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]

Core Insights - Stereotaxis reported third-quarter financial results for 2025, highlighting a focus on commercial progress and regulatory advancements in surgical robotics for minimally invasive endovascular interventions [1][2]. Financial Performance - Total revenue for Q3 2025 was $7.5 million, with system revenue at $1.9 million and recurring revenue at $5.6 million, compared to $4.4 million and $4.8 million in the same quarter of the previous year [3]. - Gross margin for the quarter was 55%, with recurring revenue gross margin at 67% and system gross margin at 19%, affected by fixed overhead costs [4]. - Operating expenses were $10.7 million, including $4.1 million in non-cash charges, with adjusted operating expenses decreasing to $6.6 million from $7.2 million year-over-year [5]. - The operating loss was ($6.6) million, and the net loss was ($6.5) million, compared to ($6.3) million and ($6.2) million in the previous year [6]. Cash Position and Liquidity - As of September 30, 2025, Stereotaxis had cash and cash equivalents of $10.5 million and no debt, with an expected increase to $14.5 million following an upcoming financing closing [7]. Future Outlook - The company anticipates Q4 2025 revenue to exceed $9 million, with system revenue around $3 million and recurring revenue greater than $6 million, supporting over 20% annual revenue growth for 2025 [8]. - Sustained growth in both system and recurring revenue is expected in 2026, with quarterly revenue projected to surpass an average of $10 million [8][9].

Core Insights - Stereotaxis has received FDA 510(k) clearance for its new robotic system, GenesisX, marking a significant advancement in surgical robotics for minimally invasive endovascular interventions [1][3] Product Features - GenesisX enhances Robotic Magnetic Navigation technology, featuring a compact design with magnetic shielding integrated into its structure, allowing for installation in existing cath labs without extensive modifications [2] - The system operates on standard 120/230V power, requires no structural anchoring, and has an 80% smaller system cabinet, improving workflow efficiency while maintaining high standards of speed and responsiveness [2] Market Impact - The approval of GenesisX is expected to broaden the adoption of robotic technology in endovascular surgery, addressing previous infrastructure challenges that limited its use among physicians [3] - Stereotaxis has initiated a limited launch of GenesisX in the U.S. and Europe, while expanding its portfolio of compatible catheters and enhancing various operational processes for a full launch [3] Company Overview - Stereotaxis is a leader in surgical robotics, focusing on the development of innovative systems for minimally invasive interventions, with a mission to improve patient care and operational efficiency in interventional laboratories [4] - The company's technology has been utilized to treat over 150,000 patients globally, demonstrating its impact and reach in the healthcare sector [4]

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]

Core Insights - Stereotaxis has received CE Mark approval in Europe and submitted a 510(k) application to the FDA for its Synchrony™ system, which is aimed at modernizing interventional cath labs [1][2]. Product Features - The Synchrony system features a 55" 4K ultra-high-definition display that integrates various systems in the cath lab, enhancing the procedure experience with custom layouts and streamlined workflows [2]. - Synchrony digitizes video streams with high fidelity and minimal latency, providing clear visualization, and is designed to protect against obsolescence as new technologies emerge [2]. - The system is complemented by SynX™, a cloud-based application that ensures secure remote connectivity and collaboration, compliant with HIPAA and GDPR [2]. Expert Opinions - Experts in the field have praised Synchrony and SynX for their advanced hardware and software architecture, which promises improved intraoperative experiences and better equipment reliability [3]. - The technology is seen as a solution for enhancing remote connectivity and collaboration in electrophysiology labs, facilitating better patient care and training for future physicians [3]. Strategic Importance - The Synchrony and SynX systems are central to Stereotaxis's digital surgery initiatives, aimed at improving workflow and enabling remote robotic procedures [4]. - The company believes that the benefits of these technologies extend beyond robotic labs to all cath labs, enhancing overall connectivity and collaboration [4]. Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular interventions, with a mission to develop robotic systems that improve patient care and operational efficiency in interventional laboratories [5]. - The company's technology has been utilized to treat over 150,000 patients globally, underscoring its impact in the healthcare sector [5].

Core Insights - Stereotaxis (STXS) has partnered with CardioFocus to develop the first robotic Pulsed Field Ablation (PFA) system for treating cardiac arrhythmias, combining robotic precision with advanced PFA technology to enhance clinical use and commercialization [1][6][8] Company Summary - The collaboration is expected to leverage the strengths of both companies, enhancing treatment options in electrophysiology and expanding their presence in the growing cardiac care market [2][4] - Stereotaxis aims to integrate CardioFocus's CE-marked Centauri PFA System into its robotic platform, enhancing its product portfolio and creating new revenue streams in the cardiac ablation market [4][11] - STXS currently has a market capitalization of $279.6 million and reported an earnings surprise of 28.6% in the last quarter [5] Market Trends - The global pulsed field ablation market is projected to grow from an estimated size of $913.1 million in 2024 at a CAGR of 33.1% from 2025 to 2030, driven by the rising prevalence of atrial fibrillation and the adoption of minimally invasive procedures [12]

Core Insights - Stereotaxis and CardioFocus have entered a Collaboration Agreement to advance robotic Pulsed Field Ablation (PFA) technology for cardiac arrhythmias [1][2][3] Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular interventions, having treated over 150,000 patients globally [5] - CardioFocus specializes in pulsed field ablation treatment for cardiac disorders, particularly atrial fibrillation, and has developed the Centauri PFA System, which has been used on over 9,000 patients in Europe [6] Collaboration Details - The collaboration aims to combine the Centauri PFA System with Stereotaxis' MAGiC robotic cardiac ablation catheter, enhancing the efficiency and safety of cardiac ablation procedures [2][3] - Extensive bench and preclinical testing have shown that the combination of Centauri and MAGiC delivers safe and efficient lesion delivery, including durable lesions in ventricular tissue [3] Clinical and Regulatory Progress - The partnership supports advancing the joint solution to clinical trials, facilitating regulatory compatibility and commercial availability [3] - Both companies anticipate transitioning to first human use and advancing the regulatory process in the coming months [4]

Core Insights - Stereotaxis (STXS) announced the successful performance of the first procedures in the Netherlands using its Genesis Robotic Magnetic Navigation (RMN) System at Erasmus University Medical Center in Rotterdam [1][9] Company Developments - The adoption of Genesis at a leading European cardiac center indicates increasing clinical confidence in robotic solutions for complex arrhythmias, addressing the needs of tens of millions suffering from these conditions globally [2][10] - The collaboration with Erasmus MC enhances Stereotaxis' credibility and supports the broader adoption of its robotic innovations, which is crucial for expanding access to advanced cardiac treatments [2][10] - The Genesis RMN System is recognized for its speed, precision, and safety, particularly when used with the MAGiC catheter, which improves care for complex arrhythmia patients [8][9] Market Performance - Following the announcement, STXS shares increased by 2.5% at the market close, with a year-to-date gain of 26.3%, outperforming the industry which declined by 11.4% [3] - The current market capitalization of STXS stands at $255.9 million [6] Long-term Outlook - The successful introduction of Genesis at a prominent cardiac center is expected to encourage wider adoption among hospitals, leading to increased recurring revenue from system usage and related products [4] - The Genesis RMN System is designed to be smaller and lighter, enhancing patient accessibility and optimizing workspace in electrophysiology labs, which may reduce infrastructure burdens [11][12] - Regulatory approvals in multiple regions, including the FDA in the U.S. and CE-mark in Europe, support the growing clinical use of Genesis, which is essential for generating data and physician experience to drive further adoption [12]

Core Insights - Stereotaxis has successfully launched its Genesis Robotic Magnetic Navigation System at Erasmus University Medical Center in Rotterdam, marking a significant advancement in surgical robotics for minimally invasive endovascular interventions [1][2]. Company Overview - Stereotaxis is a pioneer in surgical robotics, focusing on minimally invasive endovascular interventions, with a mission to develop robotic systems and solutions that enhance patient care and operational efficiency in interventional laboratories [3]. Technological Advancements - The Genesis System represents the latest in Robotic Magnetic Navigation technology, which enhances precision and safety in cardiac ablation procedures for treating arrhythmias [2]. - The combination of the Genesis system and the MAGiC Catheter has shown synergistic improvements in robotic magnetic navigation, which is crucial for providing optimal care to arrhythmia patients, including those with complex conditions [2]. Clinical Impact - Erasmus MC has performed over 4,500 procedures using Stereotaxis technology, demonstrating the effectiveness and reliability of robotic magnetic navigation in complex arrhythmia treatments [2]. - Arrhythmias affect tens of millions globally, and untreated cases can lead to severe health risks such as stroke and heart failure, highlighting the importance of advanced treatment options like those offered by Stereotaxis [2].