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 ...

ST. LOUIS, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that David Fischel, Chairman and CEO, will represent Stereotaxis at two upcoming investor conferences. H.C. Wainwright 26th Annual Global Investment Conference Mr. Fischel will present an overview of Stereotaxis business on Wednesday, September 11th, 2024, at 12:30 pm EST and will be available that same day for one-on-one m ...

ST. LOUIS, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that its technology will be prominently featured during the upcoming HRX digital health conference taking place September 5-7, 2024, in Atlanta, Georgia. HRX, an initiative pioneered by the Heart Rhythm Society (HRS), is focused on exploring digital technologies that advance the boundaries of innovation in cardiovascular me ...

eternalcreative/iStock via Getty Images Initial Takeaways From Q2 Report: GenesisX Submissions/Approval & MAGiC Making Progress Heading into the Q2 earnings report, I was most concerned about the GenesisX submission timeline. Stereotaxis (NYSE:STXS) management originally projected the robot would be submitted to regulators in late 2022. That guidance was way too aggressive. Then, in mid to late 2023, the firm suggested the robot was nearly ready for regulatory submission, but the company wanted to wait unti ...

Acquisition and Product Development - The Company issued 1,486,620 shares of its common stock as part of the acquisition of Access Point Technologies, Inc. (APT) on July 31, 2024[103]. - APT specializes in high-quality diagnostic catheters for cardiac ablation procedures, enhancing the Company's capabilities in treating complex arrhythmias[103]. - The acquisition includes contingent payments based on achieving specified product revenue and regulatory approval milestones through September 30, 2029[104]. - The primary clinical focus is on electrophysiology, specifically cardiac ablation, which is a multi-billion-dollar market with expected long-term growth[96]. - The Genesis RMN System and Odyssey Solution are key products designed to improve procedure efficiency and reduce x-ray exposure during interventions[98][99]. - The Company has received regulatory approvals for its products in the U.S., Europe, Canada, China, and Japan, and is pursuing additional registrations globally[101]. Financial Performance - Revenue decreased from $7.9 million for the three months ended June 30, 2023, to $4.5 million for the three months ended June 30, 2024, a decrease of 43%[120]. - Revenue from sales of systems decreased to $0.2 million for the three months ended June 30, 2024, from $3.3 million for the same period in 2023, driven by decreased system sales volumes[120]. - Overall gross margin increased to 74% for the three months ended June 30, 2024, from 53% for the same period in 2023, primarily due to changes in product mix[121]. - Revenue decreased from $14.4 million for the six months ended June 30, 2023, to $11.4 million for the same period in 2024, a decrease of approximately 21%[123]. - Cost of revenue decreased from $6.3 million for the six months ended June 30, 2023, to $4.1 million for the same period in 2024, a decrease of approximately 35%[124]. Expenses and Cash Flow - Research and development expenses decreased from $2.6 million for the three months ended June 30, 2023, to $2.3 million for the same period in 2024, a decrease of approximately 14%[122]. - General and administrative expenses increased from $3.5 million for the three months ended June 30, 2023, to $3.8 million for the same period in 2024, an increase of approximately 8%[123]. - Cash and cash equivalents as of June 30, 2024, were $15.2 million, down from $20.0 million as of December 31, 2023[127]. - Net cash used in operating activities was approximately $5.4 million for the six months ended June 30, 2024, compared to $5.7 million for the same period in 2023[127]. - The Company did not have any debt as of June 30, 2024[129]. Market and Operational Challenges - Supply chain disruptions and inflationary pressures continue to pose risks to the Company's operations and financial condition[105]. - The ongoing impact of the COVID-19 pandemic has affected demand for the Company's systems and disposable products, leading to potential revenue fluctuations[107].