (“SpO2”) using Masimo® algorithms;

non-magnetic respiratory CO2;

invasive and non-invasive blood pressure;

patient temperature, and optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements.

patient temperature;

and optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements.

The IRADIMED 3880 MRI compatible patient vital signs monitoring system has an easy-to-use design and allows for the effective communication of patient vital signs information to clinicians.

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We sell our products primarily to hospitals and acute care facilities, both in the United States and internationally.

We currently employ a direct sales strategy in the United States and as of December 31, 2022, our direct sales force consisted of 25 field sales representatives, supported by 3 regional sales directors, and supplemented by 5 clinical application specialists.

We currently employ a direct sales strategy in the United States and as of December 31, 2023, our direct sales force consisted of 25 field sales representatives, supported by 3 regional sales directors, and supplemented by 7

clinical application specialists.

Internationally, we market our products into approximately 80 countries through the use of independent distributors.

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We generate revenue from the sale of MRI compatible medical devices and related accessories, extended warranty agreements, services related to maintaining our products and the sale of disposable products used with our devices.

In fiscal year 2022,

our revenue was $53.3 million and our income from operations was $15.6 million representing an operating profit margin of 29.3 percent.

In fiscal year 2023, our revenue was $65.6 million and our income from operations was $20.0 million representing an operating profit margin of 30.5 percent.

Refer to the information contained under the caption “Financial Highlights and Outlook” regarding our outlook for 2024.

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Susi’s leadership, Invivo Research matured from a start-up medical device company into a leading producer of vital signs monitoring devices used during MRI procedures.

Invivo Research was acquired by Invivo Corporation in 1992, which began trading on the Nasdaq Stock Exchange in 1994.

Invivo Research Inc.

was acquired by Invivo Corporation (“Invivo”) in 1992, which began trading on the Nasdaq Capital Market (“Nasdaq”) in 1994.

Susi served as a Director of Invivo Corporation from 1998 until 2000 and oversaw technical areas from 2000 to 2004.

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This first-generation MRI compatible IV infusion pump system and its associated proprietary IV tubing sets obtained FDA 510(k) clearance in March 2005 after which we began our sales and marketing efforts.

We commenced international sales through a network of distributors and in 2006, we signed an exclusive distribution agreement with Mallinckrodt/Tyco Healthcare (now part of Medtronic plc (NYSE:

We commenced international sales through a network of distributors and in 2006;

we signed an exclusive distribution agreement with Mallinckrodt/Tyco Healthcare (now part of Medtronic plc (NYSE:

MDT)) for domestic and Canadian distribution of our products including the MRidium 3850 MRI compatible IV infusion pump system (the predecessor to our current 3860+ model).

The exclusive arrangement ended in 2010, allowing us to implement a direct marketing strategy with our own sales force in the U.S.

In 2009, we introduced our second-generation MRI compatible IV infusion pump system, the MRidium 3860+ which improved upon the previous 3850 version in a number of areas, including the addition of blood oxygen saturation monitoring (“SpO2”), and remote wireless monitoring capability.

In 2009, we introduced our second-generation MRI compatible IV infusion pump system, the MRidium 3860+ which improved upon the previous 3850 version in several areas, including the addition of SpO2 monitoring, and remote wireless monitoring capability.

An SpO2 monitor can signal when an insufficient level of oxygen is being supplied to the body.

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In 2014, we began developing our own MRI compatible patient vital signs monitoring system (“3880 Monitor”).

Through the use of current and new technologies, and our trade secrets, we believe our 3880 Monitor improves on the design of other MRI compatible vital signs monitors.

Using current and new technologies, and our trade secrets, we believe our 3880 Monitor improves on the design of other MRI compatible vital signs monitors.

Our 3880 Monitor is compact and lightweight, overcoming many of the workflow issues created by other larger and heavier MRI compatible monitors currently in the market.

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In 2022, we introduced our ferromagnetic detection device, IRadimed FMD1 3600 with Remote Alarm Logging Unit, (“RALU”).

This is the first ferromagnetic detection device with TruSense threat qualification technology.

This is the first ferromagnetic detection device with Tru Sense TM threat qualification technology.

This technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status reducing false alarms, all while simultaneously circumventing background magnetic field noise.

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and (5) attempt to shield a conventional IV infusion pump.

All of these approaches have drawbacks, introduce safety risks and may result in patient harm.

All these approaches have drawbacks, introduce safety risks and may result in patient harm.

Use of multiple lengths of extension tubing can cause infusion inaccuracies, unnecessary waste of costly medications and false alarms or, more seriously, delayed alarms for equipment issues such as occlusion, especially when low flow rates are being used.

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The powerful magnetic fields may cause metal objects in the MR environment to be drawn with great force into the bore of the MRI system, resulting in potentially deadly projectiles.

Moreover, an MRI scanner’s gradient magnetic field and RF fields can send electrical currents through cables and other conductive materials that are near the MRI system and cause the cables to heat, which may result in burns if they come into contact with the patient or facility staff.

Moreover, an MRI scanner’s gradient magnetic field and radiofrequency (“RF”) fields can send electrical currents through cables and other conductive materials that are near the MRI system and cause the cables to heat, which may result in burns if they come into contact with the patient or facility staff.

Other problems include devices malfunctioning if they are not properly designed for use in the harsh MR environment and low-quality MR images due to artifacts caused by RF interference emitted from ancillary equipment.

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We estimate there is the potential for the sale of approximately 27,350 MRI compatible IV infusion pump systems based on the number of MRI scanners installed globally in acute care facilities of sufficient sophistication as to be considered supporting favorable market conditions for utilization of our MRI compatible IV infusion pump system.

Additionally, based on historical sales data and customer purchasing behaviors, we believe, through the use of our direct U.S.

Additionally, based on historical sales data and customer purchasing behaviors, we believe, that with our direct U.S.

sales team, there is potential for sales of our MRI compatible IV infusion pump system within critical care departments of U.S.

hospitals (refer to the section below titled Expansion of Intra-Hospital Use of MRI Compatible Devices ).

Based on an estimate of the number of critical care departments in the U.S., we believe there is the potential for the sale of an additional 10,450 of our MRI compatible IV infusion pump systems.

The combination of sales based on the number of targeted MRI scanners and critical care departments of U.S.

hospitals results in a current global target market of approximately 37,800 of our MRI compatible IV infusion pump systems.

Based on an estimate of the number of critical care departments in the U.S., we believe there is the potential for the continued sales of our MRI compatible IV infusion pump systems.

MRI Compatible Patient Vital Signs Monitor

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We estimate there is the potential for the sale of approximately 27,350 MRI vital signs monitoring systems based on the number of MRI scanners installed globally in acute care facilities of sufficient sophistication as to be considered supporting favorable market conditions for utilization of our MRI vital signs monitoring system.

Additionally, based on historical sales data and customer purchasing behaviors, we believe, through the use of our direct U.S.

Additionally, based on historical sales data and customer purchasing behaviors, we believe, that with our direct U.S.

sales team, there is potential for sales of our MRI vital signs monitoring system within critical care departments of U.S.

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Based on an estimate the number of critical care departments in the U.S.

and an estimate of the anticipated adoption rate in these critical care departments, we believe there is potential for the sale of an additional 5,250 of our MRI vital signs monitoring systems.

The combination of sales based on the number of targeted MRI scanners and critical care departments of U.S.

hospitals results in a current global target market of approximately 32,600 of our MRI patient vital signs monitoring systems.

and an estimate of the anticipated

adoption rate in these critical care departments, we believe there is potential for additional sales of our MRI vital signs monitoring systems.

Expansion of Intra-Hospital Use of MRI Compatible Devices

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These additional call points within the critical care areas of a hospital often result in additional sales into radiology.

Additionally, expanded use of our MRI compatible medical devices could serve as a type of transport package and allow

for consistent and uninterrupted administration of IV fluids and monitoring of vital signs, allowing for easier and safer intra-hospital transport of patients to and from the MRI scanner.

Additionally, expanded use of our MRI compatible medical devices could serve as a type of transport package and allow for consistent and uninterrupted administration of IV fluids and monitoring of vital signs, allowing for easier and safer intra-hospital transport of patients to and from the MRI scanner.

It is often necessary for a patient in a critical care department of the hospital who is connected to a standard vital signs monitor and a standard IV infusion pump that is delivering critical medications to be quickly moved to the MRI facility for immediate imaging.

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By increasing the safety parameters of equipment operating within the harsh magnetic environment of the MRI scanner room, we hope to enable hospitals and other healthcare providers to offer the MRI diagnostic procedures patients require.

We believe our current products increase the safety of performing MRI diagnostics for patients by minimizing potential complications with IV infusions and vital signs monitoring.

We believe our current products increase the safety of performing MRI diagnostics for patients by minimizing potential complications with IV infusions, vital signs monitoring, and detection of metals possessing ferromagnetism.

We seek to grow our business by, among other things:

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and a team of experienced international distributors that we believe can effectively go to market with additional MRI compatible patient care products.

While we have not completed an acquisition, we evaluate such opportunities from time to time that might improve our product mix and profitability.

While we have not completed an acquisition, we evaluate such opportunities from time to time that might improve our value to customers via a larger product offering.

Commercial Strategy

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Additionally, with our 3880 Monitor, we focus on educating customers on the total workflow benefits our devices offer and how our devices increase the efficiency of MRI scanners via patient throughput.

In recent years, we have decreased the size of our commercial teams while increasing their collective efficiencies.

As business progress dictates, we intend to add to our specialized, MRI product-focused direct sales team, including our supporting clinical application specialists.

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Once a customer purchases our products, it is imperative that they receive first-class clinical education and support to encourage usage of our products.

We devote a significant amount of time and training to ensure that this educational experience is a success.

This training is performed most commonly by our sales staff and is augmented by our clinical application specialists.

We devote a significant amount of time and training to ensure

that this educational experience is a success.

This training is usually performed by our sales staff with the frequent assistance of our clinical application specialists.

We intend to hire more clinical application specialists to strengthen our initial training experience and increase ongoing customer support.

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The MRidium 3860+ MRI compatible IV infusion pump system utilizes proprietary fluid delivery tubing sets, each known as an “IV tubing set.” Each use of our MRI compatible IV infusion pump requires a disposable IV tubing set.

We offer a variety of IV

tubing sets for varying infusion scenarios and these include our standard “spike” infusion set, syringe adapter infusion set and extension infusion set.

Each of our IV tubing sets is latex-free and DEHP-free.

We offer a variety of IV tubing sets for varying infusion scenarios and these include our standard “spike” infusion

set, syringe adapter infusion set and extension infusion set.

Each of our IV tubing sets is latex-free and Di-2-ethylhexyl phthalate (DEHP)-free.

● MRidium 1056 Standard Infusion Set.

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Utilizing the same user interface and large bright display as the MRidium pump, our wireless remote display/control unit permits clinicians to adjust all pump parameters, including SpO2 monitoring parameters, rates, dose, volume, pump run/stop, alarms (adjust or reset), as well as real-time titration.

Our remote display/control unit utilizes a proven MRI compatible 2.4 GHz frequency hopping spread spectrum radio technology for artifact-free operation that does not disturb the MRI imaging process.

Our remote display/control unit utilizes a proven MRI compatible 2.4 GHz frequency hopping spread spectrum

radio technology for artifact-free operation that does not disturb the MRI imaging process.

Clinicians may also use the remote display/control unit to adjust a second pump channel when used in combination with our Side Car unit discussed above.

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MRI Compatible Patient Vital Signs Monitoring System

Our 3880 Monitor has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures.

Our 3880 Monitor has been designed with non-magnetic components and other special features to monitor a patient’s vital signs safely and accurately during various MRI procedures.

The 3880 Monitor system is fully operational in magnetic fields up to 30,000 gauss, which means it can operate virtually anywhere in the MRI scanner room (see above diagram).

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(1) an extended range remote tablet that allows for remote monitoring from outside the MRI scanner room;

(2) a base station control center that facilitates printing, wireless communications between the remote tablet and the monitor, and acts as a battery charger for the remote tablet, and;

(3) wireless ECG, SpO2 and invasive blood pressure pods that facilitate the respective monitoring modalities.

(2) a base station control center that facilitates printing, wireless communications between the remote tablet and the monitor, and acts as a battery charger for the remote tablet;

and (3) wireless ECG, SpO2 and invasive blood pressure pods that facilitate the respective monitoring modalities.

IRadimed FMD1 with Remote Alarm Logging Unit (“RALU”)

Our 3600 ferromagnetic detection device, IRadimed FMD1 with Remote Alarm Logging Unit (RALU) is the first ferromagnetic detection device with TruSense threat qualification technology.

Our patent pending TruSense technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status.

Our 3600 ferromagnetic detection device, IRadimed FMD1 with RALU is the first ferromagnetic detection device with Tru Sense TM threat qualification technology.

Our patent pending Tru Sense TM technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status.

with IRadimed’s expertise in Dynamic Signal Processing.

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We protect our proprietary technology through a combination of patents, trade secrets and confidentiality agreements.

During the development of our products, our founder, Roger Susi, obtained a number of patents regarding our MRI compatible IV infusion pump and related systems.

During the development of our products, our founder, President, Chief Executive Officer, and Chairman of the Board of Directors, Roger Susi, obtained a number of patents regarding our MRI compatible IV infusion pump and related systems.

Susi has irrevocably assigned these patents to us.

We consider our patents important but do not believe our future success is materially dependent upon patents.

We have 16 issued U.S.

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These programs include surveys and visits to customer sites.

We enter into agreements with integrated delivery health systems and healthcare supply contracting companies, which are commonly referred to as Group Purchasing Organizations (“GPOs”) in the U.S., which enable us to sell and distribute our products to

their member hospitals.

We enter into agreements with Integrated Delivery Networks (“IDNs”) and healthcare supply contracting companies, which are commonly referred to as Group Purchasing Organizations (“GPOs”) in the U.S., which enable us to sell and distribute our products to their member hospitals.

GPOs negotiate volume purchase prices for hospitals, group practices, and other clinics that are members of a GPO.

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Under our GPO agreements, we are required to pay the GPOs a fee of three percent of the sales of our products to members of the GPO.

Sales to participating IDNs do not have an associated fee.

Manufacturing and Suppliers

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Some of the raw materials and parts that are critical to the production and operation of our products are sourced from single suppliers.

Some components we or our suppliers utilize are from Chinese manufacturers.

Some components we or our suppliers utilize are from Chinese or Taiwanese manufacturers.

We have never encountered a significant supply interruption from any sole supplier;

however, the operations of our third-party suppliers could be disrupted by conditions unrelated to our business operations or that are beyond our control, including but not limited to the on-going global supply chain issues, international trade restrictions, excessive demand creating shortages of available supply, and conditions related to health pandemics.

however, the operations of our third-party suppliers could be disrupted by conditions unrelated to our business operations or that are beyond our control, including but not limited to the global supply chain issues, international trade restrictions, excessive demand creating

shortages of available supply, and conditions related to health pandemics.

We continuously monitor our supply chain regarding these matters.

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This company has exclusively provided us with these motors since 2005.

Our exclusive supply agreement with this company was renewed in March 2019 and extends through February 25, 2024.

This supply agreement is renewable with written mutual consent of the Company and supplier.

Our exclusive supply agreement with this company expired February 25, 2024.

This supply agreement was renewed March 2024, and extends through March 1, 2029.

We place significant emphasis on providing quality products and services to our customers.

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In October 2022, we underwent a recertification audit to maintain our ISO 13485:2016 and Medical Device Single Audit Program certifications and received our certificates.

These certificates will need renewal again in January 2025.

The medical products industry is generally characterized by intense competition and extensive research and development.

The market for medical products is subject to rapid change due to an increasingly competitive, cost-conscious environment and to government programs intended to reduce the cost of medical care.

These certificates will need renewal again by January 2025.

The medical products industry is generally characterized by intense competition and innovation via extensive research and new product development efforts.

The market for medical products is subject to rapid change due to a competitive, cost-conscious environment and to government programs intended to reduce the cost of medical care.

Many manufacturers and distributors of medical equipment are large, well-established companies whose resources, reputations, and ability to leverage existing customer relationships might give them a competitive advantage over us.

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Historically, our only direct competitor in the MRI compatible IV infusion pump market, Bayer Radiology, formerly MEDRAD, Inc., announced during 2013 its decision to remove its competing Continuum pump system from the market, and discontinued support throughout the world in June 2015 due to ongoing regulatory issues.

As a result, we believe that our MRidium 3860+ MRI compatible IV infusion pump is the only true MRI compatible IV infusion pump available today.

As a result, we believe

that our MRidium 3860+ MRI compatible IV infusion pump is the only true MRI compatible IV infusion pump available today.

The medical device and IV infusion market is highly regulated and is typically one of the areas that the FDA scrutinizes closely for new market introductions.

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Many of these potential competitors have established reputations, customer relationships and marketing, distribution, and service networks.

In addition, they have substantially longer histories in the medical products industry, larger product lines and greater financial, technical, manufacturing, management, and research and development budgets.

Many of these potential competitors may have long-term product supply relationships with our potential customers.

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There are several manufacturers that have developed competing MRI compatible vital signs monitoring systems that are currently on the market.

We believe the dominant competitor with a market-leading position in MRI compatible vital signs monitoring

is Invivo Research, Inc., which was founded by Roger Susi, our founder, President, Chief Executive Officer, and Chairman of the Board of Directors.

We believe the dominant competitor with a market-leading position in MRI compatible vital signs monitoring is Invivo Research, Inc., which was founded by Roger Susi, our founder, President, Chief Executive Officer, and Chairman of the Board of Directors.

Invivo is now owned by Koninklijke Philips NV (NYSE:

Other large and well-known companies such as General Electric Healthcare (NYSE:

Other large and well-known companies such as GE Healthcare Technologies (NYSE:

GEHC) and Schiller AG, also have competing products as do other smaller privately held companies.

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Our business is seasonal.

Our third quarter sales have typically been lower, compared to other fiscal quarters, principally because the fiscal quarter coincides with the summer vacation season, in the U.S., Europe and Japan.

Historically, our third quarter bookings have typically been lower, compared to other fiscal quarters, principally because the fiscal quarter coincides with the summer vacation season in the northern hemisphere.

Segment Information and Geographic Data

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Our research and development efforts focus on developing innovative products by utilizing our established core competencies in MRI compatible technologies and feedback from strategic relationships with hospitals, acute medical facilities and medical equipment manufacturers for new product ideas.

Our research and development efforts are driven by the leadership of our founder, Roger Susi, assisted by engineers and technical professionals with significant experience in product design.

Our research and development efforts are driven by the leadership of our founder, Roger Susi, along with engineers and technical professionals with significant experience in systems engineering and product design.

Our research and development expenses were $2.9 million or 4.4 percent of revenue in 2023 and $2.3 million or 4.3 percent of revenue in 2022.

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We endeavor to maintain a workplace that is free from discrimination or harassment on the basis of color, race, sex, national origin, ethnicity, religion, age, disability, sexual orientation, gender identification or expression or any other status protected by applicable law.

We conduct annual training to prevent harassment and discrimination and monitor employee conduct year-round, including by providing employees with access to an anonymous whistleblower hotline to report any violations.

We conduct annual training to reduce risks of harassment and discrimination and monitor employee conduct year-round, including by providing employees with access to an anonymous whistleblower hotline to report any allegations.

The basis for recruitment, hiring, development, training, compensation, and advancement at the Company is qualifications, performance, skills and experience.

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We have compliance programs in place to support and monitor compliance with these laws and regulations.

Foods Branch, the U.K.’s Medicines and Healthcare Products Regulatory Agency, and Australia’s Therapeutic Goods Agency.

All our products and facilities and those of our suppliers are subject to drug and medical device laws and regulations promulgated by the FDA and national and supranational regulatory authorities outside the U.S., including, for example, Health Canada’s Health Products and Foods Branch, the U.K.’s Medicines and Healthcare Products Regulatory Agency, and Australia’s Therapeutic Goods Agency.

These authorities regulate a range of activities including, among other matters, manufacturing, post-marketing studies in humans, advertising and promotion, product labeling, post-marketing surveillance and adverse event reporting.

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Unless an exemption applies, each medical device that we market must first receive either premarket notification clearance (by making what is commonly called “a 510(k) submission”) or premarket approval (by filing a premarket approval application (“PMA”) from the FDA pursuant to the FDC Act.

In addition, certain modifications made to marketed devices also may require 510(k) clearance or approval of a PMA supplement.

In addition, certain modifications

made to marketed devices also may require 510(k) clearance or approval of a PMA supplement.

The FDA’s 510(k) clearance process varies in length and can extend beyond twelve months.

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We cannot be sure that future medical devices or modifications of current medical devices, will qualify for the 510(k) pathway or whether 510(k) clearance or PMA approval will be obtained for any future product that we propose to market.

Our FMD1 is an example of this as a non-regulated medical device and providing no diagnostic or therapeutic claims.

Our FMD1 is an example of this as a non-regulated product without diagnostic or therapeutic claims.

In December 2014, the FDA issued guidance entitled “Infusion Pumps Total Product Life Cycle.” This guidance established substantial additional pre-market requirements for new and modified infusion pumps.

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Product quality plays a critical role in our success.

While we believe that we have made significant improvements to our product quality and overall quality systems, further quality concerns, whether real or perceived, could adversely affect our results.

While we believe that we have made significant improvements to our product quality and overall quality systems, quality concerns, whether real or perceived, could adversely affect our results.

Conversely, improving quality can be a competitive advantage and improve our results.

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The MDR initially became effective in May 2021, however the MDR transition was recently extended to 2028 for Class IIb non implanted devices.

Regardless our CE Certificates remain valid through May 2024, allowing us to continue shipping our products into the EU.

Regardless our CE Certificates remain valid through December 2028, allowing us to continue shipping our products into the EU.

MDR brings significant new requirements for many medical devices, including enhanced requirements for clinical evidence and documentation, increased focus on device identification and traceability, new definitions, and registration of economic operators throughout the distribution chain, and additional post-market surveillance and vigilance.

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Additionally, we may lose our current quality system certification due to ISO Registrar difficulties as European authorities increase regulatory pressure or increased scrutiny resulting from MDR.

The loss of the quality system certification may prevent product

shipments to the EU and to other foreign markets, such as Canada, which could significantly lower our revenues from foreign sales while we take remedial measures.

The loss of the quality system certification may prevent product shipments to the EU and to other foreign markets, such as Canada, which could significantly lower our revenues from foreign sales while we take remedial measures.

The EU has enacted legislation restricting the use of hazardous substances in electronic equipment (Directive 2011/65/EU, referred to as “RoHS 2”), such as our devices.

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Despite our training and compliance program, our internal control policies and procedures may not always protect us from reckless or criminal acts committed by our employees or agents in violation of any of these laws.

Available Information

Our principal executive office is located at 1025 Willa Springs Drive, Winter Springs, Florida 32708.

Our telephone number is (407) 677-8022, and our website address is https://www.iradimed.com.

Information contained on, or accessible through, our website is provided for textual reference only and does not constitute part of, and is not

incorporated by reference into, this Annual Report.

Our common stock is listed and traded on Nasdaq under the symbol “IRMD”.

We make our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports, available free of charge in the “Investors” section of our website as soon as reasonably practicable after we file these reports with the SEC.

We routinely post these reports, recent news and announcements, financial results and other important information about our business on our website at https://www.iradimed.com.

Information contained on our website is not a part of this Annual Report.

In addition, the SEC maintains an Internet website at www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.

Our Board has adopted a written Code of Business Conduct and Ethics (the “Code of Ethics”) applicable to all of our executives, directors, and employees.

The Code of Ethics covers fundamental ethical and compliance-related principles and practices such as accurate accounting records and financial reporting, avoiding conflicts of interest, the protection and use of our property and information and compliance with legal and regulatory requirements.

A current copy of the Code of Ethics is posted on the Governance section of the Investors page of our website, which is located at www.iradimed.com.

We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding any substantive amendment to, or waiver from, a provision of the Code of Ethics by posting such information on our website address at https://www.iradimed.com.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business