Core Insights - Stereotaxis reported a 9% increase in revenue for Q1 2025, totaling $7.5 million compared to $6.9 million in Q1 2024, driven by a 29% growth in recurring revenue [3][8] - The company is focused on advancing its innovation strategy, with key commercial advances including the initial commercialization of MAGiC in Europe and successful demonstrations of the GenesisX robot [2][8] - Stereotaxis expects double-digit revenue growth for the full year 2025, with system revenue projected at $2-3 million per quarter and recurring revenue scaling to $7 million in Q4 2025 [8][9] Financial Performance - System revenue for Q1 2025 was $2.0 million, down from $2.6 million in Q1 2024, while recurring revenue reached $5.5 million, up from $4.3 million [3][13] - Gross margin for Q1 2025 was 54%, with recurring revenue gross margin at 68% and system gross margin at 15% [4][14] - Operating loss for Q1 2025 was ($5.9) million, compared to ($4.7) million in Q1 2024, with adjusted operating loss at ($2.7) million [6][14] Cash and Liquidity - As of March 31, 2025, Stereotaxis had cash and cash equivalents of $10.7 million and no debt [7][15] - The company anticipates reduced cash use in 2025 compared to 2024, supported by growing recurring revenue and stable operating expenses [9] Regulatory and Market Outlook - Stereotaxis is advancing multiple regulatory efforts with six active reviews and plans for additional submissions, aiming for significant adoption of GenesisX pending regulatory approval in the U.S. [2][8] - The company expects substantial growth in 2026, supported by anticipated regulatory milestones and initial commercial launches in 2025 [8]

ST. LOUIS, April 22, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it will release financial results for its 2025 first quarter on Monday, May 12, 2025 at the close of the U.S. financial markets. The Company will host a conference call and webcast at 4:30 p.m. EST that day to discuss the Company's results and corporate developments. About Stereotaxis Stereotaxis (NYSE: STXS) is a pion ...

Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating ...

Industry Overview - The surgical robotics market is experiencing rapid growth, driven by advances in minimally invasive surgery, with a market value of $11.48 billion in 2024 and a projected compound annual growth rate of 12.4% from 2025 to 2030 [2] - Key growth drivers include the integration of AI, which enhances precision and reduces complications, and the increasing demand for robotic surgeries due to an aging global population [6][7] Major Areas of Growth - Minimally invasive surgery is a significant factor driving the adoption of surgical robotics, providing benefits such as precision, smaller incisions, and faster recovery times across various fields including urology, gynecology, orthopedics, and general surgery [5] - The aging population is increasing the demand for robotic surgery systems, as these systems offer improved precision and lower risks for older patients [7] Company Analysis Intuitive Surgical - Intuitive Surgical's da Vinci surgical system has been a key performance driver since its launch, offering minimally invasive surgery and supporting rapid adoption through an integrated ecosystem [9] - The company has a long-term expected EPS growth rate of 16.1%, with projected revenue growth of 14.4% for 2025 [10] Zimmer Biomet - Zimmer Biomet is focusing on expanding its ROSA Robotics portfolio, which includes systems for knee, hip, and shoulder surgeries, enhancing the surgical experience [11][12] - The company has a projected sales growth rate of 2.6% for 2025, with a favorable current cash flow rate of 3.6% [13] Stereotaxis - Stereotaxis is expanding its global presence and has achieved regulatory approvals for its next-generation robotic system, GenesisX, enhancing its competitive position [14] - The company has a projected sales growth rate of 26.3% for 2025, with a favorable current cash flow rate of 13.1% [15]

Core Insights - Stereotaxis has been recognized by NVIDIA at the GTC conference and accepted into the NVIDIA Connect program, which will enhance its technological capabilities in surgical robotics [1][2]. Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular interventions, with its technology used in over 100 hospitals globally, treating more than 150,000 patients [3][4]. - The company is focusing on advancing its robotic systems through digital solutions that incorporate AI, robotic automation, data integration, and decision support capabilities [3]. Industry Context - The NVIDIA GTC conference, attended by over 25,000 participants, emphasizes the integration of AI in various applications, including healthcare and surgical robotics [2]. - The collaboration with NVIDIA is expected to significantly enhance the precision, safety, and stability of Stereotaxis' robotic systems, potentially transforming patient treatment [4].

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]