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What changed in Stereotaxis, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Stereotaxis, Inc.'s 2024 and 2025 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 2025 report.

+260 added−249 removedSource: 10-K (2026-03-12) vs 10-K (2025-03-14)

Top changes in Stereotaxis, Inc.'s 2025 10-K

260 paragraphs added · 249 removed · 207 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

73 edited+16 added−22 removed150 unchanged
Biggest changeIn addition, effective January 1, 2020, California passed the California Consumer Privacy Act (the “CCPA”), which is considered by many to be the most far-reaching data privacy law introduced in the U.S. to date and which introduces new compliance burdens on many organizations doing business in California who collect Personal Information about California residents.
Biggest changeFailure to comply with the requirements of the GDPR and the applicable national data protection laws of the EU member states may result in fines of up to €20 million or 4% of the total worldwide annual turnover of the preceding financial year, whichever is greater, and other administrative penalties. 15 In addition, effective January 1, 2020, California passed the California Consumer Privacy Act (the “CCPA”), which is considered by many to be the most far-reaching data privacy law introduced in the U.S. to date and which introduces new compliance burdens on many organizations doing business in California who collect Personal Information about California residents.
Our system potentially has broad applicability in other areas, such as structural heart repair, interventional neurosurgery, interventional neuroradiology, peripheral vascular, renal denervation, pulmonology, urology, gynecology and gastrointestinal medicine, and some of our patents may be applicable in these areas as well. 8 Electrophysiology The rhythmic beating of the heart results from the transmission of electrical impulses.
Our system potentially has broad applicability in other areas, such as structural heart repair, interventional neurosurgery, interventional neuroradiology, peripheral vascular, renal denervation, pulmonology, urology, gynecology and gastrointestinal medicine, and some of our patents may be applicable in these areas as well. Electrophysiology The rhythmic beating of the heart results from the transmission of electrical impulses.
HIPAA also prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. 15 In addition to federal regulations issued under HIPAA, some states and foreign countries have enacted privacy and security statutes or regulations that, in some cases, are more stringent than those issued under HIPAA.
HIPAA also prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. In addition to federal regulations issued under HIPAA, some states and foreign countries have enacted privacy and security statutes or regulations that, in some cases, are more stringent than those issued under HIPAA.
Because our robotic technology provides precise, computerized control of the working tip of disposable interventional devices, we believe that it will potentially enable difficult diseases to be treated endovascularly on a much broader scale than today. ● Enhance patient and physician safety.
Because our robotic technology provides precise, computerized control of the working tip of disposable interventional devices, we believe that it will potentially enable difficult diseases to be treated endovascularly on a much broader scale than today. 5 ● Enhance patient and physician safety.
Regulatory Approval We have received regulatory clearance, licensing and/or approvals necessary for us to market the Genesis System with Cardiodrive, iCONNECT, Navigant, Odyssey and QuikCAS in the U.S., Europe, and China, and we are in the process of pursuing registrations for extending our markets in other countries.
Regulatory Approval We have received regulatory clearance, and/or approvals necessary for us to market the Genesis System with Cardiodrive, iCONNECT, Navigant, Odyssey and QuikCAS in the U.S., Europe, and China, and we are in the process of pursuing registrations for extending our markets in other countries.
We believe our robotic technology can enhance procedure results by improving navigation of disposable interventional devices to treatment sites, and by affecting more precise and safe treatments once these sites are reached. 5 ● Expand the market by enabling minimally invasive endovascular intervention.
We believe our robotic technology can enhance procedure results by improving navigation of disposable interventional devices to treatment sites, and by affecting more precise and safe treatments once these sites are reached. ● Expand the market by enabling minimally invasive endovascular intervention.
We believe more than 7,000 interventional labs around the world are currently conducting over one and a half million cardiac ablation procedures annually. The market has grown rapidly over the last decade with annualized procedure growth of approximately 10%.
We believe more than 7,000 interventional labs around the world are currently conducting nearly one and a half million cardiac ablation procedures annually. The market has grown rapidly over the last decade with annualized procedure growth of approximately 10%.
However, we believe that these measures afford only limited protection. COMPETITION The markets for medical devices are intensely competitive and are characterized by rapid technological advances, frequent new product introductions, evolving industry standards and price erosion.
However, we believe that these measures afford only limited protection. 12 COMPETITION The markets for medical devices are intensely competitive and are characterized by rapid technological advances, frequent new product introductions, evolving industry standards, and price erosion.
GenesisX RMN, Genesis RMN ® , Niobe ® , Navigant ® , Synchrony, SynX, Odyssey ® , Odyssey Cinema ™ , MAGiC ™, EMAGIN, Map-iT™, QuikCAS ™, Cardiodrive ® , Vdrive ® , Vdrive Duo ™ , V-CAS ™ , V-Loop ™ , V-Sono ™ , and NuVizion are trademarks of Stereotaxis, Inc.
GenesisX RMN ® , Genesis RMN ® , Niobe ® , Navigant ® , Synchrony™, SynX™, Odyssey ® , Odyssey Cinema ™ , MAGiC™, MAGiC Sweep™, EMAGIN™, Map-iT™, QuikCAS ™, Cardiodrive ® , Vdrive ® , Vdrive Duo ™ , V-CAS ™ , V-Loop ™ , V-Sono™, and NuVizion™ are trademarks of Stereotaxis, Inc.
Our global leadership represents a broad range of backgrounds and brings a wide array of perspectives and experiences that have helped us achieve our leadership in innovative robotic technologies designed to enhance the treatment of arrhythmias and to perform endovascular procedures. As of December 31, 2024, our employees were based in 11 different countries around the world, including the U.S.
Our global leadership represents a broad range of backgrounds and brings a wide array of perspectives and experiences that have helped us achieve our leadership in innovative robotic technologies designed to enhance the treatment of arrhythmias and to perform endovascular procedures. As of December 31, 2025, our employees were based in 11 different countries around the world, including the U.S.
The Odyssey Solution enables physicians to access recorded cases and create snapshots following procedures for enhanced clinical reporting, auditing and presentation. The Odyssey Solution enables physicians to establish a comprehensive master archive of procedures performed in the lab providing an excellent tool for training new staff on the standard practices.
The Odyssey Solution enables physicians to access recorded cases and creates snapshots following procedures for enhanced clinical reporting, auditing and presentation. The Odyssey Solution enables physicians to establish a comprehensive master archive of procedures performed in the lab providing an excellent tool for training new staff on standard practices.
In addition, we had 7 issued foreign patents and 5 pending foreign patent applications. The key patents that protect our technology and systems extend until 2028 and beyond. We also have a number of invention disclosures under consideration and several applications that are being prepared for filing.
In addition, we had 6 issued foreign patents and 5 pending foreign patent applications. The key patents that protect our technology and systems extend until 2028 and beyond. We also have a number of invention disclosures under consideration and several applications that are being prepared for filing.
Through our strategic relationships with fluoroscopy system manufacturers, providers of catheters and electrophysiology mapping systems, and other parties, we offer our customers x-ray systems and other accessory devices.
Through our strategic relationships with fluoroscopy system manufacturers, providers of catheters and electrophysiology mapping systems, and other parties, we offer our customers x-ray systems and other accessory diagnostic and therapeutic devices.
Biosense Webster’s compatible catheters used with our magnetic navigation system, as well as the MAGiC catheter, are Class III therapeutic devices and are subject to the PMA process. If U.S. clinical data are needed to support clearance, approval or a marketing application for our devices, generally, an investigational device exemption, or IDE, is assembled and submitted to the FDA.
The J&J compatible catheters used with our magnetic navigation system, as well as the MAGiC catheter, are Class III therapeutic devices and are subject to the PMA process. 13 If U.S. clinical data are needed to support clearance, approval or a marketing application for our devices, generally, an investigational device exemption, or IDE, is assembled and submitted to the FDA.
We have also collaborated with a number of highly regarded interventional physicians in key clinical areas and have entered into agreements with a number of universities and teaching hospitals, which serve to increase our access to world class physicians and to expand our name recognition in the medical community.
We have also collaborated with highly regarded interventional physicians in key clinical areas and have entered into agreements with universities and teaching hospitals, which serve to increase our access to world class physicians and to expand our name recognition in the medical community.
We pursue arrangements with fluoroscopy system manufacturers to provide such systems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms.
We pursue arrangements with fluoroscopy system manufacturers to provide RMN Systems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms.
The robotic magnetic navigation system can also be programmed to carry out sequences of complex navigation automatically further enhancing ease of use. We believe the Odyssey Solution can allow advanced training online thereby accelerating learning. ● Help hospitals recruit physicians and attract patients.
The robotic magnetic navigation system can also be programmed to carry out sequences of complex navigation automatically further enhancing ease of use. We believe the Odyssey and Synchrony & SynX Solutions can allow advanced training online thereby accelerating learning. ● Help hospitals recruit physicians and attract patients.
Software The software components of the robotic magnetic navigation system and Odyssey Solution, including control and application software, are developed both internally and with integrated modules we purchase or license. We perform final testing of software products in-house prior to their commercial release.
Software The software components of the robotic magnetic navigation system and the Odyssey and Synchrony & SynX Solutions , including control and application software, are developed both internally and with integrated modules we purchase or license. We perform final testing of software products in-house prior to their commercial release.
The Odyssey Solution improves clinical workflow and information management efficiency by integrating and synchronizing the multiple sources of diagnostic and imaging information found in the interventional labs into a large-screen user interface with single mouse and keyboard control. ● Enhance hospital efficiency by reducing and standardizing procedure times, disposables utilization and staffing needs.
The Odyssey and Synchrony & SynX Solutions improve clinical workflow and information management efficiency by integrating and synchronizing the multiple sources of diagnostic and imaging information found in the interventional labs into a large-screen user interface with single mouse and keyboard control. ● Enhance hospital efficiency by reducing and standardizing procedure times, disposables utilization and staffing needs.
We have an extensive patent portfolio that we believe protects the fundamental scope of our technology and systems, including our robotic magnetic technology, navigational methods, mapping system and procedural workflows, 3D integration technology, and disposable interventional devices. As of December 31, 2024, we had 44 issued U.S. patents and 2 pending U.S. patent application.
We have an extensive patent portfolio that we believe protects the fundamental scope of our technology and systems, including our robotic magnetic technology, navigational methods, mapping system and procedural workflows, 3D integration technology, and disposable interventional devices. As of December 31, 2025, we had 43 issued U.S. patents and 3 pending U.S. patent application.
THE STEREOTAXIS VALUE PROPOSITION Although great strides have been made in manual interventional devices and techniques, significant challenges remain that reduce interventional productivity and limit both the number of complex procedures and the types of diseases that can be treated manually.
Management’s Discussion and Analysis of Financial Condition and Results of Operations”. THE STEREOTAXIS VALUE PROPOSITION Although great strides have been made in manual interventional devices and techniques, significant challenges remain that reduce interventional productivity and limit both the number of complex procedures and the types of diseases that can be treated manually.
We believe that the Odyssey Solution enhances the physician workflow in interventional labs through a consolidated user interface of multiple systems on a single display to enable greater focus on the case and improve the efficiency of the lab.
We believe that these tools enhance the physician workflow in interventional labs through a consolidated user interface of multiple systems on a single display to enable greater focus on the case and improve the efficiency of the lab.
Revenue from product maintenance plans and software enhancements, service-type warranties, and the implied obligation to provide software enhancements are deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed on a time-and-materials basis is recognized when performed.
Revenue from services and software enhancements, including service-type warranties, are deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed on a time-and-materials basis is recognized when performed.
The Genesis RMN System is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters through the blood vessels and chambers of the heart to treatment sites.
The Genesis RMN and the GenesisX RMN Systems are designed to enable physicians to complete complex interventional procedures by providing image-guided delivery of catheters through the blood vessels and chambers of the heart to treatment sites.
Odyssey ® Solution The Odyssey Solution offers a fully integrated, real-time information solution to manage, control, record and share procedures across networks or around the world.
Odyssey ® Solution The Odyssey Solution, and the next generation, Synchrony and SynX Solution, offer a fully integrated, real-time information solution to manage, control, record and share procedures across networks or around the world.
The maintenance of strategic relationships with compatible devices, or the establishment of equivalent alternatives, is critical to our commercialization efforts. There are no guarantees that any existing strategic relationships will continue, and efforts are ongoing to ensure the availability of compatible systems and devices and/or equivalent alternatives.
Warranty costs were not material for the periods presented. The maintenance of strategic relationships with compatible devices, or the establishment of equivalent alternatives, is critical to our commercialization efforts. There are no guarantees that any existing strategic relationships will continue, and efforts are ongoing to ensure the availability of compatible devices and/or equivalent alternatives.
Our robotic technology improves physician safety and reduces physician fatigue by enabling them to conduct procedures remotely from an adjacent control room, which reduces their exposure to harmful radiation, and the orthopedic burden of wearing lead. ● Improve clinical workflow and information management.
Studies have documented increased rates of orthopedic injury and tumors in these interventional cardiologist physicians Our robotic technology improves physician safety and reduces physician fatigue by enabling them to conduct procedures remotely from an adjacent control room, which reduces their exposure to harmful radiation, and the orthopedic burden of wearing lead. ● Improve clinical workflow and information management.
The FDA regulates the development, testing, manufacturing, labeling, storage, recordkeeping, promotion, marketing, distribution and service of medical devices in the U.S. to ensure that medical products distributed domestically are safe and effective for their intended uses.
GOVERNMENT REGULATION Our products are medical devices that are subject to extensive regulation in the U.S. and in foreign countries where we do business. The FDA regulates the development, testing, manufacturing, labeling, storage, recordkeeping, promotion, marketing, distribution and service of medical devices in the U.S. to ensure that medical products distributed domestically are safe and effective for their intended uses.
We continue to evolve our programs to respond to the best interest of our workforce, as well as the communities in which we operate, in compliance with government regulations. We manage overall safety with guidance based on regional, country, and local regulations and best practices.
We also conduct on-site engagement activities that facilitate cross-team networking, collaboration, and innovation. 16 We continue to evolve our programs to respond to the best interest of our workforce, as well as the communities in which we operate, in compliance with government regulations. We manage overall safety with guidance based on regional, country, and local regulations and best practices.
Due to the clinical benefits of our products, we believe hospitals will realize significant operational benefits when recruiting physicians to work in a safer procedure environment, while attracting patients who desire to have safer procedures that lead to better long-term outcomes. 6 PRODUCTS Robotic Magnetic Navigation Our proprietary robotic magnetic navigation systems (“RMN”) include the GenesisX RMN, Genesis RMN and the prior generation Niobe Systems.
Due to the clinical benefits of our products, we believe hospitals will realize significant operational benefits when recruiting physicians to work in a safer procedure environment, while attracting patients who desire to have safer procedures that lead to better long-term outcomes.
We believe these benefits can be applicable in other endovascular indications where navigation through complex vasculature is often challenging or unsuccessful and generates significant x-ray exposure, and we are investing in research and development in these areas. Our primary products include the Genesis RMN System, the GenesisX RMN System , the Odyssey Solution, and other related devices.
We believe these benefits can be applicable in other endovascular indications where navigation through complex vasculature is often challenging or unsuccessful and generates significant x-ray exposure, and we are investing in research and development in these areas.
Outside of electrophysiology, there are at least two companies that have commercialized robotic systems for guidewire manipulation and can be viewed as potential competitors as we look to address additional clinical applications.
Outside of electrophysiology, there are at least two companies that have commercialized robotic systems for guidewire manipulation and can be viewed as potential competitors as we look to address additional clinical applications. Our Map-iT family of devices competes directly with other companies that manufacture and sell traditional interventional devices.
Of the December 31, 2024 backlog, we expect approximately 70% to be recognized as revenue over the course of 2025. We had backlog of approximately $14.7 million as of December 31, 2023.
Of the December 31, 2026 backlog, we expect approximately 78% to be recognized as revenue over the course of 2026. We had system backlog of approximately $14.4 million as of December 31, 2024.
As of December 31, 2024, we had 139 employees, 41 of whom were engaged directly in research and development, 51 in sales and marketing activities, 28 in manufacturing and service, and 19 in general administrative activities including finance, information systems, legal and general management.
As of December 31, 2025, we had 131 employees, 40 of whom were engaged directly in research and development, 47 in sales and marketing activities, 26 in manufacturing and service, and 18 in general administrative activities including finance, information systems, legal and general management.
The Stereotaxis MAGiC catheter, a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures, has obtained the CE marking in Europe, and we are in the process of obtaining necessary approvals in the U.S. and other countries.
We have received regulatory clearance, licensing and/or approvals necessary for us to market the Stereotaxis MAGiC catheter, a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures in the U.S. and Europe, and we are in the process of obtaining necessary approvals in other countries.
We have received regulatory clearances and approvals necessary for us to market the Genesis RMN System in the U.S., Europe, and China, and we are in the process of obtaining necessary registrations for extending our markets in other countries.
We have received regulatory clearance, and/or approvals necessary for us to market the GenesisX RMN System, the latest generation of the Genesis RMN System in the U.S. and Europe, and we are in the process of obtaining necessary approvals in other countries.
The GenesisX RMN System, the latest generation of the Genesis RMN System has received regulatory clearance in Europe, and we are in the process of obtaining necessary approvals in the US and other countries, We have received regulatory clearance, licensing and/or approvals necessary for us to market the Niobe System with Cardiodrive, e-Contact, Navigant, Odyssey, QuikCAS in the U.S., Canada, China, Japan, and various other countries.
We have received regulatory clearance, and/or approvals necessary for us to market the Niobe System with Cardiodrive, e-Contact, Navigant, Odyssey, QuikCAS in the U.S., Europe, Canada, China, Japan, and various other countries. We have received regulatory clearance, licensing and/or approvals necessary for us to market the Vdrive and Vdrive Duo Systems with the V-CAS in the U.S., Europe, and Canada.
These systems are designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites.
PRODUCTS Robotic Magnetic Navigation Our proprietary robotic magnetic navigation systems (“RMN”) include the GenesisX RMN, Genesis RMN and the prior generation Niobe Systems. These systems are designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites.
Through our arrangements with manufacturers and providers of fluoroscopy systems, catheters, and electrophysiology mapping systems, we provide compatibility between the robotic magnetic navigation system and the visualization and information systems used during electrophysiology and endovascular procedures to provide the physician with a comprehensive information and instrument control system.
This results in highly precise digital control of the working tip of the disposable interventional device while still giving the physician the option to manually advance the device. 6 Through our arrangements with manufacturers and providers of fluoroscopy systems, catheters, and electrophysiology mapping systems, we provide compatibility between the robotic magnetic navigation system and the visualization and information systems used during electrophysiology and endovascular procedures to provide the physician with a comprehensive information and instrument control system.
We cannot provide any assurance as to the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent alternatives on competitive terms or at all.
We cannot provide any assurance as to the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent alternatives on competitive terms or at all. Other Recurring Revenue Other recurring revenue includes revenue from product maintenance plans, service-type warranties, and other post warranty maintenance.
Examples of groups of such standards are electrical safety standards such as those of the International Electrotechnical Commission and composition standards such as the Reduction of Hazardous Substances (“RoHS”) and Waste Electrical and Electronic Equipment (“WEEE”) Directives. 13 U.S.
Failure to meet these standards could limit the ability to market our products in those regions which require compliance to such standards. Examples of groups of such standards are electrical safety standards such as those of the International Electrotechnical Commission and composition standards such as the Reduction of Hazardous Substances (“RoHS”) and Waste Electrical and Electronic Equipment (“WEEE”) Directives. U.S.
The FDA also has the authority to require us to repair, replace or refund the cost of any medical device that we have manufactured or distributed if there is a reasonable probability that the device would cause serious, adverse health consequences or death. 14 International Regulation For us to market our products in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries.
The FDA also has the authority to require us to repair, replace or refund the cost of any medical device that we have manufactured or distributed if there is a reasonable probability that the device would cause serious, adverse health consequences or death.
These regulations, including the requirements for approvals or clearance and the time required for regulatory review, vary from country to country and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries may differ from that required to obtain FDA clearance or approval.
International Regulation For us to market our products in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. These regulations, including the requirements for approvals or clearance and the time required for regulatory review, vary from country to country and can involve additional product testing and additional administrative review periods.
Louis facilities, which provides real-time clinical and technical support to our customers worldwide. MANUFACTURING Robotic Magnetic Navigation System s and Odysse y Solution Our manufacturing strategy for our Robotic Magnetic Navigation Systems and Odyssey Solution is to sub-contract many of the manufacture of major subassemblies of our systems to maximize manufacturing flexibility and lower fixed costs.
MANUFACTURING Robotic Magnetic Navigation System s and Odyssey and Synchrony & SynX Solutions Our manufacturing strategy for our Robotic Magnetic Navigation Systems and Odyssey and Synchrony & SynX Solutions is to sub-contract many of the manufacture of major subassemblies of our systems to maximize manufacturing flexibility and lower fixed costs.
Despite various attempts to reduce risk factors, each year over one million patients undergo interventional procedures in an attempt to open blocked vessels and another one half million patients undergo open heart surgery to bypass blocked coronary arteries. 9 Blockages within a coronary artery, often called lesions, are categorized by degree of obstruction as partial occlusions, non-chronic total occlusions and chronic total occlusions.
Despite various attempts to reduce risk factors, each year over one million patients undergo interventional procedures in an attempt to open blocked vessels and another one half million patients undergo open heart surgery to bypass blocked coronary arteries.
CLINICAL APPLICATIONS We have focused our clinical and commercial efforts on applications of our products primarily in electrophysiology procedures for the treatment of arrhythmias and secondarily in complex interventional cardiology procedures for the treatment of coronary artery disease.
No single country, other than the U.S., accounted for more than 10% of total revenue for the years ended December 31, 2025, and 2024. 8 CLINICAL APPLICATIONS We have focused our clinical and commercial efforts on applications of our products primarily in electrophysiology procedures for the treatment of arrhythmias and secondarily in complex interventional cardiology procedures for the treatment of coronary artery disease.
The Odyssey Solution further enables procedures to be observed remotely around the world with high-speed Internet access over a hospital VPN, even wirelessly using a standard laptop or Windows tablet computer. X-ray systems We pursue arrangements with fluoroscopy system manufacturers to provide such systems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms.
The Odyssey Solution further enables procedures to be observed remotely around the world with high-speed Internet access over a hospital VPN, even wirelessly using a standard laptop or Windows tablet computer.
This proprietary software and hardware, some of which is owned by Stereotaxis, and some of which is licensed to Stereotaxis, is a material aspect of the ability to design, manufacture and install cost-effective and efficient information integration, storage and delivery platform. 12 In addition, we seek to protect our proprietary information by entering confidentiality, assignment of inventions or license agreements with our employees, consultants, contractors, advisers and other third parties.
This proprietary software and hardware, some of which is owned by Stereotaxis, and some of which is licensed to Stereotaxis, is a material aspect of the ability to design, manufacture and install cost-effective and efficient information integration, storage, and delivery platform.
A significant majority of our employees are not covered by a collective bargaining agreement, and we consider our relationship with our employees to be positive.
A significant majority of our employees are not covered by a collective bargaining agreement, and we consider our relationship with our employees to be positive. We also engage the services of independent contractors and consultants as needed for special or temporary projects or specific expertise.
The primary regulatory environment in Europe is that of the European Union (EU), which encompasses most of the major countries in Europe.
The time required to obtain approval in other countries may differ from that required to obtain FDA clearance or approval. 14 The primary regulatory environment in Europe is that of the European Union (EU), which encompasses most of the major countries in Europe.
The maintenance of strategic relationships with compatible devices, or the establishment of equivalent alternatives, is critical to our commercialization efforts. There are no guarantees that any existing strategic relationships will continue, and efforts are ongoing to ensure the availability of compatible systems and devices and/or equivalent alternatives.
There are no guarantees that any existing strategic relationships will continue, and efforts are ongoing to ensure the availability of compatible systems and devices and/or equivalent alternatives. We cannot provide any assurance as to the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent alternatives on competitive terms or at all.
We believe approximately 11,000 interventional labs worldwide are currently capable of conducting interventional cardiology. Over 4 million interventional cardiology procedures are performed annually in the U.S. alone. We estimate that approximately 10-15% of these interventional cardiology procedures currently being performed are complex and therefore require longer procedure times and may have sub-optimal outcomes.
We estimate that approximately 10-15% of these interventional cardiology procedures currently being performed are complex and therefore require longer procedure times and may have sub-optimal outcomes. We believe that our system can substantially benefit this subset of complex interventional cardiology procedures.
Our sales and marketing efforts include two important elements: (1) selling robotic magnetic systems, Odyssey Solutions, and magnetically compatible x-ray systems directly and through distributors; and (2) leveraging our installed base of systems to drive recurring sales of disposable interventional devices, software and service.
SALES AND MARKETING We market our products in the U.S and internationally through a direct sales force of senior sales specialists, distributors and sales agents, supported by account managers and clinical specialists who provide training, clinical support, and other services to our customers. 11 Our sales and marketing efforts include two important elements: (1) selling robotic magnetic systems, the Odyssey and Synchrony & SynX Solutions , and magnetically compatible x-ray systems directly and through distributors; and (2) leveraging our installed base of systems to drive recurring sales of disposable interventional devices, software and service.
We provide our employees and their families with access to health and wellness programs that support employee wellbeing, time away from work, family care, mental health, and financial well-being. We also conduct on-site engagement activities that facilitate cross-team networking, collaboration, and innovation.
Health, Safety, and Wellness The health, safety, and wellness of our employees is a priority in which we continue to invest. We provide our employees and their families with access to health and wellness programs that support employee wellbeing, time away from work, family care, mental health, and financial well-being.
These devices include differentiated high-quality diagnostic catheters used in traditional cardiac ablation procedures and are commercially available across key global geographies.
These devices include differentiated high-quality diagnostic catheters used in traditional cardiac ablation procedures and are commercially available across key global geographies. The acquisition also provides us with the basis to develop additional magnetically enabled devices which can be used with our RMN systems.
We cannot provide any assurance as to the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent alternatives on competitive terms or at all. RESEARCH AND DEVELOPMENT We have assembled an experienced group of engineers and physicists with recognized expertise in magnetics, software, control algorithms, mechanics, electronics, systems integration and disposable interventional device design.
RESEARCH AND DEVELOPMENT We have assembled an experienced group of engineers and physicists with recognized expertise in magnetics, software, control algorithms, mechanics, electronics, systems integration and disposable interventional device design.
Interventional Cardiology More than half a million people die annually from coronary artery disease, a condition in which the formation of plaque in the coronary arteries obstructs the supply of blood to the heart, making this the leading cause of death in the U.S.
We also believe that our RMN will significantly lower the skill barriers required for physicians to perform complex electrophysiology procedures and, additionally, improve interventional lab efficiency and reduce disposable interventional device utilization. 9 Interventional Cardiology More than half a million people die annually from coronary artery disease, a condition in which the formation of plaque in the coronary arteries obstructs the supply of blood to the heart, making this the leading cause of death in the U.S.
Disposables and Other Accessories Our robotic magnetic navigation systems are designed to use a toolkit of associated disposable interventional devices. Within this toolkit, we manufacture and distribute the QuikCAS, the iCONNECT, and the V-CAS devices .
Disposables and Other Accessories Our robotic magnetic navigation systems are designed to use a toolkit of associated disposable interventional devices. We market and distribute disposable and related devices that can be used with our robotic magnetic navigation systems and in traditional, manual procedures.
The acquisition also provides us with the basis to develop additional magnetically enabled devices which can be used with our RMN systems. 7 Revenue from sales of disposable products is recognized when control is transferred to the customers, which generally occurs at the time of shipment, but can also occur at the time of delivery depending on the customer arrangement.
Revenue from sales of disposable products is recognized when control is transferred to the customers, which generally occurs at the time of shipment, but can also occur at the time of delivery depending on the customer arrangement. Disposable products are covered by an assurance-type warranty that provides for the return of defective products.
In addition, we have integrated the robotic magnetic navigation system with 3D catheter location sensing technology to provide accurate real-time information as to the 3D location of the working tip of the instrument. Our robotic magnetic navigation systems utilize two permanent magnets mounted on articulating and pivoting arms with one magnet on either side of the patient table.
In addition, we have integrated the robotic magnetic navigation system with 3D catheter location sensing technology to provide accurate real-time information as to the 3D location of the working tip of the instrument. The maintenance of these technology compatibility, integrations, and strategic relationships is critical to our commercialization efforts.
Lesions are also categorized by the degree of difficulty with which they can be opened as simple or complex. Complex lesions, such as chronic total occlusions, longer lesions, and lesions located within smaller diameter vessels, are often very difficult or time consuming to open with manual interventional techniques.
Blockages within a coronary artery, often called lesions, are categorized by degree of obstruction as partial occlusions, non-chronic total occlusions and chronic total occlusions. Lesions are also categorized by the degree of difficulty with which they can be opened as simple or complex.
The GenesisX RMN System, the latest generation of the Genesis RMN System, is designed to significantly enhance the accessibility of Robotic Magnetic Navigation by eliminating the lengthy construction cycle necessary to install prior generation RMN systems.
The GenesisX RMN System, the latest generation of the Genesis RMN System, is designed to enhance the accessibility of Robotic Magnetic Navigation by reducing the lengthy construction cycle necessary to install prior generation RMN systems. The Odyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the key information in the operating room.
The recurring payments typically include disposable costs for each procedure, equipment service costs beyond the warranty period, and ongoing software updates. In hospitals where our full suite of products has not been implemented, equipment upgrade or expansion can be implemented upon purchasing of the necessary upgrade or expansion.
The recurring payments typically include disposable costs for each procedure, equipment service costs beyond the warranty period, and ongoing software updates.
We believe that the primary competitive factors in the market we address are capability, safety, efficacy, ease of use, price, quality, reliability and effective sales, support, training and service. The length of time required for products to be developed and to receive regulatory and reimbursement approval is also an important competitive factor.
We expect to continue to face competitive pressure in this market in the future, based on the rapid pace of advancements with this technology. We believe that the primary competitive factors in the market we address are capability, safety, efficacy, ease of use, price, quality, reliability and effective sales, support, training and service.
FINANCIAL INFORMATION ABOUT CUSTOMERS No single customer accounted for more than 10% of total revenue for the years ended December 31, 2024 and 2023. No single country, other than the U.S., accounted for more than 10% of total revenue for the years ended December 31, 2024, and 2023.
We are also currently seeking regulatory clearances for the EMAGIN 5F catheter guide designed to robotically navigate tortuous venous and arterial vasculature. FINANCIAL INFORMATION ABOUT CUSTOMERS No single customer accounted for more than 10% of total revenue for the years ended December 31, 2025 and 2024.
Our principal executive offices are located at 710 North Tucker Boulevard, Suite 110, St. Louis, Missouri 63101, and our telephone number is (314) 678-6100.
Our principal executive offices are located at 710 North Tucker Boulevard, Suite 110, St. Louis, Missouri 63101, and our telephone number is (314) 678-6100. We operate our business as one segment, as defined by U.S. generally accepted accounting principles. Our financial results for the years ended December 31, 2025 and 2024 are discussed in “Item 7.
We have regulatory clearances and approvals that allow us to market the Vdrive and Vdrive Duo Systems with the V-CAS device in the U.S., Canada, and Europe. We have obtained the CE marking for us to market the Stereotaxis MAGiC catheter in Europe and are pursuing regulatory approvals in the U.S. and various other global geographies.
We have regulatory clearances and approvals that allow us to market the SynX collaboration solution in the U.S. and Europe. We have obtained the CE marking for us to market the Synchron y system in Europe and are in the process of obtaining necessary approvals in the US and other countries.
We have recently obtained the CE marking for us to market the Stereotaxis MAGiC catheter, robotically-navigated magnetic ablation catheter, in Europe and are pursuing regulatory approval in the U.S. and various other global geographies. We are aware of two other companies that also produce and sell magnetically enabled catheters. We face direct competition in certain products in our Odyssey Solution.
We also recently developed our own line of robotically enabled medical devices and are aware of two other companies that also produce and sell magnetically enabled catheters. We face direct competition in certain products in our Odyssey/Synchrony Solution. These competitors include established imaging companies as well as dedicated solution providers.
We also market and distribute other disposable and related devices that can be used with our robotic magnetic navigation systems and in traditional, manual procedures. On July 31, 2024, the Company completed its acquisition of Access Point Technologies EP, Inc, based in Rogers, Minnesota providing us with the Map-iT portfolio of devices.
Although we are ramping up production of the MAGiC ablation catheter as a replacement device, continued supply of the J&J catheters into 2026 remains of significant importance for many customers of our technology. 7 On July 31, 2024, the Company completed its acquisition of Access Point Technologies EP, Inc, based in Rogers, Minnesota providing us with the Map-iT portfolio of devices.
See “Item 1A—Risk Factors” for a discussion of other competitive risks facing our business. GOVERNMENT REGULATION Our products are medical devices that are subject to extensive regulation in the U.S. and in foreign countries where we do business.
The length of time required for products to be developed and to receive regulatory and reimbursement approval is also an important competitive factor. See “Item 1A—Risk Factors” for a discussion of other competitive risks facing our business.
The most recent ISO 13485 and MDSAP Certificate of Registration were issued in 2022 and are valid through September 2025. 11 SALES AND MARKETING We market our products in the U.S and internationally through a direct sales force of senior sales specialists, distributors and sales agents, supported by account managers and clinical specialists who provide training, clinical support, and other services to our customers.
The most recent ISO 13485 and MDSAP Certificate of Registration were issued in 2025 and are valid through September 2028.
Please refer to “Regulatory Approval” in Item 1 for a description of the regulatory clearance, licensing, and/or approvals we currently have or are pursuing. As of December 31, 2024, we had approximately $15.2 million of backlog, consisting of outstanding purchase orders and other commitments for these systems.
In hospitals where our full suite of products has not been implemented, equipment upgrade or expansion can be implemented upon purchasing of the necessary upgrade or expansion. 4 As of December 31, 2025, we had approximately $9.1 million of system backlog, consisting of outstanding purchase orders and other commitments for these systems.
We have received regulatory clearance, licensing and/or approvals necessary for us to market the Vdrive and Vdrive Duo Systems with the V-CAS in the U.S., Europe, and Canada.
We have received regulatory clearance and/or approvals necessary for us to market the Map-it diagnostic mapping catheters in the U.S. and Europe. The MAGiC Sweep™ catheter, the first robotically navigated high-density EP mapping catheter, received FDA 510(k) clearance in July 2025. We are in the process of obtaining necessary approvals in other geographies.
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The Odyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the key information in the operating room. This is designed to improve lab layout and procedure efficiency.
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Our primary products include the Genesis RMN and the GenesisX RMN Systems, the Odyssey and Synchrony & SynX Solutions, various interventional devices under the Map-iT , MAGiC and EMAGIN brands, and other related devices.
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The system also features a remote viewing and recording capability called Odyssey Cinema, which is an innovative solution that delivers synchronized content for optimized workflow, advanced care, and improved productivity. This tool includes an archiving capability that allows clinicians to store and replay entire procedures or segments of procedures.
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This is designed to improve lab layout and procedure efficiency. The system also features a remote viewing and recording capability called Odyssey Cinema . The Odyssey Solution and Odyssey Cinema are being replaced by next generation innovative solutions branded Synchrony and SynX .
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This information can be accessed from locations throughout the hospital local area network and over the global Odyssey Network providing physicians with a tool for clinical collaboration, remote consultation, and training. We are actively developing the next generation imaging and collaboration solutions with Synchrony and SynX .
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Synchrony digitizes and modernizes the interventional cath lab with a 4K high-definition display that consolidates the viewing and control of disparate systems in the lab, offering enhanced procedure experience with custom layouts, streamlined workflows, an intuitive user interface, and a decluttered environment.
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The GenesisX RMN System, the latest generation of the Genesis RMN System, has received regulatory clearances and approvals in Europe, and we are in the process of obtaining necessary registrations in the US and other countries.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRisks Related to Our Common Stock ● Our principal stockholders continue to own a large percentage of our voting stock, and they could substantially influence matters requiring stockholder approval. ● Future issuances of our securities could dilute current stockholders’ ownership. ● We have never paid dividends on our common stock, and we do not anticipate paying any cash dividends in the foreseeable future. ● Our certificate of incorporation and bylaws, Delaware law, and one of our collaboration agreements contain provisions that could discourage a takeover. ● Evolving regulation of corporate governance and public disclosure may result in additional expenses and continuing uncertainty. ● Our future operating results may be below securities analysts’ or investors’ expectations, which could cause our stock price to decline. ● We expect that the price of our common stock could fluctuate substantially, possibly resulting in class action securities litigation. ● If we fail to continue to meet all applicable NYSE American Market requirements and the NYSE American determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock, which would impair the value of your investment and ultimately harm our business by limiting our access to equity markets for capital raising.
Biggest changeSuch changes could, among other things, reduce reimbursement for procedures using our products, change coverage policies, increase compliance costs, and delay or reduce hospital capital spending. ● The application of state certificate of need regulations and compliance by our customers with federal and state licensing or other international requirements could substantially limit our ability to sell our products and grow our business. ● Hospitals or physicians may be unable to obtain reimbursement from third-party payors for procedures using our products, or reimbursement for procedures may be insufficient to recoup the costs of purchasing our products. ● Our costs could substantially increase if we receive a significant number of warranty claims or have other significant, uninsured liabilities. 18 Risks Related to Our Common Stock ● Our principal stockholders continue to own a large percentage of our voting stock, and they could substantially influence matters requiring stockholder approval. ● Future issuances of our securities could dilute current stockholders’ ownership. ● We have never paid dividends on our common stock, and we do not anticipate paying any cash dividends in the foreseeable future. ● Our certificate of incorporation and bylaws, Delaware law, and one of our collaboration agreements contain provisions that could discourage a takeover. ● Evolving regulation of corporate governance and public disclosure may result in additional expenses and continuing uncertainty. ● Our future operating results may be below securities analysts’ or investors’ expectations, which could cause our stock price to decline. ● We expect that the price of our common stock could fluctuate substantially, possibly resulting in class action securities litigation. ● If we fail to continue to meet all applicable NYSE American Market requirements and the NYSE American determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock, which would impair the value of your investment and ultimately harm our business by limiting our access to equity markets for capital raising.
RISK FACTORS SUMMARY Risks Related to Our Business and Business Operations ● We may not generate cash from operations or be able to raise the necessary capital to continue operations. ● Macroeconomic and geopolitical factors, as well as pandemics, epidemics or outbreaks of infectious disease could have an adverse effect our supply chain, our hospital customer buying patterns, and our ability to raise capital and could otherwise disrupt our normal business operations. ● We may not be able to fund our business operations in the same manner as we have done historically if we do not improve the operating performance of the Company or raise additional capital. ● Hospital decision-makers may not purchase our robotic magnetic navigation systems or related products or may think that such systems and products are too expensive. ● If we are unable to fulfill our current purchase orders and other commitments on a timely basis or at all, we may not be able to achieve future sales growth. 17 ● We will likely experience long and variable sales and installation cycles, which could result in substantial fluctuations in our quarterly results of operations. ● Physicians may not use our products if they do not believe they are safe, efficient and effective. ● Our collaborations with fluoroscopy system manufacturers and providers of catheters and electrophysiology mapping systems or other parties may fail, or we may not be able to enter additional collaborations in the future. ● The complexity associated with selling, marketing, and distributing products could impair our ability to increase revenue. ● Our marketing strategy is dependent on collaboration with physician “thought leaders.” ● Physicians may not commit enough time to sufficiently learn our system. ● Customers may choose to purchase competing products and not ours. ● If the magnetic fields generated by our system are not compatible with, or interfere with, other widely used equipment in the interventional labs, sales of our products would be negatively affected. ● The use of our products could result in product liability claims that could be expensive, divert management’s attention, and harm our reputation and business. ● We have incurred substantial losses in the past and may not be profitable in the future. ● Our reliance on contract manufacturers and on suppliers, and in some cases, a single supplier, could harm our ability to meet demand for our products in a timely manner or within budget. ● Risks associated with international manufacturing and trade could negatively impact the availability and cost of our products because materials used to manufacture our magnets, one of our key system components, are sourced from overseas. ● We may encounter problems at our manufacturing facilities or those of our subcontractors or otherwise experience manufacturing delays that could result in lost revenue. ● Our growth may place a significant strain on our resources, and if we fail to manage our growth, our ability to develop, market, and sell our products will be harmed.
RISK FACTORS SUMMARY Risks Related to Our Business and Business Operations ● We may not generate cash from operations or be able to raise the necessary capital to continue operations. ● Macroeconomic and geopolitical factors, as well as pandemics, epidemics or outbreaks of infectious disease could have an adverse effect on our supply chain, our hospital customer buying patterns, and our ability to raise capital and could otherwise disrupt our normal business operations. ● We may not be able to fund our business operations in the same manner as we have done historically if we do not improve the operating performance of the Company or raise additional capital. ● Hospital decision-makers may not purchase our robotic magnetic navigation systems or related products or may think that such systems and products are too expensive. ● If we are unable to fulfill our current purchase orders and other commitments on a timely basis or at all, we may not be able to achieve future sales growth. ● We will likely experience long and variable sales and installation cycles, which could result in substantial fluctuations in our quarterly results of operations. ● Physicians may not use our products if they do not believe they are safe, efficient and effective. ● Our collaborations with fluoroscopy system manufacturers and providers of catheters and electrophysiology mapping systems or other parties may fail, or we may not be able to enter additional collaborations in the future. ● The complexity associated with selling, marketing, and distributing products could impair our ability to increase revenue. ● Our marketing strategy is dependent on collaboration with physician “thought leaders.” ● Physicians may not commit enough time to sufficiently learn our system. ● Customers may choose to purchase competing products and not ours. 17 ● If the magnetic fields generated by our system are not compatible with, or interfere with, other widely used equipment in the interventional labs, sales of our products would be negatively affected. ● The use of our products could result in product liability claims that could be expensive, divert management’s attention, and harm our reputation and business. ● We have incurred substantial losses in the past and may not be profitable in the future. ● Our reliance on contract manufacturers and on suppliers, and in some cases, a single supplier, could harm our ability to meet demand for our products in a timely manner or within budget. ● Risks associated with international manufacturing and trade could negatively impact the availability and cost of our products because materials used to manufacture our magnets, one of our key system components, are sourced from overseas. ● We may encounter problems at our manufacturing facilities or those of our subcontractors or otherwise experience manufacturing delays that could result in lost revenue. ● Our growth may place a significant strain on our resources, and if we fail to manage our growth, our ability to develop, market, and sell our products will be harmed.
See “ —Risks Related to our 2024 Acquisition of APT—Issuance of the Earnout Consideration will result in dilution to our stockholders and may adversely affect us, including the market price of our securities.” 33 In addition, a significant number of shares of our common stock are subject to issuance under our existing stock incentive plans and we may request the ability to issue additional such securities.
See “ —Risks Related to our 2024 Acquisition of APT—Issuance of the Earnout Consideration will result in dilution to our stockholders and may adversely affect us, including the market price of our securities.” In addition, a significant number of shares of our common stock are subject to issuance under our existing stock incentive plans and we may request the ability to issue additional such securities.
This may contribute to substantial fluctuations in our quarterly operating results. As a result, in future quarters our operating results could fall below the expectations of securities analysts or investors, in which event our stock price would likely decrease. 21 Physicians may not use our products if they do not believe they are safe, efficient and effective.
This may contribute to substantial fluctuations in our quarterly operating results. As a result, in future quarters our operating results could fall below the expectations of securities analysts or investors, in which event our stock price would likely decrease. Physicians may not use our products if they do not believe they are safe, efficient and effective.
For example, the Trump administrations has implemented, or is considering the imposition of, tariffs on certain foreign goods, including on our products that emanate from China as described above and we cannot predict the implementation or effects of any such tariffs or proposed tariffs, or any potential legislation or actions taken by the U.S. federal government that restrict trade, such as additional tariffs, trade barriers, and other protectionist or retaliatory measures taken by governments in Europe, Asia, and other countries, could adversely impact our ability to sell products and services, which could increase the cost of our products and the components and raw materials that go into making them.
For example, the U.S. federal government has implemented, or is considering the imposition of, tariffs on certain foreign goods, including on our products that emanate from China as described above and we cannot predict the implementation or effects of any such tariffs or proposed tariffs, or any potential legislation or actions taken by the U.S. federal government that restrict trade, such as additional tariffs, trade barriers, and other protectionist or retaliatory measures taken by governments in Europe, Asia, and other countries, could adversely impact our ability to sell products and services, which could increase the cost of our products and the components and raw materials that go into making them.
An inability to use technologies essential to our products would have a material adverse effect on our financial condition, results of operations and cash flow and could undermine our ability to continue our current business operations. 28 Expensive intellectual property litigation is frequent in the medical device industry and may cause to incur substantial expenses to defend.
An inability to use technologies essential to our products would have a material adverse effect on our financial condition, results of operations and cash flow and could undermine our ability to continue our current business operations. Expensive intellectual property litigation is frequent in the medical device industry and may cause us to incur substantial expenses to defend.
The failure of one or more of our collaborations could have a material adverse effect on our financial condition, results of operations and cash flow.
The termination or failure of one or more of our collaborations could have a material adverse effect on our financial condition, results of operations and cash flow.
If Mr. Fischel achieves all the milestones specified in the CEO Performance Award, by increasing the Company’s market capitalization to $5.5 billion for the specified period, he will receive 13,000,000 shares of common stock subject to the vesting requirements in the agreement.
Fischel achieves all the milestones specified in the CEO Performance Award, by increasing the Company’s market capitalization to $5.5 billion for the specified period, he will receive 13,000,000 shares of common stock subject to the vesting requirements in the agreement.
Many of our hospital customers, for whom the purchase of our system involves a significant capital purchase which may be part of a larger construction project at the customer site (typically the construction of a new building), may themselves be under economic pressures.
Many of our hospital customers, for whom the purchase of our system involves a significant capital purchase which may be part of a larger construction project at the customer site (typically the construction of a new building), may themselves be under similar pressures.
These factors, as well as general economic, credit, political and market conditions, may materially adversely affect the market price of our common stock. As with the stock of many other public companies, the market price of our common stock has been particularly volatile during the recent period of upheaval in the capital markets and world economy.
These factors, as well as general economic, credit, political and market conditions, may materially adversely affect the market price of our common stock. As with the stock of many other public companies, the market price of our common stock has been particularly volatile during periods of upheaval in the capital markets and world economy.
We depend on contract manufacturers to produce and assemble certain of the components of our systems and other products such as our electrophysiology catheter advancement device and other disposable devices. We also depend on various third-party suppliers for the magnets we use in our robotic magnetic navigation system and certain components of our Odyssey Solution.
We depend on contract manufacturers to produce and assemble certain of the components of our systems and other products such as our electrophysiology catheter advancement device and other disposable devices. We also depend on various third-party suppliers for the magnets we use in our robotic magnetic navigation system and certain components of our Odyssey and Synchrony & SynX Solutions.
Our results of operations will depend upon numerous factors, including: ● demand for our products; ● the performance of third-party contract manufacturers and component suppliers; ● our ability to develop sales and marketing capabilities; ● the success of our strategic relationships with two multinational fluoroscopy system manufacturers and one provider of catheters and electrophysiology mapping systems; ● our ability to develop, introduce and market integrated next generation systems and/or alternatives to our current strategic relationships with fluoroscopy system manufacturers and the catheter and electrophysiology mapping system provider on a timely basis; ● our ability to develop, introduce and market new or enhanced versions of our products on a timely basis; ● our ability to obtain regulatory clearances or approvals for our new products; and ● our ability to obtain and protect proprietary rights or revenue streams related thereto.
Our results of operations will depend upon numerous factors, including: ● demand for our products; ● the performance of third-party contract manufacturers and component suppliers; ● our ability to develop sales and marketing capabilities; ● the success of our strategic relationships with multinational fluoroscopy system manufacturers providers of electrophysiology mapping systems and manufactures of catheters and other devices; ● our ability to develop, introduce and market integrated next generation systems and/or alternatives to our current strategic relationships with fluoroscopy system manufacturers and the catheter and electrophysiology mapping system providers on a timely basis; ● our ability to develop, introduce and market new or enhanced versions of our products on a timely basis; ● our ability to obtain regulatory clearances or approvals for our new products; and ● our ability to obtain and protect proprietary rights or revenue streams related thereto.
The manufacturing process of catheters is complex, highly technical, and our prior experience in this field is dated. The process can be subject to periodic worldwide supply chain disruptions, including labor shortages and inflationary pressures, and logistics delays which make it difficult for us to source parts and ship our products.
The manufacturing process of catheters is complex, highly technical, and our prior experience in this field is dated. The process can be subject to periodic worldwide supply chain disruptions, including labor shortages and inflationary pressures, tariffs or other trade restrictions, and logistics delays which make it difficult for us to source parts and ship our products.
Additionally, we rely on the warranty provided by our third-party suppliers, including our fluoroscopy system providers. If product returns or warranty claims increase, or if our third-party suppliers do not honor their warranty obligations to us or certain claims are not covered thereunder, we could incur unanticipated additional expenditures for parts and service.
Additionally, we rely on the warranty provided by our third-party suppliers, including our fluoroscopy system providers. If product returns or warranty claims increase, or if, as has occurred in the past, our third-party suppliers do not honor their warranty obligations to us or certain claims are not covered thereunder, we could incur unanticipated additional expenditures for parts and service.
An adverse outcome under any such investigation or audit could subject us to fines or other penalties, which could adversely affect our business and financial results. Our suppliers, subcontractors, or we may fail to comply with the FDA quality system regulation or other quality standards.
An adverse outcome under any such investigation or audit could subject us to fines or other penalties, which could adversely affect our business and financial results. Our suppliers, subcontractors, or we may fail to comply with the FDA, EU and other state and foreign government authorities quality system regulation or other quality standards.
We have incurred substantial net losses since inception, including incurring an accumulated deficit of $561.7 million as of December 31, 2024, and we expect to incur losses into the future as we continue the commercialization of our products. Moreover, the extent of our future losses and the timing of profitability are highly uncertain.
We have incurred substantial net losses since inception, including incurring an accumulated deficit of $583.4 million as of December 31, 2025, and we expect to incur losses into the future as we continue the commercialization of our products. Moreover, the extent of our future losses and the timing of profitability are highly uncertain.
Although priced significantly below a robotic magnetic navigation system, the Odyssey Solution is still an expensive product. While we have partnered with fluoroscopy manufacturers to reduce the cost of acquisition, the ongoing cost of ownership, and the complexity of installation of a robotic electrophysiology practice, this strategy may not be successful.
Although priced significantly below a robotic magnetic navigation system, our Odyssey and Synchrony Solution are still expensive products. Further, while we have partnered with fluoroscopy manufacturers to reduce the cost of acquisition, the ongoing cost of ownership, and the complexity of installation of a robotic electrophysiology practice, this strategy may not be successful.
We also experienced reductions in demand for our disposable products as our healthcare customers (physicians and hospitals) re-prioritized the treatment of patients and diverted resources away from non-pandemic related areas, leading to the performance of fewer procedures in which our disposable products are used.
We also experienced reductions in demand for our disposable products as our healthcare customers (physicians and hospitals) re-prioritized the treatment of patients and diverted resources away from non-pandemic areas, leading to the performance of fewer procedures in which our disposable products are used. The impact varied widely over time by individual geography.
In addition, we, or our subcontractors, may experience quality problems, substantial costs and unexpected delays related to efforts to upgrade and expand manufacturing, assembly and testing capabilities.
We, or our subcontractors, may also experience substantial costs and unexpected delays related to efforts to upgrade and expand manufacturing, assembly and testing capabilities.
Fischel continues to serve as CEO, or in a similar capacity, through 2030. This additional stock-based compensation expense, incurred regardless of whether any milestones are achieved, increases the difficulty for the Company to achieve a profitable position as measured by generally accepted accounting principles. Our stockholders may experience substantial dilution upon payout of shares under the CEO Performance Award.
This additional stock-based compensation expense, incurred regardless of whether any milestones are achieved, increases the difficulty for the Company to achieve a profitable position as measured by generally accepted accounting principles. Our stockholders may experience substantial dilution upon payout of shares under the CEO Performance Award. If Mr.
In addition, the share purchase agreement requires us to issue additional earnout common shares to the selling stockholder upon achievement of certain global and US revenue targets for APT products as well as US and Europe regulatory approvals of certain robotically navigated catheters that APT will develop. 26 The share purchase agreement obligated us to file a resale registration statement relating to the upfront stock consideration and additional earnout shares.
In addition, the share purchase agreement requires us to issue additional earnout common shares to the selling stockholder upon achievement of certain global and US revenue targets for APT products as well as US and Europe regulatory approvals of certain robotically navigated catheters that APT will develop.
Our future results may be adversely impacted if we do not effectively manage APT’s catheter manufacturing business following the completion of the acquisition. As a result of the acquisition, we will be managing APT’s ongoing business of manufacturing, commercializing, development and sales of APT’s catheters and related products and services.
Our future results may be adversely impacted if we do not effectively manage APT’s catheter manufacturing business following the completion of the acquisition. As a result of the acquisition of APT EP in July, 2024, we are managing APT’s ongoing business of manufacturing, commercializing, developing and selling APT’s catheters and related products and services.
However, the exact number of shares that may be issued under the share purchase agreement for such milestones will be calculated based on the average of the closing per share price of Stereotaxis common stock immediately prior to the dates such revenue performance and/or regulatory milestones are achieved, up to $24 million in total value through September 30, 2029, not to exceed 19.9% of the total number of shares of the Company’s common stock issued and outstanding immediately prior to July 31, 2024 (the “Share Cap Limitation”).
As of the date of this report, we have issued an aggregate of 1,419,523 shares as earnout consideration, However, the exact number of earnout shares that may be issued under the share purchase agreement for future milestones will be calculated based on the average of the closing per share price of Stereotaxis common stock immediately prior to the dates such revenue performance and/or regulatory milestones are achieved, up to $24 million in total value through September 30, 2029, provided that the total number of shares issued under the share purchase agreement as upfront stock consideration and earnout consideration may not exceed 16,846,595, which is 19.9% of the total number of shares of the Company’s common stock issued and outstanding immediately prior to July 31, 2024 (the “Share Cap Limitation”).
The products we design may not satisfy all the performance requirements of our customers and we may need to improve or modify the design or ask our subcontractors to modify their production process to do so.
The products we design may not satisfy all the performance requirements of our customers and we may need to improve or modify the design or ask our subcontractors to modify their production process to do so. In addition, we, or our subcontractors, have in the past experienced and may continue to experience quality problems.
Our suppliers and contract manufacturers have experienced, and may continue to experience, similar difficulties. If our manufacturing operations or supply chains are materially interrupted, it may not be possible for us to timely manufacture or service our products at required levels, or at all.
If our manufacturing operations or supply chains are materially interrupted, it may not be possible for us to timely manufacture or service our products at required levels, or at all.
Risks Relating to Regulatory and Legal Matters ● If we or the parties in our strategic collaborations fail to obtain or maintain necessary FDA clearances or approvals for our medical device products, or if such clearances or approvals are delayed, we will be unable to continue to commercially distribute and market our products. ● If our strategic collaborations elect not to or we fail to obtain regulatory approvals in other countries for products under development, we will not be able to commercialize these products in those countries. ● We may fail to comply with continuing regulatory requirements of the FDA and other authorities and become subject to enforcement action, which may include substantial penalties. ● Our suppliers, subcontractors, or we may fail to comply with the FDA quality system regulation or other quality standards. 18 ● If we fail to comply with health care regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected. ● Healthcare policy changes, including the potential repeal or amendment of any existing legislation, may have a material adverse effect on us. ● The application of state certificate of need regulations and compliance by our customers with federal and state licensing or other international requirements could substantially limit our ability to sell our products and grow our business. ● Hospitals or physicians may be unable to obtain reimbursement from third-party payors for procedures using our products, or reimbursement for procedures may be insufficient to recoup the costs of purchasing our products. ● Our costs could substantially increase if we receive a significant number of warranty claims or have other significant, uninsured liabilities.
Risks Relating to Regulatory and Legal Matters ● If we or the parties in our strategic collaborations fail to obtain or maintain necessary FDA clearances or approvals for our medical device products, or if such clearances or approvals are delayed, we will be unable to continue to commercially distribute and market our products. ● If our strategic collaborations elect not to or we fail to obtain regulatory approvals in other countries for products under development, we will not be able to commercialize these products in those countries. ● We may fail to comply with continuing regulatory requirements of the FDA and other authorities and become subject to enforcement action, which may include substantial penalties. ● Our suppliers, subcontractors, or we may fail to comply with the FDA quality system regulation or other quality standards. ● If we fail to comply with health care regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected. ● Healthcare policy changes, including the potential repeal or amendment of any existing legislation, may have a material adverse effect on us.
Any transition to alternate manufacturers or suppliers would likely result in operational problems and increased expenses and could delay the shipment of, or limit our ability to, provide our products. We cannot assure you that we would be able to enter into agreements with new manufacturers or suppliers on commercially reasonable terms or at all.
In the past, transitions to alternate manufacturers and suppliers has resulted in operational problems, increased expenses, and limitations on our ability to provide our products. We cannot assure you that we would be able to enter into agreements with new manufacturers or suppliers on commercially reasonable terms or at all.
Failure to establish alternatives may reduce the likelihood that physician users will continue to use our technology which will have a negative impact on our future revenue, cash flow and operations.
Failure to maintain an adequate supply of magnetically enabled ablation catheters may reduce the likelihood that physician users will continue to use our technology which will have a negative impact on our future revenue, cash flow and operations.
Our Series A Convertible Preferred Stock bears dividends at a rate of six percent (6.0%) per annum, which are cumulative and accrue daily from the date of issuance on the $1,000 stated value.
As of December 31, 2025, we had 50.3 million shares of our common stock issuable upon conversion of our Series A Convertible Preferred Stock. Our Series A Convertible Preferred Stock bears dividends at a rate of six percent (6.0%) per annum, which are cumulative and accrue daily from the date of issuance on the $1,000 stated value.
For example, supply chain disruptions have led to vendor discussions regarding contractual performance which we intend to resolve through continued negotiations but have required us to assert performance issues under our vendor agreements. We may not be successful in our claims, and even if we are successful, we may continue to experience supply disruptions.
For example, supply chain disruptions have led to vendor discussions regarding contractual performance which we generally resolve through negotiations, although in one instance we have been required to assert performance issues under the vendor agreement. We may not be successful in our negotiations or claim, and even if we are successful, we may continue to experience supply disruptions.
Even if we are successful in establishing one or more alternatives, we cannot guarantee that those arrangements will replace the royalty revenue stream previously received from the sale of the Biosense Webster catheter. The complexity associated with selling, marketing, and distributing products could impair our ability to increase revenue.
Even if we are successful in establishing an adequate alternate supply, it is unlikely that those arrangements will replace the royalty revenue stream previously received from the sale of the J&J catheter. The complexity associated with selling, marketing, and distributing products could impair our ability to increase revenue.
While we cannot reliably anticipate whether there will be new or periodic resurgences of pandemic-related issues, or the impact or the severity of any such pandemics or resurgences, we believe that any such instances could cause periodic disruptions to our manufacturing operations, supply chains, procedures volumes, service activities, and capital system orders and placements, any of which could have a material adverse effect on our business, financial condition, results of operations, or cash flows.
We continue to anticipate periodic disruptions to our manufacturing operations, supply chains, procedures volumes, service activities, and capital system orders and placements relating to new or ongoing periodic resurgences of pandemic-related issues, any of which could have a material adverse effect on our business, financial condition, results of operations, or cash flows.
If the capital markets are disrupted for an extended period and we need to raise additional capital, such capital may not be available on acceptable terms, or at all. Disruptions to the capital markets and other financing sources could also negatively impact our hospital customers’ ability to raise capital or otherwise obtain financing to fund their operations and capital projects.
Any disruption to the capital markets could negatively impact our ability to raise capital. If the capital markets are disrupted for an extended period and we need to raise additional capital, such capital may not be available on acceptable terms, or at all.
The Company has sustained operating losses throughout its corporate history and expects that its 2024 operating expenses will exceed its 2024 gross margin. The Company expects to continue to incur operating losses and negative cash flows until revenues reach a level sufficient to support ongoing operations or expense reductions are in place.
The Company expects to continue to incur operating losses and negative cash flows until revenues reach a level sufficient to support ongoing operations or expense reductions are in place.
In addition, if we are unable to enter into additional collaborations in the future, or if these collaborations fail, our ability to develop and commercialize products could be impacted negatively and our revenue could be adversely affected. For example, our agreement with Biosense Webster expired by its terms on December 31, 2022.
In addition, if we are unable to enter into additional collaborations in the future, or if these collaborations fail, our ability to develop and commercialize products could be impacted negatively and our revenue could be adversely affected.
If we cannot raise capital on acceptable terms, we will not be able to, among other things: ● maintain customer and vendor relationships; ● hire, train and retain employees; ● maintain or expand our operations; ● enhance our existing products or develop new ones; or ● respond to competitive pressures. 19 Our failure to do any of these things could result in lower revenue and adversely affect our financial condition and results of operations, and we may have to curtail or cease operations.
If we cannot raise capital on acceptable terms, we will not be able to, among other things: ● maintain customer and vendor relationships; ● hire, train and retain employees; ● maintain or expand our operations; ● enhance our existing products or develop new ones; or ● respond to competitive pressures.
Although we are in the process of establishing alternative catheter supply arrangements, including the development of a fully owned magnetically enabled ablation catheter, we cannot guarantee that those arrangements will be successful.
Although we are in the process of establishing alternative catheter supply arrangements, including our proprietary magnetically enabled ablation catheter, we cannot guarantee that an adequate alternative catheter supply will be available in a timely manner.
During 2024, our common stock traded between $1.66 and $3.29 per share, on trading volume ranging from approximately 67,300 to 6.4 million shares per day.
During 2025, our common stock traded between $1.54 and $3.59 per share, on trading volume ranging from approximately 75,600 to 6.0 million shares per day.
The expense will be recognized on an accelerated basis through 2030. Total stock-based compensation recorded as operating expense for the CEO Performance Award was $7.2 million for the year ended December 31, 2024. As of December 31, 2024, the Company had approximately $29.8 million of total unrecognized stock-based compensation expense remaining under the CEO Performance Award if Mr.
The expense will be recognized on an accelerated basis through 2030. Total stock-based compensation recorded as operating expense for the CEO Performance Award was $7.1 million and $7.2 million for the years ended December 31, 2025 and 2024, respectively.
It is possible that one or more of our products, including those that we have developed in conjunction with third parties, infringes existing patents. We may also be liable for patent infringement by third parties whose products we use or combine with our own and for which we have no right to indemnification.
We may also be liable for patent infringement by third parties whose products we use or combine with our own and for which we have no right to indemnification.
While we have experienced, and expect to continue to experience, these types of threats to our information technology networks and infrastructure, to date none of these threats has had a material impact on our business or operations. 27 We may be unable to protect our technology from use by third parties, which may allow them to compete with us and harm our business.
While we have experienced, and expect to continue to experience, these types of threats to our information technology networks and infrastructure, to date none of these threats has had a material impact on our business or operations.
This excessive volatility may continue for an extended period of time following the filing date of this report. Furthermore, the stock prices of many companies in the medical device industry have experienced wide fluctuations that have often been unrelated to the operating performance of these companies.
Furthermore, the stock prices of many companies in the medical device industry have experienced wide fluctuations that have often been unrelated to the operating performance of these companies.
Our collaborations with fluoroscopy system manufacturers and providers of catheters and electrophysiology mapping systems or other parties may fail, or we may not be able to enter into additional collaborations in the future.
If physicians do not use our products, we likely will not become profitable or generate sufficient cash to fund company operations going forward. 21 Our collaborations with fluoroscopy system manufacturers and providers of catheters and electrophysiology mapping systems or other parties may fail, or we may not be able to enter into additional collaborations in the future.
In addition, the vesting of the right to receive the earnout shares would be accelerated in the event of a change of control of Stereotaxis, based on a probability-weighted average estimate of the potential to achieve any remaining milestones, discounted to its net present value considering expected time when earnouts related to the milestones would become payable through September 30, 2029 As a result, the actual number of additional Earnout Shares we may be required to issue could be materially greater or less than our estimate, depending whether and to what extent the future revenue milestones are met and/or regulatory approvals are obtained, as well as the actual average closing price of our common stock calculated pursuant to a formula near the time such milestones are achieved and/or whether a change of control occurs.
As a result, the actual number of additional earnout shares we may be required to issue could be materially greater or less than our estimate, depending whether and to what extent the future revenue milestones are met and/or regulatory approvals are obtained, as well as the actual average closing price of our common stock calculated pursuant to a formula near the time such milestones are achieved and/or whether a change of control occurs.
Macroeconomic and geopolitical factors, as well as pandemics, epidemics or outbreaks of infectious disease could have an adverse effect our supply chain, our hospital customers buying patterns, and our ability to raise capital and could otherwise disrupt our normal business operations. Future results of operations could be materially adversely impacted by macroeconomic and geopolitical factors.
Our failure to do any of these things could result in lower revenue and adversely affect our financial condition and results of operations, and we may have to curtail or cease operations. 19 Macroeconomic and geopolitical factors, as well as pandemics, epidemics or outbreaks of infectious disease could have an adverse effect on our supply chain, our hospital customers buying patterns, and our ability to raise capital and could otherwise disrupt our normal business operations.
If we experience software errors or performance problems, we would likely also experience: ● loss of revenue; ● delay in market acceptance of our products; ● damage to our reputation; ● additional regulatory filings; ● product recalls; ● increased service or warranty costs; and/or ● product liability claims relating to the software defects. 29 Risks Related to Regulatory and Legal Matters If we or the parties in our strategic collaborations fail to obtain or maintain necessary FDA clearances or approvals for our medical device products, or if such clearances or approvals are delayed, we will be unable to continue to commercially distribute and market our products.
If we experience software errors or performance problems, we would likely also experience: ● loss of revenue; ● delay in market acceptance of our products; ● damage to our reputation; ● additional regulatory filings; 29 ● product recalls; ● increased service or warranty costs; and/or ● product liability claims relating to the software defects.
We rely on other parties to manufacture, and in some cases to service, magnetically compatible x-ray systems, catheter sensing technology, and a number of disposable interventional devices for use with our robotic magnetic navigation system.
Any disruptions in product flow may harm our ability to generate revenue, lead to customer dissatisfaction, damage our reputation and result in additional costs or cancellation of orders by our customers. 24 We rely on other parties to manufacture, and in some cases to service, magnetically compatible x-ray systems, catheter sensing technology, and a number of disposable interventional devices for use with our robotic magnetic navigation system.
It is also possible that as our products become more widely used, latent defects could be identified, creating negative publicity and liability problems for us and adversely affecting demand for our products. If physicians do not use our products, we likely will not become profitable or generate sufficient cash to fund company operations going forward.
It is also possible that as our products become more widely used, latent defects could be identified, creating negative publicity and liability problems for us and adversely affecting demand for our products.
The impact has varied widely over time by individual geography. We may not be able to fund our business operations in the same manner as we have done historically if we do not improve the operating performance of the Company or raise additional capital.
We may not be able to fund our business operations in the same manner as we have done historically if we do not improve the operating performance of the Company or raise additional capital. The Company has sustained operating losses throughout its corporate history and expects that its 2026 operating expenses will exceed its 2026 gross margin.
We, and our contract manufacturers, acquire materials, complete standard subassemblies and assemble fully configured systems based on sales forecasts.
We, and our contract manufacturers, acquire materials, complete standard subassemblies and assemble fully configured systems based on sales forecasts. If orders do not match forecasts, we, as well as our contract manufacturers, may have excess or inadequate inventory of materials and components.
We have generally been able to conduct normal business activities albeit in a more deliberate manner than prior to the pandemic, including taking action to increase inventory levels and engaging in discussions with our vendors on contractual obligations, but we cannot guarantee that they will not be impacted more severely in the future.
We continue to evaluate the macroeconomics business environment, taking action to increase inventory levels where appropriate and engaging in discussions with our vendors on contractual obligations, but we cannot guarantee that our business activities will not be impacted more severely in the future. Our suppliers and contract manufacturers have experienced, and may continue to experience, similar difficulties.
A material reduction or interruption in any of our manufacturing processes or a substantial increase in costs would have a material adverse effect on our business, operating results, and financial condition.
As a result of these factors, we may be unable to raise the prices of our products sufficiently to keep up with the rate of inflation, especially tariff-induced inflation. A material reduction or interruption in any of our manufacturing processes or a substantial increase in costs would have a material adverse effect on our business, operating results, and financial condition.
This prospectus is a part of that resale registration statement and covers the 1,486,620 common shares and an estimated 4,613,380 additional earnout common shares.
Pursuant to the share purchase agreement, we filed a resale registration statement covering the upfront stock consideration of 1,486,620 common shares and an estimated 4,613,380 additional earnout common shares.
These stockholders may also delay or prevent a change of control, even if such a change of control would benefit our other stockholders. This significant concentration of stock ownership may adversely affect the trading price of our common stock due to investors’ perception that conflicts of interest may exist or arise.
This significant concentration of stock ownership may adversely affect the trading price of our common stock due to investors’ perception that conflicts of interest may exist or arise. 33 Future issuances of our securities could dilute current stockholders’ ownership.
If these parties cannot or do not manufacture sufficient quantities to meet customer demand, or if their manufacturing processes are disrupted, or if they are not able to service or warrant their products, our revenue and profitability would be adversely affected.
If these parties experience, as some have had in the past, various challenges including the ability to manufacture sufficient quantities to meet customer demand, disruption of their manufacturing processes, or an inability to service or warrant their products, our revenue and profitability would be adversely affected.
In addition, connectivity with other devices in the electrophysiology lab is a key driver of value. If the Company is not able to continue to commit sufficient resources to ensure that its products are compatible with other products within the electrophysiology lab, this could have a negative impact on revenue.
If the Company is not able to continue to commit sufficient resources to ensure that its products are compatible with other products within the electrophysiology lab, this could have a negative impact on revenue. 27 Security breaches and other disruptions to our information technology infrastructure could interfere with our operations, compromise confidential information, and expose us to liability which could materially adversely impact our business and reputation.
Our competitors may acquire similar or even the same technology components that are utilized in our current offering eroding some differentiation in the marketplace. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent, as do the laws of the U.S., particularly in the field of medical products and procedures.
In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent, as do the laws of the U.S., particularly in the field of medical products and procedures. 28 Third parties may assert that we are infringing their intellectual property rights, and any defense of such assertions may be unsuccessful and expensive, even if we are successful.
If orders do not match forecasts, we, as well as our contract manufacturers, may have excess or inadequate inventory of materials and components. 24 In addition, if these manufacturers or suppliers stop providing us with the components or services necessary for the operation of our business, we may not be able to identify alternate sources in a timely fashion.
We cannot guarantee that another manufacturer or supplier will not, in the future, stop providing us with components or services necessary for the operation of our business, and if that were to occur, we cannot guarantee that we would be able to identify alternate sources in a timely fashion or at all.
Pandemics may negatively affect demand for both our systems and our disposable products in the future. For example, during the COVID-19 pandemic, we had negative demand for our products, and generally experienced other business disruptions, such as travel restrictions on us and our third-party distributors.
In addition to the macroeconomic factors, occurrences similar to the COVID-19 pandemic may negatively affect demand for both our systems and our disposable products. In the past, we have experienced business disruptions, including travel restrictions on us and our third-party distributors, which negatively affected our complex sales, marketing, installation, distribution and service network relating to our products and services.
We cannot assure you that we will obtain the patent protection we seek, that any protection we do obtain will be found valid and enforceable if challenged or that it will confer any significant commercial advantage. U.S. patents and patent applications may also be subject to interference proceedings and U.S. patents may be subject to re-examination proceedings in the U.S.
The patent positions of medical device companies, including ours, can be highly uncertain and involve complex and evolving legal and factual questions. We cannot assure you that we will obtain the patent protection we seek, that any protection we do obtain will be found valid and enforceable if challenged or that it will confer any significant commercial advantage.
Hospitals continue to experience challenges with staffing and cost pressures as supply chain constraints and inflation drive up operating costs. This may cause delays or cancellations of current purchase orders and other commitments and may exacerbate the long and variable sales and installation cycles for our robotic magnetic navigation systems.
These factors could cause delays or cancellations of current purchase orders and other commitments and may exacerbate the long and variable sales and installation cycles for our robotic magnetic navigation systems. Our hospital customers have also experienced challenges in sourcing supplies, such as catheters, needed to perform procedures.
While the agreement provides for a continuation of supply by Biosense Webster of the co-developed catheters to us or our customers for three years following the termination, we no longer receive royalty payments from Biosense Webster.
While that agreement provided for a continuation of supply by Johnson & Johnson of the J&J catheters to us or our customers for three years following the termination, that obligation lapsed on December 31, 2025.
Our commercial success depends in part on obtaining patent and other intellectual property right protection for the technologies contained in our products and on successfully defending these rights against third party challenges. The patent positions of medical device companies, including ours, can be highly uncertain and involve complex and evolving legal and factual questions.
We may be unable to protect our technology from use by third parties, which may allow them to compete with us and harm our business. Our commercial success depends in part on obtaining patent and other intellectual property right protection for the technologies contained in our products and on successfully defending these rights against third party challenges.
There can be no assurances that we will be successful in manufacturing catheter products or that we will realize the expected operating efficiencies, cost savings and other benefits anticipated from the acquisition. The issuance of the Earnout Consideration will result in dilution to our stockholders and may adversely affect us, including the market price of our securities.
We are still integrating the businesses and implementing safeguards to minimize any negative impacts on our financial position, results of operations and cash flows post-acquisition. 26 The issuance of the Earnout Consideration will result in dilution to our stockholders and may adversely affect us, including the market price of our securities.
Third parties may assert that we are infringing their intellectual property rights, and any defense of such assertions may be unsuccessful and expensive, even if we are successful. Successfully commercializing our products depends in part on not infringing patents held by third parties.
Successfully commercializing our products depends in part on not infringing patents held by third parties. It is possible that one or more of our products, including those that we have developed in conjunction with third parties, infringes existing patents.
Removed
Changes in economic conditions and supply chain constraints could lead to higher inflation than previously experienced or expected, which could, in turn, lead to an increase in costs. We may be unable to raise the prices of our products sufficiently to keep up with the rate of inflation.
Added
Future results of operations and liquidity could be materially adversely impacted by uncertainties in macroeconomic and geopolitical factors in both the U.S. and globally including continuing introduction of new or modification of existing tariffs or trade barriers, supply chain challenges, inflationary pressures, elevated interest rates, and disruptions in commodity markets stemming from conflicts, such as those between Russia and Ukraine and conflicts in the Middle East, including Israel and Iran.
Removed
Our hospital customers have also experienced challenges in sourcing supplies, such as catheters, needed to perform procedures. Such shortages have, and may continue to, put pressure on procedures and our disposable revenue. Any disruption to the capital markets could negatively impact our ability to raise capital.
Added
Changes in economic conditions, government shutdowns, tariff escalation, retaliatory measures and new import restrictions could lead to higher inflation than previously experienced or expected, which could, in turn create supply shortages as companies seek alternative sources of supply and adjust their logistics and transportation routes.
Removed
All of this negatively affected our complex sales, marketing, installation, distribution and service network relating to our products and services, and that may occur again in the future if we experience another pandemic or a significant resurgence of COVID-19.
Added
Hospitals continue to experience challenges with staffing and cost pressures as supply chain constraints and inflation drive up operating costs. Hospitals may also be adversely affected by the liquidity concerns driven by elevated interest rates and the broader macroeconomic environment.
Removed
Any disruptions in product flow may harm our ability to generate revenue, lead to customer dissatisfaction, damage our reputation and result in additional costs or cancellation of orders by our customers.
Added
Such shortages have, and may continue to, put pressure on procedures and our disposable revenue. Delays in order placement, cancellation of existing orders and reduced demand or availability of our disposable products all would have a material adverse effect on our business, financial condition, and results of operations.
Removed
Security breaches and other disruptions to our information technology infrastructure could interfere with our operations, compromise confidential information, and expose us to liability which could materially adversely impact our business and reputation.
Added
Disruptions to the capital markets and other financing sources could also negatively impact our hospital customers’ ability to raise capital or otherwise obtain financing to fund their operations and capital projects.
Removed
Future issuances of our securities could dilute current stockholders’ ownership. As of December 31, 2024, we had 49.4 million shares of our common stock issuable upon conversion of our Series A Convertible Preferred Stock.
Added
For instance, in 2022, procedure volumes were challenged by periodic resurgences of COVID-19, ongoing hospital staffing issues and other factors. In the first quarter of 2023, COVID-19 resurgences in China continued to negatively impact our procedure volumes in that region, but as infections and hospitalization decreased, we saw a recovery of procedure volumes with no further impacts in the year.
Added
For example, our agreement with Johnson & Johnson expired by its terms on December 31, 2022 ending the receipt of royalty payments on the J&J catheters.
Added
In the past, some critical suppliers have stopped providing us with the components and services necessary for the operation of our business, requiring us to identify alternate sources.
Added
In addition, the vesting of the right to receive the earnout shares would be accelerated in the event of a change of control of Stereotaxis, based on a probability-weighted average estimate of the potential to achieve any remaining milestones, discounted to its net present value considering expected time when earnouts related to the milestones would become payable through September 30, 2029.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe use these cybersecurity frameworks and information security standards as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business. 37 We also maintain third party security procedures to identify, prioritize, assess, mitigate and remediate third party risks; however, we rely on the third parties we use to implement security programs commensurate with their risk, and we cannot ensure in all circumstances that their efforts will be successful.
Biggest changeWe also maintain third party security procedures to identify, prioritize, assess, mitigate and remediate third party risks; however, we rely on the third parties we use to implement security programs commensurate with their risk, and we cannot ensure in all circumstances that their efforts will be successful.
ITEM 1C. CYBERSECURITY Cybersecurity risk management and strategy We have developed and implemented a cybersecurity risk management program intended to protect the confidentiality, integrity, and availability of our critical systems and information. Our cybersecurity risk management program includes a cybersecurity incident response plan.
ITEM 1C. CYBERSECURITY Cybersecurity risk management and strategy We have developed and implemented a cybersecurity risk management program intended to protect the confidentiality, integrity, and availability of our critical systems and information.
We design and assess our program based on various cybersecurity frameworks, such as the National Institute of Standards and Technology (“NIST”) and the System and Organizational Controls (“SOC2”), as well as information security standards issued by the International Organization for Standardization, including ISO 27001 and ISO 27002.
Our cybersecurity risk management program includes a cybersecurity incident response plan. 37 We design and assess our program based on various cybersecurity frameworks, such as the National Institute of Standards and Technology (“NIST”) and the System and Organizational Controls (“SOC2”), as well as information security standards issued by the International Organization for Standardization, including ISO 27001 and ISO 27002.
Added
We use these cybersecurity frameworks and information security standards as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeLease payments commenced on August 1, 2024, and the lease has a term of four years, with two renewal options of four years each. The Company also has leased office space in Amsterdam, The Netherlands through June 30, 2025. In addition, we lease an office space in Beijing, China under a lease agreement through November 29, 2026. 38
Biggest changeLease payments commenced on August 1, 2024, and the lease has a term of four years, with two renewal options of four years each. 38 The Company also has leased office space in Beijing, China under a lease agreement through November 29, 2026.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeITEM 3. LEGAL PROCEEDINGS The Company is involved from time to time in various lawsuits and claims arising in the normal course of business. Although the outcomes of these lawsuits and claims are uncertain, the Company does not believe any of them are likely to have a material adverse effect on our business, financial condition or results of operations.
Biggest changeITEM 3. LEGAL PROCEEDINGS The Company is involved from time to time in various lawsuits and claims arising in the normal course of business. Although the outcomes of these lawsuits and claims are uncertain, the Company does not believe any of them are presently likely to have a material adverse effect on our business, financial condition or results of operations.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 39 Part II Item 5. Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 39 Item 6. [Reserved] 39 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 39 Item 8. Financial Statements and Supplementary Data 48 Item 9.
Biggest changeItem 4. Mine Safety Disclosures 39 Part II Item 5. Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 39 Item 6. [Reserved] 39 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 39 Item 8. Consolidated Financial Statements and Supplementary Detail 48 Item 9.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeAs of February 28, 2025, there were approximately 395 stockholders of record of our common stock, although we believe that there is a significantly larger number of beneficial owners of our common stock.
Biggest changeAs of February 28, 2026, there were approximately 387 stockholders of record of our common stock, although we believe that there is a significantly larger number of beneficial owners of our common stock.

Item 7. Management's Discussion & Analysis

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

62 edited+20 added−14 removed80 unchanged
Biggest changeThis increase was primarily driven by the remeasurement of the contingent consideration, higher administrative expenses and professional service fees in the current year period, and amortization of the acquisition related intangible assets. Interest Income. Net interest income was $0.7 million for the year ended December 31, 2024, and $1.1 million for the year ended December 31, 2023.
Biggest changeGeneral and administrative expenses increased from $17.2 million for the year ended December 31, 2024, to $17.8 million for the year ended December 31, 2025, an increase of approximately 4%. This increase was primarily driven by the change in contingent consideration expense and amortization of acquisition related intangible assets offset by lower administrative expenses in the current year period.
The fair value of the grants of restricted shares and units was determined based on the closing price of our stock on the date of grant.
The fair value of the grants of stock and restricted shares and units was determined based on the closing price of our stock on the date of grant.
See Note 3, Acquisitions for further discussion of the contingent consideration recorded as of the acquisition date and as of December 31, 2024. 44 Stock-based Compensation Stock compensation expense, which is a non-cash charge, results from stock option, non-qualified stock options, stock appreciation rights, and restricted share grants made to employees, directors, and third-party consultants at the fair value of the grants.
See Note 3, Acquisitions for further discussion of the contingent consideration recorded as of the acquisition date and as of December 31, 2025 and 2024. 44 Stock-based Compensation Stock compensation expense, which is a non-cash charge, results from stock, stock option, non-qualified stock options, stock appreciation rights, and restricted share grants made to employees, directors, and third-party consultants at the fair value of the grants.
In addition to the aforementioned macroeconomic factors, the COVID-19 pandemic or similar occurrences may negatively affect demand for both our systems and our disposable products. In the past, we have experienced business disruptions, including travel restrictions on us and our third-party distributors, which negatively affected our complex sales, marketing, installation, distribution and service network relating to our products and services.
In addition to the aforementioned macroeconomic factors, occurrences similar to the COVID-19 pandemic may negatively affect demand for both our systems and our disposable products. In the past, we have experienced business disruptions, including travel restrictions on us and our third-party distributors, which negatively affected our complex sales, marketing, installation, distribution and service network relating to our products and services.
Through these strategic relationships we provide compatibility with our robotic magnetic navigation system, integrated x-ray systems, digital imaging and 3D catheter location sensing technology, and compatible disposable interventional devices. The maintenance of these strategic relationships, or the establishment of equivalent alternatives, is critical to our commercialization efforts.
Through these strategic relationships we provide compatibility with our robotic magnetic navigation systems, integrated x-ray systems, digital imaging and 3D catheter location sensing technology, and compatible disposable interventional devices. The maintenance of these strategic relationships, or the establishment of equivalent alternatives, is critical to our commercialization efforts.
In addition to the net operating loss carryovers related to our operations, in connection with our acquisition of APT as discussed in Note 3, we acquired federal and state net operating loss and tax credit carryovers of APT. Our ability to utilize those carryovers and credits will be limited under IRC Section 382.
In addition to the net operating loss carryovers related to our operations, in connection with our 2024 acquisition of APT as discussed in Note 3, we acquired federal and state net operating loss and tax credit carryovers of APT. Our ability to utilize those carryovers and credits will be limited under IRC Section 382.
The Company believes the cash, and cash equivalents on hand as of December 31, 2024, will be sufficient to meet its obligations as they become due in the ordinary course of business for at least 12 months following the date of the consolidated financial statements included in this Annual Report on Form 10-K, as well as for periods beyond that 12-month period.
The Company believes the cash, and cash equivalents on hand as of December 31, 2025, will be sufficient to meet its obligations as they become due in the ordinary course of business for at least 12 months following the date of the consolidated financial statements included in this Annual Report on Form 10-K, as well as for periods beyond that 12-month period.
In November 2024, the Genesis RMN system, our current generation system, received regulatory approval from China’s National Medical Products Administration (NMPA), and our partner MicroPort received the regulatory clearances and for their integrated mapping system and novel ablation catheter making available the most current advances minimally-invasive robotic technology to physicians and patients in China.
In November 2024, the Genesis RMN system, our current generation system, received regulatory approval from China’s National Medical Products Administration (NMPA), and our partner MicroPort received the regulatory clearances for their integrated mapping system and novel ablation catheter making available the most current advanced minimally invasive robotic technology to physicians and patients in China.
Stock compensation expense for performance-based restricted shares, if any, is amortized on a straight-line basis over the anticipated vesting period and is subject to adjustment based on the actual achievement of objectives. Compensation expense is recognized only for those options expected to vest, net of actual forfeitures.
Stock compensation expense for performance-based restricted shares, if any, is amortized on a straight-line basis over the anticipated vesting period and is subject to adjustment based on the actual achievement of objectives. Compensation expense is recognized only for those awards expected to vest, net of actual forfeitures.
The costs capitalized as contract acquisition costs included in prepaid expenses and other assets in the Company’s balance sheets were approximately $0.1 million as of December 31, 2024 and 2023. respectively. The Company did not incur any impairment losses during any of the periods presented.
The costs capitalized as contract acquisition costs included in prepaid expenses and other assets in the Company’s balance sheets were approximately $0.1 million as of December 31, 2025 and 2024, respectively. The Company did not incur any impairment losses during any of the periods presented.
The Section 382 limited net operating loss carryovers total approximately $9.1 million, of which $0.6 million was incurred prior to the 2018 effective date of the TCJA and will expire between 2035 and 2037 with the remainder available for indefinite carryforward.
The Section 382 limited net operating loss carryovers total approximately $9.2 million, of which $0.6 million was incurred prior to the 2018 effective date of the TCJA and will expire between 2035 and 2037 with the remainder available for indefinite carryforward.
Consistent with our conclusion with respect the need for valuation allowances associated with our other deferred tax assets, the net deferred tax assets related to APT of $1.6 million at the acquisition date as well as those at December 31, 2024 were fully included in our valuation allowance.
Consistent with our conclusion with respect to the need for valuation allowances associated with our other deferred tax assets, the net deferred tax assets related to APT of $1.6 million at the acquisition date as well as those at December 31, 2025 were fully included in our valuation allowance.
Consequently, revenues and/or orders resulting from sales of our robotic magnetic navigation system can vary significantly from one reporting period to the next. 40 We have strategic relationships with technology leaders and innovators in the global interventional market.
Consequently, revenues and/or orders resulting from sales of our robotic magnetic navigation systems can vary significantly from one reporting period to the next. 40 We have strategic relationships with technology leaders and innovators in the global interventional market.
Forward-looking statements include, but are not limited to, discussions regarding our operating strategy, sales and marketing strategy, regulatory strategy, industry, economic conditions, financial condition, liquidity, capital resources, results of operations, the impact of, and our response to the coronavirus (“COVID-19”) pandemic pandemics similar to the coronavirus (“COVID-19”) pandemic (or COVID-19 resurgences), and statements relating to our recent acquisition of APT including any benefits expected from the acquisition, potential strategic implications as a result of the acquisition, and the potential for achievement of the regulatory and commercial milestones that would trigger contingent payments in the transaction.
Forward-looking statements include, but are not limited to, discussions regarding our operating strategy, sales and marketing strategy, regulatory strategy, industry, economic conditions, financial condition, liquidity, capital resources, results of operations, the impact of, and our response to the coronavirus (“COVID-19”) pandemic, pandemics similar to the coronavirus (“COVID-19”) pandemic, and statements relating to our recent acquisition of APT including any benefits expected from the acquisition, potential strategic implications as a result of the acquisition, and the potential for achievement of the regulatory and commercial milestones that would trigger contingent payments in the transaction.
The applicable state net operating loss carryforwards related to APT are approximately $9.6 million with $9.1 million expiring at various dates between 2030-2038 with the remaining carried forward indefinitely.
The applicable state net operating loss carryforwards related to APT are approximately $9.6 million with $9.2 million expiring at various dates between 2030 - 2038 with the remaining carried forward indefinitely.
Through our strategic relationships with fluoroscopy system manufacturers, providers of catheters and electrophysiology mapping systems, and other parties, we offer our customers x-ray systems and other accessory devices.
Through our strategic relationships with fluoroscopy system manufacturers, providers of catheters and electrophysiology mapping systems, and other parties, we offer our customers x-ray systems and other accessory diagnostic and therapeutic devices.
The acquired tax credit carryovers total $0.2 million for federal income tax purposes, which expire between 2036 and 2043, and state credit carryovers of $0.3 million, which expire between 2031 and 2038.
The acquired tax credit carryforwards total $0.3 million for federal income tax purposes, which expire between 2036 and 2043, and state credit carryovers of $0.3 million, which expire between 2031 and 2038.
We pursue arrangements with fluoroscopy system manufacturers to provide such systems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms.
We pursue arrangements with fluoroscopy system manufacturers to provide RMN Systems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms.
The amount of compensation expense to be recorded in future periods may increase if we make additional grants of options, stock appreciation rights or restricted shares. The amount of expense to be recorded in future periods may decrease if the requisite service periods are not completed.
The amount of compensation expense to be recorded in future periods may increase if we make additional grants of options, stock appreciation rights or restricted shares. The amount of expense to be recorded in future periods may decrease if the requisite service periods are not completed or if performance targets are not achieved.
Since inception, we have financed our operations primarily through cash generated by operations and proceeds from our debt and stock offerings. Capital Resources As of December 31, 2024 and 2023, the Company did not have any debt.
Since inception, we have financed our operations primarily through cash generated by operations and proceeds from our debt and stock offerings. 46 Capital Resources As of December 31, 2025 and 2024, the Company did not have any debt.
See Note 3, Acquisitions for further discussion of the goodwill and intangible assets recorded as of the acquisition date and as of December 31, 2024.
See Note 3, Acquisitions for further discussion of the goodwill and intangible assets recorded as of the acquisition date and as of December 31, 2025.
The federal net operating loss carryforwards reflect accumulated book losses reduced for the 2013 IRC Section 382 ownership change limitation of $188.0 million, book/tax differences and expiration of carryforwards. The federal net operating loss carryforwards generated prior to the 2018 tax year of approximately $98.8 million will expire between 2030 and 2037.
The federal net operating loss carryforwards reflect accumulated book losses reduced for the 2013 IRC Section 382 ownership change limitation of $144.4 million, book/tax differences and expiration of carryforwards. The federal net operating loss carryforwards generated prior to the 2018 tax year of approximately $98.8 million will expire between 2030 and 2037.
Revenue from services and software enhancements, service-type warranties, and the implied obligation to provide software enhancements are deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed on a time-and-materials basis is recognized when performed. 43 The Company invoices its customers based on the billing schedules in its sales arrangements.
Revenue from services and software enhancements, including service-type warranties, are deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed on a time-and-materials basis is recognized when performed. The Company invoices its customers based on the billing schedules in its sales arrangements.
As a percentage of our total revenue, overall gross margin was 54% and 56% for the years ended December 31, 2024, and December 31, 2023, respectively. The decrease was primarily due to changes in product mix.
As a percentage of our total revenue, overall gross margin was 53% and 54% for the years ended December 31, 2025, and December 31, 2024, respectively. The decrease was primarily due to changes in product mix.
Gross margin for systems increased from $0.7 million for the year ended December 31, 2023, to $1.8 million for the year ended December 31, 2024. Cost of revenue for disposables, service, and accessories increased from $3.9 million for the year ended December 31, 2023, to $5.4 million for the year ended December 31, 2024.
Gross margin for systems increased from $1.8 million for the year ended December 31, 2024, to $2.2 million for the year ended December 31, 2025. Cost of revenue for disposables, service, and accessories increased from $5.4 million for the year ended December 31, 2024, to $7.3 million for the year ended December 31, 2025.
As of December 31, 2024, we had gross state net operating loss carryforward of approximately $38.1 million which will expire at various dates between 2025 and 2043 if not utilized.
As of December 31, 2025, we had gross state net operating loss carryforward of approximately $50.2 million which will expire at various dates between 2026 and 2043 if not utilized.
The Genesis RMN System is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters through the blood vessels and chambers of the heart to treatment sites.
The Genesis RMN and the GenesisX RMN Systems are designed to enable physicians to complete complex interventional procedures by providing image-guided delivery of catheters through the blood vessels and chambers of the heart to treatment sites.
Liquidity and Capital Resources Liquidity refers to the liquid financial assets available to fund our business operations and pay for near-term obligations. These liquid financial assets consist of cash, cash equivalents, and investments. As of December 31, 2024, our accumulated deficit was $561.7 million with cash and cash equivalents of $12.4 million, inclusive of restricted cash.
Liquidity and Capital Resources Liquidity refers to the liquid financial assets available to fund our business operations and pay for near-term obligations. These liquid financial assets consist of cash, cash equivalents, and investments. As of December 31, 2025, our accumulated deficit was $583.4 million with cash and cash equivalents of $13.4 million.
Revenue from sales of disposable interventional devices, service and accessories increased to $18.3 million for the year ended December 31, 2024, from $18.0 million for the year ended December 31, 2023, an increase of approximately 1%.
Revenue from sales of disposable interventional devices, service and accessories increased to $22.2 million for the year ended December 31, 2025, from $18.3 million for the year ended December 31, 2024, an increase of approximately 21%.
Our revenue recognition policy affects the following revenue streams in our business as follows: Systems: Contracts related to the sale of systems typically contain separate obligations for the delivery of system(s), installation, service-type warranty, and an implied obligation to provide software enhancements if and when available for one year following installation.
Our revenue recognition policy affects the following revenue streams in our business as follows: Systems: Contracts related to the sale of systems typically contain separate obligations for the delivery of system(s), installation, and a service-type warranty for one year following installation.
Of the December 31, 2024 backlog, we expect approximately 70% to be recognized as revenue over the course of 2025. We had backlog of approximately $14.7 million as of December 31, 2023.
Of the December 31, 2025 system backlog, we expect approximately 78% to be recognized as revenue over the course of 2026. We had system backlog of approximately $14.4 million as of December 31, 2024.
Our principal source of liquidity is cash provided by operations and by the issuance of common stock through the exercise of stock options and our employee stock purchase program as well as cash received from past equity raises.
The increase in working capital was primarily driven by the proceeds from our equity offerings in 2025. Our principal source of liquidity is cash provided by operations and by the issuance of common stock through the exercise of stock options and our employee stock purchase program as well as cash received from past equity raises.
Cost of revenue for systems sold decreased from $8.1 million for the year ended December 31, 2023, to $6.9 million for the year ended December 31, 2024, primarily due to decreased system sales volume and changes in product mix in the current year period.
Cost of revenue for systems sold increased from $6.9 million for the year ended December 31, 2024, to $8.0 million for the year ended December 31, 2025, primarily due to increased system sales volume in the current year period.
The integration with APT provides in-house catheter development, manufacturing expertise and specialized knowledge that will further Stereotaxis’ innovation efforts in developing a broad family of interventional devices navigated by our robots within electrophysiology and across a range of endovascular procedures. In addition to the integration with APT, Stereotaxis has made other advancements in robotically enabled interventional devices.
The integration with APT provides in-house catheter development, manufacturing expertise and specialized knowledge that will further Stereotaxis’ innovation efforts in developing a broad family of interventional devices navigated by our robots within electrophysiology and across a range of endovascular procedures. Stereotaxis has continued to advance development and regulatory approval of its Robotic Magnetic Navigation systems and proprietary interventional devices.
Liquidity The following table summarizes our cash flow by operating, investing and financing activities for years ended December 31, 2024 and 2023 (in thousands): Year Ended December 31, 2024 2023 Cash flow used in operating activities $ (8,497 ) $ (9,139 ) Cash flow provided by investing activities 74 19,765 Cash flow provided by financing activities 297 81 Net cash used in operating activities .
Liquidity The following table summarizes our cash flow by operating, investing and financing activities for years ended December 31, 2025 and 2024 (in thousands): Year Ended December 31, 2025 2024 Cash flow used in operating activities $ (13,685 ) $ (8,497 ) Cash flow (used in) provided by investing activities (93 ) 74 Cash flow provided by financing activities 14,763 297 Net cash used in operating activities .
We believe these benefits can be applicable in other endovascular indications where navigation through complex vasculature is often challenging or unsuccessful and generates significant x-ray exposure, and we are investing in research and development in these areas. Our primary products include the Genesis RMN System, the GenesisX RMN System , the Odyssey Solution, and other related devices.
We believe these benefits can be applicable in other endovascular indications where navigation through complex vasculature is often challenging or unsuccessful and generates significant x-ray exposure, and we are investing in research and development in these areas.
Results of Operations Comparison of the Years ended December 31, 2024 and 2023 Revenue . Revenue increased from $26.8 million for the year ended December 31, 2023, to $26.9 million for the year ended December 31, 2024, an increase of less than 1%.
Results of Operations Comparison of the Years ended December 31, 2025 and 2024 Revenue . Revenue increased from $26.9 million for the year ended December 31, 2024, to $32.4 million for the year ended December 31, 2025, an increase of 20%.
Risks and Uncertainties Future results of operations could be materially adversely impacted by macroeconomic and geopolitical factors. The Company continues to experience difficulties with periodic worldwide supply chain disruptions, including shortages and inflationary pressures, tariffs or other trade restrictions, and logistics delays which make it difficult for us to source parts and ship our products.
The Company continues to experience difficulties with periodic worldwide supply chain disruptions, including shortages and inflationary pressures, tariffs or other trade restrictions, and logistics delays which make it difficult for us to source parts and ship our products.
Warranty costs were not material for the periods presented. Royalty: The Company receives royalties on the sale of various devices as provided by co-development and co-placement arrangements with various manufacturers.
Warranty costs were not material for the periods presented. 43 Royalty: The Company receives royalties on the sale of various devices as provided by co-development and co-placement arrangements with various manufacturers. Other Recurring Revenue: Other recurring revenue includes revenue from product maintenance plans, service-type warranties, and other post warranty maintenance.
The increase was primarily driven by the contributions from our recent acquisition of APT partially offset by decreased service revenue in the current year period. Cost of Revenue . Cost of revenue increased from $11.9 million for the year ended December 31, 2023, to $12.3 million for the year ended December 31, 2024, an increase of approximately 3%.
The increase was primarily driven by the full year contribution from our 2024 acquisition of APT and increased service revenue in the current year period. Cost of Revenue . Cost of revenue increased from $12.3 million for the year ended December 31, 2024, to $15.3 million for the year ended December 31, 2025, an increase of approximately 24%.
We are still integrating the businesses and implementing safeguards to minimize any negative impacts on our financial position, results of operations and cash flows post-acquisition. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents and marketable securities.
We are still integrating the businesses and implementing safeguards to minimize any negative impacts on our financial position, results of operations and cash flows post-acquisition.
We used approximately $8.5 million and $9.1 million of cash in operating activities during the years ended December 31, 2024 and 2023, respectively. The decrease in cash used in operating activities was driven by the increased operating loss partially offset by changes in working capital. 46 Net cash provided by investing activities .
We used approximately $13.7 million and $8.5 million of cash in operating activities during the years ended December 31, 2025 and 2024, respectively. The increase in cash used in operating activities was primarily driven by changes in working capital. Net cash used in/provided by investing activities .
The Company’s system contracts generally do not provide a right of return. Systems may be covered by a one-year assurance-type warranty in lieu of a service-type warranty. Assurance-type warranty costs were less than $0.1 million for the year ended December 31, 2024 and approximately $0.5 million for the year ended December 31, 2023, respectively.
Systems may be covered by a one-year assurance-type warranty in lieu of a service-type warranty. Assurance-type warranty costs were less than $0.1 million for the years ended December 31, 2025 and 2024.
In accordance with Accounting Standards Codification Topic 606 (“ASC 606”), “Revenue from Contracts with Customers,” we account for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable.
We account for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable.
Revenue from sales of systems decreased from $8.7 million for the year ended December 31, 2023, to $8.6 million for the year ended December 31, 2024, a decrease of approximately 1%, driven by decreased system sales volumes in the current year period.
Revenue from sales of systems increased from $8.6 million for the year ended December 31, 2024, to $10.2 million for the year ended December 31, 2025, an increase of approximately 18%, driven by increased system sales volumes in the current year period.
Revenue from service-type warranties and the implied obligation to deliver software enhancements if and when available is included in Other Recurring Revenue and is recognized ratably typically over the first year following installation of the system as the customer receives the service-type warranty and right to software updates throughout the period.
Revenue from service-type warranties is included in Other Recurring Revenue and is recognized ratably typically over the first year following installation of the system as the customer receives the service-type warranty throughout the period. The Company’s system contracts generally do not provide a right of return.
Sales and marketing expenses remained consistent at $12.4 million for the years ended December 31, 2024 and 2023. General and Administrative Expense . General and administrative expenses include finance, information systems, legal, and general management expenses, amortization of acquisition related intangible assets, and the gain or loss associated with the remeasurement of the acquisition related contingent consideration.
General and administrative expenses include finance, information systems, legal, and general management expenses, amortization of acquisition related intangible assets, and the gain or loss associated with the remeasurement of the acquisition related contingent consideration.
The contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved. Changes in fair value are recognized in the Company’s earnings as a charge to General and Administrative expenses.
Changes in fair value are recognized in the Company’s earnings as a charge to General and Administrative expenses.
The Company has established short-term and long-term contingent liabilities for the net present fair value of contingent payments which are both probable of occurrence and reasonably estimable. The initial fair value of the contingent consideration was determined by a third-party valuation firm using both a Monte Carlo simulation and probability based approaches.
The Company has established short-term and long-term contingent liabilities for the net present fair value of contingent payments which are both probable of occurrence and reasonably estimable.
Gross margin for disposables, service and accessories was 70% for the current year period compared to 79% for the year ended December 31, 2023, primarily driven by acquisition related accounting which required the valuation of acquired finished good inventory to fair value. 45 Research and Development Expense .
Gross margin for disposables, service and accessories was 67% for the current year period compared to 70% for the year ended December 31, 2024, primarily driven by product mix. 45 Research and Development Expense .
The Stereotaxis MAGiC catheter, a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures, obtained the CE marking in Europe in the first quarter, 2025, and we are in the process of obtaining necessary approvals in the U.S. and other countries.
In October, 2025, we attained CE Mark for the Synchrony Solution and are working towards FDA 510(k) regulatory clearance within the United States. The Stereotaxis MAGiC catheter, a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures, obtained the CE marking in Europe during the first quarter, 2025 and U.S.
Research and development expenses decreased from $10.3 million for the year ended December 31, 2023, to $9.8 million for the year ended December 31, 2024, a decrease of approximately 5%. This decrease was primarily driven by the reversal of an accrued regulatory license fee. Sales and Marketing Expense.
Research and development expenses decreased from $9.8 million for the year ended December 31, 2024, to $9.4 million for the year ended December 31, 2025, a decrease of approximately 4%. This decrease was primarily driven by the attainment of technological feasibility and regulatory approval of the GenesisX in 2025 offset by acquired headcount expense from our acquisition.
We generated approximately $0.3 million and $0.1 million of cash for the years ended December 31, 2024 and 2023, respectively. The cash generated in both periods was driven by the exercise of stock options, net of issuance costs, and our employee stock purchase program.
The cash generated in 2024 was driven by the proceeds from issuance of stock from the exercise of options, net of issuance costs, and from our employee stock purchase program. At December 31, 2025, we had working capital of approximately $11.5 million, compared to working capital of approximately $4.8 million at December 31, 2024.
During the periods presented, the Company has not experienced any losses on its deposits of cash, cash equivalents or marketable securities. 42 Critical Accounting Policies and Estimates Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles.
The Company closely monitors events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally. 42 Critical Accounting Policies and Estimates Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles.
Beyond interventional devices, we continue to drive our broad-based innovation plan with ongoing regulatory and development efforts for our RMN systems. In the third quarter of 2024, we attained CE Mark for the GenesisX RMN System and are working towards FDA 510(k) regulatory clearance within the United States.
In the third quarter of 2024, we attained CE Mark for the GenesisX RMN System, and in the fourth quarter of 2025 we received FDA 510(k) regulatory clearance within the United States.
The GenesisX RMN System, the latest generation of the Genesis RMN System, is designed to significantly enhance the accessibility of Robotic Magnetic Navigation by eliminating the lengthy construction cycle necessary to install prior generation RMN systems.
The GenesisX RMN System, the latest generation of the Genesis RMN System, is designed to enhance the accessibility of Robotic Magnetic Navigation by reducing the lengthy construction cycle necessary to install prior generation RMN systems. The Odyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the key information in the operating room.
Please refer to “Regulatory Approval” in Item 1 for a description of the regulatory clearance, licensing, and/or approvals we currently have or are pursuing. As of December 31, 2024, we had approximately $15.2 million of backlog, consisting of outstanding purchase orders and other commitments for these systems.
Not all products have and/or require regulatory clearance in all the markets we serve. Please refer to “Regulatory Approval” in Item 1 for a description of the regulatory clearance, licensing, and/or approvals we currently have or are pursuing.
The decrease was driven by lower invested balances and declining interest rates in the current year period. Income Taxes Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain.
The decrease was driven by lower invested balances and declining interest rates in the current year period. Income Taxes In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized.
Cash provided by investing activities for the year ended December 31, 2024, consisted of $0.1 million. The cash generated during the year ended December 31, 2024, was primarily from cash acquired in the APT business acquisition. C ash provided by investing activities for the year ended December 31, 2023, consisted of 19.8 million.
We used less than $0.1 million of cash for investing activities during the year ended December 31, 2025 for the purchase of equipment. We generated approximately $0.1 million for investing activities during the year ended December 2024 from the acquisition of Access Point Technologies EP, Inc. Net cash provided by financing activities .
Approval processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical data, and regulatory applications could be denied. Not all products have and/or require regulatory clearance in all the markets we serve.
Approval processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical data, and regulatory applications could be denied. As of December 31, 2025, we had approximately $9.1 million of system backlog, consisting of outstanding purchase orders and other commitments for these systems.
We are also currently seeking FDA clearances for other devices including the MAGiC Sweep™ catheter, the first high-density EP mapping catheter developed to be robotically navigated using Stereotaxis’ Robotic Magnetic Navigation system, and the EMAGIN 5F catheter guide designed to robotically navigate tortuous venous and arterial vasculature.
We are also currently seeking regulatory clearances for the EMAGIN 5F catheter guide designed to robotically navigate tortuous venous and arterial vasculature. Risks and Uncertainties Future results of operations could be materially adversely impacted by macroeconomic and geopolitical factors.
Accordingly, net deferred tax assets have been fully offset by valuation allowances as of December 31, 2024, and December 31, 2023, to reflect these uncertainties. As of December 31, 2024, we had gross federal net operating loss carryforwards arising from our operations of approximately $134.9 million.
Based upon the level of historical taxable losses, and projections for future periods over which the deferred tax assets are deductible, the Company determined that a 100% valuation allowance of net deferred tax assets was appropriate. As of December 31, 2025, we had gross federal net operating loss carryforwards arising from our operations of approximately $159.1 million.
Removed
The Odyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the key information in the operating room. This is designed to improve lab layout and procedure efficiency.
Added
Our primary products include the Genesis RMN and the GenesisX RMN Systems, the Odyssey and Synchrony & SynX Solutions, various interventional devices under the Map-iT , MAGiC and EMAGIN brands, and other related devices.
Removed
The system also features a remote viewing and recording capability called Odyssey Cinema, which is an innovative solution that delivers synchronized content for optimized workflow, advanced care, and improved productivity. This tool includes an archiving capability that allows clinicians to store and replay entire procedures or segments of procedures.
Added
This is designed to improve lab layout and procedure efficiency. The system also features a remote viewing and recording capability called Odyssey Cinema . The Odyssey Solution and Odyssey Cinema are being replaced by next generation innovative solutions branded Synchrony and SynX .
Removed
This information can be accessed from locations throughout the hospital local area network and over the global Odyssey Network providing physicians with a tool for clinical collaboration, remote consultation, and training. We are actively developing the next generation imaging and collaboration solutions with Synchrony and SynX .
Added
Synchrony digitizes and modernizes the interventional cath lab with a 4K high-definition display that consolidates the viewing and control of disparate systems in the lab, offering enhanced procedure experience with custom layouts, streamlined workflows, an intuitive user interface, and a decluttered environment.
Removed
We have received regulatory clearances and approvals necessary for us to market the Genesis RMN System in the U.S., Europe, and China, and we are in the process of obtaining necessary registrations for extending our markets in other countries.
Added
Synchrony is made available with SynX a cloud-based HIPAA and GDPR-compliant browser and mobile-based app that allows for secure remote connectivity, collaboration, recording, and monitoring of the cath lab. As these technologies gain regulatory approvals they are being commercialized alongside RMN systems and as stand-alone solutions.
Removed
The GenesisX RMN System, the latest generation of the Genesis RMN System has received regulatory clearances and approvals in Europe, and we are in the process of obtaining necessary registrations in the US and other countries, The Niobe System, our prior generation robotic magnetic navigation system, the Odyssey Solution, Cardiodrive , e-Contact, and various disposable interventional devices, including the Map-iT family of devices, have received regulatory clearances and approvals in the U.S., Europe, Canada, China, Japan and various other countries.
Added
Food and Drug Administration (FDA) 510(k) clearance in January, 2026. MAGiC Sweep ™, the first robotically navigated high-density EP mapping catheter, received U.S. Food and Drug Administration (FDA) 510(k) clearance in July 2025. We are in the process of obtaining necessary approvals for both devices in other geographies.
Removed
We have regulatory clearances and approvals that allow us to market the Vdrive and Vdrive Duo Systems with the V-CAS device in the U.S., Canada, and Europe. We have obtained the CE marking for us to market the Stereotaxis MAGiC catheter in Europe and are pursuing regulatory approval in the U.S. and various other global geographies.
Added
We have arrangements with technology leaders in the global interventional market, including manufacturers of fluoroscopy systems, ablation catheters, and electrophysiology mapping systems, that we believe are critical for us in commercializing our robotic magnetic navigation systems.
Removed
The Company closely monitors events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, including Silicon Valley Bank.
Added
These arrangements are important to us as they provide for the integration of our system with digital imaging and 3D catheter location sensing technology, as well as catheters compatible with our system.
Removed
On March 10, 2023, Silicon Valley Bank (“SVB”), where the Company maintained accounts with a cash balance of less than 6% of the Company’s total cash, cash equivalents and marketable securities, was closed by the California Department of Financial Protection and Innovation and the FDIC was appointed as receiver. On March 12, 2023, the U.S.
Added
Prior to regulatory clearance of a replacement device, our propriety MAGiC ablation catheter, in Europe in 2025 and regulatory approval in the U.S. in early 2026, the robotically enabled ablation catheters predominantly used with our RMN Systems were co-developed with Biosense Webster, a wholly owned subsidiary of Johnson and Johnson (the “J&J catheters”).
Removed
Department of the Treasury, Federal Reserve Board, and FDIC released a joint statement announcing that the FDIC would complete its resolution of SVB in a manner that fully protected all depositors at SVB and that depositors would have access to all of their money starting March 13, 2023.
Added
The J&J catheters were solely manufactured and distributed by them and their obligation to supply those catheters ended on December 31, 2025. We do not know their plans for the continuation of the J&J catheters, and we have no guarantees that supply of those catheters will continue into 2026.

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Other STXS 10-K year-over-year comparisons