Latest news with #GenesisX
Yahoo
13-05-2025
- Business
- Yahoo
Stereotaxis Inc (STXS) Q1 2025 Earnings Call Highlights: Strong Revenue Growth Amidst ...
Release Date: May 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Stereotaxis Inc (STXS) reported a solid 9% year-over-year revenue growth for Q1 2025. The company is seeing commercial progress with its differentiated EP catheters, including the recently approved Magic catheter in Europe. Recurring revenue growth is driven by the Mapi family of diagnostic EP catheters, with sales in the US growing 30% sequentially. Stereotaxis Inc (STXS) received European approval for the Magic ablation catheter, with initial sales expected to ramp up significantly. The company is preparing for the first commercial installation of Genesis X, which is expected to drive robotic system growth. Structural challenges of the old product ecosystem remain a significant headwind for Stereotaxis Inc (STXS). The process of getting catheters adopted is gradual, requiring administrative efforts and clinical support. Recurring revenue gross margins are impacted by acquisition-related accounting, temporarily reducing disposable margins. Operating loss and net loss increased compared to the previous year, with operating expenses rising due to acquisition-related costs. Uncertainty in the Chinese market and macroeconomic conditions could impact potential revenue from Genesis systems. Warning! GuruFocus has detected 8 Warning Signs with STXS. Q: Can you provide more details on the backlog for Genesis and Genesis X systems in the US and Europe, and how the capital equipment environment is affecting these? A: David Fischer, CEO: The capital environment varies by region. In the US, the ecosystem is less advanced due to pending approvals for Genesis X and related catheters. Interest exists, but actionable steps await regulatory clearance. In Europe, there's a robust pipeline for both Genesis and Genesis X, with some hospitals already planning for Genesis. In China, despite macroeconomic uncertainties, there's potential upside with recent regulatory approval. Q: How is the Magic RF ablation catheter performing in Europe, and what is the expected scaling over the next quarters? A: David Fischer, CEO: The reception has been positive, with usage across a variety of procedures. The catheter is predominantly used in complex cases like VTs and PVCs. We expect Magic to reach a $1 million quarterly run rate in Europe by year-end, with full market conversion anticipated over two years. Q: What are the ordering patterns for the 20% of European customers using Magic, and how is the adoption process? A: David Fischer, CEO: Initial orders typically consist of 5-10 catheters, with hospitals testing them before full adoption. Feedback has been positive, and repeat orders are starting. The adoption process involves hospital reviews and national approvals, which is progressing well. Q: What is the status of the Magic catheter's FDA approval in the US, and what remains in the submission process? A: David Fischer, CEO: The FDA review is ongoing, with detailed questions being addressed. Most supplementary tests are complete, and clinical data from European studies are being shared with the FDA. An on-site audit may be required, but the timeline for approval remains realistic for the second half of the year. Q: How do you envision the case mix for robotic magnetic navigation cardiac ablation procedures evolving with the expanded catheter portfolio? A: David Fischer, CEO: The focus remains on complex cases like VTs, PVCs, and congenital patients, where robotic navigation offers the most value. While there's potential to expand into atrial ablations, the current strategy is to capitalize on the significant growth opportunity within complex ablations. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
21-04-2025
- Business
- Yahoo
Stereotaxis to Feature First-Ever Live Demo of GenesisX Robotic System at HRS 2025
GenesisX pairs clinical capability with broad accessibility in surgical robotics ST. LOUIS, April 21, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, announced today it will host a live demonstration of the GenesisX Robotic System at this year's Heart Rhythm Symposium (HRS), taking place April 24 – 27 in San Diego, CA. This marks the first live, public demonstration of GenesisX, offering a glimpse to HRS attendees into the robot's revolutionary clinical capabilities and 'weekend' installation. GenesisX represents the latest advance in endovascular surgical robotics, building upon the proven benefits of Robotic Magnetic Navigation while significantly enhancing accessibility for healthcare providers. The system features a compact and efficient design, incorporating magnetic shielding into its structure to eliminate the need for room-based shielding, reducing infrastructure requirements. GenesisX operates on standard 120/230V power, requires no structural anchoring, and features an 80% smaller system cabinet that conveniently fits under an operating room table. The system's smaller and lighter design enhances workflow efficiency while maintaining the highest standards in speed and responsiveness. Stereotaxis will be located at Booth 1034 and will be featured during several events throughout the congress, including: Stereotaxis Investor Technology Demonstration: Friday April 25th at 12:00 PM PDT Joint Session with Africa Heart Rhythm Association on leveraging telerobotics to advance care in underserved communities: Saturday April 26th at 2:45 PM PDT Joint Session of HRS & Society for Cardiac Robotic Navigation (SCRN): April 27th at 12:45 PM PDT 'We are thrilled to bring GenesisX to HRS and allow the electrophysiology community to experience firsthand this cutting-edge innovation along with our expanding portfolio of proprietary catheters and digital technologies,' said David Fischel, Stereotaxis Chairman and CEO. 'We look forward to engaging with the electrophysiology community at HRS, who, together with us, are pioneering the frontiers of medicine.' GenesisX obtained CE Mark approval in Europe in 2024 and is currently under review for FDA 510(k) clearance in the United States. In addition to GenesisX, Stereotaxis will showcase its portfolio of compatible EP and vascular catheters, including the Map-iT™, MAGiC™, and EMAGIN™ product lines, as well as its advanced Synchrony™ and SynX™ digital lab technologies. If you are interested in a meeting to learn more about GenesisX or other Stereotaxis technology, please contact info@ 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 room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe', "estimate', "project', "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to manage expenses at sustainable levels, acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company's control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts:David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@ in to access your portfolio
Yahoo
04-03-2025
- Business
- Yahoo
Stereotaxis Inc (STXS) Q4 2024 Earnings Call Highlights: Strong Revenue Growth Amid Strategic ...
Fourth Quarter Revenue: $6.3 million, a 39% increase year-over-year. System Revenue (Q4 2024): $1.4 million, up from $0.1 million in Q4 2023. Recurring Revenue (Q4 2024): $4.9 million, compared to $4.5 million in Q4 2023. Full-Year 2024 Revenue: $26.9 million, slightly up from $26.8 million in 2023. Full-Year System Revenue: $8.6 million, compared to $8.7 million in 2023. System Backlog (Start of 2025): $15.2 million. Full-Year Recurring Revenue: $18.3 million, up from $18 million in 2023. Gross Margin (Q4 2024): Approximately 51%. Gross Margin (Full-Year 2024): Approximately 54%. Operating Expenses (Q4 2024): $10.8 million, including $2.5 million in non-cash stock compensation and $1.1 million non-cash mark-to-market adjustment. Adjusted Operating Expenses (Q4 2024): $7.2 million. Operating Loss (Q4 2024): $7.6 million. Net Loss (Q4 2024): $7.5 million. Adjusted Operating Loss (Q4 2024): $4 million. Adjusted Net Loss (Q4 2024): $3.8 million. Free Cash Flow (Q4 2024): Positive $1.3 million. Free Cash Flow (Full-Year 2024): Negative $8.5 million. Cash and Cash Equivalents (End of 2024): $12.4 million, with no debt. Warning! GuruFocus has detected 9 Warning Signs with STXS. Release Date: March 03, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Stereotaxis Inc (STXS) announced significant milestones with FDA submissions for key catheter innovations, indicating progress in their strategic transformation. The company reported a 39% year-over-year increase in fourth-quarter revenue, totaling $6.3 million, showcasing strong financial performance. Stereotaxis Inc (STXS) received European CE mark approval for the GenesisX robot and MAGiC ablation catheter, with plans for commercial launch in Europe. The strategic acquisition of APT has enhanced Stereotaxis Inc (STXS)'s in-house catheter development and manufacturing capabilities. The company is expanding its product portfolio with the introduction of the EMAGIN vascular catheter, targeting multiple new endovascular indications. Stereotaxis Inc (STXS) faces challenges with FDA regulatory approval timelines, particularly for the MAGiC catheter in the US. The company has a system backlog of $15.2 million, indicating potential delays in revenue recognition. Recurring revenue growth is impacted by catheter shortages from Johnson & Johnson, affecting overall financial performance. Operating expenses increased due to non-cash stock compensation and acquisition-related costs, impacting profitability. The macroeconomic environment and anti-corruption campaigns in China present headwinds for commercial efforts in the region. Q: Can you provide more details on the MAGiC catheter's approval process in the US and what needs to happen for a second-half approval? A: David Fischel, Chairman and CEO, explained that they are enrolling patients in Europe to meet FDA's unmet medical need criteria. The FDA is conducting a detailed review of the PMA submission, and Stereotaxis is responding to questions and refining the submission. There might be an audit of the manufacturing facility in Germany, but it's not certain. The FDA is working collaboratively to ensure a thorough and timely review. Q: How will the MAGiC Sweep high-density mapping catheter fit into the broader ecosystem, and how might it affect your relationship with Abbott? A: David Fischel stated that the MAGiC Sweep will be used in the majority of robotic procedures, allowing physicians to perform high-density mapping robotically. This development is part of a broader strategy and has been communicated to partners like Abbott, with no concerns about its impact on existing relationships. Q: Can you clarify the system revenue guidance for 2025, given the GenesisX launch in Europe and China? A: David Fischel noted that the guidance is conservative, focusing on transitioning existing backlog into revenue. The unpredictability of sales in China and the timing of revenue recognition contribute to the cautious outlook. The guidance does not assume significant sales in China and reflects modest expectations for GenesisX. Q: What is the expected timeline for GenesisX commercial approval in the US? A: David Fischel mentioned that they are responding to FDA questions and expect GenesisX approval before the compatible catheters are approved. They anticipate having at least one compatible catheter approved in the third quarter, allowing for a commercial launch in the US. Q: What is the strategic importance of the EMAGIN vascular guidance catheter, and how do you plan to prioritize its applications? A: David Fischel emphasized that while short-term revenue expectations for EMAGIN are modest, its strategic value is substantial. The catheter will enable the robot to become a multi-specialty platform, expanding its use into neurointervention, interventional cardiology, and oncology. The focus will be on demonstrating clinical utility in these areas to expand the robot's value proposition. Q: Is there any capacity constraint related to the MAGiC catheter, and how are you addressing it? A: David Fischel confirmed that they are ramping up manufacturing in Europe and working through administrative processes with hospitals. The goal is to ensure a steady supply as they scale up sales throughout the year. Q: How frequently do you expect the MAGiC Sweep mapping catheter to be used, and what is the expected impact on catheter sales? A: David Fischel anticipates that the MAGiC Sweep will be used in a significant portion of procedures, potentially increasing the pool of robotic users. The combined sales of MAGiC and MAGiC Sweep are expected to increase disposable revenue per procedure by more than fivefold. Q: What is included in the guidance for the MAGiC launch in Europe and the US? A: David Fischel clarified that the guidance includes $3 million to $4 million related to the MAGiC launch in Europe, with no revenue from a potential US launch included due to uncertainty in approval timelines. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Associated Press
30-01-2025
- Business
- Associated Press
Stereotaxis Announces First GenesisX Robotic System Order
ST. LOUIS, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it has received the first order for its latest generation robotic system, GenesisX™. 'We are thrilled to announce the first firm order for GenesisX from a pioneering European hospital,' said David Fischel, Stereotaxis Chairman and CEO. 'Establishing the first GenesisX robotic lab is a critical milestone for us as we advance towards full commercial launch. We look forward to demonstrating the performance and reliability of GenesisX in the demanding clinical environment. GenesisX promises to transform the accessibility of Robotic Magnetic Navigation and is central to our mission of driving broad robotic adoption throughout endovascular surgery.' GenesisX is the latest advance in endovascular surgical robotics, building upon the established benefits of Robotic Magnetic Navigation while significantly enhancing the accessibility of the technology for healthcare providers. GenesisX utilizes smaller magnets and incorporates magnetic shielding into its structure in place of the shielding otherwise installed in the walls of the operating room. It requires no structural anchoring through the floor and operates using standard 120/230V power outlets. A single fiber is routed from each robot to the system cabinet, which is 80% smaller than previous cabinets and can fit under a table in the operating room. GenesisX is smaller and lighter than any previous generation system, while maintaining the highest standards in speed, responsiveness, and efficient workflow. GenesisX obtained CE Mark in Europe in 2024 and has been submitted to the FDA for 510(k) clearance in the United States. During 2025, Stereotaxis plans to gain regulatory approvals in Europe and the US for a portfolio of compatible EP and vascular catheters, demonstrate real-world use of GenesisX, enhance compatibility of GenesisX with various x-rays, and prepare supply chain, manufacturing, installation and commercial processes for a full launch. About Stereotaxis 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 room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit This press release includes statements that may constitute 'forward-looking' statements, usually containing the words 'believe', 'estimate', 'project', 'expect' or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to manage expenses at sustainable levels, acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company's control and may be revised, modified, delayed, or canceled. David L. Fischel Kimberly Peery Chief Financial Officer 314-678-6100
