Group 1 - The company Stereotaxis (NYSE: STXS) was initially expected to receive approval for its MAGiC technology in Europe by late 2022 and in the United States two years later, indicating a miscalculation in the timeline for regulatory approval [1] - Stereotaxis represents the largest investment position for the analyst, highlighting significant confidence in the company's potential [2]

Company Developments - Stereotaxis, Inc. has received its first order for the GenesisX robotic system from a European hospital, marking a significant step in expanding the adoption of robotics in endovascular interventions [1][3] - GenesisX, which has received CE Mark approval in Europe and is pending FDA clearance, is designed to simplify installation and operational requirements, making it more accessible for hospitals [3][5] - The system is smaller and lighter than previous models, requiring no structural anchoring and operating on standard power outlets, which enhances its usability in operating rooms [6] Financial Performance - Stereotaxis has a market capitalization of $205.1 million, with a Zacks Consensus Estimate indicating a 37.2% year-over-year increase in fiscal 2025 earnings, alongside a 67.5% revenue improvement [4] Industry Prospects - The global surgical robots market is projected to grow from $9.6 billion in 2023 to $23.7 billion by 2029, reflecting a compound annual growth rate of 16.6% [8] - The demand for minimally invasive surgery is increasing due to its benefits, such as improved precision and shorter hospital stays, which is driving market expansion [9] Recent Innovations - In January, Stereotaxis received CE Mark approval for the MAGiC ablation catheter, which is designed for cardiac ablation procedures, further establishing its presence in the robotics field [10]

Core Viewpoint - Stereotaxis will announce its financial results for the fourth quarter and full year of 2024 on March 3, 2025, before the U.S. financial markets open, followed by a conference call to discuss the results and corporate developments [1]. Group 1: Financial Results Announcement - The financial results for the fourth quarter and full year of 2024 will be released on March 3, 2025 [1]. - A conference call and webcast will take place at 8:30 a.m. ET on the same day to discuss the results [1][2]. Group 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, enhancing patient care with robotic precision and safety [3].

Core Insights - Stereotaxis has received its first order for the GenesisX robotic system, marking a significant milestone towards its commercial launch [1][2] - The GenesisX system enhances the accessibility of Robotic Magnetic Navigation in endovascular surgery, featuring a compact design and requiring no structural anchoring [2][3] - The company aims to obtain regulatory approvals for GenesisX and compatible catheters in both Europe and the US during 2025 [3] Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular interventions, focusing on the development of robotic systems and solutions to improve patient care [4] - The technology has been utilized to treat over 150,000 patients globally, demonstrating its impact in the healthcare sector [4]

Core Insights - Stereotaxis has received European CE Mark approval for its MAGiC™ ablation catheter, marking a significant milestone in the field of surgical robotics for minimally invasive endovascular intervention [1][3][4] - The MAGiC catheter is designed for cardiac ablation procedures to treat heart arrhythmias, enhancing treatment precision and control while maintaining safety [2][3] - The approval follows extensive development, testing, and clinical research, indicating strong potential for broad adoption among robotic users [3][4] Company Overview - Stereotaxis is a pioneer in surgical robotics, focusing on minimally invasive endovascular interventions and has treated over 150,000 patients globally [5] - The company's mission includes the development of robotic systems and solutions that improve patient care and enhance operational efficiency in interventional laboratories [5] Product Features - The MAGiC catheter features optimized navigation, force, and stability through unique magnet placement and design [7] - It offers improved data and information capabilities with iConnect and eContact modules, providing critical contact and temperature data for physicians [7] - The catheter utilizes efficient low-flow uniform cooling to minimize fluid load on patients while preventing char and coagulation [7]

Company Overview - Stereotaxis is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention [4] - The company's mission is to discover, develop, and deliver robotic systems, instruments, and information solutions for the interventional laboratory [4] - Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere [4] Technological Advancements - Physicians at Oulu University Hospital in Finland have successfully treated the first patients using the advanced Genesis Robotic Magnetic Navigation (RMN) System from Stereotaxis [1] - The Genesis System introduces significant advances in Robotic Magnetic Navigation technology, offering precision and stability for cardiac ablation procedures [2][3] - Oulu University Hospital has treated over 2,000 patients with earlier versions of the technology, demonstrating significant experience in robotic heart rhythm treatments [2] Industry Impact - Robotic Magnetic Navigation technology enhances the precision and safety of cardiac ablation, a common minimally invasive procedure for treating arrhythmias [2] - Tens of millions of individuals worldwide suffer from arrhythmias, which can lead to serious health risks such as stroke, heart failure, and sudden cardiac arrest if left untreated [2] - The partnership between Stereotaxis and Oulu University Hospital aims to expand access to leading cardiac care in Finland [3] Leadership and Vision - David Fischel, Chairman and CEO of Stereotaxis, emphasized the company's commitment to enhancing and expanding its partnership with Oulu University to ensure access to advanced cardiac care [3] - Dr. Jarkko Magga, Cardiac Electrophysiologist at Oulu University, highlighted the importance of advanced robotic technology in providing superior patient care for complex cardiac arrhythmias [3]

Stereotaxis, Inc. (STXS) and Shanghai MicroPort EP Medtech Co., Ltd. announced the receipt of regulatory approval from China’s National Medical Products Administration (“NMPA”) for the Magbot Magnetic Navigation Ablation Catheter last Monday. Stereotaxis had previously announced its collaboration with MicroPort EP in August 2021.It is worthwhile to note that the Magbot Catheter is a single-use magnetic saline-irrigated radiofrequency ablation catheter designed and developed by MicroPort EP in collaboration ...

Financial Data and Key Metrics - Revenue for Q3 2024 totaled $9.2 million, an 18% YoY increase compared to $7.8 million in Q3 2023 [22] - System revenue was $4.4 million, driven by partial revenue recognition from the delivery of three Genesis systems, compared to $3.5 million in Q3 2023 [22] - Recurring revenue was $4.8 million, up from $4.3 million in Q3 2023, reflecting the two-month contribution from the APT acquisition [23] - Gross margin for Q3 2024 was 45%, with recurring revenue gross margin at 70% and system gross margin at 16% [24] - Operating loss and net loss for Q3 2024 were $6.3 million and $6.2 million, respectively, compared to $5.6 million and $5.4 million in Q3 2023 [26] - Adjusted operating loss and adjusted net loss, excluding non-cash charges, were $3.1 million and $3 million, respectively [27] - Negative free cash flow for Q3 2024 was $4.2 million [27] - Cash and cash equivalents, including restricted cash, stood at $11 million at the end of September 2024, increasing to $13.3 million by the end of October 2024 [28] Business Line Data and Key Metrics - Revenue growth in Q3 2024 was driven by the partial revenue recognition of three Genesis systems delivered to European hospitals [6] - The company received orders for two additional Genesis systems in Q3, leaving a capital backlog of $15.5 million at the end of the quarter [7] - The APT acquisition contributed approximately $0.5 million in catheter revenue in Q3, with expectations for larger contributions in Q4 [10] - The company is advancing regulatory approvals for the MAGiC catheter, high-density mapping catheter, and vascular guidance catheter, with submissions expected in early 2025 [15][55] Market Data and Key Metrics - Europe remains the strongest market for the company, with the most advanced product ecosystem and regulatory approvals [9] - The U.S. and China are slightly behind Europe in terms of regulatory approvals, but the company expects these regions to increasingly contribute to capital orders and revenue [9] - The company is working with MicroPort in China to gain regulatory approval for the Genesis robot, mapping integration, and a novel ablation catheter [20] Company Strategy and Industry Competition - The company is focused on building a comprehensive product ecosystem, including the Genesis X system, MAGiC catheter, and vascular guidance devices, to drive growth and adoption [8][15] - The acquisition of APT is seen as a strategic move to enhance the company's product portfolio and recurring revenue streams [10][11] - The company is investing in innovation and regulatory efforts to expand its presence in the electrophysiology and broader endovascular markets [4][18] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the near-term approval of the MAGiC catheter in Europe and expects significant commercial adoption [12][13] - The company is maintaining its revenue guidance for 2024, expecting year-over-year growth in both system and recurring revenue in upcoming quarters [29] - Management is focused on protecting the balance sheet and managing expenses prudently while investing in growth opportunities [30][31] Other Important Information - The company is preparing for the regulatory submission of the high-density mapping catheter and vascular guidance catheter in early 2025 [15][55] - The company is also advancing preclinical studies for robotic PFA programs, with potential first-in-human studies expected in 2025 [63][64] Q&A Session Summary Question: Timeline for MAGiC catheter approval in Europe and the U.S. [33] - Management expects CE Mark approval for MAGiC in Europe in the very short term, with U.S. approval likely in the next couple of quarters [34][35] Question: Market dynamics in the U.S. and Europe [36] - Europe's advanced product ecosystem is driving strong commercial results, while the U.S. and China are catching up [39][41] Question: APT catheter portfolio and revenue growth expectations [47] - The APT catheter portfolio is seeing positive reception, with expectations for meaningful sequential revenue growth in Q4 and beyond [51][52] Question: Robotic HD mapping catheter and recurring revenue per case [54] - Regulatory submissions for the high-density mapping catheter and vascular guidance catheter are expected in early 2025, with potential to significantly increase recurring revenue per procedure [55][56] Question: MAGiC catheter supply and sales force [59] - The company is confident in its ability to supply the market with MAGiC and is preparing to expand its sales force in Europe [60][61] Question: PFA program updates [62] - The company is advancing two robotic PFA programs, with potential first-in-human studies in 2025 [63][64] Question: Guidewire and guide catheter development [66] - The guide catheter is expected to be submitted for regulatory approval in Q1 2025, while the guidewire development is progressing more slowly [67][68]

ST. LOUIS, Nov. 11, 2024 (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, 2024. “The past quarter was marked by solid commercial execution, continued broad-based technological progress, successful operational integration of APT, and maintained financial discipline,” said David Fischel, Chairman and CEO. “We are making broad, methodical pro ...

ST. LOUIS, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it will participate in the Society for Cardiac Robotic Navigation’s Annual Meeting taking place October 28-29 in Lisbon, Portugal. The global physician-led Society for Cardiac Robotic Navigation (SCRN) is dedicated to establishing a community and platform for users of robotic technologies in cardiology. The annual SCRN ...