Financial Performance and Backlog - As of December 31, 2024, the company had approximately $15.2 million in backlog, with an expectation that about 70% will be recognized as revenue in 2025[28]. - No single customer accounted for more than 10% of total revenue for the years ended December 31, 2024, and 2023, indicating a diversified customer base[53]. Acquisitions and Strategic Relationships - The company completed the acquisition of Access Point Technologies EP, Inc. on July 31, 2024, enhancing in-house catheter development and manufacturing expertise[30]. - The company completed the acquisition of Access Point Technologies EP, Inc. on July 31, 2024, enhancing its portfolio with high-quality diagnostic catheters for cardiac ablation procedures[43]. - The company has established strategic relationships with technology leaders in the interventional market to enhance the commercialization of its robotic magnetic navigation systems[63]. Product Development and Regulatory Approvals - The Genesis RMN System and GenesisX RMN System have received regulatory clearances in the U.S., Europe, and China, with ongoing efforts to obtain registrations in additional markets[26]. - The company has developed the MAGiC catheter, which has obtained CE marking for marketing in Europe and is seeking regulatory approvals in the U.S.[46]. - The GenesisX RMN System has received regulatory clearance in Europe, and the company is pursuing approvals in the U.S. and other countries[50]. - The company is currently seeking FDA clearances for additional devices, including the MAGiC Sweep™ catheter, designed for robotic navigation[52]. - The MAGiC catheter has received CE marking for marketing in Europe and is pursuing regulatory approval in the U.S., with approval processes being lengthy and uncertain[66]. Research and Development - The company is investing in research and development to expand its technology's clinical focus to additional endovascular indications[20]. - The company has assembled a team of engineers and physicists with expertise in various fields to enhance its research and development efforts[68]. - Research and development focuses on robotic magnetic navigation systems, new proprietary disposable interventional devices, and software enhancements[69]. Market and Industry Insights - The market for cardiac ablation procedures is a multi-billion-dollar industry with expectations for substantial long-term growth[19]. - The company estimates that over 1.5 million cardiac ablation procedures are performed annually, with a market growth rate of approximately 10% per year[57]. - Approximately 49% of interventional cardiologists face orthopedic injuries, highlighting the safety benefits of the company's robotic technology in reducing physician exposure to radiation[36]. - The robotic magnetic navigation system is indicated for use in cardiac, peripheral, and neurovascular applications, providing precise control over interventional devices[39]. - The robotic technology aims to reduce procedure times and variability, enhancing hospital efficiency and potentially lowering costs associated with disposables[36]. Compliance and Regulatory Environment - The company’s products are subject to extensive FDA regulations, requiring 510(k) clearance or pre-market approval for commercial marketing in the U.S.[99]. - The FDA's 510(k) clearance process typically takes between 4 to 12 months, but can extend longer[101]. - If a device is not eligible for 510(k) clearance, a PMA must be submitted, which generally takes 1 to 3 years and is more costly and uncertain[102]. - The CE Mark is required for medical products to be sold in the European Economic Area, and compliance with the Medical Device Regulation (MDR) is necessary to obtain it[106]. - The company is subject to various federal and state laws relating to healthcare fraud and abuse, including anti-kickback and false claims laws[108]. - The company must comply with the Health Insurance Portability and Accountability Act (HIPAA) and other privacy laws, which impose requirements on the handling of patient medical information[111]. - The California Consumer Privacy Act (CCPA) took effect in 2020, introducing significant compliance burdens and potential fines for violations[113]. - The company is subject to unannounced inspections by the FDA to ensure compliance with regulatory requirements, with potential penalties for non-compliance[104]. Workforce and Company Culture - As of December 31, 2024, the company had 139 employees, with 41 in research and development, 51 in sales and marketing, 28 in manufacturing and service, and 19 in general administration[120]. - The company provides a competitive total rewards package, including equity ownership opportunities through stock option grants and employee stock purchase plans[123]. - The company is committed to attracting and retaining top talent, with a focus on creating a positive work environment free from discrimination[119].

ST. LOUIS, March 10, 2025 (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 participate in the 37th Annual ROTH Conference in Dana Point, California. Mr. Fischel will be available for one-on-one meetings on Monday, March 17th, 2025. “We appreciate the opportunity to participate in the Roth Conference and to share Stereotaxis’ differentiated technology and ...

Stereotaxis (STXS) recently submitted an application seeking FDA regulatory clearance for its MAGiC Sweep catheter, which is the first-ever robotically navigated high-density electrophysiology (EP) mapping catheter. This submission marks a significant advancement in integrating Robotic Magnetic Navigation (RMN) technology with high-density mapping, aiming to enhance the precision and safety of cardiac arrhythmia treatments.With this regulatory submission, Stereotaxis is taking a critical step toward strengt ...

I’m going to get to the nuances of Stereotaxis’ (NYSE: STXS ) quarterly report and new regulatory submissions later on, but I want to address the bears’ points first. While small cap biotech and medicalAnalyst’s Disclosure: I/we have a beneficial long position in the shares of STXS either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship ...

Company Overview - Stereotaxis has submitted an application for FDA regulatory clearance for its EMAGIN 5F catheter, which is a significant advancement in its Robotic Magnetic Navigation (RMN) technology for endovascular procedures [1][2] - The EMAGIN 5F catheter is the first robotically navigated endovascular device under the EMAGIN brand, featuring a 5-French diameter and utilizing magnetic fields for navigation [5][6] Market Potential - If approved, the EMAGIN 5F catheter could significantly expand Stereotaxis' market reach and revenue potential, particularly in neurointerventional, cardiology, and radiology procedures [2][4] - The global market for robotic catheterization systems is projected to grow from $54.4 million in 2025 to $190.2 million by 2035, driven by increasing demand for minimally invasive procedures [9][10] Financial Performance - Following the announcement of the FDA application, Stereotaxis shares fell by 5.8%, closing at $1.94, with a 6-month decline of 11.4% compared to the industry's 1.9% decline [3] - The current market capitalization of Stereotaxis stands at $174.5 million [4] Future Outlook - The company anticipates regulatory approval for the EMAGIN 5F catheter in the second half of 2025, which could enhance its competitive edge and attract strategic partnerships [2][8] - The growing preference for minimally invasive surgeries is expected to bolster the long-term outlook for Stereotaxis and its robotic technologies [10]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 totaled $6.3 million, a 39% year-over-year increase compared to $4.6 million in Q4 2023 [37] - Full year revenue for 2024 was $26.9 million compared to $26.8 million in 2023 [38] - Operating loss for Q4 2024 was $7.6 million, compared to $5.3 million in Q4 2023 [41] - Adjusted operating loss for the full year 2024 was $12.8 million, compared to $11.3 million in the prior year [42] Business Line Data and Key Metrics Changes - System revenue for Q4 2024 was $1.4 million, compared to $0.1 million in Q4 2023 [37] - Recurring revenue for Q4 2024 was $4.9 million, reflecting a full quarter's contribution from the acquisition of APT, compared to $4.5 million in Q4 2023 [37] - Full year system revenue was $8.6 million, compared to $8.7 million in the prior year [38] Market Data and Key Metrics Changes - The company expects to achieve approximately $1 million of MAGIC revenue per quarter in Europe by the end of 2024 [20] - The company anticipates a few GenesisX system sales this year, scaling to double-digit numbers next year [18] Company Strategy and Development Direction - The company aims to improve endovascular surgery with robotics, focusing on four primary pillars: making the robot widely available, building an ecosystem of catheters, developing interventional devices, and establishing connectivity and AI capabilities [11][12] - A strategic acquisition of APT has enhanced the company's catheter development and manufacturing capabilities [13] - The company is focused on expanding its addressable market by introducing a family of interventional guidewires and catheters [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regulatory milestones and early commercial efforts setting the stage for substantial growth in 2026 [35] - The company expects to keep adjusted operating expenses flat over the next few quarters while investing in commercial capabilities funded by profits from new product launches [47] - Management noted that the existing balance sheet allows the company to reach key milestones and profitably grow [48] Other Important Information - The company has a system backlog of $15.2 million as it enters 2025 [38] - The gross margin for recurring revenue was 70%, while system gross margin was 20% [39] Q&A Session Summary Question: Can you provide more color around MAGIC in the US market? - Management indicated that patient enrollment in Europe is ongoing and that the FDA is conducting a detailed review of the PMA submission, with no definitive number of patients needed for approval [50][52] Question: How will MAGIC Sweep fit into the broader ecosystem? - Management explained that MAGIC Sweep is a high-density mapping catheter that will enhance robotic procedures by providing safety and precision, which has been a long-standing request from physicians [57][62] Question: Can you clarify the system revenue guidance for 2025? - Management stated that the guidance reflects a conservative approach due to the volatility in revenue recognition and ongoing construction timelines for system sales [68][70] Question: What is the expected timing for GenesisX commercial approval in the US? - Management expects to respond to FDA questions soon and anticipates approval before compatible catheters are available [75][76] Question: What is the revenue expectation for the EMAGIN vascular guidance catheter? - Management noted that there are no significant revenue expectations for EMAGIN in the guidance due to uncertainty around regulatory approval [80]

Stereotaxis (STXS) Q4 2024 Earnings Call March 03, 2025 06:50 PM ET Company Participants David Fischel - CEO & ChairmanKimberly Peery - CFO & Secretary Conference Call Participants Frank Takkinen - Senior Research AnalystAdam Maeder - Senior Research AnalystJason Wittes - Managing Director & Senior Research Analyst Operator Good morning. Thank you for joining us for Stereotaxis Fourth Quarter and Full Year twenty twenty four Earnings Conference Call. Certain statements during the conference call and questio ...

Stereotaxis Inc. (STXS) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.05. This compares to loss of $0.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -80%. A quarter ago, it was expected that this company would post a loss of $0.05 per share when it actually produced a loss of $0.08, delivering a surprise of -60%.Over the last four quarters, the company has surpassed c ...

Revenue Performance - Revenue for Q4 2024 was $6.3 million, a 39% increase from $4.6 million in Q4 2023[5] - Full year 2024 revenue totaled $26.9 million, slightly up from $26.8 million in 2023[5] - System revenue for Q4 2024 was $1.4 million, while recurring revenue was $4.9 million, compared to $0.1 million and $4.5 million in Q4 2023, respectively[5] - Stereotaxis expects double-digit revenue growth for the full year 2025, with recurring revenue projected to scale from $5 million in Q1 to $7 million in Q4[9] Profitability and Loss - Gross margin for Q4 2024 was approximately 51%, with full year gross margins at 54%[6] - Operating loss for Q4 2024 was ($7.6) million, compared to ($5.3) million in Q4 2023[7] - Adjusted operating loss for the full year 2024 was ($12.8) million, compared to ($11.3) million in 2023[7] Financial Position - Cash and cash equivalents at year-end 2024 were $12.4 million, with no debt[8] - System backlog at the start of 2025 is $15.2 million[5] Future Outlook - Anticipated regulatory milestones and initial commercial launches in 2025 are expected to support substantial growth in 2026[9]

Core Insights - Stereotaxis has announced the FDA regulatory submission for the EMAGIN™ 5F, the first robotically navigated catheter aimed at expanding Robotic Magnetic Navigation into the endovascular field [1][2] - The EMAGIN brand will include a range of robotic catheters and wires, with the 5F catheter designed for navigating complex vascular structures [2] - The company anticipates launching the EMAGIN 5F in the second half of 2025, following expected regulatory approvals [3][4] Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular interventions, with a mission to develop robotic systems that enhance patient care and operational efficiency [5] - The technology has been utilized in over 150,000 procedures globally, indicating a strong market presence and acceptance [5] Industry Impact - Robotic Magnetic Navigation is positioned to address significant clinical challenges in neurointerventional and interventional cardiology, enhancing safety and precision in complex procedures [3][4] - Experts in the field express optimism about the potential of the EMAGIN catheter to improve outcomes in various challenging medical procedures [3]