Stereotaxis, Inc.

Previous wording

We have received regulatory clearances and approvals necessary for us to market theGenesis 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. TheGenesisX 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. TheNiobe System, our prior generation robotic magnetic navigation system, theOdyssey 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. We have regulatory clearances and approvals that allow us to market theVdrive andVdrive Duo Systems with theV-CASdevice in the U.S., Canada, and Europe. We have regulatory clearances and approvals that allow us to market theSynX networking solution in the U.S. 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. Approval processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical data, and regulatory applications could be denied.

Current wording

We have received regulatory clearances and approvals necessary for us to market theGenesis 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. TheGenesisX RMN System,the latest generation of the Genesis RMN System, has received clearances and approvals in Europe and in the United States. TheNiobe System, our prior generation robotic magnetic navigation system, theOdyssey 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. We have regulatory clearances and approvals that allow us to market theVdrive andVdrive Duo Systems with theV-CASdevice in the U.S., Canada, and Europe. We have regulatory clearances and approvals that allow us to market theSynX networking solution in the U.S. and Europe. We have obtained the CE marking for us to market the Stereotaxis MAGiC catheter and theSynchrony system in Europe and are pursuing regulatory approvals in the U.S. and various other global geographies. Approval processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical data, and regulatory applications could be denied.

Previous wording

Stereotaxis has continued to advance development and regulatory approval of its Robotic Magnetic Navigation systems and proprietary interventional devices. In the third quarter of 2024, we attained CE Mark for theGenesisX RMN System and are working towards FDA 510(k) regulatory clearance within the United States. 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 November 2024, theGenesis 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.

Current wording

Stereotaxis has continued to advance development and regulatory approval of its Robotic Magnetic Navigation systems and proprietary interventional devices. In the third quarter of 2024, we attained CE Mark for theGenesisX RMN System, and in the fourth quarter of 2025 we received FDA 510(k) regulatory clearance within the United States. 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 November 2024, theGenesis 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.

Previous wording

The global tariff environment remains fluid and could materially affect our cost structure, gross margins, and timing of product launches.

Current wording

The global tariff environment remains fluid and could materially affect our cost structure, gross margins, and the timing of product launches.

Previous wording

On February 1, 2025, the United States announced a 25 percent tariff on most imports from Mexico and Canada. Goods meeting the rules of origin under the United States-Mexico-Canada Agreement (“USMCA”) are expressly exempt. All sub-assemblies we source from Mexico qualify under USMCA; therefore, these items were not subject to the tariff, and the effect on our cost of revenues for the six months ended June 30, 2025, was immaterial. An Executive Order dated July 31, 2025, raised the general tariff rate on non-USMCA Canadian imports from 25 % to 35 %. Because our Canadian and Mexican sub-assemblies continue to qualify under USMCA, we do not expect a material impact.

Current wording

On February 1, 2025, the United States announced a 25 percent tariff on most imports from Mexico and Canada. Goods meeting the rules of origin under the United States-Mexico-Canada Agreement (“USMCA”) are expressly exempt. All sub-assemblies we source from Mexico qualify under USMCA; therefore, these items were not subject to the tariff, and the effect on our cost of revenues for the six months ended June 30, 2025, was immaterial. An Executive Order dated July 31, 2025 raised the general tariff rate on non-USMCA Canadian imports from 25 percent to 35 percent. Because our Canadian and Mexican sub-assemblies continue to qualify under USMCA, we do not expect a material impact from this change.

Previous wording

On April 2, 2025, the United States imposed a 10 percent universal ‘baseline” tariff on all imports that do not qualify under USMCA and announced additional country-specific tariffs. Higher “reciprocal” country-specific rates, which were initially suspended for 90 days, became effective as of August 7, 2025, under the July 31, 2025, Executive Order. We procure certain specialty metals and other raw materials from suppliers in Japan and several European countries that remain subject to the 10 percent baseline tariff. We expect some vendors to pass the incremental duty through price increases, which could elevate our cost of revenues and research and development (“R&D”) expenses in the second half of 2025.

Current wording

On April 2, 2025, the United States imposed a 10 percent universal “baseline” tariff on all imports that do not qualify under USMCA and announced additional country-specific “reciprocal” tariffs. These higher rates, which were initially suspended for 90 days, became effective August 7, 2025, pursuant to the July 31 Executive Order. We procure certain specialty metals and other raw materials from suppliers in Japan and several European countries that remain subject to the 10 percent baseline tariff. We expect some vendors to pass these incremental duties through price increases. These changes did not have a material impact on our business in the third quarter 2025 but could elevate our cost of revenues and research and development (“R&D”) expenses during the fourth quarter of 2025.

Previous wording

Our proprietary Magic Catheter is manufactured in Germany and currently distributed only in Europe. If tariffs comparable to those described above are extended to European medical devices entering the United States, our planned U.S. product launch could be delayed or rendered uneconomical, which would, in turn, slow adoption of our RMN platform.

Current wording

Our proprietary Magic® Catheter is manufactured in Germany and currently distributed only in Europe. If tariffs comparable to those described above are extended to European medical devices entering the United States, our planned U.S. product launch could be delayed or rendered uneconomical, which would, in turn, slow adoption of our Robotic Magnetic Navigation (“RMN”) platform.

Previous wording

On April 7, 2025, the United States increased tariffs on imports from the People’s Republic of China (“China”) to rates of up to 145 percent, and China imposed a 125 percent retaliatory tariff on U.S.-origin goods. On May 12, 2025, following negotiations in Geneva, the United States and China issued a Joint Statement suspending most of the reciprocal tariff increases while talks continued. The initial 90-day period expired on August 12, 2025, and then renewed to November 10, 2025. Under the agreement, (i) U.S. duties on Chinese goods have been reduced to a base rate of approximately 30 percent, down from the prior 145 percent ceiling, and (ii) China has lowered its duty on U.S. goods to approximately 10 percent, down from 125 percent. All other non-tariff counter-measures announced since April 2025 have been suspended until August 12, 2025. We import limited quantities of R&D consumables and manufacturing inputs from China and, through our partner MicroPort Scientific Corporation, sell U.S.-manufactured Robotic Magnetic Navigation (“RMN”) systems into China. Both inbound materials and outbound finished products are now subject to these reciprocal tariffs. If the reduced rates remain in place, we anticipate a less than one percent increase in expenses for the second half of 2025. If the higher tariffs are reinstated, the impact could be more material, particularly to sales of RMN systems in China. We are actively pursuing mitigation strategies.

Current wording

On April 7, 2025, the United States increased tariffs on imports from the People’s Republic of China (“China”) to rates of up to 145 percent, and China imposed a 125 percent retaliatory tariff on U.S.-origin goods. Following negotiations in Geneva, the United States and China issued a Joint Statement on May 12, 2025, suspending most of the reciprocal tariff increases while talks continued. The initial 90-day suspension expired on August 12, 2025, and was subsequently extended. Under the Executive Order issued November 4, 2025, the heightened reciprocal tariff increases remain suspended through November 10, 2026, while negotiations continue. As a result, (i) U.S. duties on Chinese goods remain at a reduced base rate of approximately 30 percent, rather than the previously announced ceiling of up to 145 percent, and (ii) China has maintained its reduced duty on U.S. goods at approximately 10 percent, down from 125 percent, for the duration of the suspension. All other non-tariff countermeasures announced since April 2025 remain suspended for so long as the reciprocal tariff suspension remains in effect.

Previous wording

Effective June 4, 2025, Proclamation 11 043 increased Section 232 tariffs on steel and aluminum from 25 % to 50 %. These duties apply in addition to the 10 % baseline tariff, resulting in an effective rate of up to 60 % (“tariff stacking”) on certain specialty alloys that we source from Europe and Japan. This did not result in a material direct impact on our operations in the first half of 2025, but the long-term effects of these and other existing and future tariff actions are difficult to predict.

Current wording

Effective June 4, 2025, Presidential Proclamation 11043 increased Section 232 tariffs on steel and aluminum from 25 percent to 50 percent. These duties apply in addition to the 10 percent baseline tariff, resulting in an effective rate of up to 60 percent (“tariff stacking”) on certain specialty alloys that we source from Europe and Japan. This action did not have a material direct impact on our operations in the first half of 2025, but the long-term effects of these and other existing or future trade measures are difficult to predict.

Previous wording

The ultimate effect of any tariff or trade barrier will depend on factors outside our control, including, potential extensions, escalations, or reciprocal tariff responses, as well as the reactions of our suppliers and customers.

Current wording

The ultimate effect of any tariff or trade barrier will depend on factors outside our control, including the duration of the current U.S.–China suspension, potential extensions or escalations, future executive or legislative actions, and the responses of our suppliers and customers.

Previous wording

Future results of operations and liquidity could be materially adversely impacted by uncertainties in macroeconomic and geopolitical factors. The Company continued 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, market disruptions stemming from conflicts, such as in the Middle East, including Israel and Iran, 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, 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. The Company continued 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, market disruptions stemming from conflicts, such as in the Middle East, including Israel and Iran, 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.

Previous wording

Since our inception, we have generated significant losses. As of June 30, 2025, we have incurred cumulative net losses of approximately $571.4 million. In 2025, the Company plans to advance adoption of its robotic magnetic navigation systems and its propriety 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 2025 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 2025, 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 September 30, 2025, we have incurred cumulative net losses of approximately $577.8 million. In 2025, 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 2025 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 2025, 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

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. 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 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. 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, 2025, and 2024.

Current wording

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. 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 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. 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 nine months ended September 30, 2025, and 2024.

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 six months ended June 30, 2025, and 2024.

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 nine months ended September 30, 2025, and 2024.

Previous wording

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, non-employee directors, and third-party consultants at the fair value of the grants. For time-based awards, the fair value of options and stock appreciation rights granted was determined using the Black-Scholes valuation method which gives consideration to the estimated value of the underlying stock at the date of grant, the exercise price of the option, the expected dividend yield and volatility of the underlying stock, the expected life of the option and the corresponding risk-free interest rate. 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. Stock compensation expense for options, stock appreciation rights and for time-based restricted share grants and units is amortized on a straight-line basis over the vesting period of the underlying issue, generally over four years except for grants to non-employee directors which are generally earned over a period of six months. 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. Estimates of the expected life of options have been based on the average of the vesting and expiration periods, which is the simplified method under general accounting principles for share-based payments. Estimates of volatility utilized in calculating stock-based compensation have been prepared based on historical data. Actual experience to date has been consistent with these estimates.

Current wording

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, non-employee directors, and third-party consultants at the fair value of the grants. For time-based awards, the fair value of options and stock appreciation rights granted was determined using the Black-Scholes valuation method which gives consideration to the estimated value of the underlying stock at the date of grant, the exercise price of the option, the expected dividend yield and volatility of the underlying stock, the expected life of the option and the corresponding risk-free interest rate. 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. Stock compensation expense for options, stock appreciation rights and for time-based restricted share grants and units is amortized on a straight-line basis over the vesting period of the underlying issue, generally over four years except for grants to non-employee directors which are generally earned over a period of six months. Stock compensation expense for performance-based restricted shares, 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. Estimates of the expected life of options have been based on the average of the vesting and expiration periods, which is the simplified method under general accounting principles for share-based payments. Estimates of volatility utilized in calculating stock-based compensation have been prepared based on historical data. Actual experience to date has been consistent with these estimates.

Previous wording

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.

Current wording

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, or if we change our achievement expectations for performance based grants. The amount of expense to be recorded in future periods may decrease if the requisite service periods are not completed or if achievement expectations for performance based grants become improbable.

Previous wording

Revenue. Revenue increased from $4.5 million for the three months ended June 30, 2024, to $8.8 million for the three months ended June 30, 2025, an increase of 95%. Revenue from the sales of systems increased to $3.0 million for the three months ended June 30, 2025, from $0.2 million for the three months ended June 30, 2024, driven by increased sales volume in the current year period. Revenue from sales of disposable interventional devices, service, and accessories increased to approximately $5.8 million for the three months ended June 30, 2025, from $4.3 million for the three months ended June 30, 2024, an increase of approximately 35%. The increase was primarily driven by the impact of post-acquisition non-magnetic disposable device sales recorded in the current year period.

Current wording

Revenue. Revenue decreased from $9.2 million for the three months ended September 30, 2024, to $7.5 million for the three months ended September 30, 2025, a decrease of 19%. Revenue from the sales of systems decreased to $1.9 million for the three months ended September 30, 2025, from $4.4 million for the three months ended September 30, 2024, driven by decreased sales volume in the current year period. Revenue from sales of disposable interventional devices, service, and accessories increased to approximately $5.6 million for the three months ended September 30, 2025, from $4.8 million for the three months ended September 30, 2024, an increase of approximately 17%. The increase was primarily driven by the full quarter impact of post-acquisition non-magnetic disposable device sales and new magnetic disposable device sales recorded in the current year period.

Previous wording

Cost of Revenue. Cost of revenue increased from $1.2 million for the three months ended June 30, 2024, to $4.2 million for the three months ended June 30, 2025, an increase of approximately 255%. As a percentage of our total revenue, overall gross margin decreased to 52% for the three months ended June 30, 2025, from 74% for the three months ended June 30, 2024, primarily due to changes in product mix. Cost of revenue for systems sold increased from $0.2 million for the three months ended June 30, 2024, to $2.4 million for the three months ended June 30, 2025, driven by increased system sales volume in the current year period. Gross margin for systems was less than $0.1 million for the three months ended June 30, 2024, compared to $0.7 million for the three months ended June 30, 2025. Cost of revenue for disposables, service, and accessories increased from $1.0 million for the three months ended June 30, 2024, to $1.9 million for the three months ended June 30, 2025. Gross margin for disposables, service, and accessories was 68% for the three months ended June 30, 2025, compared to 76% for the three months ended June 30, 2024. Gross margin for disposables, service, and accessories continues to be depressed by acquisition related accounting which required the valuation of acquired finished good inventory to fair value and by changes in product mix in the current period.

Current wording

Cost of Revenue. Cost of revenue decreased from $5.1 million for the three months ended September 30, 2024, to $3.4 million for the three months ended September 30, 2025, a decrease of approximately 34%. As a percentage of our total revenue, overall gross margin increased to 55% for the three months ended September 30, 2025, from 45% for the three months ended September 30, 2024, primarily due to changes in product mix. Cost of revenue for systems sold decreased from $3.7 million for the three months ended September 30, 2024, to $1.5 million for the three months ended September 30, 2025, driven by decreased system sales volume in the current year period. Gross margin for systems was $0.7 million for the three months ended September 30, 2024, compared to $0.4 million for the three months ended September 30, 2025. Cost of revenue for disposables, service, and accessories increased from $1.4 million for the three months ended September 30, 2024, to $1.9 million for the three months ended September 30, 2025. Gross margin for disposables, service, and accessories was 67% for the three months ended September 30, 2025, compared to 71% for the three months ended September 30, 2024. Gross margin for disposables, service, and accessories decreased due to changes in product mix in the current period.

Previous wording

Sales and Marketing Expenses. Sales and marketing expenses remained consistent at $3.3 million for the three months ended June 30, 2024, and 2025.

Current wording

Research and Development Expenses. Research and development expenses remained consistent at $2.5 million for the three months ended September 30, 2024, and 2025.

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 $7.2 million for the six months ended June 30, 2024, to $8.5 million for the six months ended June 30, 2025, an increase of approximately 18%. This increase was primarily driven by the acquisition related contingent consideration, amortization of the acquisition related intangible assets, and higher professional service fees 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 $4.8 million for the three months ended September 30, 2024, to $5.2 million for the three months ended September 30, 2025, an increase of approximately 7%. This increase was primarily driven by the change in contingent consideration expense partially offset by lower administrative expenses.

Previous wording

Revenue. Revenue increased from $11.4 million for the six months ended June 30, 2024, to $16.3 million for the six months ended June 30, 2025, an increase of approximately 43%. Revenue from the sales of systems increased from $2.9 million for the six months ended June 30, 2024, to $5.0 million for the six months ended June 30, 2025, driven by increased system sales volumes in the current year period. Revenue from sales of disposable interventional devices, service and accessories increased to $11.3 million for the six months ended June 30, 2025, from $8.5 million for the six months ended June 30, 2024, an increase of approximately 32%. The increase was primarily driven by the impact of post-acquisition non-magnetic disposable device sales recorded in the current year period.

Current wording

Revenue. Revenue increased from $20.6 million for the nine months ended September 30, 2024, to $23.7 million for the nine months ended September 30, 2025, an increase of approximately 15%. Revenue from the sales of systems decreased from $7.2 million for the nine months ended September 30, 2024, to $6.9 million for the nine months ended September 30, 2025, driven by changes in product mix in the current year period. Revenue from sales of disposable interventional devices, service and accessories increased to $16.9 million for the nine months ended September 30, 2025, from $13.3 million for the nine months ended September 30, 2024, an increase of approximately 27%. The increase was primarily driven by the full year impact of post-acquisition non-magnetic disposable device sales, new magnetic device sales, and additional service work recorded in the current year period.

Previous wording

Cost of Revenue. Cost of revenue increased from $4.1 million for the six months ended June 30, 2024, to $7.6 million for the six months ended June 30, 2025, an increase of approximately 86%. As a percentage of our total revenue, overall gross margin decreased to 53% for the six months ended June 30, 2025, from 64% for the six months ended June 30, 2024, primarily due to changes in product mix. Cost of revenue for systems sold increased from $2.1 million for the six months ended June 30, 2024, to $4.0 million for the six months ended June 30, 2025, driven by increased system sales volume in the current year period. Gross margin for systems was $0.8 million for the six months ended June 30, 2024, compared to $1.0 million for the six months ended June 30, 2025. Cost of revenue for disposables, service, and accessories increased from $2.0 million for the six months ended June 30, 2024, to $3.6 million for the six months ended June 30, 2025, driven by increased disposables sales volume in the current period. Gross margin for disposables, service and accessories was 76% for the six months ended June 30, 2024, compared to 68% for the six months ended June 30, 2025. Gross margin for disposables, service, and accessories was impacted by acquisition related accounting which required the valuation of acquired finished good inventory to fair value and by changes in product mix in the current period.

Current wording

Cost of Revenue. Cost of revenuei ncreased from $9.2 million for the nine months ended September 30, 2024, to $11.0 million for the nine months ended September 30, 2025, an increase of approximately 19%. As a percentage of our total revenue, overall gross margin decreased to 54% for the nine months ended September 30, 2025, from 55% for the nine months ended September 30, 2024, primarily due to changes in product mix. Cost of revenue for systems sold decreased from $5.8 million for the nine months ended September 30, 2024, to $5.5 million for the nine months ended September 30, 2025, driven by changes in product mix in the current year period. Gross margin for systems was $1.5 million for the nine months ended September 30, 2024, compared to $1.3 million for the nine months ended September 30, 2025. Cost of revenue for disposables, service, and accessories increased from $3.4 million for the nine months ended September 30, 2024, to $5.4 million for the nine months ended September 30, 2025, driven by increased disposables sales volume in the current period. Gross margin for disposables, service and accessories was 74% for the nine months ended September 30, 2024, compared to 68% for the nine months ended September 30, 2025. The change in gross margin for disposables, service, and accessories was related to acquisition related accounting which required the valuation of acquired finished goods inventory to fair value in the prior period and by changes in product mix in the current period.

Previous wording

Research and Development Expenses. Research and development expenses decreased from $4.5 million for the six months ended June 30, 2024, to $4.1 million for the six months ended June 30, 2025, a decrease of 9%. This decrease was primarily driven by the capitalization of GenesisX into inventory offset by acquired headcount expense from our acquisition.

Current wording

Research and Development Expenses. Research and development expenses decreased from $7.0 million for the nine months ended September 30, 2024, to $6.7 million for the nine months ended September 30, 2025, a decrease of 4%. This decrease was primarily driven by the capitalization ofGenesisX system components into inventory partially offset by the full year impact of acquired headcount expense from our acquisition.

Previous wording

Sales and Marketing Expenses. Sales and marketing expenses increased from $6.3 million for the six months ended June 30, 2024, to $6.4 million for the six months ended June 30, 2025, an increase of approximately 2%. This increase was primarily driven by tradeshow expenses in the current year period.

Current wording

Sales and Marketing Expenses. Sales and marketing expenses decreased from $9.5 million for the nine months ended September 30, 2024, to $9.4 million for the nine months ended September 30, 2025, a decrease of approximately 1%. This decrease was primarily driven by lower headcount costs, partially offset by an increase in tradeshow 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 $3.8 million for the three months ended June 30, 2024, to $4.0 million for the three months ended June 30, 2025, an increase of approximately 6%. This increase was primarily driven by the amortization of the acquisition related intangible assets offset by lower professional service fees 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 $12.1 million for the nine months ended September 30, 2024, to $13.7 million for the nine months ended September 30, 2025, an increase of approximately 13%. 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.

Previous wording

Interest Income (Expense). Net interest income was approximately $0.4 million for the six months ended June 30, 2024, compared to $0.2 million for the six months ended June 30, 2025. The decrease was driven by lower invested balances and interest rates in the current year period partially offset by interest received with payment of the employee retention tax credit in the current year period.

Current wording

Interest Income. Net interest income was $0.6 million for the nine months ended September 30, 2024, compared to $0.3 million for the nine months ended September 30, 2025. The decrease was driven by lower invested balances and interest rates in the current year period partially offset by interest received with payment of the employee retention tax credit in the current year period.

Previous wording

As of June 30, 2025, we had $7.0 million of cash and cash equivalents. We had working capital of $1.2 million as of June 30, 2025, compared to $4.8 million as of December 31, 2024.

Current wording

As of September 30, 2025, we had $10.5 million of cash and cash equivalents. We had working capital of $6.3 million as of September 30, 2025, compared to $4.8 million as of December 31, 2024.

Previous wording

The following table summarizes our cash flow by operating, investing and financing activities for the six months ended June 30, 2025, and 2024 (in thousands):

Current wording

The following table summarizes our cash flow by operating, investing and financing activities for the nine months ended September 30, 2025, and 2024 (in thousands):

Previous wording

Net cash used in operating activities. We used approximately $5.5 million and $5.4 million of cash for operating activities during the six months ended June 30, 2025, and 2024, respectively. The increase in cash used in operating activities was driven by changes in working capital partially offset by a lower net loss.

Current wording

Net cash used in operating activities. We used approximately $9.7 million and $9.8 million of cash for operating activities during the nine months ended September 30, 2025, and 2024, respectively. The decrease in cash used in operating activities was driven by a lower net loss partially offset by 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 six months ended June 30, 2025, and 2024. The cash used for both periods was for the purchase of equipment.

Current wording

Net cash used in/provided by investing activities. We used less than $0.1 million of cash for investing activities during the nine months ended September 30, 2025 for the purchase of equipment. We generated approximately $0.1 million for investing activities during the nine months ended September 2024 from the acquisition of Access Point Technologies EP, Inc.

Previous wording

Net cash provided by financing activities. We generated less than $0.1 million of cash from financing activities during the six months ended June 30, 2025, and 2024. The cash generated in both periods 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 $7.8 million of cash from financing activities during the nine months ended September 30, 2025, and $0.1 million during the nine months ended September 30, 2024. The cash generated in 2025 was primarily driven by the proceeds from the registered direct offering during the third quarter. 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.