Financial Data and Key Metrics Changes - Revenue for Q2 2025 totaled $8.8 million, a growth of 95% from $4.5 million in Q2 2024 and an 18% sequential growth compared to $7.5 million in Q1 2025 [15][16] - System revenue for Q2 was $3 million, while recurring revenue was $5.8 million, compared to $200,000 and $4.3 million in the prior year's second quarter [15][16] - Gross margin for Q2 2025 was 52% of revenue, with recurring revenue gross margin at 68% and system gross margin at 22% [17] - Operating loss and net loss for Q2 2025 were $4 million and $3.8 million, respectively, compared to $6 million and $5.8 million in the previous year [18] Business Line Data and Key Metrics Changes - The Genesis X system was successfully transferred to manufacturing, with the first commercial system expected to be installed in Europe [6][14] - The MAGIC ablation catheter contributed approximately $200,000 in revenue from initial European customers during Q2 2025, with usage at about 30% of EU accounts [7][10] - The FDA clearance of the MAGIC Sweep high-density mapping catheter was a significant milestone, expected to enhance robotic utilization and disposable revenue per procedure [9][10] Market Data and Key Metrics Changes - The company anticipates a gradual increase in the utilization of MAGIC catheters across various procedures, with a broad label for ablation in all four chambers of the heart [35] - The company expects to launch new technologies with a focus on accelerating growth while improving margins and achieving profitability [20] Company Strategy and Development Direction - The innovation strategy is based on four pillars: making robots widely available, building an ecosystem of catheters, developing interventional devices, and establishing a digital backbone [4] - The transition from a single-application robot to a platform for endovascular surgery is expected to significantly increase the total addressable market [12] - The company plans to gradually shift to a model of having one clinical representative per hospital to enhance support and utilization [28][30] Management's Comments on Operating Environment and Future Outlook - Management reiterated revenue guidance of double-digit growth for the full year 2025, with expectations of system revenue fluctuating between $2 million to $3 million per quarter [20] - The company is preparing for a full launch of Genesis X and expects to see significant growth in capital sales next year [30] - Management expressed confidence in achieving regulatory approvals and the collaborative nature of interactions with the FDA [43] Other Important Information - The company had cash and cash equivalents of $7 million as of June 30, 2025, with no debt, and announced a registered direct financing for the sale of $12.5 million in shares [18][19] - Following the financing, the company expects to have $18.8 million in cash, which will support the acceleration of its innovation strategy [19] Q&A Session Summary Question: Discussion on financing and commercial strategy - Management indicated plans to build out the sales force to support new product launches, with a current commercial team of about 40 people [26][28] Question: Progress of MAGIC RF catheter in Europe - Approximately 30% of European accounts have started using MAGIC, with usage across a broad range of procedures [35] Question: FDA interactions regarding MAGIC - Management described ongoing collaborative interactions with the FDA, with expectations for approval in the second half of the year [43]

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]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 totaled $6.3 million, a 39% year-over-year increase compared to $4.6 million in Q4 2023 [37] - Full year revenue for 2024 was $26.9 million compared to $26.8 million in 2023 [38] - Operating loss for Q4 2024 was $7.6 million, compared to $5.3 million in Q4 2023 [41] - Adjusted operating loss for the full year 2024 was $12.8 million, compared to $11.3 million in the prior year [42] Business Line Data and Key Metrics Changes - System revenue for Q4 2024 was $1.4 million, compared to $0.1 million in Q4 2023 [37] - Recurring revenue for Q4 2024 was $4.9 million, reflecting a full quarter's contribution from the acquisition of APT, compared to $4.5 million in Q4 2023 [37] - Full year system revenue was $8.6 million, compared to $8.7 million in the prior year [38] Market Data and Key Metrics Changes - The company expects to achieve approximately $1 million of MAGIC revenue per quarter in Europe by the end of 2024 [20] - The company anticipates a few GenesisX system sales this year, scaling to double-digit numbers next year [18] Company Strategy and Development Direction - The company aims to improve endovascular surgery with robotics, focusing on four primary pillars: making the robot widely available, building an ecosystem of catheters, developing interventional devices, and establishing connectivity and AI capabilities [11][12] - A strategic acquisition of APT has enhanced the company's catheter development and manufacturing capabilities [13] - The company is focused on expanding its addressable market by introducing a family of interventional guidewires and catheters [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regulatory milestones and early commercial efforts setting the stage for substantial growth in 2026 [35] - The company expects to keep adjusted operating expenses flat over the next few quarters while investing in commercial capabilities funded by profits from new product launches [47] - Management noted that the existing balance sheet allows the company to reach key milestones and profitably grow [48] Other Important Information - The company has a system backlog of $15.2 million as it enters 2025 [38] - The gross margin for recurring revenue was 70%, while system gross margin was 20% [39] Q&A Session Summary Question: Can you provide more color around MAGIC in the US market? - Management indicated that patient enrollment in Europe is ongoing and that the FDA is conducting a detailed review of the PMA submission, with no definitive number of patients needed for approval [50][52] Question: How will MAGIC Sweep fit into the broader ecosystem? - Management explained that MAGIC Sweep is a high-density mapping catheter that will enhance robotic procedures by providing safety and precision, which has been a long-standing request from physicians [57][62] Question: Can you clarify the system revenue guidance for 2025? - Management stated that the guidance reflects a conservative approach due to the volatility in revenue recognition and ongoing construction timelines for system sales [68][70] Question: What is the expected timing for GenesisX commercial approval in the US? - Management expects to respond to FDA questions soon and anticipates approval before compatible catheters are available [75][76] Question: What is the revenue expectation for the EMAGIN vascular guidance catheter? - Management noted that there are no significant revenue expectations for EMAGIN in the guidance due to uncertainty around regulatory approval [80]