UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER 001-36159 STEREOTAXIS, INC. (Exact name of the Registrant as Specified in its Charter) DELAWARE 94-3120386 (State or Other Jurisdict ...

Stereotaxis Inc. (STXS) came out with a quarterly loss of $0.07 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.06 per share a year ago. These figures are adjusted for non-recurring items.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 $0.09, delivering a surprise of -80%.Over the last four quarters, the company has not been able to surpass consensus EPS estimates.Stereotaxis, which belongs to the Zack ...

Stereotaxis (STXS) Q1 2025 Earnings Call May 12, 2025 04:30 PM ET Speaker0 Good afternoon. Thank you for joining us for Stereotaxis First Quarter twenty twenty five Earnings Conference Call. Certain statements during the conference call and question and answer period to follow may relate to future events, expectations and as such constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and ...

Exhibit 99.1 Stereotaxis Reports 2025 First Quarter Financial Results St. Louis, MO, May 12, 2025 (Globe Newswire) – Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the first quarter ended March 31, 2025. Revenue for the first quarter of 2025 totaled $7.5 million, a 9% increase compared to $6.9 million in the prior year first quarter. System revenue for the first quarter was $2.0 million, compar ...

ST. LOUIS, May 12, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the first quarter ended March 31, 2025. “We’ve started the year with solid execution on key commercial and innovation efforts,” said David Fischel, Chairman and CEO. “This is a milestone rich year in which we are beginning to demonstrate the tangible reality and commercial impact of our comprehensive inno ...

ST. LOUIS, March 19, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that NVIDIA highlighted Stereotaxis’ technology at NVIDIA GTC and has accepted Stereotaxis into the NVIDIA Connect program. NVIDIA GTC (GPU Technology Conference) is a global artificial intelligence (AI) conference that brings together engineers, researchers, and inventors working to pioneer applications for AI. This year’s ...

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 ...