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What changed in IRADIMED CORP's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of IRADIMED CORP's 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+272 added−330 removedSource: 10-K (2025-03-06) vs 10-K (2024-03-01)

Top changes in IRADIMED CORP's 2024 10-K

272 paragraphs added · 330 removed · 234 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

99 edited+9 added−8 removed140 unchanged
Biggest changeWe 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. 5 Table of Contents We seek to grow our business by, among other things: Driving market awareness of our MRI compatible IV infusion pump and the safety risks associated with using conventional IV pumps with long IV lines.
Biggest changeWe seek to grow our business by, among other things: Driving market awareness of our MRI compatible IV infusion pump and the safety risks associated with using conventional IV pumps with long IV lines. We believe that the largest potential market for our MRI compatible IV infusion pumps is the segment of the market that is currently using workaround solutions.
We also offer rechargeable lithium polymer battery packs which have 12-hour life when not connected to an electrical outlet. 3861 Side Car Pump Module Our Side Car Pump Module can be attached to our 3860+ MRidium MRI compatible IV infusion pump to provide a second channel for infusion delivery.
We also offer rechargeable lithium polymer battery packs which have a 12-hour life when not connected to an electrical outlet. 3861 Side Car Pump Module Our Side Car Pump Module can be attached to our 3860+ MRidium MRI compatible IV infusion pump to provide a second channel for infusion delivery.
We believe, however, based on feedback and historical successes selling our devices, that there is continued potential for expanded deployment of our MRI compatible IV infusion pumps and MRI compatible monitors within the Intensive Care Unit (ICU), Emergency Room (ER), and other critical care departments within U.S. hospitals where there is a high probability that MRI procedures will need to be performed on these patients.
We believe, however, based on feedback and historical successes selling our devices, that there is potential for expanded deployment of our MRI compatible IV infusion pumps and MRI compatible monitors within the Intensive Care Unit (ICU), Emergency Room (ER), and other critical care departments within U.S. hospitals where there is a high probability that MRI procedures will need to be performed on these patients.
While we generally do not file claims for reimbursement from government payers, the U.S. federal government has asserted theories of liability against manufacturers under the Federal False Claims Act, which prohibits the submission of false claims to Medicare, Medicaid, and other state and federal programs. Many states have similar fraud and abuse laws which may apply to us.
While we do not file claims for reimbursement from government payers, the U.S. federal government has asserted theories of liability against manufacturers under the Federal False Claims Act, which prohibits the submission of false claims to Medicare, Medicaid, and other state and federal programs. Many states have similar fraud and abuse laws which may apply to us.
Because of this, the FDA 510(k) clearance process for new infusion pumps is usually long and requires significant testing and documentation. This long development timeline coupled with the low market penetration to date may discourage new competitors from undertaking a complex project like building an MRI compatible IV infusion pump.
Because of this, the FDA 510(k) clearance process for new infusion pumps is usually long and requires significant testing and documentation. This long timeline coupled with the low market penetration to date may discourage new competitors from undertaking a complex project like building an MRI compatible IV infusion pump.
Susi served as the President of Invivo Research Inc. from 1979 until 1998, and as its Chairman of the Board of Directors from 1998 until 2000. Under Mr. 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.
Susi served as the President of Invivo Research from 1979 until 1998, and as its Chairman of the Board of Directors from 1998 until 2000. Under Mr. 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.
MRidium’s strengths include the following: ● The only non-magnetic MRI compatible IV infusion pump system specifically designed and built to operate inside the MR environment. ● A mobile, rugged, easy-to-operate, and reliable system with a strong safety record. ● Able to operate virtually anywhere in the MRI scanner room; approved for use in the presence of 0.2T to 3T magnets and fully operational up to the 10,000 gauss-line. ● Available with a Dose Error Reduction System (“DERS”) to reduce the risk of medication errors and simplify clinician monitoring. ● Available with a wireless remote display/control providing clinicians and technicians control and visibility from outside of the MRI scanner room. ● Available with an add-on channel (3861 Side Car Module) allowing for the easy addition of a second IV line for patients requiring multiple IV medications at a low incremental cost to the hospital. ● Available with a built-in SpO2 monitor using Masimo SET® technology and a specially designed fiber optic SpO2 sensor allowing one device to monitor oxygen saturation levels while safely providing IV infusion during an MRI procedure.
MRidium’s strengths include the following: ● The only non-magnetic MRI compatible IV infusion pump system specifically designed and built to operate inside the MR environment. 8 Table of Contents ● A mobile, rugged, easy-to-operate, and reliable system with a strong safety record. ● Able to operate virtually anywhere in the MRI scanner room; approved for use in the presence of 0.2T to 3T magnets and fully operational up to the 10,000 gauss-line. ● Available with a Dose Error Reduction System (“DERS”) to reduce the risk of medication errors and simplify clinician monitoring. ● Available with a wireless remote display/control providing clinicians and technicians control and visibility from outside of the MRI scanner room. ● Available with an add-on channel (3861 Side Car Module) allowing for the easy addition of a second IV line for patients requiring multiple IV medications at a low incremental cost to the hospital. ● Available with a built-in SpO2 monitor using Masimo SET® technology and a specially designed fiber optic SpO2 sensor allowing one device to monitor oxygen saturation levels while safely providing IV infusion during an MRI procedure.
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.
Using current and new technologies, and our trade secrets, we believe our 3880 Monitor improves on the design of competitive 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.
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. Mr. Susi has irrevocably assigned these patents to us.
During the development of our products, our founder, President, Chief Executive Officer, and Chairman of the Board, Roger Susi, obtained a number of patents regarding our MRI compatible IV infusion pump and related systems. Mr. Susi has irrevocably assigned these patents to us.
When a quality issue is identified, we investigate the issue and seek to take appropriate corrective action, such as withdrawal of the product from the market, correction of the product at the customer location, notice to the customer of revised labeling or a combination of these or other corrective actions.
When a quality issue is identified, we investigate the issue and take appropriate corrective action, such as withdrawal of the product from the market, correction of the product at the customer location, notice to the customer of revised labeling or a combination of these or other corrective actions.
MRidium 3860+ IV Tubing Sets 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.
MRidium 3860+ IV Tubing Sets - Disposables 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.
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 The market for MRI compatible multi-parameter vital signs monitors is well-developed and more subject to replacement cycles than new adoptions.
Based on an estimate of the number of critical care departments in the U.S., we believe there is the potential for growth in sales of our MRI compatible IV infusion pump systems. MRI Compatible Patient Vital Signs Monitor The market for MRI compatible multi-parameter vital signs monitors is well-developed and more subject to replacement cycles than new adoptions.
We believe that the market for MRI compatible IV infusion pump products is underpenetrated and may become highly competitive if, and when, the market develops further. We also compete with manufacturers of “shielded box” solutions that are intended to permit use of conventional IV pumps inside the MRI scanner room. The providers of shielded boxes include B.
We believe that the market for MRI compatible IV infusion pump products is underpenetrated and may become highly competitive if, and when, the market develops further. We also compete with manufacturers of “shielded box” solutions that are intended as “workarounds” to permit use of conventional IV pumps inside the MRI scanner room. The providers of shielded boxes include B.
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: PHG).
We believe the dominant competitor with a market-leading position in MRI compatible vital signs monitoring is Invivo Research, which was founded by Roger Susi, our founder, President, Chief Executive Officer, and Chairman of the Board. Invivo Research is now owned by Koninklijke Philips NV (NYSE: PHG).
Only certified medical devices bearing a CE Mark can be sold in the EU and European Free Trade Association (“EFTA”) countries and Türkiye. EFTA includes Iceland, Norway, Principality of Liechtenstein and Switzerland. In May 2017, the European Union (the “EU”) implemented a new regulatory scheme for medical devices under the Medical Device Regulation (“MDR”).
Only certified medical devices bearing a CE Mark can be sold in the EU and European Free Trade Association (“EFTA”) countries and Türkiye. EFTA includes Iceland, Norway, Principality of Liechtenstein and Switzerland. In May 2017, the EU implemented a new regulatory scheme for medical devices under the Medical Device Regulation (“MDR”).
A similar requirement was imposed at the federal level under the “sunshine” provision of Patient Protection and Affordable Care Act, (the “Sunshine Provisions”), to track and report payments and “transfers of value” to U.S. physicians or teaching hospitals by manufacturers of medical products that are available for reimbursement by a federal insurer.
A similar requirement was imposed at the federal level under the “sunshine” provision of Patient Protection and Affordable Care Act, to track and report payments and “transfers of value” to U.S. physicians or teaching hospitals by manufacturers of medical products that are available for reimbursement by a federal insurer.
Intraoperative MRI is expanding demand for our MRI compatible devices from the MRI suite to the surgical suite of the hospital. Strategy Company Objective Our objective is to become the leader in providing safe and effective care for all patients undergoing MRI procedures through the development and commercialization of a portfolio of MRI compatible products, accessories, disposables, and related services.
Intraoperative MRI is expanding demand for our MRI compatible devices from the MRI suite to the surgical suite of the hospital. Strategy Company Objective Our objective is to be the leader in providing safe and effective care for all patients undergoing MRI procedures through the development and commercialization of a portfolio of MRI compatible products, accessories, disposables, and related services.
In January 2007, we received ISO 13485 certification and met the requirements under the European Medical Device Directive to use the CE Mark, thereby allowing us to continue to market our products in the European Community. 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.
In January 2007, we received ISO 13485 certification and met the requirements under the European Medical Device Directive to use the CE Mark, thereby allowing us to continue to market our products in the European Community. In October 2024, we underwent a recertification audit to maintain our ISO 13485:2016 and Medical Device Single Audit Program certifications and received our certificates.
When an incident occurs, this wireless touchscreen uniquely allows users to quickly and easily log all ferrous items as they enter the MRI Zone IV improving the reporting accuracy hospitals require for accreditation. Intellectual Property We protect our proprietary technology through a combination of patents, trade secrets and confidentiality agreements.
When an incident occurs, this wireless touchscreen uniquely allows users to quickly and easily log all ferrous items as they enter the MRI Zone IV improving the reporting accuracy hospitals require for accreditation. 11 Table of Contents Intellectual Property We protect our proprietary technology through a combination of patents, trade secrets and confidentiality agreements.
In December 2016, we made our first shipments of the 3880 Monitor to international customers. In October 2017, we received FDA 510(k) clearance for our 3880 Monitor and immediately began our direct selling efforts in the United States. 2 Table of Contents In 2022, we introduced our ferromagnetic detection device, IRadimed FMD1 3600 with Remote Alarm Logging Unit, (“RALU”).
In December 2016, we made our first shipments of the 3880 Monitor to international customers. In October 2017, we received FDA 510(k) clearance for our 3880 Monitor and immediately began our direct selling efforts in the United States. In 2022, we introduced our ferromagnetic detection device, IRadimed FMD1 3600 with Remote Alarm Logging Unit, (“RALU”).
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 ).
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” ).
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. hospitals (refer to the section below titled Expansion of Intra-Hospital Use of MRI Compatible Devices ).
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. hospitals (refer to the section below titled “ Expansion of Intra-Hospital Use of MRI Compatible Devices” ).
These certificates will need renewal again by January 2025. Competition 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.
These certificates will need renewal again by January 2028. Competition The medical products industry is 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.
If we are unable to remain compliant with RoHS 2, there may be an interruption of sales to the EU, which could significantly lower our revenues from foreign sales while we take remedial measures. 18 Table of Contents Anti-Bribery Laws Our global activities are subject to the U.S. Foreign Corrupt Practices Act, the U.K.
If we are unable to remain compliant with RoHS 2, there may be an interruption of sales to the EU, which could significantly lower our revenues from foreign sales while we take remedial measures. Anti-Bribery Laws Our global activities are subject to the U.S. Foreign Corrupt Practices Act, the U.K.
Such solutions include using conventional pumps outside the MRI scanner room and attaching multiple extension lines of IV tubing sets through the wall or under the door into the MRI scanner room to reach the patient. This practice of makeshift setups is fraught with risks to the patient and unnecessary costs and inefficiencies.
Such solutions include using conventional pumps outside the MRI 5 Table of Contents scanner room and attaching multiple extension lines of IV tubing sets through the wall or under the door into the MRI scanner room to reach the patient. This practice of makeshift setups is fraught with risks to the patient and unnecessary costs and inefficiencies.
The gauss-lines illustrate the distance from the magnet where various types of medical devices can safely operate. Our 3880 MRI compatible patient vital signs monitor is the only MRI monitor that can operate safely and reliably in very close proximity to the bore of the powerful magnet used to operate the MRI (area shown in red).
The gauss-lines illustrate the distance from the magnet where various types of medical devices can safely 7 Table of Contents operate. Our 3880 MRI compatible patient vital signs monitor is the only MRI monitor that can operate safely and reliably in very close proximity to the bore of the powerful magnet used to operate the MRI (area shown in red).
We devote a significant amount of time and training to ensure 7 Table of Contents 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.
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.
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 global supply chain issues, international trade restrictions, excessive demand creating 13 Table of Contents shortages of available supply, and conditions related to health pandemics.
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 global supply chain issues, international trade restrictions and tariffs, excessive demand creating shortages of available supply, and conditions related to health pandemics.
To this extent, we are in competition with conventional IV infusion pump manufacturers and distributors. There are many manufacturers of conventional IV infusion pump devices, and if any of these manufacturers, or other potential competitors, decide to enter the MRI compatible IV infusion pump market, they may have competitive advantages over us.
To this extent, we are in competition with conventional IV infusion pump manufacturers and distributors. 14 Table of Contents There are many manufacturers of conventional IV infusion pump devices, and if any of these manufacturers, or other potential competitors, decide to enter the MRI compatible IV infusion pump market, they may have competitive advantages over us.
In addition, certain modifications 16 Table of Contents 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. The process of obtaining PMA approval is much more costly, lengthy, and uncertain than the 510(k) process.
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. The process of obtaining PMA approval is much more costly, lengthy, and uncertain than the 510(k) process.
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. ​
We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding any 19 Table of Contents 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. ​
Our remote display/control unit utilizes a proven MRI compatible 2.4 GHz frequency hopping spread spectrum 10 Table of Contents 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.
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.
As a result, we believe 14 Table of Contents 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.
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.
Braun, Fresenius Kabi and MIPM Mammendorfer Institut für Physik und Medizin. Many of our potential customers opt not to purchase our MRI compatible IV infusion pump systems and instead use makeshift workarounds, such as placing conventional IV infusion devices outside of the MRI scanning room and utilizing extension tubing to reach the patient.
Braun, Fresenius Kabi and MIPM Mammendorfer Institut für Physik und Medizin. Many of our potential customers opt not to purchase our MRI compatible IV infusion pump systems and instead use makeshift workarounds, such as placing conventional IV infusion devices outside of the MRI scanning room and utilizing extension tubing to reach the patient, introducing additional patient safety issues.
Since there is no current direct competitor for an MRI compatible IV infusion pump, our focus is on expanding the market through better education on the advantages to patients, clinicians and hospitals of our infusion pump solution and the shortcomings of current workaround practices.
Since there is no current direct competitor for an MRI compatible IV infusion pump, our focus is on expanding the market through better education on the advantages to patients, clinicians and hospitals of our current and expected infusion pump solutions and the shortcomings of current workaround practices.
We offer a variety of IV tubing sets for varying infusion scenarios and these include our standard “spike” infusion 9 Table of Contents 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.
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.
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.
Other large and well-known companies such as GE Healthcare Technologies (Nasdaq: GEHC) and Schiller AG, also have competing products as do other smaller privately held companies.
The features of the IRADIMED 3880 include: 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.
The features of the IRADIMED 3880 include: wireless Electrocardiogram (“ECG”) with dynamic gradient filtering; wireless blood oxygen saturation monitoring (“SpO2”) using Masimo® algorithms; non-magnetic respiratory carbon dioxide (“CO2”); invasive and non-invasive blood pressure; patient temperature; and optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements.
The dose applied via DERS is displayed and can be adjusted directly on the running screen at any time during the infusion. The memory card port allows for easy archiving and updating of the drug library.
The dose applied via DERS is displayed and can be 10 Table of Contents adjusted directly on the running screen at any time during the infusion. The memory card port allows for easy archiving and updating of the drug library.
Future delays in the receipt of, or failure to obtain, approvals could result in delayed or no realization of attendant product revenues. After a device is placed on the market, numerous regulatory requirements continue to apply.
Future delays in the receipt of, or failure to obtain, approvals could result in delayed or no realization of attendant product revenues. 16 Table of Contents After a device is placed on the market, numerous regulatory requirements continue to apply.
We communicate with our customers on a regular basis to understand potential issues or concerns as well as to improve our products and services in response to their needs. Product orders and inquiries are handled by trained service representatives who communicate with customers after equipment shipments, installations, and service repair calls.
We communicate with our customers on a regular basis to understand potential issues or concerns as well as to improve our products and services in response to their needs. Product orders and inquiries are handled by trained service representatives who communicate with customers after equipment shipments, installations, and service repair 12 Table of Contents calls.
We continuously monitor our supply chain regarding these matters. We typically maintain no less than a three-month supply of raw materials and parts that are sourced from sole suppliers and make efforts to identify additional suppliers who may be able to provide such raw materials or parts.
We continuously monitor our supply chain regarding these matters to anticipate and prevent risk of disruption. We typically maintain no less than a three-month supply of raw materials and parts that are sourced from sole suppliers and make efforts to identify additional suppliers who may be able to provide such raw materials or parts.
Our founder, President, Chief Executive Officer, and Chairman of the Board of Directors, Roger Susi, is a pioneer in the MRI compatible medical device industry, having invented the first MRI compatible patient monitoring system in 1986 and the first non-magnetic MRI compatible IV infusion system in 2004.
Our founder, President, Chief Executive Officer, and Chairman of our Board of Directors (the “Board” or the “Board of Directors”), Roger Susi, is a pioneer in the MRI compatible medical device industry, having invented the first MRI compatible patient monitoring system in 1986 and the first non-magnetic MRI compatible IV infusion system in 2004.
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.
The powerful magnetic fields may cause metal objects in the MR environment to be drawn with 3 Table of Contents great force into the bore of the MRI system, resulting in potentially deadly projectiles.
To deal with the harsh environment of MR, some manufacturers have offered a “shielded box” solution (also known as a Faraday cage) for use with their standard IV pumps, but the approach has not been widely accepted by customers.
To deal with the harsh environment of MR, some manufacturers have offered a “shielded box” solution (also known as a “Faraday cage”) for use with their standard IV pumps, but the approach has not been widely accepted by customers.
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 19 Table of Contents incorporated by reference into, this Annual Report. Our common stock is listed and traded on Nasdaq under the symbol “IRMD”.
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 the Nasdaq Global Market (“Nasdaq”) under the symbol “IRMD”.
In the U.S., we sell our products through our 25 direct field sales representatives, 3 regional sales directors and 7 clinical application specialists. We have distribution agreements for our products with independent distributors selling our products internationally. We have developed an experienced team of international distributors that have a strong MRI/radiology product portfolio and focus.
In the U.S., we sell our products through our 27 direct field sales representatives, 4 regional sales directors and 10 clinical application specialists. We have distribution agreements for our products with independent distributors selling our products internationally. We have developed an experienced team of international distributors that have a strong MRI/radiology product portfolio and focus.
We believe that a positive user experience is critical to driving increased rates of utilization of our products. Our Products Typical MRI Scanner Room The following diagram is representation of an aerial view of a typical MRI scanner room with a typical three Tesla magnet.
We believe that a positive user experience is critical to driving increased rates of utilization of our products which can increase sales of disposables. Our Products Typical MRI Scanner Room The following diagram is representation of an aerial view of a typical MRI scanner room with a typical three Tesla magnet.
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. Through this guidance, the FDA indicated more data demonstrating product safety will be required for future 510(k) submissions for infusion pumps, including the potential for more clinical and human factors data.
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. Through this guidance, the FDA required more data needed to demonstrate product safety for future 510(k) submissions for infusion pumps, including the potential for more clinical and human factors data.
Human Capital As of December 31, 2023, we had 148 full-time employees, including 57 in manufacturing and service, 48 in sales, marketing and customer support services, 15 in regulatory affairs and quality assurance, 13 in finance and administration and 15 in research and development. No employees are represented by a labor union.
Human Capital As of December 31, 2024, we had 160 full-time employees, including 59 in manufacturing and service, 57 in sales, marketing and customer support services, 15 in regulatory affairs and quality assurance, 13 in finance and administration and 16 in research and development. No employees are represented by a labor union.
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 1 Table of Contents clinical application specialists. Internationally, we market our products into approximately 80 countries through the use of independent distributors.
We currently employ a direct sales strategy in the United States and as of December 31, 2024, our direct 1 Table of Contents sales force consisted of 27 field sales representatives, supported by 4 regional sales directors, and supplemented by 10 clinical application specialists. Internationally, we market our products into approximately 80 countries through the use of independent distributors.
As such, practitioners at hospitals and other medical facilities have been increasingly developing and using MRI for new procedures. These procedures include cardiac stress testing, intraoperative MRI and neurology MRI techniques.
This is particularly true for children. As such, practitioners at hospitals and other medical facilities have been increasingly developing and using MRI for new procedures. These procedures include cardiac stress testing, intraoperative MRI and neurology MRI techniques.
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 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.
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 2024, our revenue was $73.2 million and our income from operations was $22.0 million representing an operating profit margin of 30 percent.
Neurosurgical interventions have been at the forefront of this development in image-guided surgery, followed by otolaryngological procedures. As MR-guided intervention during surgery has been deployed, the degree of complexity in supplemental devices has increased markedly.
Neurosurgical interventions have been at the forefront of this development in image-guided surgery, followed by otolaryngological procedures. As MR-guided intervention during surgery has been deployed, the degree of complexity in supplemental devices has increased markedly potentially introducing additional safety issues for patients.
As of December 31, 2023, we have sold approximately 7,196 MRI compatible IV infusion pump systems and approximately 2,166 of our 3880 MRI compatible patient vital signs monitoring systems.
As of December 31, 2024 we have sold approximately 7,832 MRI compatible IV infusion pump systems and approximately 2,679 of our 3880 MRI compatible patient vital signs monitoring systems.
Need for MRI Compatible IV Infusion Pumps and Vital Signs Monitors MRI is a widely used, non-invasive medical imaging technique to visualize vital organs, bodily function and to identify blockages, abnormalities, and growths. MRI is generally considered safer than other scanning techniques that expose the body to radiation. This is particularly true for children.
Industry We currently compete in the MRI compatible medical device market. Need for MRI Compatible IV Infusion Pumps and Vital Signs Monitors MRI is a widely used, non-invasive medical imaging technique to visualize vital organs, bodily function and to identify blockages, abnormalities, and growths. MRI is generally considered safer than other scanning techniques that expose the body to radiation.
Invivo Research Inc. was acquired by Invivo Corporation (“Invivo”) in 1992, which began trading on the Nasdaq Capital Market (“Nasdaq”) in 1994. Mr. Susi served as a Director of Invivo Corporation from 1998 until 2000 and oversaw technical areas from 2000 to 2004.
Invivo Research was acquired by Invivo Corporation (“Invivo”) in 1992, which began trading on the Nasdaq Capital Market in 1994. Mr. Susi served as a Director of Invivo from 1998 until 2000 and oversaw technical areas from 2000 to 2004. Invivo was acquired by Intermagnetics General Corporation in 2004, which was later acquired by Koninklijke Philips NV (NYSE: PHG). Mr.
ITEM 1. BUSINESS Overview 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.
ITEM 1. BUSINESS Overview 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.
A clinician’s adjustment of dosage and other settings may take longer to reach the patient due to the over-extended tubing. 3 Table of Contents Further, there are risks in using a standard IV infusion pump that is mistakenly believed to be at a safe distance from the MR scanner.
Such makeshift extension sets can also affect the effectiveness of fluid delivery. A clinician’s adjustment of dosage and other settings may take longer to reach the patient due to the over-extended tubing. Further, there are risks in using a standard IV infusion pump that is mistakenly believed to be at a safe distance from the MR scanner.
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. Industry We currently compete in the MRI compatible medical device market.
This is the first ferromagnetic detection device with Tru Sense TM threat qualification technology for MRI safety strategy in hospitals. This technology predicts an approaching ferrous hazard by uniquely 2 Table of Contents sensing a threat’s speed, trajectory, and Zone IV door status reducing false alarms, all while simultaneously circumventing background magnetic field noise.
The 3600 can be self-installed and does not require drilling, special tools, permits or contractors like traditional FMD systems. The wireless touchscreen, RALU is unique in the industry and provides a full color visual representation of the MRI door and FMD status.
This technology reduces false alarms, all while simultaneously circumventing background magnetic field noise. The 3600 can be self-installed and does not require drilling, special tools, permits or contractors like traditional FMD systems. The wireless touchscreen, RALU is unique in the industry and provides a full color visual representation of the MRI door and FMD status.
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.
Susi began the formal and detailed development of what subsequently has become our MRidium MRI compatible IV infusion pump system. 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.
The percentage of total revenue generated by geographic region was as follows: ​ ​ ​ ​ ​ ​ ​ Percent of Revenue ​ ​ Years Ended December 31, ​ ​ 2023 2022 United States 80.1 % 82.4 % International 19.9 % 17.6 % ​ 12 Table of Contents The percentage of total revenue generated by product type was as follows: ​ ​ ​ ​ ​ ​ ​ ​ Percent of Revenue ​ ​ Years Ended December 31, ​ ​ 2023 ​ 2022 Devices 70.1 % 68.5 % Disposable, service and other 26.8 % 27.4 % Amortization of extended warranty agreements 3.1 % 4.1 % ​ Selling cycles for our devices have varied widely and have historically ranged between three and six months in duration.
The percentage of total revenue generated by geographic region was as follows: ​ ​ ​ ​ ​ ​ ​ Percent of Revenue ​ ​ Year Ended December 31, ​ ​ 2024 2023 United States 83 % 80 % International 17 % 20 % ​ The percentage of total revenue generated by product type was as follows: ​ ​ ​ ​ ​ ​ ​ ​ Percent of Revenue ​ ​ Year Ended December 31, ​ ​ 2024 ​ 2023 Devices 71 % 70 % Disposable, service and other 26 % 27 % Amortization of extended warranty agreements 3 % 3 % ​ Selling cycles for our devices have varied widely and have historically ranged between three and six months in duration.
Based on an estimate the number of critical care departments in the U.S. and an estimate of the anticipated 4 Table of Contents adoption rate in these critical care departments, we believe there is potential for additional sales of our MRI vital signs monitoring systems.
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 growth in sales of our MRI vital signs monitoring systems. 4 Table of Contents Expansion of Intra-Hospital Use of MRI Compatible Devices Historically, we marketed our MRI compatible devices primarily to the MRI departments of U.S. hospitals.
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. Quality management and oversight play an essential role in understanding and meeting customer requirements, effectively resolving quality issues and improving our products and services.
We place significant emphasis on providing quality products and services to our customers. Quality management and oversight play an essential role in understanding and meeting customer requirements, effectively resolving quality issues and improving our products and services.
We also believe that documented evidence will serve to inform the quality and risk management leaders in these organizations, which in turn may help drive the overall adoption of our MRI compatible products.
We believe this kind of evidence-based documentation will help us provide widespread education to the clinicians that are driving clinical practice. We also believe that documented evidence will serve to inform the quality and risk management leaders in these organizations, which in turn may help drive the overall adoption of our MRI compatible products.
We have not experienced any work stoppages and consider our relations with our employees to be good. 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 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 15 Table of Contents law.
Standard infusion pumps contain magnetic and electronic components which can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system.
We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components which can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system.
The IV pole is 66 inches (1.68 meters) high, stabilized with a wide pole radius and mobilized with five casters designed to roll easily during transport. The IV pole is equipped with four hooks for holding fluid bags.
The IV pole can support two MRidium 3860+ MRI compatible IV infusion pumps, each with a 3861 Side Car Pump Module. The IV pole is 66 inches (1.68 meters) high, stabilized with a wide pole radius and mobilized with five casters designed to roll easily during transport. The IV pole is equipped with four hooks for holding fluid bags.
The recent introduction of our Ferromagnetic Detection system (“FMD”) is an example of this expansion. 6 Table of Contents When reasonably available, acquiring synergistic MRI patient care companies, products, or technology licenses to accelerate our product development and leverage our existing sales organization.
We intend to leverage this experience and collaboration to innovate and commercialize other technologically advanced MRI compatible patient care products. Our 2022 introduction of our Ferromagnetic Detection system (“FMD”) is an example of this expansion. When reasonably available, acquiring synergistic MRI patient care companies, products, or technology licenses to accelerate our product development and leverage our existing sales organization.
All other pumps must be placed at a distance from the MRI scanner, which may include being outside of the scanner room entirely. ​ We currently offer three primary products for sale: (1) our MRidium 3860+ MRI compatible IV infusion pump system with associated disposable IV tubing sets, (2) our 3880 MRI compatible patient vital signs monitoring system with associated disposable products, and (3) our 3600 FMD1 with RALU ferromagnetic detection device. 8 Table of Contents MRidium MRI Compatible IV Infusion Pump System The patented MRidium MRI compatible IV infusion pump system is based upon a non-magnetic, ultrasonic motor and other uniquely designed non-ferrous parts to provide accurate and dependable fluid delivery to patients undergoing an MRI procedure.
All other pumps must be placed at a distance from the MRI scanner, which may include being outside of the scanner room entirely. ​ We currently offer three primary products for use in the scanner room: (1) our MRidium 3860+ MRI compatible IV infusion pump system with associated disposable IV tubing sets, (2) our 3880 MRI compatible patient vital signs monitoring system with associated disposable products, and (3) our 3600 FMD1 with RALU ferromagnetic detection device.
The MRI compatible patient vital signs monitoring system also includes: (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. 11 Table of Contents IRadimed FMD1 with Remote Alarm Logging Unit (“RALU”) Our 3600 ferromagnetic detection device, IRadimed FMD1 with RALU is the first ferromagnetic detection device with Tru Sense TM threat qualification technology.
The MRI compatible patient vital signs monitoring system also includes: (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.
Our syringe adapter IV set enables users to provide accurate delivery of IV fluids directly from standard syringes. The 1057 vented syringe adapter set benefits from a low priming volume of 4 ml, which minimizes inefficient waste of medication. This product is most commonly used for cardiac medications, anesthesia, and pediatric drug delivery. ● MRidium 1058 Extension Infusion Set.
Our syringe adapter IV set enables users to provide accurate delivery of IV fluids directly from standard syringes. The 1057 vented syringe adapter set benefits from a low priming volume of 4 ml, which minimizes inefficient waste of medication.
Inspection of and controls over manufacturing, as well as monitoring of device-related adverse events, also are components of most of these regulatory systems. Most of our business is subject to varying degrees of governmental regulation in the countries in which we operate, and the general trend is toward increasingly stringent regulation balanced with a goal of optimizing international harmonization.
Most of our business is subject to varying degrees of governmental regulation in the countries in which we operate, and the general trend is toward increasingly stringent regulation balanced with a goal of optimizing international harmonization.
If we were unable to document and implement the controls and procedures required in a timely manner or otherwise violate such laws, we might suffer adverse regulatory consequences or face criminal sanctions, which could harm our operations, financial reporting, or financial results.
If we were unable to document and implement the controls and procedures required in a timely manner or otherwise violate such laws, we might suffer adverse regulatory consequences or face criminal sanctions, which could harm our operations, financial reporting, or financial results. 17 Table of Contents Regulation of Medical Devices Outside of the United States Medical device laws also are in effect in many of the non-U.S. markets in which we do business.
We are also continuing the development of and enhancing our materials documenting the benefits of uninterrupted vital signs monitoring that allows for easy transfer of critically ill patients from critical care to the MRI scanner room and back. We believe this kind of evidence-based documentation will help us provide widespread education to the clinicians that are driving clinical practice.
We are also continuing the development of and enhancing our materials documenting the benefits of patient-centered care with uninterrupted vital signs monitoring that allows for easy transfer of critically ill patients from critical care to the MRI scanner room and back.
From time to time, we may determine that products manufactured or marketed by us do not meet our specifications, published standards or regulatory requirements.
In addition, we conduct quality management reviews designed to inform management of key issues that may affect the quality of our products. From time to time, we may determine that products manufactured or marketed by us do not meet our specifications, published standards or regulatory requirements.
MRidium 3860+ MRI Compatible IV Infusion Pump System We are the only known provider of a non-magnetic intravenous (“IV”) infusion pump system that is specifically designed to be safe for use during MRI procedures. We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures.
MRidium 3860+ MRI Compatible IV Infusion Pump System We are the only known provider of a non-magnetic intravenous (“IV”) infusion pump system that is specifically designed to be safe for use during MRI procedures and operates dependably in magnetic fields up to 10,000 gauss.
Commercial Strategy We believe that the MRI compatible IV infusion pump market continues to have growth potential given the low rate of market penetration, and we aim to drive increased awareness, adoption and utilization of our MRI compatible products by: Continued development of our MRI-focused U.S. direct sales force and our international sales efforts We believe the most meaningful aspect of our commercialization strategy in the U.S. is the continued development of the market through driving awareness and education by our direct sales force.
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. 6 Table of Contents Commercial Strategy We believe that the MRI compatible IV infusion pump market continues to have growth potential and we continue to drive increased awareness, adoption and utilization of our MRI compatible products by: Continued development of our MRI-focused U.S. direct sales force and our international sales efforts We believe the most meaningful aspect of our commercialization strategy in the U.S. is the continued development of the market through driving awareness and education by our direct sales force.
We have a network of quality systems throughout our facilities that relate to the design, development, assembly, packaging, sterilization, handling, distribution and labeling of our products. To assess and facilitate compliance with applicable requirements, we periodically review our quality systems to determine their effectiveness and identify areas for improvement.
We have a network of quality systems throughout our facilities that relate to the design, development, assembly, packaging, sterilization, handling, distribution and labeling of our products.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRisks Relating to Our Business and Financial Condition ● The strict adherence to regulatory requirements governing medical devices during the manufacturing process and that of suppliers. ● Successful development and commercialization of enhanced products or new products to remain competitive. ● Our dependence on a limited number of products, and disruptions in our ability to sell these products. ● Dependence upon the integrity of our supply chain, including multiple single-source suppliers. ● Our reliance on third-party suppliers for certain of our raw materials and components. ● Securities class action litigation or derivative litigation. 20 Table of Contents ● Our markets are very competitive, and we sell certain of our products in a mature market. ● We manufacture and store our products at a single facility in Florida. ● Our inability to collect on our accounts receivables from our customers. ● Failure to maintain relationships with Integrated Delivery Networks and Group Purchasing Organizations. ● Cost-containment efforts of our customers and purchasing groups. ● A failure in our efforts to access and educate clinicians, anesthesiologists, radiologists, and hospital administrators regarding the advantages of our products. ● The lengthy sales cycle for medical devices could delay our sales. ● Our reliance on distributors to sell our products outside the U.S. ● Our dependency on our founder, Chairman, President and Chief Executive Officer, Roger Susi. ● Failure to attract and retain the talent required for our business. ● Sufficiency of our internal and external sources of liquidity. ● Inability to scale our operations or adequately manage generational upgrades to our own products. ● Difficulties associated with integrating acquisitions of technologies, products, and businesses. ● Difficulties associated with accurately forecasting our business performance. ● Inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with GAAP. ● Changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns. ● Our engagement in related party transactions. ● We are subject to various privacy and consumer protection laws.
Biggest changeRisks Relating to Our Business and Financial Condition ● Our dependence on a limited number of products, and disruptions in our ability to sell these products. ● Dependence upon the integrity of our supply chain and third-party suppliers for certain raw materials and components. ● Failure to protect our information technology infrastructure which could adversely affect our business and operating results. ● The strict adherence to regulatory requirements governing medical devices during the manufacturing process and that of suppliers. ● Our markets are very competitive, and we sell certain of our products in a mature market. ● We manufacture and store our products at a single facility in Florida. ● Failure to maintain relationships with IDNs and GPOs. ● The lengthy sales cycle for medical devices could delay our sales. ● Our reliance on distributors to sell our products outside the U.S. ● Successful development and commercialization of enhanced or new products to remain competitive. ● Our dependency on our founder, Chairman, President and Chief Executive Officer, Roger Susi. ● Inability to scale our operations or adequately manage generational upgrades to our own products. ● Our engagement in related party transactions. ● Difficulties associated with accurately forecasting our business performance. ● Inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with U.S. generally accepted accounting principles (“U.S.
Our stock could be subject to wide fluctuations in price in response to various factors, including the following: ● a lack of liquidity in the public trading of our common stock; ● the commercial success or failure of our key products; ● delayed or reduced orders from our customers; ● manufacturing or supply interruptions; ● changes or developments in laws or regulations applicable to our products and product candidates; ● introduction of competitive products or technologies; ● poorly executed acquisitions or acquisitions whose projected potential is not realized; ● actual or anticipated variations in quarterly operating results; 38 Table of Contents ● failure to meet or exceed our own estimates and projections or the estimates and projections of securities analysts or investors; ● new or revised earnings estimates or guidance by us or securities analysts or investors; ● varying economic and market conditions in the U.S.; ● negative developments impacting the medical device industry in general and changes in the market valuations of companies deemed similar to us; ● negative developments concerning our sources of manufacturing supply; ● disputes or other developments relating to patents, trademarks or other proprietary rights; ● litigation or investigations involving us, our industry, or both; ● issuances of debt, equity or convertible securities at terms deemed unfavorable by the market; ● major catastrophic events; ● sales of large blocks of our stock; ● changes in our Board of Directors, management or key personnel; or ● the other factors described in this “Risk Factors” section.
Our stock could be subject to wide fluctuations in price in response to various factors, including the following: ● sales of large blocks of our stock or lack of liquidity in the public trading of our common stock; ● the commercial success or failure of our key products; ● delayed or reduced orders from our customers; ● negative developments concerning our sources of manufacturing or manufacturing or supply interruptions; ● changes or developments in laws or regulations applicable to our products and product candidates; ● introduction of competitive products or technologies; 34 Table of Contents ● poorly executed acquisitions or acquisitions whose projected potential is not realized; ● actual or anticipated variations in quarterly operating results; ● failure to meet or exceed our own estimates and projections or the estimates and projections of securities analysts or investors; ● new or revised earnings estimates or guidance by us or securities analysts or investors; ● varying economic and market conditions in the U.S.; ● negative developments impacting the medical device industry in general and changes in the market valuations of companies deemed similar to us; ● disputes or other developments relating to patents, trademarks or other proprietary rights; ● litigation or investigations involving us, our industry, or both; ● issuances of debt, equity or convertible securities at terms deemed unfavorable by the market; ● major catastrophic events; ● changes in our Board of Directors, management or key personnel; or ● the other factors described in this “Risk Factors” section.
If our suppliers are unable or fail to fulfill their obligations to us for any reason, we may not be able to manufacture our products and satisfy customer demand or our obligations under sales agreements in a timely manner, and our business could be harmed as a result.
If our material suppliers are unable or fail to fulfill their obligations to us for any reason, we may not be able to manufacture our products and satisfy customer demand or our obligations under sales agreements in a timely manner, and our business could be harmed as a result.
We may seek to sell additional equity or debt securities or to obtain a credit facility, which we may not be able to do on favorable terms, or at all. The sale of additional equity or convertible debt securities could result in additional dilution to our stockholders.
We may seek to sell additional equity or debt securities or to obtain a credit facility, which we may not be able to do on favorable terms, or at all. The sale of additional equity or debt securities could result in additional dilution to our stockholders.
Such assumptions and estimates include those related to revenue recognition, accruals for product returns, allowances for doubtful accounts, valuation of inventory, impairment of intangibles and long-lived assets, accounting for leases, accounting for income taxes and stock-based compensation and allowances for uncertainties. These factors are also influenced by regular changes to GAAP, some of which are material to many companies.
Such assumptions and estimates include those related to revenue recognition, accruals for product returns, allowances for doubtful accounts, valuation of inventory, impairment of intangibles and long-lived assets, accounting for leases, accounting for income taxes and stock-based compensation and allowances for uncertainties. These factors are also influenced by regular changes to U.S. GAAP, some of which are material to many companies.
We are highly dependent on our founder, Chairman, President and Chief Executive Officer, Roger Susi. We believe that Mr. Susi will continue to play a significant role in the development of new products. Our current and future operations could be adversely impacted if we were to lose his services.
We are highly dependent on our founder, Chairman of the Board of Directors, President and Chief Executive Officer, Roger Susi. We believe that Mr. Susi will continue to play a significant role in the development of new products. Our current and future operations could be adversely impacted if we were to lose his services.
As inflationary measures have affected the greater market in the last two years, we have considered the effects of inflation on our business operations and financial results. We have assessed that inflation has not had a material impact on our revenues, expenses, assets, liabilities, or cash flows for the current reporting period.
As inflationary measures have affected the greater market in the last several years, we have considered the effects of inflation on our business operations and financial results. We have assessed that inflation has not had a material impact on our revenues, expenses, assets, liabilities, or cash flows for the current reporting period.
There can be no assurance that the Patent and Trademark Office will have sufficient resources to review our patent applications in a timely manner. Consequently, even if our patent applications are ultimately successful, our patent applications may be delayed, which would prevent intellectual property protection for our products.
There can be no assurance that the U.S. Patent and Trademark Office will have sufficient resources to review our patent applications in a timely manner. Consequently, even if our patent applications are ultimately successful, our patent applications may be delayed, which would prevent intellectual property protection for our products.
Provisions in our charter documents, as well as provisions of the Delaware General Corporation Law (“DGCL”), could depress the trading price of our common stock by making it more difficult for a third party to acquire us at a price favorable to our shareholders.
Provisions in our charter documents, as well as provisions of the Delaware General Corporation Law (“DGCL”), could depress the trading price of our common stock by making it more difficult for a third party to acquire us at a price favorable to our stockholders.
Continued sales to our existing customers are expected to be significant to our revenue in the future, and if our existing customers do not continue to purchase from us, our revenue may decline. We manufacture and store our products at a single facility in Florida. We manufacture and store our products at a single facility in Winter Springs, Florida.
Continued sales to our existing customers are expected to be significant to our revenue in the future, and if our existing customers do not continue to purchase from us, our revenue may decline. We manufacture and store our products at a single facility in Florida.
If our competitors independently develop equivalent knowledge, methods and know-how, we would not be able to effectively assert our trade secret protections against them, which could have a material adverse effect on our business. There can be no assurance of timely patent review and approval to minimize competition and generate sufficient revenues.
If our competitors independently develop equivalent knowledge, methods and know-how, we would not be able to effectively assert our trade secret protections against them, which could have a material adverse effect on our business. There can be no assurance of timely patent review and approval that would minimize competition and allow us to generate sufficient revenues.
This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders, which could also affect the price that some investors are willing to pay for our common stock. ITEM 1B. UNRESOLVED STAFF COMMENTS None.
This 37 Table of Contents provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders, which could also affect the price that some investors are willing to pay for our common stock. ITEM 1B. UNRESOLVED STAFF COMMENTS None.
In the case of a willful infringement, the definition of which is subjective, such damages may be increased up to three times. An adverse decision could have a material adverse effect 37 Table of Contents on our business, financial position and results of operations and could cause the market value of our common stock to decline.
In the case of a willful infringement, the definition of which is subjective, such damages may be increased up to three times. An adverse decision could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline.
If problems are not discovered before the product is released to the market, voluntary recalls, corrective actions, or product liability related costs may also be incurred. Should we encounter difficulties in the manufacture of our products or be subject to a product recall, our business could suffer materially.
If problems are not discovered before the product is released to the market, voluntary recalls, corrective actions, or product liability related 24 Table of Contents costs may also be incurred. Should we encounter difficulties in the manufacture of our products or be subject to a product recall, our business could suffer materially.
Based on our experience, we believe the period between initial discussions with customers regarding our products and a customer’s purchase of our products have varied widely and have historically ranged between three and six months in duration. Sales cycles can also be delayed because of capital budgeting procedures.
Based on our experience, we believe the period between initial discussions with customers regarding our products and a customer’s purchase of our 25 Table of Contents products have varied widely and have historically ranged between three and six months in duration. Sales cycles can also be delayed because of capital budgeting procedures.
Such payment could have a material impact on how investors view our company and result in a decline in our stock price. 41 Table of Contents If securities or industry analysts fail to initiate research coverage of our stock, downgrade our stock, or discontinue coverage, our trading volume might be reduced, and our stock price could decline.
Such payment could have a material impact on how investors view our Company and result in a decline in our stock price. If securities or industry analysts fail to initiate research coverage of our stock, downgrade our stock, or discontinue coverage, our trading volume might be reduced, and our stock price could decline.
Furthermore, these agreements may not provide meaningful protection for our trade secrets or other confidential or proprietary information or result in the effective assignment to us of intellectual property and may not provide an adequate remedy in the event of unauthorized use or disclosure of confidential information or other breaches of the agreements.
Furthermore, these agreements may not provide meaningful protection for our trade secrets or other confidential or proprietary information or result in the effective assignment to us of intellectual property and may not provide an adequate remedy in the event of unauthorized use or disclosure of confidential information or other 32 Table of Contents breaches of the agreements.
We may need to invest in additional 40 Table of Contents resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities.
We may need to invest in additional resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities.
Furthermore, certain state governments have enacted legislation to limit and/or increase transparency of interactions with healthcare providers, pursuant to which we are required by law to disclose payments and other transfers of value to healthcare providers licensed by certain states.
Furthermore, certain state governments have enacted 30 Table of Contents legislation to limit and/or increase transparency of interactions with healthcare providers, pursuant to which we are required by law to disclose payments and other transfers of value to healthcare providers licensed by certain states.
Foreign Corrupt Practices Act and similar worldwide anti-bribery laws. ● We and our suppliers and customers are required to obtain regulatory approvals and maintain compliance with regulations applicable to medical devices and infusion pumps. ● Our operations are subject to environmental laws and regulations.
Foreign Corrupt Practices Act and similar worldwide anti-bribery laws. ● We and our suppliers and customers are required to obtain regulatory approvals and maintain compliance with regulations applicable to medical devices and infusion pumps.
Risks Relating to our Intellectual Property ● Protection of our intellectual property. ● Uncertainties associated with timely patent reviews and approvals. ● We may become involved in patent litigation or other intellectual property proceedings relating to our current and future products. ● Disclosure of confidential or proprietary information, unpatented trade secrets, know-how, confidential and proprietary technology.
Risks Relating to our Intellectual Property ● Protection of confidential intellectual property, unpatented trade secrets, and proprietary technology. ● Uncertainties associated with timely patent reviews and approvals. ● We may become involved in patent litigation or other intellectual property proceedings relating to our current and future products.
Risks Related to Ownership of Our Common Stock ● Significant fluctuations and volatility of our common stock. ● Use of capital to repurchase shares of our common stock and need or choice to raise additional capital in the future. ● The ability of Roger Susi, who serves as our Chairman of the Board of Directors, President and Chief Executive Officer, to exert significant influence over matters subject to stockholder approval due to his significant minority ownership. ● Payment of dividends, or a reduction or cessation of expected dividends. ● The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members. ● Failure to develop and maintain adequate internal controls or to implement new or improved controls. ● Impact of being a public company on our competitive environment and our risk of potential litigation. ● Impact from our involvement in securities class action litigation, if any. ● Impact of securities or industry analysts’ failing to initiate research coverage of our stock, downgrading our stock, or discontinuing coverage. 22 Table of Contents ● Our charter documents and Delaware law have provisions that may discourage an acquisition of us by others and may prevent attempts by our stockholders to replace or remove our current management.
Risks Related to Ownership of Our Common Stock ● Significant fluctuations and volatility of our common stock ● Use of capital to repurchase shares of our common stock, need or choice to raise additional capital in the future, payment of dividends, or reduction or cessation of expected dividends. ● The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified Board members. ● The ability of Roger Susi, who serves as our Chairman of the Board, President and Chief Executive Officer, to exert significant influence over matters subject to stockholder approval due to his significant minority ownership. ● Impact of being a public company on our competitive environment and our risk of potential litigation or involvement in securities class action litigation, if any. 21 Table of Contents ● Impact of securities or industry analysts’ failing to initiate research coverage of our stock, downgrading our stock, or discontinuing coverage. ● Our charter documents and Delaware law have provisions that may discourage an acquisition of us by others and may prevent attempts by our stockholders to replace or remove our current management.
Our products could be rendered obsolete or economically impractical by numerous factors, many of which are beyond our control, including but not limited to: ● entrance of new competitors into our markets; ● technological advancements of MRI scanners; ● technological developments such as new imaging modalities which render MRI procedures obsolete or reduce the instances where MRI imaging is utilized; ● loss of key relationships with suppliers, integrated delivery healthcare systems, group purchasing organizations, distributors, or direct end-user customers; ● manufacturing or supply interruptions; ● product liability claims; ● our reputation and product market acceptance; ● loss of existing regulatory approvals or the imposition of new requirements to maintain such approvals; and ● product recalls or safety alerts.
Our products could be rendered obsolete or economically impractical by numerous factors, many of which are beyond our control, including but not limited to: ● entrance of new competitors into our markets; ● technological advancements of MRI scanners; ● technological developments such as new imaging modalities which render MRI procedures obsolete or reduce the instances where MRI imaging is utilized; ● loss of key relationships with suppliers, IDNs, GPOs, distributors, or direct end-user customers; ● manufacturing or supply interruptions; ● product liability claims; ● our reputation and product market acceptance; ● loss of existing regulatory approvals or the imposition of new requirements to maintain such approvals; and ● product recalls or safety alerts.
Foreign Corrupt Practices Act and similar anti-bribery laws in other jurisdictions; ● foreign currency fluctuations that can impact our financial statements when foreign denominations are translated into U.S. dollars; 31 Table of Contents ● different local product preferences and product requirements, which might increase with increasing nationalism; ● trade protection and restriction measures under international trade treaties and via tariffs, and import or export licensing requirements; ● difficulty in establishing, staffing and managing non-U.S. operations; ● failure to maintain relationships with distributors, especially those who have assisted with foreign regulatory or government clearances; ● uncertainties regarding judicial systems and procedures, changes in labor, environmental, health and safety laws; ● healthcare crises or epidemics; ● potentially negative consequences from changes in or interpretations of tax laws, including U.S. state and foreign tax jurisdiction responses to recent changes in U.S. federal tax laws; ● political instability and actual or anticipated military or political conflicts, including instability related to war and terrorist attacks, such as Russia’s invasion of Ukraine, and to political matters, such as the U.K.’s Brexit; ● economic instability, inflation, deflation, recession or interest rate fluctuations; ● potential disruption in supply chains; and ● minimal or diminished protection of intellectual property.
Foreign Corrupt Practices Act and similar anti-bribery laws in other jurisdictions; ● foreign currency fluctuations that can impact our financial statements when foreign denominations, particularly the Japanese yen, are translated into U.S. dollars; ● different local product preferences and product requirements, which might increase with increasing nationalism; ● trade protection and restriction measures under international trade treaties and via tariffs, and import or export licensing requirements; ● difficulty in establishing, staffing and managing non-U.S. operations; ● failure to maintain relationships with distributors, especially those who have assisted with foreign regulatory or government clearances; ● uncertainties regarding judicial systems and procedures, changes in labor, environmental, health and safety laws; ● healthcare crises or epidemics; ● potentially negative consequences from changes in or interpretations of tax laws, including U.S. state and foreign tax jurisdiction responses to recent changes in U.S. federal tax laws and tariff practices; ● political instability and actual or anticipated military or political conflicts, including instability related to war and terrorist attacks, such as Russia’s invasion of Ukraine, and conflict in the Middle East; 29 Table of Contents ● longer payment cycles; ● economic instability, inflation, deflation, recession or interest rate fluctuations; ● potential disruption in supply chains; and ● minimal or diminished protection of intellectual property.
Our unpatented trade secrets, know-how, confidential and proprietary information, and technology may be inadequately protected. We rely on unpatented trade secrets, know-how and technology. This intellectual property is difficult to protect, especially in the medical device industry, where much of the information about a product must be submitted to regulatory authorities during the clearance process.
We rely on unpatented trade secrets, know-how and technology. This intellectual property is difficult to protect, especially in the medical device industry, where much of the information about a product must be submitted to regulatory authorities during the clearance process.
Sales to customers outside of the U.S. have recently been approximately 20 percent of our net revenues and we expect that non-U.S. sales will contribute to future growth. A majority of our international sales originate from Europe and Japan, and we also make sales in Canada, Hong Kong, Australia, Mexico and certain parts of the Middle East.
Sales to customers outside of the U.S. were approximately 17 percent of our net revenues in 2024 and we expect that non-U.S. sales will contribute to future growth. A majority of our international sales originate from Europe and Japan, and we also make sales in Canada, Hong Kong, Australia, Mexico and certain parts of the Middle East.
We may be unable to protect our rights in 35 Table of Contents trade secrets and unpatented proprietary technology in these countries. If our trade secrets become known, we may lose our competitive advantages.
We may be unable to protect our rights in trade secrets and unpatented proprietary technology in these countries. If our trade secrets become known, we may lose our competitive advantages.
We rely on distributors for all our sales outside the U.S. and hence do not have direct control over foreign sales activities. These distributors also assist us with regulatory approvals and the education of physicians and government agencies. Our revenues outside the U.S. have recently represented approximately 20 percent of our net revenues.
We rely on distributors for all our sales outside the U.S. and hence do not have direct control over foreign sales activities. These distributors also assist us with regulatory approvals and the education of physicians and government agencies. Our revenues outside the U.S. in fiscal year 2024 represented approximately 17 percent of our net revenues.
The environment in which we operate makes it difficult to accurately forecast our business performance. Significant changes and volatility in most aspects of the current business environment, including financial markets, customer behavior, speed of technological, regulatory, and competitive changes, and the recent health pandemic, make it increasingly difficult for us to predict our revenues and earnings into the future.
Significant changes and volatility in most aspects of the current business environment, including financial markets, customer behavior, speed of technological, regulatory, and competitive changes, and the recent health pandemic, make it increasingly difficult for us to predict our revenues and earnings into the future.
Even though our board of directors has approved the payment of a regular quarterly cash dividend on the Company’s common stock, there can be no assurance as to whether or when we may pay dividends on our common stock in the future.
In February 2025, our Board of Directors declared a regular quarterly cash dividend of $0.17 per share. Even though our Board of Directors has approved the payment of a regular quarterly cash dividend on the Company’s common stock, there can be no assurance as to whether or when we may pay dividends on our common stock in the future.
Historically, companies that have overstated their operating guidance have suffered significant declines in their stock price when such results are announced to the public. 29 Table of Contents There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with GAAP.
Historically, companies that have overstated their operating guidance have suffered significant declines in their stock price when such lesser results are announced to the public. There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with U.S. GAAP. Furthermore, portions of U.S.
In February 2023, we purchased 26 acres of land in Orlando, Florida on which we plan to build an expanded facility to increase capacity. Any failure to successfully construct and operate such a facility expansion might limit our ability to grow as we expect.
In February 2023, we purchased 26 acres of land in Orlando, Florida and continue construction on an expanded facility to increase capacity. Any failure to successfully complete construction and operate such a facility expansion might limit our ability to grow as we expect.
Any use of capital to repurchase shares of our common stock, or the election to continue to pay a regular cash dividend, could have a material adverse effect on our stock price and our business.
Any use of capital to repurchase shares of our common stock, need to or choice to raise future capital, the election to continue, reduce or cease to pay a regular cash dividend, could have a material adverse effect on our stock price and our business.
Furthermore, portions of GAAP require the use of fair value models which are variable in application and methodology from appraiser to appraiser. Any changes in estimates, judgments and assumptions used could have a material adverse effect on our business, financial position, and operating results.
GAAP require the use of fair value models which are variable in application and methodology from appraiser to appraiser. Any changes in estimates, judgments and assumptions used could have a material adverse effect on our business, financial position, and operating results. The preparation of financial statements in conformity with U.S.
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.
GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.
Additionally, any failure by us to forecast demand for, or to maintain an adequate supply of raw materials, parts, or finished products, could result in an interruption in the supply of certain products and a decline in our sales. We rely on third-party suppliers for certain of our raw materials and components.
Additionally, any failure by us to forecast demand for, or to maintain an adequate supply of raw materials, parts, or finished products, could result in an interruption in the supply of certain products and a decline in our sales.
Our ability to sell our products to U.S. hospitals, acute care facilities and outpatient imaging centers depends in part on our relationships with Integrated Delivery Networks and Group Purchasing Organizations (“GPOs”). Many existing and potential customers for our products are members of GPOs.
Our ability to sell our products to U.S. hospitals, acute care facilities and outpatient imaging centers depends in part on our relationships with IDNs and GPOs. Many existing and potential customers for our products are members of GPOs.
Risks Relating to our Intellectual Property Our success depends on our ability to protect our intellectual property. We intend to rely on a combination of patents, trademarks, trade secrets, know-how, license agreements and contractual provisions to establish and protect our proprietary rights to our technologies and products.
We intend to rely on a combination of patents, trademarks, trade secrets, know-how, license agreements and contractual provisions to establish and protect our proprietary rights to our technologies and products.
We and our suppliers and customers are required to obtain regulatory approvals to comply with regulations applicable to medical devices, including infusion pumps, and these approvals could result in delays or increased costs in developing new products.
We and our suppliers and customers are required to obtain regulatory approvals and maintain compliance with regulations applicable to medical devices, including infusion pumps, and these approvals could result in delays or increased costs in developing new products, subject us to sanctions and could adversely affect our business.
The only significant ongoing related party transaction is the lease agreement between our company and Susi, LLC, an affiliate of Roger Susi, with respect to our current sole production and headquarters facility in Winter Springs, Florida.
We have engaged in the past, and continue to engage, in related party transactions, particularly between our Company and Roger Susi and his affiliates. The only significant ongoing related party transaction is the lease agreement between our Company and Susi, LLC, an affiliate of Roger Susi, with respect to our current sole production and headquarters facility in Winter Springs, Florida.
Any potential intellectual property litigation also could force us to do one or more of the following: ● stop selling, making, or using products that use the disputed intellectual property; ● obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royalty payments and may not be available on reasonable terms, or at all; ● pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing; ● pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or ● redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive and/or infeasible.
Any potential intellectual property litigation also could force us to do one or more of the following: ● stop selling, making, or using products that use the disputed intellectual property; ● obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may require substantial royalty payments and may not be available on reasonable terms, or at all; ● pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing; ● pay the attorney fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing; or ● redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive and/or infeasible. 33 Table of Contents If any of the foregoing events occur, we may have to withdraw existing products from the market or may be unable to commercialize one or more of our products, all of which could have a material adverse effect on our business, results of operations and financial condition.
These requirements include, among other things, regulations regarding manufacturing practices, product labeling, off-label marketing, advertising and post-marketing reporting, adverse event reports and field alerts. Compliance with these FDA requirements is subject to continual review and is monitored through periodic inspections by the FDA. For example, the FDA conducted routine inspections of our facility in Winter Springs, Florida in June 2019.
These requirements include, among other things, regulations regarding manufacturing practices, product labeling, off-label marketing, advertising and post-marketing reporting, adverse event reports and field alerts. Compliance with these FDA requirements is subject to continual review and is monitored through periodic inspections by the FDA.
Certain of those raw materials and components are proprietary products of those unaffiliated third-party suppliers and are specifically cited in our applications with regulatory agencies so that they must be obtained from that specific sole source or sources and could not be obtained from another supplier unless and until an appropriate application amendment is approved by the regulatory agency. 24 Table of Contents Among the reasons we may be unable to obtain these raw materials and components include, but are not limited to: ● a supplier’s inability or unwillingness to continue supplying raw materials and/or components; ● regulatory requirements or action by regulatory agencies or others, including changes in international trade treaties and/or tariffs; ● adverse financial or other strategic developments at or affecting the supplier, including bankruptcy; ● unexpected demand for or shortage of raw materials or components; ● failure of the supplier to comply with quality standards which results in quality and product failures, product contamination and/or recall; ● discovery of previously unknown or undetected imperfections in raw materials or components; ● labor disputes or shortages, including from natural disasters and the effects of health emergencies or pandemics; and ● political instability and actual or anticipated military or political conflicts.
Among the reasons we may be unable to obtain these raw materials and components include, but are not limited to: ● a supplier’s inability or unwillingness to continue supplying raw materials and/or components; ● regulatory requirements or action by regulatory agencies or others, including changes in international trade treaties and/or tariffs; ● adverse financial or other strategic developments at or affecting the supplier, including bankruptcy; ● unexpected demand for or shortage of raw materials or components; ● failure of the supplier to comply with quality standards which results in quality and product failures, product contamination and/or recall; ● discovery of previously unknown or undetected imperfections in raw materials or components; ● labor disputes or shortages, including from natural disasters and the effects of health emergencies or pandemics; and ● political instability and actual or anticipated military or political conflicts.
Even if we are able to obtain approval for introducing new products to the market, we and our suppliers may not be able to remain in compliance with applicable FDA and other material regulatory requirements once clearance or approval has been obtained for a product.
Future delays in the receipt of, or failure to obtain, approvals could result in delayed or no realization of product revenues. 31 Table of Contents Even if able to obtain approval for introducing new products to the market, we and our suppliers may not be able to remain in compliance with the applicable FDA and other material regulatory requirements once clearance or approval has been obtained for a product.
These delays could have an adverse effect on our business, financial condition, and results of operations. 27 Table of Contents Because we rely on distributors to sell our products outside of the U.S., our revenues could decline if our existing distributors do not continue to purchase products from us or if our relationship with any of these distributors is terminated.
Because we rely on distributors to sell our products outside of the U.S., our revenues could decline if our existing distributors do not continue to purchase products from us or if our relationship with any of these distributors is terminated.
Our Board of Directors has historically authorized stock repurchase programs and, pursuant to these authorizations, we have used a significant amount of cash to repurchase shares of common stock of our company. During 2016 and 2017, we repurchased 779,135 shares of our common stock for approximately $11.8 million.
Our Board of Directors has historically authorized stock repurchase programs and, pursuant to these authorizations, we have used a significant amount of cash to repurchase shares of common stock of our Company.
As a public company, we are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (“Exchange Act”), the Sarbanes-Oxley Act, the Dodd-Frank Act, the listing requirements of the Nasdaq Stock Market and other applicable securities rules and regulations.
As a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq and other applicable securities rules and regulations.
Risks Related to Our Industry ● Changes in government regulations or U.S. healthcare policy could force us to make modifications to how we develop, manufacture, market, and price our products. ● Failure to obtain, or experience significant delays in obtaining, FDA clearances or other necessary approvals to commercially distribute new products. ● Risks associated with doing business outside of the U.S. ● We may incur product liability losses or become subject to other lawsuits related to our products, business, and insurance coverage could be inadequate or unavailable to cover these losses. 21 Table of Contents ● Defects or failures associated with our products and/or our quality control systems. ● Our products or product types, or MR imaging could be subject to negative publicity. ● Healthcare fraud and abuse regulations could potentially result in significant liability, require us to change our business practices and/or restrict our operations in the future. ● Impact of violations of the U.S.
GAAP”). ● Changes in effective tax rates or results from examination of income or other tax returns. 20 Table of Contents ● The development and increased use of Artificial Intelligence presents operational risks and challenges that could damage our reputation or materially harm our business. ​ Risks Related to Our Industry ● Changes in government regulations or U.S. healthcare policy could force us to make modifications to how we develop, manufacture, market, and price our products which may have a material adverse effect on our financial condition and results of operations. ● Failure to obtain, or experience significant delays in obtaining, FDA clearances or other necessary approvals to commercially distribute new products. ● Risks associated with doing business outside of the U.S. ● We may incur product liability losses or become subject to other lawsuits related to our products, business, and insurance coverage could be inadequate or unavailable to cover these losses. ● Our products or product types, or MR imaging could be subject to negative publicity. ● Healthcare fraud and abuse regulations could potentially result in significant liability, require us to change our business practices and/or restrict our operations in the future. ● Impact of violations of the U.S.
We do not plan to retain the current Winter Springs, Florida leased facility once the larger facility is fully operational. We engage in related party transactions, which result in a conflict of interest involving our management. We have engaged in the past, and continue to engage, in related party transactions, particularly between our company and Roger Susi and his affiliates.
We do not plan to retain the current Winter Springs, Florida leased facility once the larger facility is fully operational. 26 Table of Contents We engage in related party transactions, which result in a conflict of interest involving our management.
In the future, the Board of Directors may elect to allocate capital based on our continued ability to generate cash from operations, our capital needs to support normal operations, and making investments that are 39 Table of Contents aimed at supporting growth, rather than paying cash dividends.
In the future, the Board of Directors may elect to allocate capital based on our continued ability to generate cash from operations, our capital needs to support normal operations, and making investments aimed at supporting growth, rather than paying cash dividends. These capital allocation decisions could have a material adverse effect on our stock price.
Product liability claims and lawsuits, safety alerts, recalls or corrective actions, regardless of their ultimate outcome, could have a material adverse effect on our business, financial condition, reputation and on our ability to attract and retain customers.
Product liability claims and lawsuits, safety alerts, recalls or corrective actions, regardless of their ultimate outcome, could have a material adverse effect on our business, financial condition, reputation and on our ability to attract and retain customers. In addition, we may not be able to obtain insurance in the future on terms acceptable to us or at all.
We and our customers are subject to various U.S. federal, state and local laws targeting fraud and abuse in the healthcare industry, including anti-kickback and false claims laws.
We are subject to healthcare fraud and abuse regulations that could result in significant liability, require us to change our business practices and restrict our operations in the future. We and our customers are subject to various U.S. federal, state and local laws targeting fraud and abuse in the healthcare industry, including anti-kickback and false claims laws.
Foreign governmental authorities that regulate the manufacture and sale of medical devices have become increasingly stringent and, to the extent we sell our products in foreign countries, we may be subject to more rigorous regulation in the future.
The failure to obtain, or the loss or suspension of any such pre-approval, would negatively affect our ability to sell our products and harm our anticipated revenues. 28 Table of Contents Foreign governmental authorities that regulate the manufacture and sale of medical devices have become increasingly stringent and, to the extent we sell our products in foreign countries, we may be subject to more rigorous regulation in the future.
Some of these parts require our partners to engage in complex manufacturing processes and involve long lead times or delivery periods.
Many of the component parts of our products are obtained through supply agreements with unaffiliated third parties. Some of these parts require our partners to engage in complex manufacturing processes and involve long lead times or delivery periods.
In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. We have become, and may in the future, become involved in this type of litigation. Litigation is expensive and could divert management’s attention and resources from our primary business, which could adversely affect our operating results.
In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities, whatever the cause. We have become, and may in the future, become involved in this type of litigation.
If we fail to successfully commercialize our products due to the lack of intellectual property protection, we may be unable to generate sufficient revenues to meet or grow our business according to our expected goals and this may have a materially adverse effect on our profitability, financial condition, and operations. 36 Table of Contents We may become involved in patent litigation or other intellectual property proceedings relating to our current and future product clearances, which could result in liability for damages or delay or stop our development and commercialization efforts.
If we fail to successfully commercialize our products due to the lack of intellectual property protection, we may be unable to generate sufficient revenues to meet or grow our business according to our expected goals and this may have a materially adverse effect on our profitability, financial condition, and operations.
These events could negatively impact our ability to satisfy demand for our products, which could have a material adverse effect on our products’ use and sales and our business and results of operations. We may experience these or other shortages in the future resulting in delayed shipments, supply constraints, contract disputes and/or stock-outs of our products.
These events could negatively impact our ability to satisfy demand for our products, which could have a material adverse effect on our products’ use and sales and our business and results of operations.
Such time would delay potential sales of additional units and disposable products or additional optional accessories to that medical facility or hospital.
Such time would delay potential sales of additional units and disposable products or additional optional accessories to that medical facility or hospital. These delays could have an adverse effect on our business, financial condition, and results of operations.
Future dividends, if any, will be declared and paid at the discretion of the Company’s board of directors and will depend on a number of factors. Similarly, on February 2, 2023, the Board of Directors declared a special cash dividend of $1.05 per share on the Company’s common stock.
Future dividends, if any, will be declared and paid at the discretion of the Board of Directors and will depend on a number of factors.
Our business practices are more visible as a public company, and this could impact our competitive environment and our risk of potential litigation.
Our business practices are more visible as a public company, and this could impact our competitive environment and risk of potential litigation or involvement in securities class action litigation that could adversely affect our business and could subject us to significant liabilities.
While those stock repurchase programs have expired, should our Board of Directors authorize another stock repurchase program, there can be no assurance that we will be able to repurchase shares on favorable terms or, if we do repurchase shares, that such repurchases will increase shareholder value.
If our Board of Directors authorize another stock repurchase program, there can be no assurance that we will be able to repurchase shares on favorable terms or, if we do repurchase shares, that such repurchases will increase stockholder value. Stock repurchases now are burdened with a federal excise tax which diminishes their attraction to deliver returns to stockholders.
We anticipate that the government will continue to scrutinize our industry closely, and any new regulations or statutory provisions could result in delays or increased costs during the periods of product development, clinical trials and regulatory review and approval, as well as increased costs to assure compliance. 33 Table of Contents We are subject to healthcare fraud and abuse regulations that could result in significant liability, require us to change our business practices and restrict our operations in the future.
The current government administration has not indicated whether it will continue to scrutinize our industry as closely as it has in the past. Any new regulations or statutory provisions could result in delays or increased costs during the periods of product development, clinical trials and regulatory review and approval, as well as increased costs to assure compliance.
Susi, our founder, who serves as our Chairman of the Board of Directors, President and Chief Executive Officer, and his affiliates, beneficially own approximately 36 percent of our outstanding common stock. Mr. Susi may be able to significantly influence matters requiring approval by our stockholders, including the election of directors and the approval of mergers, acquisitions, or other extraordinary transactions.
Susi, our founder, who serves as our Chairman of the Board of Directors, President and Chief Executive Officer, and his affiliates, beneficially own approximately 36 percent of our outstanding common stock as of December 31, 2024. Mr.
We cannot guarantee that any of the personnel, systems, procedures and controls we put in place will be adequate to support the manufacture and distribution of our products.
This growth, if it occurs as planned, will place significant demands on our management and manufacturing capacity, as well as our financial, administrative, and other resources. We cannot guarantee that any of the personnel, systems, procedures, controls and new facilities we put in place will be adequate to support the manufacture and distribution of our products.
Any adverse determination in any such litigation or any amounts paid to settle any such actual or threatened litigation could require us to make significant payments.
Litigation is expensive and could divert management’s attention and resources from our primary business, which could adversely affect our operating results. Any adverse determination in any such litigation or any amounts paid to settle any such actual or threatened litigation could require us to make significant payments.
Additionally, if we use a significant portion of our capital to repurchase shares or pay cash dividends, our financial flexibility will be reduced, and we may not be able to execute on other strategic initiatives or tolerate periods of operating losses.
If the Board of Directors chose to reduce or omit a dividend and retain future earnings for the operation and expansion of our business, realization of a gain on your investment will depend solely on the appreciation of the price of our common stock, which may never occur. 35 Table of Contents Additionally, if we use a significant portion of our capital to repurchase shares or pay cash dividends, our financial flexibility will be reduced, and we may not be able to execute on other strategic initiatives or tolerate periods of operating losses.
We may and have become involved in securities class action litigation that could divert management’s attention from our business and adversely affect our business and could subject us to significant liabilities. The stock markets have from time-to-time experienced significant price and volume fluctuations that have affected the market prices of small capitalization medical device companies.
The stock markets have from time-to-time experienced significant price and volume fluctuations that have affected the market prices of small capitalization medical device companies.
Changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our results. We are subject to the continuous examination of our income tax returns by the Internal Revenue Service, or IRS, and other tax authorities.
Changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our results. In July 2024, the Company received notice of examination from the U.S. Internal Revenue Service (the “IRS”) for the tax year ended December 31, 2021.
Any major factor adversely affecting the sale of our products or services would cause our revenues to decline and have a material adverse impact on our business, financial condition, and our common stock. 23 Table of Contents We have significant international sales as well as international supply chain links and we face risks related to health epidemics that could adversely affect our revenue.
Any major factor adversely affecting the sale of our products or services would cause our revenues to decline and have a material adverse impact on our business, financial condition, and our common stock. 22 Table of Contents Our continued success depends on the integrity of our supply chain and unaffiliated third-party suppliers for certain of our raw materials and components, the disruption of which could negatively impact our business.
If we fail to demonstrate the safety, reliability and economic benefits of our products to hospitals and acute medical facilities, our products may not be adopted, and our expected and actual sales would suffer. The lengthy sales cycle for medical devices could delay our sales. The decision-making process of customers is often complex and time-consuming.
The lengthy sales cycle for medical devices could delay our sales. The decision-making process of customers is often complex and time-consuming.
He may also have interests that differ from yours and may vote in a way with which you disagree, and which may be adverse to your interests. This concentration of ownership may have the effect of promoting, delaying or deterring a change of control of our company.
This concentration of ownership may have the effect of promoting, delaying or deterring a change of control of our Company.
In such event, it could materially and adversely affect our commercial activities, operating results, and financial condition. In the near term, we do not anticipate finding alternative sources for our primary suppliers, including single source suppliers.
In the near term, we do not anticipate finding alternative sources for our primary suppliers.
The medical device industry has been characterized by significant litigation and other proceedings regarding patents, patent applications, and other intellectual property rights.
We may become involved in patent litigation or other intellectual property proceedings relating to our current and future product clearances, which could result in liability for damages or delay or stop our development and commercialization efforts. The medical device industry has been characterized by significant litigation and other proceedings regarding patents, patent applications, and other intellectual property rights.
Furthermore, an adverse regulatory action with respect to any of our products or operating procedures or to our suppliers’ manufacturing facilities could materially harm our reputation in the marketplace. Our operations are subject to environmental laws and regulations, with which compliance is costly and which exposes us to penalties for non-compliance.
Furthermore, an adverse regulatory action with respect to any of our products or operating procedures or to our suppliers’ manufacturing facilities could materially harm our reputation in the marketplace. Risks Relating to our Intellectual Property Our success depends on our ability to protect our intellectual property, unpatented trade secrets, know-how, confidential and proprietary information, and technology.
Accordingly, our success will be dependent on appropriately managing the risks related to maintaining his continued services, including having a succession plan. If we fail to attract and retain the talent required for our business, our business could be materially harmed.
Accordingly, our success will be dependent on appropriately managing the risks related to maintaining his continued services, including having a succession plan. We may be unable to scale our operations successfully. We are working to expand our size and scale via more penetration of existing markets and the launch of new complementary products and updates to existing products.
There can be no assurance that the outcomes from continuous examinations will not have an adverse effect on our business, financial condition, and results of operations. We are subject to various privacy and consumer protection laws.
There can be no assurance that the outcomes from continuous examinations will not have an adverse effect on our business, financial condition, and results of operations. ​ The constant growth and development of technology, including the increased use of Artificial Intelligence, presents risks and challenges to our operations that could give rise to legal or regulatory action, damage our reputation or otherwise materially harm of our business. ​ Emerging technology is a consistent subject of new laws or regulations and evolving interpretations and applications of laws and regulations.
A breach of our network security and systems could have negative consequences for our business and future prospects, including possible fines, penalties and damages, reduced customer demand for our products, and harm to our reputation and brand. 30 Table of Contents Risks Related to Our Industry We are subject to substantial government regulation that is subject to change and could force us to make modifications to how we develop, manufacture, market, and price our products.
Additionally, if we fail to keep pace with various AI technological developments, our competitive position and business results may be negatively impacted. ​ Risks Related to Our Industry We are subject to substantial government regulation that is subject to change and could force us to make modifications to how we develop, manufacture, market, and price our products.
Removed
Our business could be adversely impacted by the effects of various health epidemics. With respect to our sales, in the past, some customers implemented heightened security policies that inhibited the ability of our domestic sales force and international distributors to access hospitals for purposes of selling our products.
Added
Certain raw materials and components are proprietary products of those unaffiliated third-party suppliers and are specifically cited in our applications with regulatory agencies so that they must be obtained from that specific sole source or sources and could not be obtained from another supplier unless and until an appropriate application amendment is approved by the regulatory agency.
Removed
This caused delays of orders for our products and negatively affected our revenues. These heightened security policies and delays of orders may be reinstated or continue. Our materials suppliers could also be disrupted by epidemic related conditions, possibly resulting in disruption to our supply chain.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeCybersecurity risks are managed and controlled through multiple overlapping layers of cybersecurity defenses that include: ​ ● the implementation of a comprehensive cybersecurity policy that encompasses but is not limited to, information governance, monitoring, authentication, encryption, vulnerability management, third-party management, and recovery; ​ 42 Table of Contents ● required annual cybersecurity training for all employees with additional supplemental cybersecurity training required based on role; ​ ● random employee phish testing, training and follow-up; ​ ● procedural and automated cyber controls in conjunction with robust detection, mitigation, and recovery capabilities; ​ ● the integration of multiple threat intelligence sources into our cybersecurity tools and processes; ​ ● the retention of external cybersecurity threat response resources; and ​ ● the formation of a multidisciplinary cybersecurity incident response team. ​ The IRadimed board of directors provides enterprise-level oversight of risks associated with cybersecurity threats through the Audit Committee, which serves and functions as the Board’s primary oversight body to monitor the Company’s cybersecurity and related information technology risk and assists the Company’s board of directors in fulfilling its oversight responsibilities regarding the Company policies and processes with respect to risk assessment and risk management, including any significant non-financial risk exposures; reviewing and discussing our information security policies and internal controls regarding information security; and reviewing the annual disclosures concerning the role of the Board in the risk oversight of the Company.
Biggest changeCybersecurity risks are managed and controlled through multiple overlapping layers of cybersecurity defenses that include: ​ ● the implementation of a comprehensive cybersecurity policy that encompasses but is not limited to, information governance, monitoring, authentication, encryption, vulnerability management, third-party management, and recovery; ​ ● required annual cybersecurity training for all employees with additional supplemental cybersecurity training required based on role; ​ ● random employee phish testing, training and follow-up; ​ ● procedural and automated cyber controls in conjunction with robust detection, mitigation, and recovery capabilities; ​ ● the integration of multiple threat intelligence sources into our cybersecurity tools and processes; ​ ● the retention of external cybersecurity threat response resources; and ​ ● the formation of a multidisciplinary cybersecurity incident response team. ​ The Board provides enterprise-level oversight of risks associated with cybersecurity threats through the Audit Committee, which serves and functions as the Board’s primary oversight body to monitor the Company’s cybersecurity and related information technology risks and assists the Board of Directors in fulfilling its oversight responsibilities regarding Company policies and processes with respect to risk assessment and risk management, including any significant non-financial risk exposures; reviewing and discussing our information security policies and internal controls regarding information security; and reviewing the annual disclosures concerning the role of the Board in the risk oversight of the Company.
External third-party security firms are engaged to assist with cybersecurity risk assessments, penetration testing and system security analysis. Our cybersecurity team works in conjunction with the management, legal, finance, accounting, operations, and information technology areas to assess the risk these identified cybersecurity threats present to the organization.
External third-party security firms are engaged to assist with cybersecurity risk assessments, penetration testing and system security analysis. ​ Our cybersecurity team works in conjunction with management, legal, finance, accounting, operations, and information technology areas to assess the risk these identified cybersecurity threats present to the organization.
To ensure consistency, these cybersecurity risk assessments are incorporated into IRadimed’s enterprise risk management process, and our information technology leadership reviews the Company’s enterprise risk management-level cybersecurity risks on a quarterly basis, and key cybersecurity risks are incorporated into the enterprise risk management framework.
To ensure consistency, these cybersecurity risk assessments are incorporated into IRadimed’s enterprise risk management process, and our information technology leadership team reviews the Company’s enterprise risk management-level cybersecurity risks on a quarterly basis, and key cybersecurity risks are incorporated into the enterprise risk management framework.
The Audit Committee oversees the Company’s disclosure of any cybersecurity incident deemed material (and such materiality determination will be made by the Board upon recommendation of the Audit Committee) as required by the SEC or any other governmental authority, as applicable. ​ In addition to managing our own cybersecurity preparedness, we also consider and evaluate cybersecurity risks associated with the use of third-party service providers.
The Audit Committee 38 Table of Contents oversees the Company’s disclosure of any cybersecurity incident deemed material (and such materiality determination will be made by the Board upon recommendation of the Audit Committee) as required by the SEC or any other governmental authority, as applicable. ​ In addition to managing our own cybersecurity preparedness, we also consider and evaluate cybersecurity risks associated with the use of third-party service providers.
Added
The Chief Executive Officer is responsible for overseeing our information technology leadership team and leading the Company’s efforts to mitigate technology risks in partnership with various business leaders in the organization .

Item 2. Properties

Properties — owned and leased real estate

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Biggest changePursuant to the terms of our lease, the current monthly base rent is $34,133, adjusted annually for changes in the consumer price index.
Biggest changePursuant to the terms of the Lease Amendment, the monthly base rent is $34,133, adjusted annually for changes in the consumer price index, and the Lease Amendment has an expiration date of May 31, 2025, and includes an option to renew on a month-to-month basis for up to six months thereafter.
ITEM 2. PROPERTIES Our principal offices are currently located in a leased facility of approximately 23,100 square feet located in Winter Springs, Florida. This facility has been leased from an entity controlled by our founder, President, Chief Executive Officer, and Chairman of the Board of Directors, Roger Susi.
ITEM 2. PROPERTIES Our principal executive offices are currently located in a leased facility of approximately 23,100 square feet located in Winter Springs, Florida. This facility has been leased from an entity controlled by our founder, President, Chief Executive Officer, and Chairman of the Board of Directors, Roger Susi, Susi LLC.
For the twelve months ended December 31, 2023 and 2022, the Company paid $110,605 and $0 respectively. Under the terms of the lease, we are responsible for insurance and maintenance expenses. Pursuant to the contract terms, the leases will expire February 2025 and do not contain any residual value guarantee or material restrictive covenants.
For the twelve months ended December 31, 2024 and 2023, the Company paid $126,522 and $110,605 respectively. Under the terms of the leases, we are responsible for insurance and maintenance expenses. Pursuant to the contract terms, these leases expired February 2025, which the Company did not extend, and does not contain any residual value guarantee or material restrictive covenants.
The property was acquired as a site for future office, assembly and warehouse/shipping space to accommodate our increased operations and anticipated growth. In February 2023, we entered into two, two-year, non-cancelable operating leases for approximately 5,400 square feet of additional office space in Winter Springs, Florida. Pursuant to the lease terms the total monthly base rent is $10,055.
This Lease Amendment does not contain any residual value guarantee or material restrictive covenants In February 2023, we entered into two, two-year, non-cancelable operating leases for approximately 5,400 square feet of additional office space in Winter Springs, Florida. Pursuant to the lease terms the total monthly base rent is $10,055.
Removed
Prior to May 31, 2019, the expiration date of the initial lease term, and pursuant to the terms of the lease contract, we renewed the lease for an 43 Table of Contents additional five years, resulting in a new lease expiration date of May 31, 2024.
Added
On May 29, 2024, the Company entered into a lease amendment (the “Lease Amendment”) with Susi, LLC under which it did not exercise the second five-year option because of the Company’s continued construction of a new corporate office and manufacturing facility in Orange County, Florida, to accommodate our increased operations and anticipated growth.
Removed
Unless advance written notice of termination is timely provided, the lease will automatically renew for one additional successive term of five years beginning in 2024, and thereafter will be renewed for successive terms of one year each.
Removed
Pursuant to a reinstatement and amendment, dated February 2, 2023, to the previously announced sale and purchase agreement with O Property, Ltd., a Florida limited partnership, and the Company, dated November 1, 2022, the parties consummated the sale of approximately 26.518 acres of land located in Orange County, Florida to the Company for a purchase price of $6,200,000.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeMINE SAFETY DISCLOSURES Not applicable. ​ 44 Table of Contents PART II
Biggest changeMINE SAFETY DISCLOSURES Not applicable. 39 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changePurchases of Equity Securities by the Issuer The following table provides information regarding repurchases of common stock for the year ended December 31, 2023. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total Number Maximum ​ ​ ​ ​ ​ ​ ​ of Shares ​ Dollar Value of ​ ​ ​ ​ ​ ​ ​ Purchased as ​ Shares that ​ ​ Total ​ ​ ​ ​ Part of ​ May Yet ​ ​ Number of ​ ​ ​ ​ Publicly ​ Be Purchased ​ ​ Shares ​ Average Price ​ Announced ​ Under the ​ ​ Purchased ​ Paid per Share ​ Plans or ​ Plans or ​ (1) (2) Programs Programs January 1, 2023—January 31, 2023 898 $ — — $ — February 1, 2023—February 28, 2023 48 $ — — $ — March 1, 2023—March 31, 2023 469 $ — — $ — April 1, 2023—April 30, 2023 23 $ — — $ — May 1, 2023—May 31, 2023 524 $ — — $ — June 1, 2023—June 30, 2023 1,502 $ — — $ — July 1, 2023—July 31, 2023 588 $ — — $ — August 1, 2023—August 31, 2023 17 $ — — $ — September 1, 2023—September 30, 2023 66 $ — — $ — October 1, 2023—October 31, 2023 338 $ — — $ — November 1, 2023—November 30, 2023 — $ — — $ — December 1, 2023—December 31, 2023 10,004 $ — — $ — Total 14,477 $ — — $ — (1) The number of shares purchased reflects shares withheld for taxes on vesting of restricted stock.
Biggest changePurchases of Equity Securities by the Issuer The following table provides information regarding repurchases of common stock for the three months ended December 31, 2024. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total Number Maximum ​ ​ ​ ​ ​ ​ ​ of Shares ​ Dollar Value of ​ ​ ​ ​ ​ ​ ​ Purchased as ​ Shares that ​ ​ Total ​ ​ ​ ​ Part of ​ May Yet ​ ​ Number of ​ ​ ​ ​ Publicly ​ Be Purchased ​ ​ Shares ​ Average Price ​ Announced ​ Under the ​ ​ Purchased ​ Paid per Share ​ Plans or ​ Plans or ​ (1) (2) Programs Programs October 1, 2024—October 31, 2024 337 $ — — $ — November 1, 2024—November 30, 2024 379 $ — — $ — December 1, 2024—December 31, 2024 9,329 $ — — $ — Total 10,045 $ — — $ — (1) The number of shares purchased reflects shares withheld for taxes on vesting of restricted stock.
The following graph shows a comparison, from December 31, 2018 through December 31, 2023, of cumulative total return for our common stock, the Russell 2000 Index and the Nasdaq Medical Equipment Index. Such returns are based on historical results and are not intended to suggest future performance.
The following graph shows a comparison, from December 31, 2019 through December 31, 2024, of cumulative total return for our common stock, the Russell 2000 Index and the Nasdaq Medical Equipment Index. Such returns are based on historical results and are not intended to suggest future performance.
Data for the Russell 2000 Index and the Nasdaq Medical Equipment Index assumes reinvestment of dividends. ​ ITEM 6. [RESERVED] ​ 47 Table of Contents
Data for the Russell 2000 Index and the Nasdaq Medical Equipment Index assumes reinvestment of dividends. ​ ITEM 6. [RESERVED] ​ 41 Table of Contents
Equity Compensation Plan Information The information required by this item regarding our equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report Stock Performance Graph The following information of Part II Item 5 is being furnished and shall not be deemed to be “soliciting material” or to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor will it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that we specifically incorporate such information by reference thereto.
Equity Compensation Plan Information The information required by this item regarding our equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report 40 Table of Contents Stock Performance Graph The following information of Part II Item 5 is being furnished and shall not be deemed to be “soliciting material” or to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that Section, nor will it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that we specifically incorporate such information by reference thereto.
The special cash dividend and the quarterly dividend are payable on January 12, 2024, to shareholders of record at the close of business on December 18, 2023. ​ The decision on whether to pay cash dividends on our common stock in the future will be made by our Board of Directors, at its discretion, and will depend on our financial condition, operating results, capital requirements and other factors that the board of directors considers significant. ​ Unregistered Sales of Securities; Use of Proceeds from Registered Securities None.
The decision on whether to pay, and the amount of cash dividends, if any, on our common stock in the future will be made by our Board of Directors, at its discretion, and will depend on our financial condition, operating results, capital requirements and other factors that the Board of Directors considers significant. ​ Unregistered Sales of Securities; Use of Proceeds from Registered Securities None.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market for Common Stock Our common stock has been publicly traded on Nasdaq under the stock symbol “IRMD” since July 16, 2014. Prior to that date, there was no public market for our common stock.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market for Common Stock Our common stock was publicly traded under the stock symbol “IRMD” on the Nasdaq “Capital Market” from July 16, 2014 until June 13, 2024 and on the Nasdaq “Global Market” since June 14, 2024.
There were no shares repurchased pursuant to the open market repurchase authorization. (2) The average price paid per share does not include the withheld shares discussed in (1). 46 Table of Contents Transfer Agent The transfer agent and registrar for our common stock is Broadridge Financial Solutions, Inc.
There were no shares repurchased pursuant to the open market repurchase authorization. (2) The average price paid per share does not include the withheld shares discussed in (1).
On February 21, 2023, we paid $13,222,907, to shareholders of record at the close of business on February 13, 2023. On December 12, 2023, the Board of Directors declared a special cash dividend of $0.48 per share and the initiation of a regular quarterly dividend on the Company's outstanding common stock. The regular quarterly dividend is $0.15 per share.
Dividends On December 12, 2023, the Board of Directors declared the initiation of a regular quarterly dividend on the Company's outstanding common stock. On February 13, 2025, the Company announced that the Board increased our quarterly cash dividend from $0.15 to $0.17 per share.
This number is significantly less than and does not include “street name” or beneficial holders, whose shares are held by banks, brokers, financial institutions and other nominees. Dividends On February 2, 2023, the Board of Directors declared a special cash dividend of $1.05 per share on the Company’s common stock.
Prior to July 16, 2014, there was no public market for our common stock. Stockholders As of February 28, 2025, we had 3 stockholders of record. This number does not include “street name” or beneficial holders, whose shares are held by banks, brokers, financial institutions and other nominees.
Removed
The stock market in general has experienced significant stock price fluctuations in the past few years. In some cases, these fluctuations have been unrelated to the operating performance of the affected companies. Therefore, many companies have experienced dramatic volatility in the market prices of their common stock.
Removed
We believe that a number of factors, both within and outside our control, could cause the price of our common stock to fluctuate, perhaps substantially.
Removed
Factors such as the following (and others) could have a significant adverse impact on the market price of our common stock: ● Our financial position and results of operations; ● Our ability, if needed, to obtain additional financing and, if available, the terms and conditions of the financing; ● Concern as to, or other evidence of, the reliability and efficiency of our proposed products or our competitors’ products; ● Announcements of innovations or new products by us or our competitors; ● Federal, state, and international governmental regulatory actions and the impact of such requirements on our business; ● The development of litigation against us; ● Period-to-period fluctuations in our operating results; ● Changes in estimates of our performance by any securities analysts; ● The issuance of new equity securities pursuant to a future offering or acquisition; ● Poorly executed acquisitions or acquisitions whose projected potential is not realized; ● Changes in interest rates; ● Competitive developments, including announcements by competitors of new products or significant contracts, acquisitions, strategic partnerships, joint ventures or capital commitments; ● Sales of large blocks of our stock; ● Investor perceptions of our company; and ● General economic and other national and international conditions. 45 Table of Contents Stockholders As of February 29, 2024, we had 3 stockholders of record.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeOur historical operating results are not necessarily indicative of the results for any future period. ​ ​ ​ ​ ​ ​ ​ ​ Percent of Revenue ​ ​ Year Ended ​ ​ December 31, ​ ​ 2023 2022 Revenue ​ 100.0 % 100.0 % Cost of revenue ​ 23.5 22.6 ​ Gross profit ​ 76.5 77.4 ​ Operating expenses: ​ ​ ​ ​ General and administrative ​ 23.1 20.1 ​ Sales and marketing ​ 18.5 23.8 ​ Research and development ​ 4.4 4.3 ​ Total operating expenses ​ 46.0 48.2 ​ Income from operations ​ 30.5 29.3 ​ Other income, net ​ 2.6 1.0 ​ Income before provision for income taxes ​ 33.1 30.3 ​ Provision for income tax expense ​ 6.9 6.3 ​ Net income ​ 26.2 % 24.0 % ​ Comparison of the Years Ended December 31, 2023 and 2022 Revenue by Geographic Region ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2023 2022 ​ ​ ​ United States ​ $ 52,525,449 ​ $ 43,898,735 International ​ 13,036,847 ​ 9,404,410 Total revenue ​ $ 65,562,296 ​ $ 53,303,145 ​ 50 Table of Contents Revenue by Type ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2023 2022 ​ ​ ​ Devices: ​ ​ ​ MRI Compatible IV Infusion Pump Systems ​ $ 19,611,128 ​ $ 14,526,017 MRI Compatible Patient Vital Signs Monitoring Systems ​ 25,414,537 ​ 21,721,720 Ferro Magnetic Detection Systems ​ 944,793 ​ 257,112 Total Devices revenue ​ 45,970,458 ​ 36,504,849 Disposables, services and other ​ 17,578,366 ​ 14,622,327 Amortization of extended warranty agreements ​ 2,013,472 ​ 2,175,969 Total revenue ​ $ 65,562,296 ​ $ 53,303,145 ​ Revenue increased $12.3 million, or 23.0 percent, to $65.6 million from $53.3 million for the same period in 2022.
Biggest changeOur historical operating results are not necessarily indicative of the results for any future period. ​ ​ ​ ​ ​ ​ ​ ​ ​ Percent of Revenue ​ ​ ​ Year Ended December 31, ​ ​ 2024 2023 Revenue ​ 100.0 % 100.0 % Cost of revenue ​ 23.1 23.5 ​ Gross profit ​ 76.9 76.5 ​ Operating expenses: ​ ​ ​ ​ General and administrative ​ 21.8 23.1 ​ Sales and marketing ​ 21.3 18.5 ​ Research and development ​ 3.9 4.4 ​ Total operating expenses ​ 47.0 46.0 ​ Income from operations ​ 30.0 30.6 ​ Other income, net ​ 3.2 2.6 ​ Income before provision for income taxes ​ 33.2 33.2 ​ Provision for income tax expense ​ 6.9 6.9 ​ Net income ​ 26.3 % 26.3 % ​ Comparison of the Years Ended December 31, 2024 and 2023 Revenue by Geographic Region ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2024 2023 United States ​ $ 60,606,884 ​ $ 52,525,449 International ​ 12,635,237 ​ 13,036,847 Total revenue ​ $ 73,242,121 ​ $ 65,562,296 ​ 44 Table of Contents Revenue by Type ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2024 2023 Devices: ​ ​ ​ MRI Compatible IV Infusion Pump Systems ​ $ 26,598,792 ​ $ 19,611,128 MRI Compatible Patient Vital Signs Monitoring Systems ​ 24,411,777 ​ 25,414,537 Ferro Magnetic Detection Systems ​ 909,615 ​ 944,793 Total Devices revenue ​ 51,920,184 ​ 45,970,458 Disposables, services and other ​ 19,072,795 ​ 17,578,366 Amortization of extended warranty agreements ​ 2,249,142 ​ 2,013,472 Total revenue ​ $ 73,242,121 ​ $ 65,562,296 ​ For the year ended December 31, 2024, total revenue increased $7.6 million, or 12 percent, to $73.2 million from $65.6 million for the same period in 2023.
Each IV infusion pump system consists of an MRidium® MRI compatible IV infusion pump, non-magnetic mobile stand, proprietary disposable IV tubing sets and many of these systems contain additional optional upgrade accessories.
Each IV infusion pump system generally consists of an MRidium® MRI compatible IV infusion pump, non-magnetic mobile stand, proprietary disposable IV tubing sets and many of these systems contain additional optional upgrade accessories.
This increase is primarily due to higher expenses for legal and professional costs, regulatory approval and consulting costs, and payroll and employee benefits costs. These increases are a direct result of the continuous growth of the Company and need for additional support resources.
This increase is primarily due to higher expenses for legal and professional costs, regulatory approval and consulting costs, and payroll and employee benefits costs. These increases are a direct result of the continued growth of the Company and need for additional support resources.
Our future liquidity and capital requirements will depend on numerous factors, including the: ● Amount and timing of revenue and expenses; ● Dividend policy; ● Extent to which our existing and new products gain market acceptance; ● Extent to which we make acquisitions; ● Cost and timing of product development efforts and the success of these development efforts; ● Cost and timing of selling and marketing activities; and ● Availability of borrowings or other means of financing.
Our future liquidity and capital requirements will depend on numerous factors, including the: ● Amount and timing of revenue and expenses; 47 Table of Contents ● Dividend policy; ● Extent to which our existing and new products gain market acceptance; ● Extent to which we make acquisitions; ● Cost and timing of product development efforts and the success of these development efforts; ● Cost and timing of selling and marketing activities; and ● Availability of borrowings or other means of financing.
From time to time, we may explore additional financing sources to meet our working capital requirements, make continued investment in research and development, expand our business and acquire products or businesses that complement our current business. These actions would likely affect our future capital 53 Table of Contents requirements and the adequacy of our available funds.
From time to time, we may explore additional financing sources to meet our working capital requirements, make continued investment in research and development, expand our business and acquire products or businesses that complement our current business. These actions would likely affect our future capital requirements and the adequacy of our available funds.
We believe our sources of liquidity, including cash flow from operations, existing cash, and available financing sources will be sufficient to meet our projected cash requirements for at least the next 12 months from the date the financial statements are issued.
We believe our sources of liquidity, including cash flow from operations, existing cash, and available financing sources will be sufficient to meet our projected cash requirements for at least the next 12 months from the date the financial statements are issued and into the foreseeable future.
The principal customers for our MRI compatible products include hospitals and acute care facilities, both in the United States and internationally. As of December 31, 2023, our direct U.S. sales force consisted of 25 field sales representatives, 3 regional sales directors and supplemented by 7 clinical application specialists. Internationally, we have distribution agreements with independent distributors selling our products.
The principal customers for our MRI compatible products include hospitals and acute care facilities, both in the United States and internationally. As of December 31, 2024, our direct U.S. sales force consisted of 27 field sales representatives, 4 regional sales directors and supplemented by 10 clinical application specialists. Internationally, we have distribution agreements with independent distributors selling our products.
We consider transfer of control evidenced upon the passage of title and risks and rewards of ownership to the customer, which is typically at a point in time, except for our extended warranty agreements.
We consider transfer of control evidenced upon the passage of title and risks and rewards of ownership to the customer, which is typically at a point in time, except for our extended warranty agreements. We allocate the transaction price using the relative standalone selling price method.
During 2023, cash provided by operations was positively impacted by higher net income, accounts receivable, stock compensation, and deferred revenue. Cash provided by operations was negatively impacted by inventory, accounts payable, and deferred income taxes.
During 2024, cash provided by operations was positively impacted by higher net income, lower inventory, lower accounts receivable, and increased stock compensation. Cash provided by operations was negatively impacted by higher accounts payable and other accruals, higher deferred revenue, and higher deferred income taxes.
Revenue from the amortization of our extended warranty agreements decreased $0.2 million, or 7.5%, to $2.0 million from $2.2 million for the same period in 2022. The increase in ancillary product sales aligns with the increased sales of our devices.
Revenue from the amortization of our extended warranty agreements increased $0.2 million, or 11.7 percent, to $2.2 million from $2.0 million for the same period in 2023. The increase in ancillary product sales and revenue from amortization aligns with the increased gross sales of our devices.
Gross profit increased approximately $8.9 million, or 21.5 percent, to $50.2 million for the year ended December 31, 2023 from $41.3 million for the same period in 2022. The increase in cost of revenue and gross profit is primarily due to higher revenue during the year ended December 31, 2023, compared to the same period in 2022.
Gross profit increased approximately $6.1 million, or 12.1 percent, to $56.3 million for the year ended December 31, 2024 from $50.2 million for the same period in 2023. The increase in cost of revenue and gross profit is primarily due to higher revenue during the year ended December 31, 2024, compared to the same period in 2023.
Gross profit margin was 76.5 percent and 77.4 percent for the years ended December 31, 2023 and 2022, respectively. The increase in gross profit margin is the result of favorable overhead variance adjustments and higher average selling prices in 2023 compared to 2022, offset by increased raw material costs due to inflation.
Gross profit margin was 76.9 percent and 76.5 percent for the years ended December 31, 2024 and 2023, respectively. The increase in gross profit margin is the result of favorable overhead variance adjustments and higher average selling prices in 2024 compared to 2023, a reduction in raw material costs, and increased management oversight of inventory.
Our estimated installed base of medical devices is as follows: ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2023 2022 IV Infusion Pump Systems 7,196 6,582 Patient Vital Signs Monitoring Systems 2,166 1,596 ​ Critical Accounting Policies and Estimates We prepare our financial statements in conformity with U.S. GAAP.
Our estimated cumulative unit sales of medical devices are as follows: ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2024 2023 IV Infusion Pump Systems 7,832 7,196 Patient Vital Signs Monitoring Systems 2,679 2,166 ​ Critical Accounting Policies and Estimates We prepare our financial statements in conformity with U.S. GAAP.
Standard infusion pumps contain magnetic and electronic components which can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system.
We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components which can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system.
This increase was the result of higher overall unit sales, particularly our IV infusion pump systems. Revenue from sales of our disposables, service and other increased $3.0 million, or 20.2 percent, to $17.6 million from $14.6 million for the same period in 2022.
This increase was the result of higher overall unit sales, particularly our IV infusion pump systems. For the year ended December 31, 2024, revenue from sales of our disposables, service and other increased $1.5 million, or 8.5 percent, to $19.1 million from $17.6 million for the same period in 2023.
Domestic sales accounted for 80.1 percent of total revenue for the year ended December 31, 2023, compared to 82.4 percent for the same period in 2022. Revenue from sales of devices increased $9.5 million, or 25.9 percent, to $46.0 million from $36.5 million for the same period in 2022.
Domestic sales accounted for 83 percent of total revenue for the year ended December 31, 2024, compared to 80 percent for the same period in 2023. For the year ended December 31, 2024, revenue from sales of devices increased $6.0 million, or 13.0 percent, to $51.9 million from $45.9 million for the same period in 2023.
Sales and Marketing Sales and marketing expenses decreased approximately $0.6 million, or 4.3 percent, to $12.1 million for the year ended December 31, 2023, from $12.7 million for the same period in 2022. This decrease is primarily the result of lower expenses for sales commissions, partially offset by higher expenses for payroll and benefits.
Sales and Marketing Sales and marketing expenses increased approximately $3.5 million, or 28.6 percent, to $15.6 million for the year ended December 31, 2024, from $12.1 million for the same period in 2023. This increase is primarily the result of increased expenses for sales commissions, sales-related travel costs, and higher expenses for payroll and benefits.
We allocate the transaction price using the relative standalone selling price method. 49 Table of Contents Customer sale prices for our medical devices and related disposables and services are contractually fixed over the contract term. We recognize a receivable at the point in time we have an unconditional right to payment.
Customer sale prices for our medical devices and related disposables and services are contractually fixed over the contract term. We recognize a receivable at the point in time we have an unconditional right to payment. Payment 43 Table of Contents terms are typically within 45 days after transferring control to U.S. customers.
Income Taxes We recorded a provision for income tax expense of approximately $4.5 million for the year ended December 31, 2023, compared to a tax expense of approximately $3.4 million for the year ended December 31, 2022.
This increase is primarily the result of higher interest income during the year ended December 31, 2024 compared to the same period in 2023. Income Taxes We recorded a provision for income tax expense of approximately $5.0 million for the year ended December 31, 2024, compared to a tax expense of approximately $4.5 million for the same period in 2023.
Our effective tax rate for the year ended December 31, 2023 was 20.8 percent compared to 20.7 percent for the same period in 2022.
Our effective tax rate for the year ended December 31, 2024 was 20.8 percent compared to 20.9 percent for the same period in 2023. The decrease in our effective tax rate is negligible and attributable to a number of immaterial factors.
Revenue from sales in the U.S. increased $8.6 million, or 19.7 percent, to $52.5 million from $43.9 million for the same period in 2022. Revenue from sales internationally increased $3.6 million, or 38.6 percent, to $13.0 million from $9.4 million for the same period in 2022.
For the year ended December 31, 2024, revenue from sales in the U.S. increased $8.1 million, or 15.4 percent, to $60.6 million from $52.5 million for the same period in 2023. Revenue from sales internationally decreased $0.4 million, or 3.1 percent, to $12.6 million from $13.0 million for the same period in 2023.
Cost of Revenue and Gross Profit ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ Years Ended December 31, ​ ​ ​ 2023 2022 Revenue ​ ​ $ 65,562,296 ​ $ 53,303,145 ​ Cost of revenue ​ ​ 15,404,027 ​ 12,020,742 ​ Gross profit ​ ​ $ 50,158,269 ​ $ 41,282,403 ​ Gross profit percentage ​ ​ 76.5 % 77.4 % ​ Cost of revenue increased approximately $3.4 million, or 28.1 percent, to $15.4 million for the year ended December 31, 2023, from $12.0 million for the same period in 2022.
Cost of Revenue and Gross Profit ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ December 31, ​ ​ ​ 2024 2023 Revenue ​ ​ $ 73,242,121 ​ $ 65,562,296 ​ Cost of revenue ​ ​ 16,892,240 ​ 15,404,027 ​ Gross profit ​ ​ $ 56,349,881 ​ $ 50,158,269 ​ Gross profit percentage ​ ​ 76.9 % 76.5 % ​ Cost of revenue increased approximately $1.5 million, or 9.7 percent, to $16.9 million for the year ended December 31, 2024, from $15.4 million for the same period in 2023.
As of December 31, 2023, we had cash and investments of $49.8 million, stockholders’ equity of $71.4 million, and working capital of $59.7 million, compared to cash and cash equivalents and investments of $58.0 million, stockholders’ equity of $73.7 million, and working capital of $68.9 million as of December 31, 2022. ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2023 2022 Net cash provided by operating activities ​ $ 13,465,012 ​ $ 10,042,711 Net cash used in investing activities ​ (8,007,167) ​ (1,374,997) Net cash used in financing activities ​ (13,656,511) ​ (12,706,400) ​ Comparison of the Years Ended December 31, 2023 and 2022 Operating Activities For the year ended December 31, 2023, cash provided by operations increased $3.5 million to $13.5 million, from $10.0 million in 2022.
Our principal uses of cash are operating expenses, working capital requirements, capital expenditures and dividend payments. 46 Table of Contents As of December 31, 2024, we had cash and investments of $52.2 million, stockholders’ equity of $86.8 million, and working capital of $66.2 million, compared to cash and cash equivalents and investments of $49.8 million, stockholders’ equity of $71.4 million, and working capital of $59.7 million as of December 31, 2023. ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2024 2023 Net cash provided by operating activities ​ $ 25,624,463 ​ $ 13,465,012 Net cash used in investing activities ​ (8,816,786) ​ (8,007,167) Net cash used in financing activities ​ (14,335,968) ​ (13,656,511) ​ Comparison of the Years Ended December 31, 2024 and 2023 Operating Activities For the year ended December 31, 2024, cash provided by operations increased $12.1 million to $25.6 million, from $13.5 million in 2023.
Our Business We develop, manufacture, market and distribute Magnetic Resonance Imaging (“MRI”) compatible medical devices and accessories, disposables and services relating to them. We are a leader in the development of innovative MRI compatible medical devices.
Our Business We develop, manufacture, market and distribute MRI compatible medical devices and accessories, disposables and services relating to them. We are a leader in the development of innovative MRI compatible medical devices. We are the only known provider of a non-magnetic IV infusion pump system that is specifically designed to be safe for use during MRI procedures.
The increase in our effective tax rate is primarily the result of higher book income before the provision for income taxes. 52 Table of Contents Liquidity and Capital Resources Our principal sources of liquidity have historically been our cash and cash equivalents balances, our investments, cash flow from operations and access to the financial markets.
Liquidity and Capital Resources Our principal sources of liquidity have historically been our cash and cash equivalents balances, our investments, cash flow from operations and access to the financial markets.
Our manufacturing operations and headquarters facility is approximately 23,100 square feet located in Winter Springs, Florida. This facility has been leased from Susi, LLC, an entity controlled by our President, Chief Executive Officer, and Chairman, Roger Susi. Pursuant to the terms of our lease, the monthly base rent is $34,133, adjusted annually for changes in the consumer price index.
Sales to end users in the United States are generally made on open credit terms. Management maintains an allowance for potential credit losses. Our manufacturing operations and headquarters facility is approximately 23,100 square feet located in Winter Springs, Florida. This facility has been leased from Susi, LLC, an entity controlled by our President, Chief Executive Officer, and Chairman, Roger Susi.
Other Income, Net Other income, net consists of interest income, foreign currency transactional gains and losses, and other miscellaneous income. We reported other income of approximately $1.7 million and $0.6 million for the years ended December 31, 2023 and 2022, respectively.
This is primarily due to higher payroll and benefits costs, offset by lower prototype design and consulting expenses. Other Income, Net Other income, net consists of interest income, foreign currency transactional gains and losses, and other miscellaneous income. We reported other income of approximately $2.3 million and $1.7 million for the years ended December 31, 2024 and 2023, respectively.
Investing Activities For the year ended December 31, 2023, cash related to investing activities decreased $6.6 million to a use of $8.0 million, from $1.4 million used in 2022. During 2023, cash related to investing activities was impacted by purchases of property and equipment, specifically the purchase of land.
Investing Activities For the year ended December 31, 2024, cash used in investing activities increased $0.8 million to $8.8 million, from $8.0 million used in 2023. During 2024, cash related to investing activities was impacted by purchases of property and equipment, specifically ongoing construction costs for our new corporate office and manufacturing facility in Orange County, Florida.
Our diluted earnings per share was $1.35 in 2023, and $1.02 in 2022. Our cash provided by operations was $13.5 million in 2023, and $10.0 million in 2022.
Financial Highlights and Outlook Our revenue was $73.2 million in 2024 and $65.6 million in 2023. Our diluted earnings per share was $1.50 in 2024, and $1.35 in 2023. Our cash provided by operations was $25.6 million in 2024, and $13.5 million in 2023.
We also enter into agreements with IDNs and healthcare supply contracting companies, which are commonly referred to as GPOs in the U.S., which enable us to sell and distribute our products to their member hospitals. GPOs negotiate volume 48 Table of Contents purchase prices for hospitals, group practices, and other clinics that are members of a GPO.
Selling cycles for our devices have varied widely and have historically ranged between three and six months in duration. We also enter into agreements with IDNs and healthcare supply contracting companies, which are commonly referred to as GPOs in the U.S., which enable us to sell and distribute our products to their member hospitals.
Operating Expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ ​ 2023 2022 General and administrative ​ ​ $ 15,122,065 ​ $ 10,697,067 ​ Percentage of revenue ​ ​ 23.1 % 20.1 % Sales and marketing ​ ​ $ 12,142,090 ​ $ 12,679,610 ​ Percentage of revenue ​ ​ 18.5 % 23.8 % Research and development ​ ​ $ 2,858,656 ​ $ 2,278,081 ​ Percentage of revenue ​ ​ 4.4 % 4.3 % ​ General and Administrative General and administrative expense increased approximately $4.4 million, or 41.4 percent, to $15.1 million for the year ended December 31, 2023, from $10.7 million for the same period last year.
The increase in year over year sales also positively impacts the Company’s ability to favorably absorb overhead costs and increase gross profit margin. 45 Table of Contents Operating Expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ ​ 2024 2023 General and administrative ​ ​ $ 15,937,123 ​ $ 15,122,065 ​ Percentage of revenue ​ ​ 21.8 % 23.1 % Sales and marketing ​ ​ $ 15,616,442 ​ $ 12,142,090 ​ Percentage of revenue ​ ​ 21.3 % 18.5 % Research and development ​ ​ $ 2,831,589 ​ $ 2,858,656 ​ Percentage of revenue ​ ​ 3.9 % 4.4 % ​ General and Administrative General and administrative expense increased approximately $0.8 million, or 5.4 percent, to $15.9 million for the year ended December 31, 2024, from $15.1 million for the same period in 2023.
Results of Operations The following table sets forth for the periods indicated selected statements of operations data as a percentage of total revenue.
We have elected to exclude the amounts collected for these taxes from revenue and record them as a liability until remitted to the taxing authority. Results of Operations The following table sets forth, for the periods indicated, selected statements of operations data as a percentage of total revenue.
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. Financial Highlights and Outlook Our revenue was $65.6 million in 2023 and $53.3 million in 2022.
GPOs negotiate volume purchase prices for hospitals, group practices, and other clinics that are members of a GPO. Under our 42 Table of Contents 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.
In certain U.S. states we are required to collect sales taxes from our customers. We have elected to exclude the amounts collected for these taxes from revenue and record them as a liability until remitted to the taxing authority.
We have elected to account for shipping and handling charges billed to customers as revenue and shipping and handling related expenses as cost of revenue. In certain U.S. states we are required to collect sales taxes from our customers.
Payment terms are typically within 45 days after transferring control to U.S. customers. Most international distributors are required to pay a portion of the transaction price in advance and the remaining amount within 30 days of receiving the related products.
Most international distributors are required to pay a portion of the transaction price in advance and the remaining amount within 30 days of receiving the related products. Accordingly, we have elected to use the practical expedient that allows us to ignore the possible existence of a significant financing component within the contract.
During 2022, cash related to investing activities was impacted by maturities of investments, purchases of property and equipment, and capitalized intangible assets. Financing Activities For the year ended December 31, 2023, cash related to financing activities decreased $1.0 million to a use of $13.7 million, from $12.7 million used in 2022.
Financing Activities For the year ended December 31, 2024, cash used in financing activities increased $0.6 million to $14.3 million, from $13.7 million used in 2023. During 2024, cash used in financing activities was related to cash payments for dividends and taxes paid for the net share settlement of restricted stock units.
Lower commissions are related to the sales cycle, and not necessarily in line with revenue growth. The increases are a direct result of the continuing growth of the Company.
Higher commissions are related to the sales cycle, and in line with revenue growth. The increases are a direct result of the continued growth of the Company. Research and Development Research and development expense remained relatively consistent at $2.8 million for the year ended December 31, 2024, compared to $2.9 million for the same period in 2023.
Removed
We are the only known provider of a non-magnetic intravenous (“IV”) infusion pump system that is specifically designed to be safe for use during MRI procedures. We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures.
Added
Pursuant to the terms of the Amended Lease Amendment, the monthly base rent is $34,133, adjusted annually for changes in the consumer price index.
Removed
Selling cycles for our devices have varied widely and have historically ranged between three and six months in duration with more recent trends lengthening beyond this historical range due to lingering pandemic issues.
Removed
Accordingly, we have elected to use the practical expedient that allows us to ignore the possible existence of a significant financing component within the contract. We have elected to account for shipping and handling charges billed to customers as revenue and shipping and handling related expenses as cost of revenue.
Removed
The decline in revenue from the amortization of deferred revenue year-over-year is primarily due to a higher initial volume of deferred revenue during the pandemic, as more companies were purchasing extended warranties at that time.
Removed
The increase 51 Table of Contents in year over year sales also positively impacts the Company’s ability to favorably absorb overhead costs and increase gross profit margin.
Removed
Research and Development Research and development expense increased approximately $0.6 million, or 25.5 percent, to $2.9 million for the year ended December 31, 2023, from $2.3 million for the same period in 2022. This is primarily due to higher payroll and benefits costs, offset by lower prototype design and consulting expenses.
Removed
This increase is primarily the result of higher interest income during the year ended December 31, 2023 compared to the same period in 2022.
Removed
Our principal uses of cash are operating expenses, working capital requirements and capital expenditures.
Removed
During 2023, cash used in financing activities was related to a cash payment for a dividend and taxes paid for the net share settlement of restricted stock units. Sales to end users in the United States are generally made on open credit terms. Management maintains an allowance for potential credit losses.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

3 edited+0 added−0 removed5 unchanged
Biggest changeOur interest income is sensitive to changes in the general level of interest rates in the U.S. If market interest rates were to change by 100 basis points from levels at December 31, 2023, we expect a corresponding change of approximately $431,000 in interest income earned on our excess cash held in interest bearing accounts. ITEM 8.
Biggest changeOur interest income is sensitive to changes in the general level of interest rates in the U.S. If market interest rates were to change by 100 basis points from levels at December 31, 2024, we expect a corresponding change of approximately $489,000 in interest income earned on our excess cash held in interest bearing accounts. ITEM 8.
Dollar uniformly increased or decreased in strength by 10 percent relative to the Yen, our net income would have correspondingly increased or decreased by an immaterial amount for the year ended December 31, 2023. Interest Rate Risk When able, we invest excess cash in money-market funds, and in the past, corporate debt securities or discrete short-term investments.
Dollar uniformly increased or decreased in strength by 10 percent relative to the Yen, our net income would have correspondingly increased or decreased by an immaterial amount for the year ended December 31, 2024. Interest Rate Risk When able, we invest excess cash in money-market funds, and in the past, corporate debt securities or discrete short-term investments.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The Financial Statements and Supplementary Data required by this Item 8 are incorporated by reference to information beginning on Page F-1 of this Form 10-K. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. 54 Table of Contents
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The Financial Statements and Supplementary Data required by this Item 8 are incorporated by reference to information beginning on Page F-1 of this Form 10-K. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. 48 Table of Contents

Other IRMD 10-K year-over-year comparisons