Financial Data and Key Metrics Changes - Revenue for Q1 2025 totaled $7.5 million, a 9% increase from $6.9 million in Q1 2024 [20] - System revenue was $2 million, while recurring revenue was $5.5 million, compared to $2.6 million and $4.3 million in the prior year [20] - Gross margin for Q1 was 54%, with recurring revenue gross margin at 68% and system gross margin at 15% [21] - Operating loss and net loss for Q1 2025 were $5.9 million and $5.8 million, respectively, compared to $4.7 million and $4.5 million in the previous year [22] Business Line Data and Key Metrics Changes - MAPIT sales exceeded $1 million in Q1, with a 30% sequential growth from Q4 [5] - The MAGIC catheter received European approval, with initial sales expected to generate a couple hundred thousand dollars this quarter, projected to reach approximately $1 million per quarter by the end of the year [8][24] - Genesis X had its first purchase order in Q1, with expectations for steady orders in the coming quarters [11][12] Market Data and Key Metrics Changes - The U.S. market remains challenging due to the lack of MAGIC approval, impacting capital equipment purchases [33] - In Europe, there is a more robust pipeline for both Genesis and Genesis X, with ongoing interest from hospitals [36] - The Chinese market presents uncertainty due to macroeconomic conditions, although there is potential upside following recent regulatory approval [25] Company Strategy and Development Direction - The company is focused on growing recurring revenue through its MAPIT portfolio and expanding the adoption of the MAGIC catheter and Genesis X [4][7] - A comprehensive innovation strategy is in place, with multiple regulatory reviews ongoing for key products [13] - The goal is to transition into a company with a significant installed base of robotic systems, enhancing the overall market presence [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential, with expectations for double-digit revenue growth in 2025 [24] - The company anticipates reduced cash use in 2025 compared to 2024, supported by growing recurring revenue [26] - Management highlighted the importance of regulatory approvals for future growth, particularly for MAGIC and Genesis X [15][16] Other Important Information - The company is working on enhancing compatibility of Genesis X with various x-ray systems and preparing for a full launch in the U.S. and Europe [11] - There are ongoing efforts to finalize regulatory submissions for additional products, including the Synchrony Cath Lab technology [18] Q&A Session Summary Question: Can you provide insights on the backlog for Genesis and Genesis X systems? - Management indicated that the capital equipment environment is challenging in the U.S. due to pending approvals, but there is ongoing interest from hospitals [30][33] Question: What feedback has been received from European customers using the MAGIC catheter? - The reception has been positive, with usage across a spectrum of procedures, and management expects scaling to a $1 million run rate by the end of the year [40][42] Question: How are ordering patterns for the MAGIC catheter among active users? - Initial orders typically consist of small quantities, with hospitals gradually increasing usage as they gain confidence [46][48] Question: What is the status of the MAGIC submission process with the FDA? - The FDA is actively reviewing the submission, and management is addressing detailed questions while compiling clinical data from ongoing studies [50][52] Question: What are the plans for financing options for Genesis X systems? - Discussions are ongoing regarding various financing models, including leasing and placement, to facilitate adoption once the product is approved [60][62]

[Management Commentary & Business Update](index=1&type=section&id=Management%20Commentary%20%26%20Business%20Update) Q1 2025 execution showed recurring revenue growth, MAGiC European launch, and initial GenesisX orders, positioning for 2026 growth - Key Q1 commercial advances include **growth in recurring revenue**, initial **MAGiC catheter commercialization in Europe**, successful **GenesisX robot demonstrations**, and the **first GenesisX system order** along with an additional Genesis system order[3](index=3&type=chunk) - **Six regulatory reviews are ongoing**, with timelines consistent with previous expectations[3](index=3&type=chunk) - Strategic transformation focuses on an easily adopted robotic system with proprietary catheters, projected to drive **breakout growth in 2026**[3](index=3&type=chunk) [Q1 2025 Financial Performance](index=1&type=section&id=Q1%202025%20Financial%20Performance) Q1 2025 total revenue increased 9% to $7.5 million, driven by 29% recurring revenue growth, with net loss widening to $5.8 million due to higher expenses and lower gross margins Q1 2025 Key Financial Metrics (vs. Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $7.5M | $6.9M | +9% | | System Revenue | $2.0M | $2.6M | -23% | | Recurring Revenue | $5.5M | $4.3M | +29% | | Gross Margin | 54% | 58% | -4 p.p. | | Operating Loss | ($5.9)M | ($4.7)M | +25% | | Net Loss | ($5.8)M | ($4.5)M | +29% | | Adjusted Operating Loss* | ($2.7)M | ($2.2)M | +23% | | Negative Free Cash Flow | ($1.8)M | ($2.3)M | -22% | *Excludes non-cash charges - Gross margins were impacted by **acquisition-related accounting** and **fixed overhead allocation over low system production levels**[5](index=5&type=chunk) - Operating expenses increased to **$10.0 million** (or **$6.8 million adjusted**), primarily due to **Access Point Technologies operations**[6](index=6&type=chunk) [Financial Position and Liquidity](index=2&type=section&id=Financial%20Position%20and%20Liquidity) As of March 31, 2025, Stereotaxis maintained a debt-free balance sheet with **$10.7 million** in cash and equivalents Cash and Debt Position | Metric | As of March 31, 2025 ($ million) | | :--- | :--- | | Cash and Cash Equivalents | $10.7 | | Debt | $0 | [2025 Full Year Outlook](index=2&type=section&id=2025%20Full%20Year%20Outlook) Stereotaxis expects **double-digit revenue growth** for 2025, with **$2-3 million** quarterly system revenue and **$7 million** recurring revenue by Q4, anticipating reduced cash usage - Stereotaxis expects **double-digit revenue growth** for the full year 2025[9](index=9&type=chunk) - Guidance assumes **$2-3 million** system revenue per quarter and recurring revenue scaling to **$7 million in Q4 2025**, with modest GenesisX Europe contributions and no China system revenue[9](index=9&type=chunk) - The company expects **reduced cash use in 2025** compared to 2024, supported by growing recurring revenue and stable operating expenses[10](index=10&type=chunk) [Consolidated Financial Statements](index=3&type=section&id=Consolidated%20Financial%20Statements) Unaudited consolidated financial statements detail a **$5.8 million net loss** for Q1 2025, with total assets of **$45.7 million** and total liabilities of **$37.5 million** as of March 31, 2025 [Consolidated Statements of Operations](index=3&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2025 Statement of Operations (Unaudited, in thousands) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | **2025** | **2024** | | **Total revenue** | **$7,472** | **$6,880** | | Gross margin | $4,064 | $3,966 | | Total operating expenses | $9,993 | $8,712 | | **Operating loss** | **($5,929)** | **($4,746)** | | Interest income, net | $106 | $239 | | **Net loss** | **($5,823)** | **($4,507)** | | Net loss per share (Basic & Diluted) | ($0.07) | ($0.06) | [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Highlights (Unaudited, in thousands) | | **March 31, 2025** | **December 31, 2024** | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $10,601 | $12,217 | | Inventories, net | $9,812 | $8,331 | | **Total Assets** | **$45,705** | **$46,724** | | **Current Liabilities** | | | | Accounts payable | $6,544 | $5,668 | | Deferred revenue | $8,163 | $6,804 | | **Total Liabilities** | **$37,529** | **$35,292** | | **Total Stockholders' Equity** | **$2,880** | **$6,080** |

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 ...