ST. LOUIS, May 22, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that Hospital Santa Maria della Pietà, in Nola in the Metropolitan City of Naples, has established the first robotic cardiac heart program in Southern Italy. Patients suffering from heart rhythm disorders are now being successfully treated with robotic ablation procedures using this advanced technology, and Hospital Santa Maria della Pietà is ...

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, 2024 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. DELAWARE 94-3120386 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Iden ...

Financial Data and Key Metrics Changes - Revenue for Q1 2024 totaled $6.9 million, a growth of 5% from $6.5 million in Q1 2023 [17] - Operating loss for Q1 2024 was $4.7 million, compared to $5.6 million in the previous year [18] - Adjusted operating loss for the quarter was $2.2 million, down from $3 million in the prior year [18] - Gross margin for Q1 2024 was 58% of revenue, with recurring revenue gross margin at 76% and system gross margin at 27% [37] Business Line Data and Key Metrics Changes - System revenue for Q1 2024 was $2.6 million, while recurring revenue was $4.3 million, compared to $1.8 million and $4.7 million in the prior year [17][61] - The company experienced a backlog increase to $16 million due to two additional orders for Genesis robots from existing customers in Europe [23] Market Data and Key Metrics Changes - Recurring revenue remains impacted by Johnson & Johnson catheter shortages, affecting procedure volumes [24] - In Europe, the company received a completeness check shortly after submitting its CE application, indicating progress in regulatory processes [25] Company Strategy and Development Direction - The company aims to maintain sales momentum and financial strength while preparing for a breakout through a comprehensive innovation strategy [4] - The acquisition of APT is seen as strategic, enhancing in-house capabilities for catheter development and manufacturing [14][16] - The company plans to demonstrate the new robot's real-world use and enhance compatibility with various X-ray systems in 2024, with a full launch expected in 2025 [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing regulatory processes and the potential for significant growth in 2025 and beyond [13][39] - The company anticipates modest double-digit revenue growth for the full year, driven by system backlog and new orders [39] Other Important Information - The company has a healthy active pipeline of customers across key geographies, despite challenges from the existing product ecosystem [5] - The digital surgery platform, Sync, is in limited release, with additional features being incorporated [12] Q&A Session Summary Question: Synergies from APT acquisition - Management indicated that the acquisition is not expected to impact current catheter developments but will focus on future innovations [42] Question: PMA conversion impact - The conversion from PMA supplement to traditional PMA is not expected to significantly alter timelines, with ongoing collaborative discussions with the FDA [43] Question: Capital equipment environment - Management noted ongoing challenges in the macro environment but highlighted interest in their technology and innovation strategy [44] Question: APT's catheter integration - APT's catheters are compatible with existing mapping systems, and there are plans to develop robotically steered versions [90] Question: Pipeline development - The company is pleased with the progress of its robot development and anticipates regulatory submissions in the near future [91]

[Management Commentary & Strategic Update](index=1&type=section&id=Management%20Commentary%20%26%20Strategic%20Update) Stereotaxis reported Q1 2024 progress with revenue growth, increased system orders, and innovation advancements, expecting profitability - Received **two Genesis system orders**, increasing the system backlog[3](index=3&type=chunk) - Acquired APT to gain valuable commercial synergies and strategic strength[3](index=3&type=chunk) - Regulatory submissions for the MAGiC catheter were completed in Europe and the United States during Q1[3](index=3&type=chunk) - A new, smaller robot is progressing with regulatory submissions expected in Q2 2024, anticipating European clearance mid-year and FDA clearance in H2[3](index=3&type=chunk) - The company expects to launch a new guidewire, a product ecosystem in China, and a digital surgery solution later in 2024[3](index=3&type=chunk) [Q1 2024 Financial Performance](index=1&type=section&id=Q1%202024%20Financial%20Performance) Stereotaxis reported Q1 2024 total revenue of **$6.9 million** (+**5%**), a **58% gross margin**, and narrowed operating and net losses [Revenue Analysis](index=1&type=section&id=Revenue%20Analysis) Q1 2024 revenue increased by **5%** year-over-year, primarily driven by a **44.4%** rise in system revenue Q1 2024 Revenue vs. Q1 2023 (in millions) | Revenue Category | Q1 2024 | Q1 2023 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | System Revenue | $2.6 | $1.8 | +$0.8 | +44.4% | | Recurring Revenue | $4.3 | $4.7 | -$0.4 | -8.5% | | **Total Revenue** | **$6.9** | **$6.5** | **+$0.4** | **+5.0%** | [Profitability Analysis](index=1&type=section&id=Profitability%20Analysis) Stereotaxis achieved a **58% total gross margin** in Q1 2024, with significant reductions in operating and net losses Q1 2024 Gross Margin | Margin Category | Q1 2024 | | :--- | :--- | | Total Gross Margin | 58% | | Recurring Revenue Gross Margin | 76% | | System Gross Margin | 27% | Q1 2024 Loss Summary vs. Q1 2023 (in millions) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Operating Loss | ($4.7) | ($5.6) | | Net Loss | ($4.5) | ($5.3) | | Adjusted Operating Loss* | ($2.2) | ($3.0) | | Adjusted Net Loss* | ($1.9) | ($2.7) | - Adjusted operating expenses, excluding non-cash stock compensation, decreased to **$6.1 million** from **$6.9 million** year-over-year[5](index=5&type=chunk) [Financial Position and Outlook](index=2&type=section&id=Financial%20Position%20and%20Outlook) Stereotaxis maintains a strong financial position with **$18.2 million** cash and no debt, expecting profitability without additional financing [Balance Sheet and Liquidity](index=2&type=section&id=Balance%20Sheet%20and%20Liquidity) As of March 31, 2024, Stereotaxis held **$18.2 million** cash and no debt, with **($2.3) million** negative free cash flow - As of March 31, 2024, the company held **$18.2 million** in cash and cash equivalents with no debt[7](index=7&type=chunk) - Negative free cash flow for Q1 was **($2.3) million**[6](index=6&type=chunk) [Full-Year 2024 Outlook](index=2&type=section&id=Full-Year%202024%20Outlook) Stereotaxis reaffirms **double-digit revenue growth** for FY2024 and anticipates reaching profitability without additional financing - The company maintains its expectation of **double-digit revenue growth** for the full year 2024, excluding APT acquisition contributions[8](index=8&type=chunk) - Stereotaxis anticipates a lower rate of cash utilization and believes its balance sheet is sufficient to reach profitability without additional financing[9](index=9&type=chunk) [Consolidated Financial Statements](index=3&type=section&id=Consolidated%20Financial%20Statements) This section presents Stereotaxis, Inc.'s unaudited consolidated Q1 2024 financial statements, including Statements of Operations and Balance Sheets [Statements of Operations (Unaudited)](index=3&type=section&id=STEREOTAXIS%2C%20INC.%20STATEMENTS%20OF%20OPERATIONS) The unaudited Statements of Operations detail Stereotaxis's revenue, gross margin, operating expenses, and net loss for Q1 2024 and 2023 Three Months Ended March 31, (in thousands) | Description | 2024 | 2023 | | :--- | :--- | :--- | | Total revenue | $6,880 | $6,548 | | Gross margin | $3,966 | $3,876 | | Total operating expenses | $8,712 | $9,495 | | Operating loss | ($4,746) | ($5,619) | | Net loss | ($4,507) | ($5,347) | | Net loss attributable to common stockholders | ($4,838) | ($5,678) | | Net loss per share (Basic & Diluted) | ($0.06) | ($0.07) | [Balance Sheets (Unaudited)](index=4&type=section&id=STEREOTAXIS%2C%20INC.%20BALANCE%20SHEETS) The unaudited Balance Sheets present Stereotaxis's financial position, including cash, assets, liabilities, and equity as of March 31, 2024 Balance Sheet Highlights (in thousands) | Description | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $17,633 | $19,818 | | Total current assets | $31,208 | $33,267 | | **Total assets** | **$39,452** | **$41,909** | | Total current liabilities | $12,852 | $13,247 | | **Total liabilities** | **$19,421** | **$19,989** | | **Total stockholders' equity** | **$14,567** | **$16,343** |

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (MARK ONE) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023 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 Jurisdiction o ...

Financial Data and Key Metrics Changes - Revenue for the full year 2023 totaled $26.8 million, a decrease from $28.1 million in 2022 [36] - Gross margin for the fourth quarter and full year 2023 were approximately 60% and 56% of revenue, with full year gross margins of 79% on recurring revenue and 8% for system revenue [15][36] - Operating loss for the fourth quarter of 2023 was $5.3 million compared to $4.5 million in the previous year [37] - Adjusted operating loss for the full year 2023 was $11.3 million compared to $8.3 million in the prior year [133] Business Line Data and Key Metrics Changes - System revenue for the full year was $8.7 million compared to $6.8 million in the prior year, reflecting increased system deliveries and installations [132] - Recurring revenue for the full year was $18 million compared to $21.3 million, impacted by the absence of J&J royalties and periodic catheter shortages [132][130] Market Data and Key Metrics Changes - The company began 2024 with a backlog of $14.7 million from orders that were received but not yet shipped or installed [12] - The company expects recurring revenue to remain stable until the MAGiC catheter can contribute to disposable revenue growth [17] Company Strategy and Development Direction - The company is focused on addressing structural weaknesses in its product ecosystem and has developed a proprietary ablation catheter, the MAGiC catheter, to enhance its offerings [6][27] - The company plans to leverage its collaboration with MicroPort to establish a China-specific EP product ecosystem and expects regulatory approval for the Genesis robot in China midyear [127] - The company aims for a full launch of its digital surgery platform, Sync, to enhance operating room connectivity [10][32] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that progress has taken longer than expected but sees key regulatory submissions and technology developments aligning this year [11] - The company expects overall double-digit revenue growth for 2024 driven by system revenue growth from its backlog and new orders [17] - Management expressed confidence in the regulatory submissions for the MAGiC catheter and anticipates a collaborative review process with the FDA [64][90] Other Important Information - The company has a strong balance sheet with approximately $20 million in cash and no debt, allowing it to advance its product ecosystem to market [13][16] - The company has invested in significant inventory and has direct commercial teams globally to launch new products as they become available [105] Q&A Session All Questions and Answers Question: What is the outlook for MAGiC catheter submissions? - The EU submission is a resubmission with additional clinical data, and the company expects a more efficient review process [19][110] Question: How quickly can the company ramp up manufacturing for MAGiC? - The company has demonstrated capability to scale manufacturing and produced nearly 1,000 units during regulatory testing [73] Question: What is the plan for the sales force with the MAGiC launch? - The existing sales teams will be utilized for the MAGiC launch, with incremental hiring planned as revenue grows [82][150] Question: What is the expected revenue for the first quarter of 2024? - The company expects revenue of approximately $7 million for the first quarter of 2024 [134]

Exhibit 99.1 Stereotaxis Reports 2023 Full Year Financial Results ST. LOUIS, MO, Mar. 4, 2024 (GLOBE NEWSWIRE) – Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the fourth quarter and full year ended December 31, 2023. "We enter 2024 having made significant progress in realizing our strategic transformation. This is the year in which we expect all the key puzzle pieces to come together, setting ...

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 SEPTEMBER 30, 2023 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 Juris ...

Financial Data and Key Metrics Changes - Revenue for Q3 2023 totaled $7.8 million, up 2% from $7.7 million in the prior year [24] - Operating loss and net loss for Q3 were $5.6 million and $5.4 million, compared to $5.1 million and $4.9 million in the previous year [5] - Gross margin for Q3 2023 was 52% of revenue, with recurring revenue gross margin at 80% and system gross margin at 18% [25] - Negative free cash flow for Q3 was $1 million, with cash and cash equivalents at $23 million and no debt [6] Business Line Data and Key Metrics Changes - System revenue of $3.5 million reflects revenue recognition on the delivery of two Genesis systems [24] - Recurring revenue for the quarter was $4.3 million, predominantly impacted by the absence of J&J royalty and residual pressure on procedures [24] - The company recognized revenue from the adoption of Genesis by both Greenfield new accounts and existing upgrade customers [13] Market Data and Key Metrics Changes - The company has seen strengths in capital activity out of Europe, benefiting from enhanced commercial leadership and greater market appreciation for upcoming innovations [14] - In contrast, several projects in China have been delayed due to a countrywide anti-corruption drive, freezing hospital capital purchasing activity [15] Company Strategy and Development Direction - The company is actively driving a broad-based comprehensive innovation strategy forward, including the development of MAGiC and a smaller self-shielding robot [2][16] - The innovation strategy aims to expand the clinical use of the robotic platform beyond electrophysiology to various endovascular procedures [22] - The company plans to submit a PMA supplement for MAGiC using existing data, aiming to accelerate access for US physicians and patients [18] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the ability to advance the innovation strategy to market and reach profitability without additional financings [8] - The company acknowledges the importance of maintaining financial strength in the current macro environment while delivering commercial results [8] - Management expressed optimism about the impact of the innovation strategy and the potential for growth beyond the current backlog [1][24] Other Important Information - The company has a cash balance expectation of $22 million by year-end with no debt [6] - The company is working on regulatory submissions for MAGiC and expects to receive responses from European health authorities soon [17] Q&A Session Questions and Answers Question: What is being done differently in Europe to drive increased activity? - The new leadership in Europe has implemented a disciplined process and is leveraging product ecosystem aspects, including the anticipation of MAGiC approval [28] Question: Can you clarify the expectations for revenue growth in 2023? - Management indicated that while they are confident in growth in the coming quarters, they are not certain about achieving annualized double-digit revenue growth based on fourth-quarter results [46] Question: What is the timeline for collecting data in Europe for MAGiC? - The trial is structured to capture acute clinical data from 20 patients, with the potential to enroll up to 30 patients at each of the three sites [67] Question: How does the company view the replacement cycle for its systems? - A significant majority of the installed base is over 10 years old, indicating a ripe opportunity for replacement, although the replacement cycle is still tied to X-ray system replacements [65][66]

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, 2023 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 ...