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Stereotaxis, Inc.

For the period ended Jun 30, 2026. Filed Aug 12, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 12, 2026

STXS$1.09+3.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-13.

0001493152-26-022697

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-12.

0001493152-26-037357

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 80 previous paragraphs and 91 current paragraphs.

48 unchanged; 32 reworded; 8 added; 0 removed; 0 previous and 3 current paragraphs rearranged.

Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (8)

Current report

At closing, the Company made certain cash payments for the benefit of Robocath’s securityholders and issued (i) 1,469,485 shares of common stock and (ii) pre-funded warrants to purchase 4,575,143 shares of common stock to the securityholders. The Company also issued 225,000 shares of common stock to Robocath’s financial advisor as partial payment of a success fee for acquisition advisory services. The Share Sale Agreement provides for up to $25.0 million of additional earnout consideration, payable in cash, shares of common stock (including shares issuable upon exercise of Purchaser Warrants) or a combination thereof at the Company’s election, upon achievement of one regulatory milestone and two commercial milestones during periods ending December 31, 2033, December 31, 2035 and December 31, 2037, respectively.

Current report

Other Operating Expense. The Company received approximately $0.5 million in an employee retention tax credit in the second quarter of 2025.

Current report

Revenue. Revenue decreased from $16.3 million for the six months ended June 30, 2025, to $14.0 million for the six months ended June 30, 2026, a decrease of approximately 14%. Revenue from sales of systems decreased to $2.8 million for the six months ended June 30, 2026, from $5.0 million for the six months ended June 30, 2025, driven by decreased sales volume in the current-year period. Revenue from sales of disposable interventional devices, service, and accessories decreased to approximately $11.2 million for the six months ended June 30, 2026, from $11.3 million for the six months ended June 30, 2025, a decrease of approximately 1%. The decrease in the current period was primarily driven by the transition from catheters provided by Johnson & Johnson to Stereotaxis-supplied catheters including sales of our proprietaryMAGiCablation catheter.

Current report

Cost of Revenue. Cost of revenue decreased from $7.6 million for the six months ended June 30, 2025, to $5.7 million for the six months ended June 30, 2026, a decrease of approximately 26%. As a percentage of our total revenue, overall gross margin increased to 59% for the six months ended June 30, 2026, from 53% for the six months ended June 30, 2025, primarily due to changes in product mix. Cost of revenue for systems sold decreased from $4.0 million for the six months ended June 30, 2025, to $1.9 million for the six months ended June 30, 2026, driven by decreased system sales volume in the current year period. Gross margin for systems was $1.0 million for the six months ended June 30, 2025, compared to $0.9 million for the six months ended June 30, 2026. Cost of revenue for disposables, service, and accessories increased from $3.6 million for the six months ended June 30, 2025, to $3.8 million for the six months ended June 30, 2026, driven by increased disposable sales volumes. Gross margin for disposables, service, and accessories decreased to 66% for the six months ended June 30, 2026, from 68% for the six months ended June 30, 2025 due to changes in product mix in the current period.

Current report

Research and Development Expenses. Research and development expenses increased from $4.1 million for the six months ended June 30, 2025, to $4.8 million for the six months ended June 30, 2026, an increase of approximately 16%. This increase was primarily driven by the capitalization ofGenesisX into inventory in the prior year period and partially offset by lower headcount-related costs in the current year period.

Current report

Sales and Marketing Expenses. Sales and marketing expenses decreased from $6.4 million for the six months ended June 30, 2025, to $5.2 million for the six months ended June 30, 2026, a decrease of approximately 19%. This decrease was primarily due to lower headcount-related costs and trade-show expenses in the current year period.

Current report

Other Operating Expense. The Company received approximately $0.5 million in an employee retention tax credit in the second quarter of 2025.
Reworded paragraphs (32)

Previous wording

This report includes various forward-looking statements that are subject to risks and uncertainties, many of which are beyond our control. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in “Part II - Item 1A. Risk Factors” included in this Quarterly Report on Form 10-Q and in Part I, Item 1A, “Risk Factors,” included in our Annual Report on Form 10-K for the year ended December 31,2025, as well as various impacts related to our previously announced acquisition of Access Point Technologies EP, Inc. (“APT”) and our recently announced acquisitions of Robocath. Forward-looking statements discuss matters that are not historical facts. 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 on-going impact of the coronavirus (“COVID -19”) pandemic and our response to it or any impact of a similar 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. Such statements include, but are not limited to, statements preceded by, followed by, or that otherwise include the words “believe”, “expects”, “anticipates”, “intends”, “estimates”, “projects”, “can”, “could”, “may”, “would”, or similar expressions. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You should not unduly rely on these forward-looking statements, which speak only as of the date on which they are made. They give our expectations regarding the future but are not guarantees. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.

Current wording

This report includes various forward-looking statements that are subject to risks and uncertainties, many of which are beyond our control. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in Part II, Item 1A, “Risk Factors,” of this Quarterly Report on Form 10-Q and in Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2025, as amended, as well as risks and uncertainties related to our acquisition of Access Point Technologies EP, Inc. (“APT”) and our recently completed acquisition of Robocath. Forward-looking statements discuss matters that are not historical facts. 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 and results of operations; the ongoing impact of the coronavirus (“COVID-19”) pandemic and our response to it or the impact of any similar pandemic; and statements relating to our acquisitions of APT and Robocath, including the anticipated benefits and strategic implications of the acquisitions; our ability to integrate acquired operations; manufacture, develop, commercialize and sell acquired products; retain key personnel; fund Robocath’s operations; and achieve regulatory and commercial milestones that could trigger contingent payments. Such statements include, but are not limited to, statements preceded by, followed by, or that otherwise include the words “believe,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “would” or similar expressions. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You should not unduly rely on these forward-looking statements, which speak only as of the date on which they are made. They give our expectations regarding the future but are not guarantees. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.

Previous wording

TheGenesis RMNand theGenesisX RMNSystems 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. This is achieved using externally applied magnetic fields that govern the motion of the working tip of the catheter, resulting in improved navigation, efficient procedures, and reduced x-ray exposure. TheGenesisX RMNSystem, the latest generation of theGenesis 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.

Current wording

TheGenesis RMNand theGenesisX RMNSystems 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. This is achieved using externally applied magnetic fields that govern the motion of the working tip of the catheter, resulting in improved navigation, efficient procedures, and reduced x-ray exposure. TheGenesisX RMNSystem, the latest generation of theGenesis RMN System, is designed to enhance the accessibility of Robotic Magnetic Navigation by reducing the lengthy construction cycle necessary to install prior generationRMN systems.

Previous wording

TheSynchronysystem is designed to digitize and modernize the interventional catheter lab. Synchrony’s ultra-high-definition display consolidates the viewing and control of all disparate systems in the lab, offering an enhanced procedure experience with custom layouts, streamlined workflows, an intuitive user interface, and a decluttered environment. Synchrony digitizes the video streams with full fidelity and ultra-low latency, offering crystal-clear visualization. Its architecture allows obsolescence protection for labs as new technologies are introduced in the future. Synchrony is made available withSynX, a cloud-based HIPAA and GDPR-compliant app that allows for secure remote connectivity, collaboration, recording, and monitoring of the cath lab. These technologies are sold alongside RMN systems and as stand-alone solutions.

Current wording

TheSynchronysystem is designed to digitize and modernize the interventional catheter lab. Synchrony’s ultra-high-definition display consolidates the viewing and control of all disparate systems in the lab, offering an enhanced procedure experience with custom layouts, streamlined workflows, an intuitive user interface, and a decluttered environment. Synchrony digitizes the video streams with full fidelity and ultra-low latency, offering crystal-clear visualization. Its architecture allows obsolescence protection for labs as new technologies are introduced in the future. Synchrony is made available withSynX, a cloud-based HIPAA and GDPR-compliant app that allows for secure remote connectivity, collaboration, recording, and monitoring of the cath lab. These technologies are sold alongsideRMN systems and as stand-alone solutions.

Previous wording

We pursue arrangements with fluoroscopy system manufacturers to provideRMNSystems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms. An integrated x-ray system is critical for customer adoption ofRMN Systems, and when offered as a bundled purchase offer with theRMNSystem, may reduce the cost of acquisition, the ongoing cost of ownership, and the complexity of installation of a robotic electrophysiology practice.

Current wording

We pursue arrangements with fluoroscopy system manufacturers to provideRMNSystems in a bundled purchase for hospitals establishing robotic interventional operating rooms. An integrated x-ray system is critical for customer adoption ofRMN Systems and, when offered in a bundled purchase with theRMNSystem, may reduce the cost of acquisition, the ongoing cost of ownership, and the complexity of installation of a robotic electrophysiology practice.

Previous wording

On April 14, 2026, the Company entered into a share sale agreement to acquire shares and other securities collectively representing 100% of the share capital and voting power of Robocath, a Frenchsociété par actions simplifiée, for $20.0 million in the form of cash, a number of shares of Stereotaxis common stock based on a value of $2.00 per share, or a combination of cash and shares at closing and, in addition, consideration contingently delivered after closing upon achieving certain key regulatory and commercial milestones. The acquisition is expected to close by the end of the third quarter of 2026 subject to customary closing conditions. Robocath is a venture-backed innovator of advanced mechanical robotic technology for interventional cardiology and neurointerventions headquartered in Rouen, France.

Current wording

On July 7, 2026, the Company completed its previously announced acquisition of shares and other securities collectively representing 100% of the share capital and voting power of Robocath, a Frenchsociété par actions simplifiée (“Robocath”), pursuant to the Share Sale Agreement dated April 14, 2026, for approximately $20.0 million in cash and common stock.

Previous wording

In the fourth quarter of 2025 we received FDA 510(k) regulatory clearance within the United States for theGenesisX RMN System. This latest generation of the 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. In October 2025, we attained CE Mark for theSynchronySolution and in the first quarter of 2026 we received FDA 510(k) regulatory clearance within the United States.

Current wording

In the fourth quarter of 2025, we received FDA 510(k) clearance in the United States for theGenesisX RMN System. This latest generation of the 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. In October 2025, we obtained CE Mark for theSynchronySolution, and in April 2026, we received FDA 510(k) clearance in the United States.

Previous wording

The StereotaxisMAGiC 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. 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. We are also currently seeking regulatory clearances for theEMAGIN 5F catheter guide designed to robotically navigate tortuous venous and arterial vasculature.

Current wording

The StereotaxisMAGiC catheter, a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures, obtained CE marking in Europe during the first quarter of 2025 and FDA 510(k) clearance in January 2026.MAGiC Sweep™, 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 for both devices in other geographies. We are also currently seeking regulatory clearances for theEMAGIN 5F catheter guide, which is designed to robotically navigate tortuous venous and arterial vasculature.

Previous wording

Beginning in 2025, the U.S. implemented a baseline tariff framework on most imports with higher country and product-specific rates for certain trading partners, including Mexico, Germany, Japan and China, among others, alongside reciprocal measures announced by other jurisdictions. In February 2026, the U.S. Supreme Court ruled that these tariffs levied under the International Emergency Economic Powers Act (“IEEPA”) are unconstitutional. As a result of this ruling, the U.S. Court of International Trade issued an order directing the U.S. Customs and Border Protection (the “CBP”) agency to begin formalizing a process for refunds. On April 20, 2026, the CBP launched an online portal that can be used to submit IEEPA tariff refund requests. All requests will be reviewed by the CBP to determine validity prior to the issuance of refunds. In response to the Supreme Court’s ruling, a new 10% tariff for all imports under Section 122 of the Trade Act of 1974 was imposed. These tariffs took effect on February 24, 2026, and will remain in effect for 150 days, the maximum period that Section 122 permits without congressional action. However, previous exclusions, such as for the United States-Mexico-Canada Agreement (“USMCA”), remain in place.

Current wording

Beginning in 2025, the U.S. implemented a baseline tariff framework on most imports, with higher country- and product-specific rates for certain trading partners, including Mexico, Germany, Japan and China, among others, alongside reciprocal measures announced by other jurisdictions. In February 2026, the U.S. Supreme Court ruled that tariffs levied under the International Emergency Economic Powers Act (“IEEPA”) were unconstitutional. As a result of this ruling, the U.S. Court of International Trade issued an order directing U.S. Customs and Border Protection (“CBP”) to begin formalizing a refund process. On April 20, 2026, CBP launched an online portal for IEEPA tariff refund requests, which are subject to review by CBP. Such refund process was appealed and is subject to ongoing litigation, as well as refund process developments. In response to the Supreme Court’s ruling, a new 10% surcharge on most imports was imposed under Section 122 of the Trade Act of 1974. The surcharge took effect on February 24, 2026, and expired on July 24, 2026. These Section 122 tariffs are currently subject to legal challenge and in May 2026, the CIT issued a ruling that the Section 122 tariffs are unauthorized by the statute, although this ruling is currently stayed pending appeal. Previous exclusions, including for qualifying goods under the United States-Mexico-Canada Agreement (“USMCA”), remained in place. In July 2026, the U.S. presidential administration imposed additional tariffs under Section 301 of the Trade Act of 1974. These Section 301 tariffs are also currently subject to legal challenge.

Previous wording

We source certain sub-assemblies from Mexico, all of which qualify under USMCA; therefore, these items were not subject to increased tariff, and the effect on our cost of revenues for the three months ended March 31, 2026, was immaterial. We currently expect our Mexican sub-assemblies to continue to qualify under USMCA, and we do therefore not expect a material impact from changes in the future.

Current wording

We source certain subassemblies from Mexico, all of which qualify under USMCA; therefore, these items were not subject to the increased tariff, and the effect on our cost of revenue for the six months ended June 30, 2026, was immaterial. We currently expect our Mexican subassemblies to continue to qualify under USMCA and therefore do not expect a material impact from future changes relating to these items.

Previous wording

Some of our suppliers have also incurred incremental tariffs and have passed or may pass on those additional costs to us. These pass-through tariffs and other specific tariff actions against steel and aluminum have resulted in an effective rate of up to 60 percent (“tariff stacking”) on certain specialty alloys that we source from Europe and Japan. This action has not had a material direct impact on our operations to date, but the long-term effects of these and other existing or future trade measures are difficult to predict.

Current wording

Some of our suppliers have also incurred incremental tariffs and have passed or may pass those additional costs on to us. These pass-through tariffs and other specific tariff actions against steel and aluminum have resulted in an effective rate of up to 60% (“tariff stacking”) on certain specialty alloys that we source from Europe and Japan. These measures have not had a material direct impact on our operations to date, but the long-term effects of these and other existing or future trade measures are difficult to predict.

Previous wording

We also import certain raw materials and finished goods from outside of the U.S. that are subject to tariffs, including our proprietaryMAGiC Catheter which is manufactured in Germany and currently distributed principally in Europe. This device received 510(k) clearance in the US in January 2026, and we are currently ramping up production of this device as a replacement for catheters previously supplied by to users by J&J. Tariffs could render the US product launch ofMAGiC Catheter uneconomical, which would, in turn, slow adoption of our Robotic Magnetic Navigation (“RMN”) platform.

Current wording

We also import certain raw materials and finished goods from outside of the U.S. that are subject to tariffs, including our proprietaryMAGiC catheter, which is manufactured in Germany and currently distributed principally in Europe. This device received FDA 510(k) clearance in the U.S. in January 2026, and we are currently ramping up production as a replacement for catheters previously supplied to users by J&J. Tariffs could render the U.S. product launch ofthe MAGiC catheter uneconomical, which could slow adoption of our Robotic Magnetic Navigation (“RMN”) platform.

Previous wording

During the three months ended March 31, 2026, tariffs and other trade measures recognized in total cost of revenue were not material. Future changes to tariff rates and the imposition of new tariffs by the U.S. and/or other countries could result in a material impact to our results of operations. The ultimate impact of changes to tariffs and trade barriers will depend on various factors, including the timing, amount, scope, and nature of any tariffs or trade barriers that are implemented, all of which could have a material adverse effect on our business, financial condition, or results of operations.

Current wording

During the six months ended June 30, 2026, tariffs and other trade measures recognized in total cost of revenue were not material. Future changes to tariff rates, the availability of tariff refunds and the imposition of new tariffs by the U.S. and/or other countries could result in a material impact to our results of operations. There remains substantial uncertainty regarding the duration of various existing and newly announced or intended tariffs, potential changes or pauses to such tariffs, tariff levels, and whether further additional tariffs or other retaliatory actions may be imposed, modified, suspended, or invalidated, and the ultimate impact of changes to tariffs and trade barriers will depend on various factors, including the timing, amount, scope, and nature of any tariffs or trade barriers that are implemented and the availability of refunds, all of which could have a material adverse effect on our business, financial condition, or results of operations. We continue to monitor and evaluate these developments and assess their potential impact on our business, financial condition, and results of operations.

Previous wording

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. The Company continues to experience difficulties with periodic worldwide supply chain disruptions, including shortages and inflationary pressures, tariffs and other trade regulations that are or may be imposed, and logistics delays which make it difficult for us to source parts and ship our products. 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. 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. 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. 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.

Current wording

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. The Company continues to experience difficulties with periodic worldwide supply chain disruptions, including shortages and inflationary pressures, tariffs and other trade regulations that are or may be imposed, and logistics delays which make it difficult for us to source parts and ship our products. We continue to evaluate the macroeconomic 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. 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. 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. 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.

Previous wording

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 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. 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. Significant decreases to our capital or recurring revenues could have a material adverse effect on our business, operating results, and financial condition. 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.

Current wording

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 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. Significant decreases to our capital or recurring revenues could have a material adverse effect on our business, operating results, and financial condition. 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.

Previous wording

As a result of the July 2024 acquisition of APT EP, Inc., we are managing APT’s ongoing business of manufacturing, commercializing, development and sales of APT’s catheters and related products and services. 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. We may require a higher level of overhead than currently anticipated. Our ability to successfully manage this new aspect of our business will depend, in part, upon management’s ability to design and implement strategic initiatives that address not only the integration of APT into us, but also the increased scope of the combined business with its associated increased costs and complexity. 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.

Current wording

As a result of our acquisition of APT EP, Inc. July 2024 and of Robocath in July 2026, we are managing the ongoing businesses of both APT and Robocath, which include the manufacturing, commercializing, developing and selling catheters, interventional products and other related products and services. The manufacturing process for catheters is complex and highly technical, and our experience in this field is prior to the APT acquisition was 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 that make it difficult for us to source parts and ship our products. We may require a higher level of overhead than currently anticipated. Our ability to successfully manage this aspect of our business will depend, in part, upon management’s ability to design and implement strategic initiatives that address not only the integration of APT and Robocath into our business, but also the increased scope of the combined business and its associated costs and complexity. We are integrating both APT’s and Robocath’s respective businesses into our own, and implementing safeguards to minimize any negative impacts on our financial position, results of operations and cash flows. In addition, Robocath is located in, and organized under the law of, France, and that may present additional accounting, cultural, regulatory and other issues. Please refer to Part II, Item 1A, Risk Factors, for a description of the risks associated with the Robocath acquisition.

Previous wording

Since our inception, we have generated significant losses. As of March 31, 2026, we have incurred cumulative net losses of approximately $589.2 million. In 2026, the Company plans to advance adoption of its robotic magnetic navigation systems and its proprietary devices in those markets where regulatory clearance has been received and to work with regulatory approval authorities in those geographies where approval is pending, with the goal of furthering clinical adoption and new system placements. We expect to incur additional losses in 2026 as we continue the development and commercialization of our products, conduct our research and development activities, advance new products into clinical development from our existing research programs and fund additional sales and marketing initiatives. During the remainder of 2026, we will continue to monitor the impact of the macroeconomic environment on our project timing, regulatory approvals, customer and supplier operations, and our operating results. Until we can generate significant cash flow from our operations, we expect to continue to fund our operations with cash resources primarily generated from the proceeds of our past and future public offerings, and private sales of our equity securities. We cannot accurately predict the timing and amount of our utilization of capital, which will depend on several factors outside of our control.

Current wording

Since our inception, we have generated significant losses. As of June 30, 2026, we have incurred cumulative net losses of approximately $593.7 million. In 2026, the Company plans to advance adoption of its robotic magnetic navigation systems and its proprietary devices in those markets where regulatory clearance has been received and to work with regulatory approval authorities in those geographies where approval is pending, with the goal of furthering clinical adoption and new system placements. We expect to incur additional losses in 2026 as we continue the development and commercialization of our products, conduct our research and development activities, advance new products into clinical development from our existing research programs, fund additional sales and marketing initiatives, and fund Robocath’s ongoing operations and development of its next-generation R-Two products. Robocath has sustained historical operating losses, and we expect that it will continue to incur operating losses and negative cash flows in the coming years. We may be required to fund Robocath’s ongoing operations for the foreseeable future. During the remainder of 2026, we will continue to monitor the impact of the macroeconomic environment on our project timing, regulatory approvals, customer and supplier operations, and our operating results. Until we can generate significant cash flow from our operations, we expect to continue to fund our operations with cash resources primarily generated from the proceeds of our past and future public offerings and private sales of our equity securities. We cannot accurately predict the timing and amount of our utilization of capital, which will depend on several factors outside of our control.

Previous wording

While we believe our existing cash and cash equivalents, including the proceeds from our July 2025 equity raise, will be sufficient to fund our operating expenses and capital equipment requirements, in light of the macroeconomic environment, we cannot guarantee that we will not need additional funding in the future. We will continue to explore financing alternatives, and we cannot guarantee that additional financing will be available on acceptable terms or that such financing will not be dilutive to our stockholders. If adequate funds are not available to us, we could be required to delay development or commercialization of new products, to license to third parties the rights to commercialize products or technologies that we would otherwise seek to commercialize ourselves, or to reduce the sales, marketing, customer support or other resources devoted to our products, any of which could have a material adverse effect on our business, financial condition, and operational results. In addition, we could be required to cease operations.

Current wording

Based on our current plans and assumptions, we believe our existing cash and cash equivalents, including the proceeds from our at-the-market offering program and July 2025 equity raise, will be sufficient to fund our operating expenses and capital equipment requirements, including currently anticipated funding requirements for Robocath’s operations and development activities. In light of the macroeconomic environment and the uncertainties associated with integrating and funding Robocath, however, we cannot guarantee that we will not need additional funding in the future. We will continue to explore financing alternatives, and we cannot guarantee that additional financing will be available on acceptable terms or that such financing will not be dilutive to our stockholders. If adequate funds are not available to us, we could be required to delay development or commercialization of new products, license to third parties rights to commercialize products or technologies that we would otherwise seek to commercialize ourselves, or reduce the sales, marketing, customer support or other resources devoted to our products, any of which could have a material adverse effect on our business, financial condition and results of operations. In addition, we could be required to cease operations.

Previous wording

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. Revenue is recognized when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment of delivery or installation, depending on the terms of the arrangement. 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. 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 three months ended March 31, 2026, and 2025.

Current wording

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. Revenue is recognized when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment of delivery or installation, depending on the terms of the arrangement. 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. 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 six months ended June 30, 2026, and 2025.

Previous wording

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. Warranty costs were not material for the three months ended March 31, 2026, and 2025.

Current wording

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. Warranty costs were not material for the six months ended June 30, 2026, and 2025.

Previous wording

Revenue. Revenue decreased from $7.5 million for the three months ended March 31, 2025, to $6.3 million for the three months ended March 31, 2026, a decrease of 16%. Revenue from the sales of systems decreased to $1.3 million for the three months ended March 31, 2026, from $2.0 million for the three months ended March 31, 2025, driven by decreased sales volume in the current year period. Revenue from sales of disposable interventional devices, service, and accessories decreased to approximately $5.0 million for the three months ended March 31, 2026, from $5.5 million for the three months ended March 31, 2025, a decrease of approximately 10%. The decrease was lower current period disposable sales volumes related to the transition from the Johnson and Johnson catheter to our proprietaryMAGiCcatheter in the current year period.

Current wording

Revenue. Revenue decreased from $8.8 million for the three months ended June 30, 2025, to $7.7 million for the three months ended June 30, 2026, a decrease of 13%. Revenue from the sales of systems decreased to $1.5 million for the three months ended June 30, 2026, from $3.0 million for the three months ended June 30, 2025, driven by decreased sales volume in the current year period. Revenue from sales of disposable interventional devices, service, and accessories increased to approximately $6.2 million for the three months ended June 30, 2026, from $5.8 million for the three months ended June 30, 2025, an increase of approximately 7%. The increase in the current period was primarily driven by higher current period disposable sales of Stereotaxis supplied catheters which include our proprietaryMAGiCablation catheter partially offset by continuing pressure from the Johnson & Johnson transition.

Previous wording

Cost of Revenue. Cost of revenue decreased from $3.4 million for the three months ended March 31, 2025, to $2.5 million for the three months ended March 31, 2026, a decrease of approximately 27%. As a percentage of our total revenue, overall gross margin increased to 60% for the three months ended March 31, 2026, from 54% for the three months ended March 31, 2025, primarily due to changes in product mix. Cost of revenue for systems sold decreased from $1.7 million for the three months ended March 31, 2025, to $0.8 million for the three months ended March 31, 2026, driven by decreased system sales volume in the current year period. Gross margin for systems was $0.3 million for the three months ended March 31, 2025, compared to $0.5 million for the three months ended March 31, 2026. Cost of revenue for disposables, service, and accessories remained consistent at $1.7 million for the three months ended March 31, 2025 and 2026. Gross margin for disposables, service, and accessories was 66% for the three months ended March 31, 2026, compared to 68% for the three months ended March 31, 2025. Gross margin for disposables, service, and accessories decreased due to changes in product mix in the current period.

Current wording

Cost of Revenue. Cost of revenue decreased from $4.2 million for the three months ended June 30, 2025, to $3.2 million for the three months ended June 30, 2026, a decrease of approximately 25%. As a percentage of our total revenue, overall gross margin increased to 58% for the three months ended June 30, 2026, from 52% for the three months ended June 30, 2025, primarily due to changes in product mix. Cost of revenue for systems sold decreased from $2.4 million for the three months ended June 30, 2025, to $1.1 million for the three months ended June 30, 2026, driven by decreased system sales volume in the current year period. Gross margin for systems was $0.7 million for the three months ended June 30, 2025, compared to $0.4 million for the three months ended June 30, 2026. Cost of revenue for disposables, service, and accessories increased from $1.9 million for the three months ended June 30, 2025, to $2.1 million for the three months ended June 30, 2026, driven by increased disposable sales volumes. Gross margin for disposables, service, and accessories decreased to 66% for the three months ended June 30, 2026, from 68% for the three months ended June 30, 2025 due to changes in product mix in the current period.

Previous wording

Research and Development Expenses. Research and development expenses increased from $2.3 million for the three months ended March 31, 2025, to $2.4 million for the three months ended March 31, 2026, an increase of approximately 2%. This increase was primarily due to project timing partially offset by lower headcount-related costs.

Current wording

Research and Development Expenses. Research and development expenses increased from $1.8 million for the three months ended June 30, 2025, to $2.4 million for the three months ended June 30, 2026, an increase of approximately 34%. This increase was primarily driven by the capitalization ofGenesisX into inventory in the prior year period and partially offset by lower headcount-related costs in the current year period.

Previous wording

Sales and Marketing Expenses. Sales and marketing expenses decreased from $3.1 million for the three months ended March 31, 2025, to $2.6 million for the three months ended March 31, 2026. This decrease was primarily due to lower headcount-related costs in the current year period.

Current wording

Sales and Marketing Expenses. Sales and marketing expenses decreased from $3.3 million for the three months ended June 30, 2025, to $2.6 million for the three months ended June 30, 2026, a decrease of approximately 21%. This decrease was primarily due to lower headcount-related costs and trade-show expenses in the current year period.

Previous wording

General and Administrative Expenses. 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 increased from $4.5 million for the three months ended March 31, 2025, to $4.8 million for the three months ended March 31, 2026, an increase of approximately 6%. This increase was primarily driven by the change in contingent consideration expense and costs related to the pending Robocath acquisition, partially offset by lower headcount-related costs in the current year period.

Current wording

General and Administrative Expenses. 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 increased from $4.0 million for the three months ended June 30, 2025, to $4.1 million for the three months ended June 30, 2026, an increase of approximately 2%.

Previous wording

As of March 31, 2026, we had $14.6 million of cash and cash equivalents. We had working capital of $12.9 million as of March 31, 2026, compared to $11.5 million as of December 31, 2025.

Current wording

As of June 30, 2026, we had $10.5 million of cash and cash equivalents. We had working capital of $11.2 million as of June 30, 2026, compared to $11.5 million as of December 31, 2025.

Previous wording

In July 2025, we closed a registered direct offering of our common stock for $8.5 million in gross proceeds before deducting offering expenses. In November 2025, we completed the Additional Closing from the July direct registering offering for $4.0 million in gross proceeds deducting offering expenses.

Current wording

In July 2025, we closed a registered direct offering of our common stock for $8.5 million in gross proceeds before deducting offering expenses. In November 2025, we completed the additional closing from the July registered direct offering for $4.0 million in gross proceeds before deducting offering expenses.

Previous wording

On March 13, 2026, we filed a new shelf registration statement on Form S-3 (File No. 333-294288) to register (i) $100.0 million of debt securities, common stock, preferred stock, warrants, rights or units consisting of any two or more of such securities (the “2026 Shelf”) and (ii) $50 million shares of common stock to be issued under the at-the-market offering program with Roth Capital described below. The 2026 Shelf was declared effective by the SEC on March 20, 2026.

Current wording

On March 13, 2026, we filed a new shelf registration statement on Form S-3 (File No. 333-294288) to register (i) $100.0 million of debt securities, common stock, preferred stock, warrants, rights or units consisting of any two or more of such securities (the “2026 Shelf”) and (ii) $50.0 million of common stock that may be issued under the at-the-market offering program with Roth Capital described below. The 2026 Shelf was declared effective by the SEC on March 20, 2026.

Previous wording

As noted above, in August 2025, we entered into a sales agreement with Roth Capital Markets (“Roth”), as sales agent and/or principal, under which we may issue and sell up to $50.0 million of our common stock. On March 13, 2026, we entered into a first amendment to the sales agreement, which modified the original sales agreement to, among other things, reflect our filing of a new Registration Statement on Form S-3 with the SEC on March 13, 2026 and set the maximum amount of shares of our common stock that we may offer and sell through or to Roth at $50 million from the date of the amendment to the sales agreement, subject to certain limitations set forth in the amendment. During the three months ended March 31, 2026, we sold an aggregate of 2,005,308 shares of common stock under the sales agreement, at an average price of approximately $2.39 per share for gross proceeds of $4.8 million and net proceeds of $4.6 million, after deducting Roth’s commission and other expenses. As of March 31, 2026, $50.0 million of common stock remained available to be sold under this facility, subject to certain conditions as specified in the sales agreement.

Current wording

As noted above, in August 2025, we entered into a sales agreement with Roth Capital Markets (“Roth”), as sales agent and/or principal, under which we may issue and sell up to $50.0 million of our common stock. On March 13, 2026, we entered into a first amendment to the sales agreement, which modified the original sales agreement to, among other things, reflect our filing of a new Registration Statement on Form S-3 with the SEC on March 13, 2026 and set the maximum amount of shares of our common stock that we may offer and sell through or to Roth at $50 million from the date of the amendment to the sales agreement, subject to certain limitations set forth in the amendment. During the six months ended June 30, 2026, we sold an aggregate of 2,361,579 shares of common stock under the sales agreement, at an average price of approximately $2.34 per share for gross proceeds of $5.5 million and net proceeds of $5.3 million, after deducting Roth’s commission and other expenses. As of June 30, 2026, $49.3 million of common stock remained available to be sold under this facility, subject to certain conditions as specified in the sales agreement.

Previous wording

The following table summarizes our cash flow by operating, investing and financing activities for the three months ended March 31, 2026, and 2025 (in thousands):

Current wording

The following table summarizes our cash flow by operating, investing and financing activities for the six months ended June 30, 2026, and 2025 (in thousands):

Previous wording

Net cash used in operating activities. We used approximately $3.4 million and $1.8 million of cash for operating activities during the three months ended March 31, 2026, and 2025, respectively. The increase in cash used in operating activities was driven by changes in working capital.

Current wording

Net cash used in operating activities. We used approximately $7.1 million and $5.5 million of cash for operating activities during the six months ended June 30, 2026 and 2025, respectively. The increase in cash used in operating activities was driven by the higher operating loss in the current-year period and changes in working capital.

Previous wording

Net cash used in investing activities. We used less than $0.1 million of cash for investing activities during the three months ended March 31, 2026 for the purchase of equipment. We did not use any cash for investing activities during the three months ended March 31, 2025.

Current wording

Net cash used in investing activities. We used approximately $1.2 million of cash for investing activities during the six months ended June 30, 2026, for interim financing provided to Robocath and the purchase of equipment. We used less than $0.1 million of cash for investing activities during the six months ended June 30, 2025, for the purchase of equipment.

Previous wording

Net cash provided by financing activities. We generated approximately $4.7 million of cash from financing activities during the three months ended March 31, 2026, and less than $0.1 million during the three months ended March 31, 2025. The cash generated in 2026 was primarily driven by the proceeds from the at-the-market offering during the first quarter. The cash generated in in 2025 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.

Current wording

Net cash provided by financing activities. We generated approximately $5.4 million of cash from financing activities during the six months ended June 30, 2026, and approximately $0.1 million during the six months ended June 30, 2025. The cash generated in 2026 was primarily driven by proceeds from the at-the-market offering. The cash generated in 2025 was driven by proceeds from the issuance of stock upon the exercise of options, net of issuance costs, and from our employee stock purchase program.
Rearranged current paragraphs (3)

Current report — wording carried from elsewhere

Robocath, headquartered in Rouen, France, is an innovator of advanced mechanical robotic technology for interventional cardiology and neurointerventions.

Current report — wording carried from elsewhere

General and Administrative Expenses. 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 increased from $8.5 million for the six months ended June 30, 2025, to $8.8 million for the six months ended June 30, 2026, an increase of approximately 4%.

Current report — wording carried from elsewhere

Interest Income. Net interest income remained consistent at approximately $0.2 million for the six months ended June 30, 2025, and 2026.