Core Insights - Stereotaxis (STXS) has received FDA 510(k) clearance for its next-generation robotic system, GenesisX, which aims to enhance accessibility in endovascular surgical robotics [1][8] - The approval is expected to strengthen STXS's commercial trajectory by providing a scalable platform that appeals to a broader range of hospitals and cath labs [2][4] Company Developments - The GenesisX system features a compact design that eliminates the need for specialized wall shielding and structural changes, allowing for easier installation in existing cath labs [9][10] - STXS has initiated a limited launch of GenesisX in the U.S. and Europe to validate its performance in clinical settings while expanding its catheter options and imaging integration [10] - The company is positioning GenesisX as a flexible capital solution with various commercial pathways, including direct sales and lease options, to lower barriers for hospitals hesitant due to cost [11] Financial Performance - STXS has a market capitalization of $259.6 million and reported a 50% earnings surprise in the last quarter [5] - Year-to-date, STXS shares have increased by 6.6%, outperforming the industry growth of 4.1% [3] Industry Outlook - The global surgical robot systems market is projected to grow from $11.48 billion in 2024 to $23.13 billion by 2030, with a CAGR of 12.4% from 2025 to 2030, driven by technological advancements and a preference for minimally invasive procedures [12]

Regulatory Approvals and Product Development - The company completed the acquisition of Access Point Technologies EP, Inc. on July 31, 2024, enhancing its in-house catheter development and manufacturing capabilities[155]. - The GenesisX RMN System received CE Mark approval in Q3 2024 and FDA 510(k) clearance in Q4 2025, aimed at improving accessibility and reducing installation time for robotic systems[157]. - The Stereotaxis MAGiC catheter obtained CE marking in Europe in Q1 2025, and the MAGiC Sweep™ catheter received FDA 510(k) clearance in July 2025, expanding the product portfolio for cardiac ablation procedures[158]. - The Genesis RMN System and GenesisX RMN System have received regulatory approvals in the U.S., Europe, and China, facilitating market expansion[152]. - The company is pursuing regulatory approvals for the EMAGIN 5F catheter guide, designed for navigating complex vascular structures[158]. - The company plans to advance the adoption of its robotic magnetic navigation systems and proprietary devices in markets where regulatory clearance has been received in 2025[173]. Financial Performance - 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%[192]. - 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 same period in 2024, driven by decreased sales volume[192]. - 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 same period in 2024, an increase of approximately 17%[192]. - 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%[198]. - 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%[198]. Expenses and Losses - Cumulative net losses incurred by the company reached approximately $577.8 million as of September 30, 2025[173]. - The company anticipates incurring additional losses in 2025 as it continues product development and commercialization efforts[173]. - Cost of revenue increased 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%[199]. - Overall gross margin decreased to 54% for the nine months ended September 30, 2025, from 55% for the nine months ended September 30, 2024[199]. - 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%[203]. - 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%[200]. - 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%[201]. Cash Flow and Financial Position - As of September 30, 2025, the company had $10.5 million of cash and cash equivalents and working capital of $6.3 million[205]. - The company generated approximately $7.8 million of cash from financing activities during the nine months ended September 30, 2025, compared to $0.1 million during the same period in 2024[209]. - The company did not have any debt as of September 30, 2025[210]. Market and Economic Factors - The global tariff environment remains fluid, with potential impacts on cost structure and product launch timing due to recent tariff changes[159]. - The company anticipates less than a 1% increase in expenses for H2 2025 if current reduced reciprocal tariffs remain in place[165]. - Supply chain disruptions and geopolitical factors continue to pose risks to future operations and liquidity[168]. - The company continues to monitor the impact of macroeconomic factors on project timing, regulatory approvals, and operating results[173]. - The company expects to fund operations primarily through proceeds from past and future public offerings and private sales of equity securities[173]. - The company cannot guarantee that additional funding will not be needed in the future due to the macroeconomic environment[174]. Patient Treatment and Clinical Support - The company has treated over 150,000 arrhythmia patients globally using its robotic technology, supported by over 500 clinical publications[146]. - The Odyssey Solution is being replaced by next-generation solutions, Synchrony and SynX, which enhance procedure efficiency and remote connectivity[149].

Stereotaxis Reports 2025 Third Quarter Financial Results St. Louis, MO, November 11, 2025 (Globe Newswire) – Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2025. "We continue to focus on driving commercial progress while advancing a robust portfolio of technologies through regulatory and development milestones," said David Fischel, Chairman and CEO. "This i ...

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Core Insights - Stereotaxis Inc. reported a quarterly loss of $0.03 per share, better than the Zacks Consensus Estimate of a loss of $0.06, marking a 50% earnings surprise [1] - The company generated revenues of $7.46 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 13.21% and down from $9.2 million a year ago [2] - Stereotaxis shares have increased by approximately 22.4% year-to-date, outperforming the S&P 500's gain of 16.2% [3] Earnings Outlook - The earnings outlook for Stereotaxis is crucial for investors, with current consensus EPS estimates at -$0.06 for the next quarter and -$0.23 for the current fiscal year [7] - The company holds a Zacks Rank 2 (Buy), indicating expectations for the stock to outperform the market in the near future [6] Industry Context - The Medical - Instruments industry, to which Stereotaxis belongs, is currently in the top 25% of Zacks industries, suggesting a favorable environment for stock performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 totaled $7.5 million, with system revenue of $1.9 million and recurring revenue of $5.6 million, compared to $4.4 million and $4.8 million in the prior year [15] - Gross margin for Q3 2025 was 55% of revenue, with recurring revenue gross margin at 67% and system gross margin at 19% [15] - Operating loss for Q3 2025 was $6.6 million, compared to $6.3 million in the previous year, while adjusted operating loss was $2.5 million, down from $3.1 million [16] Business Line Data and Key Metrics Changes - Recurring revenue growth was driven by a full quarter's contribution from MAPIT catheters and initial sales of the Magic ablation catheter and Magic Sweep high-density mapping catheter [15] - The company has seen over $300,000 in revenue from the Magic Sweep catheter in its first two months of launch [8] Market Data and Key Metrics Changes - The company received hospital orders for two Genesis robots from European hospitals, indicating a healthy pipeline and continued interest, particularly in Europe [4] - The launch of Genesis X is expected to enhance system opportunities and is anticipated to outpace Genesis orders following its full launch [5][24] Company Strategy and Development Direction - The company aims to scale robotic system sales and build a high-margin recurring revenue business with its catheter portfolio, supporting a razor-razor blade business model [3] - The company is focusing on expanding its catheter portfolio, which is crucial for driving revenue and enhancing the value of its robotic systems [48] Management's Comments on Operating Environment and Future Outlook - Management expects revenue for the current quarter to exceed $9 million, with over 20% annual revenue growth for the full year 2025 [18] - The company anticipates sustained growth in both system and recurring revenue through 2026, with quarterly revenue expected to surpass an average of $10 million [18] Other Important Information - The company has a robust pipeline of innovation efforts, including multiple products in late stages of regulatory review and development projects [9] - The company had cash and cash equivalents of $10.5 million as of September 30, with no debt [17] Q&A Session Summary Question: Update on Genesis X sales pipeline and order mix - Management views Genesis X as additive to Genesis, with continued demand for Genesis systems expected alongside Genesis X orders [21][22] Question: Pricing strategy for Genesis X and revenue expectations - Genesis X will be sold at a premium price compared to Genesis, with expectations for initial non-EP applications in the coming year [26][27] Question: Timeline for full launch of Genesis X and Magic catheter approval - Full launch of Genesis X is expected in early 2026, contingent on manufacturing ramp-up and FDA approval for the Magic catheter [33] Question: Revenue mix expectations for 2026 - The company expects system revenue to be between 30%-50% of overall revenue, with recurring revenues scaling as catheter approvals progress [35] Question: FDA interactions regarding Magic catheter - Management reported a comprehensive review by the FDA with no significant issues, and they feel positive about their responses to FDA inquiries [39] Question: Changes in Q4 revenue guidance - The company adjusted Q4 guidance due to timing of approvals and market conditions, but remains optimistic about the ramp-up of new devices [41]

ST. LOUIS, Nov. 11, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2025. “We continue to focus on driving commercial progress while advancing a robust portfolio of technologies through regulatory and development milestones,” said David Fischel, Chairman and CEO. “This is an exciting milestone-rich period in which we are demonstratin ...

ST. LOUIS, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it received U.S. Food and Drug Administration 510(k) clearance for its latest generation robotic system, GenesisX™. GenesisX is the latest advance in endovascular surgical robotics, building upon the established benefits of Robotic Magnetic Navigation while significantly enhancing the accessibility of the technology for ...

Core Insights - Stereotaxis will release its financial results for the third quarter of 2025 on November 11, 2025, after the U.S. financial markets close [1] - A conference call and webcast will be held on the same day at 4:30 p.m. ET to discuss the results and corporate developments [1][2] Company Overview - Stereotaxis is a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention [3] - The company's mission focuses on the discovery, development, and delivery of robotic systems, instruments, and information solutions for interventional laboratories [3] - Stereotaxis technology has been utilized to treat over 150,000 patients globally, including in the United States, Europe, and Asia [3]

Core Insights - Stereotaxis (STXS) has launched its Synchrony system in Europe and submitted a 510(k) application to the U.S. FDA, aiming to modernize interventional cath labs with a unified digital interface [1][5] - The Synchrony system enhances workflow, visualization, and connectivity, positioning Stereotaxis to expand its market presence in both robotic and non-robotic cath labs [2][4] Product Features - Synchrony features a 55-inch ultra-high-definition 4K display that integrates multiple system feeds into a single interface, providing near-zero latency video streams and customizable layouts [3] - The system is paired with SynX, a secure cloud-based application that enables remote connectivity, collaboration, and real-time monitoring, compliant with HIPAA and GDPR standards [3][4] Strategic Vision - Synchrony and SynX are foundational platforms designed to support future advancements, including AI-driven automation and long-distance robotic procedures, aligning with Stereotaxis' long-term digital surgery vision [4] - The CE Mark approval allows for commercial rollout in EU markets, while the FDA submission paves the way for potential entry into the U.S. market, enhancing Stereotaxis' geographic reach [5] Competitive Landscape - Stereotaxis competes with key players like Intuitive Surgical (ISRG), which has advanced its da Vinci 5 platform with new software features and gained CE Mark approval for broader international rollout [6][7] - Microbot Medical (MBOT) has achieved FDA clearance for its LIBERTY Endovascular Robotic System, marking a significant milestone in the endovascular robotics market [8][10] - PROCEPT BioRobotics (PRCT) reported strong revenue growth and wider adoption of its Aquablation therapy, indicating a competitive environment in robotic-assisted surgical solutions [11][12]