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Stereotaxis(STXS) - 2025 Q2 - Quarterly Report
2025-08-13 19:00
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 JUNE 30, 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 Jurisdicti ...
Stereotaxis(STXS) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Stereotaxis (STXS) Q2 2025 Earnings Call August 07, 2025 04:30 PM ET Speaker0Good afternoon. Thank Thank you for joining us for Stereotaxis' Second 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, uncerta ...
Stereotaxis(STXS) - 2025 Q2 - Quarterly Results
2025-08-07 20:03
Exhibit 99.1 Stereotaxis Reports 2025 Second Quarter Financial Results St. Louis, MO, August 7, 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 second quarter ended June 30, 2025. "We are pleased with our commercial results in the quarter. Sequential and year-over-year growth in both recurring and system revenue reflects the early positive impact of our innovations on ...
Stereotaxis Receives U.S. FDA Clearance for MAGiC Sweep Catheter
Globenewswire· 2025-07-28 11:48
Core Insights - Stereotaxis has received FDA 510(k) clearance for its MAGiC Sweep™ catheter, marking a significant advancement in electrophysiology mapping technology [1][2][3] - The MAGiC Sweep is the first robotically navigated high-density electrophysiology mapping catheter, enhancing the diagnosis and treatment of complex arrhythmias [1][2] Company Overview - Stereotaxis is a pioneer in surgical robotics for minimally invasive endovascular interventions, focusing on the development of robotic systems and instruments to improve patient care [3] - The company has treated over 150,000 patients globally, showcasing its commitment to advancing robotic technology in healthcare [3] Product Features - The MAGiC Sweep catheter is equipped with 20 electrodes for rapid and detailed electroanatomical mapping of heart chambers [4] - It integrates seamlessly with Stereotaxis' robotic systems, allowing precise navigation to challenging areas of the heart [4] - The catheter's atraumatic design prioritizes patient safety and supports anatomically accurate mapping by minimizing distortion [4] - It enhances workflow efficiency in robotic procedures, particularly with the development of automated mapping algorithms [4] Industry Impact - The introduction of the MAGiC Sweep catheter is expected to significantly improve cardiac ablation procedures by providing more efficient and detailed mapping of arrhythmias [2] - Experts in the field view this development as a major milestone that will positively impact patient outcomes and expand the capabilities of robotic electrophysiology [2]
Stereotaxis to Report Second Quarter 2025 Financial Results on August 7, 2025
GlobeNewswire News Room· 2025-07-23 12:00
Core Viewpoint - Stereotaxis will release its financial results for the second quarter of 2025 on August 7, 2025, and will host a conference call to discuss these results and corporate developments [1][2]. Company Overview - Stereotaxis is a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, focusing on the discovery, development, and delivery of robotic systems and solutions for interventional laboratories [4]. - The company's technology has been utilized to treat over 150,000 patients globally, enhancing patient care with robotic precision and safety [4]. Conference Call Details - The conference call will take place on August 7, 2025, at 4:30 p.m. ET, with dial-in numbers provided for both U.S. and international participants [2]. - A replay of the call will be available for one month following the event [3].
Stereotaxis Announces $12.5 Million Registered Direct Offering of Common Stock
Globenewswire· 2025-07-17 12:32
Core Viewpoint - Stereotaxis, Inc. has announced a registered direct offering to sell approximately $12.5 million of its common stock at a price of $2.00 per share, aimed at accelerating product commercialization and supporting research and development efforts [1][2]. Group 1: Offering Details - The gross proceeds from the offering are expected to be around $12.5 million, with an initial closing of approximately $8.5 million expected on or about July 18, 2025, and a second closing of $4.0 million scheduled for on or before November 25, 2025 [3]. - Lake Street Capital Markets LLC is acting as the exclusive placement agent for the offering [3]. Group 2: Use of Proceeds - Proceeds from the offering will be utilized to accelerate product commercialization, support research and development, and for other corporate purposes [2]. Group 3: Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular intervention, with a mission to develop robotic systems and solutions that enhance patient care and operational efficiency [6]. - The company's technology has been used to treat over 150,000 patients globally, indicating a significant market presence [6].
Stereotaxis Reports Positive Initial Data From MAGiC Catheter Trial
ZACKS· 2025-07-07 16:55
Core Insights - Stereotaxis (STXS) announced initial clinical results for its MAGiC catheter, marking the first peer-reviewed evidence of its safety and efficacy in treating cardiac arrhythmias [1][4] - The MAGiC catheter is the first robotic, fully integrated radiofrequency ablation catheter designed for use with Stereotaxis' Robotic Magnetic Navigation system, demonstrating consistent navigation accuracy and a strong safety profile [2][4] Company Performance - Following the announcement, STXS shares remained flat, with a year-to-date decline of 3.5%, compared to the industry's 7.4% decline and the S&P 500's gain of 6.3% [3] - The company currently has a market capitalization of $189.2 million [6] Clinical Study Results - The MAGiC catheter study involved 67 patients, showing an acute efficacy rate of 94% and a low procedure-related adverse event rate of 1.5% [7][8] - The study reported no adverse events linked to catheter malfunction, with an average procedure time of 83 minutes [8] Technological Advancements - The MAGiC catheter demonstrated improved stability, steady tip temperatures during ablation, and low irrigation rates, enhancing safety and efficiency in robotic ablation procedures [9] - These advancements are expected to boost physician confidence and accelerate the adoption of Stereotaxis' robotic system [4] Industry Outlook - 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 the demand for minimally invasive procedures [10][11]
Stereotaxis: Recurring Revenue Inflection
Seeking Alpha· 2025-07-06 06:13
Core Insights - Stereotaxis, Inc. (NYSE: STXS) is making significant advancements in robotic interventional cardiology while the market remains underweight on the stock [1] - The company is expected to see recurring revenue growth exceeding 25% over the next 18 months [1] Company Overview - Stereotaxis is focused on innovating within the robotic interventional cardiology space, which is gaining attention amidst the broader focus on generative AI [1] - The market perception of Stereotaxis is currently undervalued, presenting a potential investment opportunity [1] Financial Outlook - The anticipated growth in recurring revenue indicates a positive shift in the company's financial trajectory, suggesting strong future performance [1]
First Clinical Results from MAGiC Catheter Study Published in the Journal of Interventional Cardiac Electrophysiology
Globenewswire· 2025-07-01 13:00
Core Insights - Stereotaxis has published initial clinical results of the MAGiC catheter in a peer-reviewed journal, demonstrating its efficacy and safety for minimally invasive endovascular interventions [1][2]. Company Overview - Stereotaxis is a pioneer in surgical robotics for minimally invasive endovascular interventions, with a mission to develop robotic systems and solutions that enhance patient care and operating room efficiency [6]. Clinical Study Details - The study involved a prospective multi-center, single-arm design, treating 67 patients with various arrhythmias, including atrial fibrillation and ventricular tachycardia, with ongoing enrollment expected to reach around 100 patients [2][3]. - The acute efficacy of the MAGiC catheter was reported at 94%, with an average procedure time of 83 minutes and a procedure-related adverse event rate of 1.5% [3]. Product Features - The MAGiC catheter is designed for cardiac ablation procedures, enhancing treatment precision and control while maintaining safety through its soft flexible design [4]. - The catheter has shown improved stability, not requiring sheaths for support, and maintaining steady temperatures during ablation, which benefits patients with compromised cardiac and renal function [3][4]. Market Presence - Stereotaxis' robotic technologies have been utilized in over 100 leading hospitals globally, treating more than 150,000 patients [4].
Stereotaxis(STXS) - 2025 Q1 - Quarterly Report
2025-05-13 20:00
Part I: Financial Information [Item 1. Consolidated Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20(unaudited)) Unaudited Q1 2025 consolidated financial statements show increased revenue, a larger net loss, reduced cash and equity, and improved operating cash flow [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets slightly decreased, total liabilities increased, and total stockholders' equity significantly declined Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $10,601 | $12,217 | ($1,616) | | Inventories, net | $9,812 | $8,331 | $1,481 | | Total assets | $45,705 | $46,724 | ($1,019) | | Accounts payable | $6,544 | $5,668 | $876 | | Deferred revenue (current) | $8,163 | $6,804 | $1,359 | | Total liabilities | $37,529 | $35,292 | $2,237 | | Total stockholders' equity | $2,880 | $6,080 | ($3,200) | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2025 operations show increased revenue driven by disposables, but higher costs and expenses resulted in a widened operating and net loss Consolidated Statement of Operations Summary (in thousands) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $7,472 | $6,880 | +8.6% | | Gross Margin | $4,064 | $3,966 | +2.5% | | Total Operating Expenses | $9,993 | $8,712 | +14.7% | | Operating Loss | ($5,929) | ($4,746) | +24.9% | | Net Loss | ($5,823) | ($4,507) | +29.2% | | Net Loss per Share (Basic & Diluted) | ($0.07) | ($0.06) | - | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 cash flows show improved operating cash usage due to working capital, no investing activities, minimal financing, and an overall decrease in cash balances Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,779) | ($2,346) | | Net cash provided by (used in) investing activities | $0 | $0 | | Net cash provided by financing activities | $32 | $30 | | **Net decrease in cash** | **($1,747)** | **($2,316)** | | Cash at end of period | $10,689 | $18,246 | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) The notes detail business operations, the APT acquisition, significant accounting policies, and key risks, highlighting the company's substantial accumulated deficit - The company designs, manufactures, and markets robotic systems (Robotic Magnetic Navigation) for endovascular interventions, primarily focusing on cardiac ablation procedures for arrhythmias[24](index=24&type=chunk)[25](index=25&type=chunk) - On July 31, 2024, the company acquired Access Point Technologies EP, Inc. (APT) to gain in-house catheter development and manufacturing capabilities, involving upfront stock and contingent payments up to **$24.0 million** based on milestones[35](index=35&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - The company obtained CE marking for its MAGiC catheter in Europe in Q1 2025 and is pursuing approvals in the U.S. and other regions, while the GenesisX RMN System also has CE Mark and awaits FDA clearance[38](index=38&type=chunk)[151](index=151&type=chunk) - The company faces risks from new tariffs on imports from Mexico, Canada, and China, which could increase costs, alongside ongoing supply chain disruptions, inflation, and logistics delays[42](index=42&type=chunk)[44](index=44&type=chunk)[47](index=47&type=chunk) - As of March 31, 2025, the company has an accumulated deficit of approximately **$567.5 million**, with management believing existing cash is sufficient for the next twelve months but acknowledging the potential need for additional financing[52](index=52&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 revenue growth driven by acquisition, declining gross margin, increased operating expenses leading to higher net loss, and liquidity amidst external risks [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Q1 2025 results show revenue growth from disposables offsetting systems decline, a decrease in gross margin percentage, and a significant increase in total operating expenses Revenue and Gross Margin Comparison (in millions) | Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Systems Revenue | $2.0 | $2.6 | -23.1% | | Disposables, Service & Accessories Revenue | $5.5 | $4.3 | +29.0% | | **Total Revenue** | **$7.5** | **$6.9** | **+9.0%** | | **Gross Margin** | **$4.1 (54%)** | **$4.0 (58%)** | **+2.5%** | Operating Expense Comparison (in millions) | Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $2.3 | $2.2 | +5.0% | | Sales & Marketing | $3.1 | $3.0 | +5.0% | | General & Administrative | $4.5 | $3.5 | +30.0% | | **Total Operating Expenses** | **$9.9** | **$8.7** | **+14.7%** | [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company maintains **$10.7 million** in cash and **$1.7 million** in working capital with no debt, believing current liquidity is sufficient for the next year despite historical losses Liquidity Position (in millions) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents (incl. restricted) | $10.7 | $12.4 | | Working Capital | $1.7 | $4.8 | - Net cash used in operating activities decreased to **$1.8 million** in Q1 2025 from **$2.3 million** in Q1 2024, driven by changes in working capital[190](index=190&type=chunk) - The company has no debt as of March 31, 2025[193](index=193&type=chunk) [Critical Accounting Policies and Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section details critical accounting policies requiring significant judgment, primarily focusing on revenue recognition for multi-element contracts and stock-based compensation valuation - Revenue from contracts with multiple performance obligations is allocated based on relative standalone selling prices, which may be estimated if not directly observable[171](index=171&type=chunk) - Stock-based compensation expense is determined using valuation models (Black-Scholes for time-based, Monte Carlo for market-based awards) and is amortized over the vesting period[180](index=180&type=chunk)[181](index=181&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, with no material changes to internal controls, while integrating controls of the acquired business - The CEO and CFO concluded that disclosure controls and procedures were effective as of the end of the quarter[196](index=196&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[197](index=197&type=chunk) - The company is currently reviewing and integrating the internal control structure of the acquired business, Access Point Technologies EP, Inc[198](index=198&type=chunk) Part II: Other Information [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings, noting a contested minor vendor dispute regarding a **$0.6 million** UCC financing statement - The company states there are no material legal proceedings[200](index=200&type=chunk) - A vendor filed a UCC financing statement on inventory for approximately **$0.6 million**, which the company is fully contesting[130](index=130&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section formally states 'None,' indicating no new or materially changed risk factors are reported here compared to the prior annual filing - The report formally states 'None' for this item, meaning no new risk factors are disclosed in this section[201](index=201&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities[202](index=202&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, CEO and CFO certifications, and XBRL data files - The filing includes certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[209](index=209&type=chunk) - Corporate governance documents and Inline XBRL files are included as exhibits[206](index=206&type=chunk)[209](index=209&type=chunk)