Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $13.7 million for Q3 2025, compared to a net loss of $13.6 million in Q3 2024 [31] - Revenue for Q3 2025 was $3.4 million, an increase from $3.0 million in the comparable period [31] - Non-GAAP gross loss for the reported period was $0.3 million, compared to a gross loss of $0.2 million in the comparable period, representing a gross loss margin of approximately 8% [32] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for Q3 2025 was $3.1 million, with a gross profit of $0.1 million, compared to revenue of $2.6 million and a gross profit of $0.3 million in the comparable period [32] - Revenue from the sale and deployment of imaging systems and OEM services amounted to $175,000 for the reported period, with a gross loss of $1.7 million [35] - Revenue from AI solutions for the reported period was $0.1 million, with a gross loss of $1.9 million [35] Market Data and Key Metrics Changes - The company is expanding its presence in Europe with new agreements in the Czech Republic and France, indicating rising demand for its imaging ecosystem [7][15] - The company aims to deploy 100 systems worldwide by the end of 2025, with several systems pending regulatory approval [7] Company Strategy and Development Direction - The company is focused on building a comprehensive medical imaging portfolio, reinforcing its position in the medical AI sector, and deepening its foothold in the U.S. healthcare system [4][5] - The acquisition of VasoHealthcare IT is intended to enhance customer service and expand the company's operational capabilities [10][22] - The company is preparing to launch the next-generation Nanox.ARC X system, which is designed to meet diverse clinical needs and expand the addressable market [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over $35 million in revenues for 2026, driven by strategic partnerships and the acquisition of VasoHealthcare IT [5][39] - The company anticipates that the AI business segment will achieve EBITDA break-even on a quarterly basis in 2026, while the overall company aims for break-even in 2027 [30][62] Other Important Information - The company has a strong presence planned at the RSNA annual meeting, where it will provide insights into its commercial progress and future strategy [13][21] - The company is actively engaged in clinical trials to support the use of its solutions in lung cancer detection and management [18][20] Q&A Session Summary Question: How many systems were in the field and performing scans that resulted in your revenue of $175,000? - The CEO mentioned that a few dozen systems were deployed, with some pending installation and regulatory approvals [44] Question: What types of agreements should we be thinking about in terms of those being lease versus capital sales? - The CFO indicated that the majority of agreements are expected to be MSES, with some CapEx sales anticipated [48] Question: Could you talk about how OpEx could look over the next four to six quarters? - Management indicated that sales and marketing expenses will increase due to deployment efforts, while R&D expenses will be more controlled [56] Question: Could you talk about Vaso and the types of customers they currently have? - The CEO stated that Vaso's customers are primarily medical-related, serving hospitals and imaging centers, presenting cross-selling opportunities [58] Question: Could you reiterate the break-even expectations for the AI business and ARC division? - Management reiterated that the AI business is expected to reach quarterly break-even in 2026, while the ARC division aims for break-even in 2027 [60][62]

Core Insights - Nanox Imaging Ltd will showcase its Nanox.ARC X multi-source digital tomosynthesis system and AI solutions at the RSNA 2025 Annual Meeting from November 30 to December 4, 2025 [1][2] Product Overview - The Nanox.ARC X system, which received FDA 510(k) clearance in April 2025, enables advanced 3D imaging at lower costs and radiation doses compared to CT scans, applicable for various medical indications [2][4] - Live demonstrations of the Nanox.ARC X will occur every 30 minutes at RSNA booth 3914, along with clinical data presentations supporting digital tomosynthesis [3][6] AI Innovations - Nanox is developing a pulmonary nodule AI solution as part of the Nanox.ARC X, along with two standalone AI innovations for measuring aortic valve calcification and body composition [3][4] - The company aims to leverage AI to enhance routine medical imaging efficiency and improve early detection of chronic conditions [9] Event Details - Presentations at RSNA include a focus on AI and digital tomosynthesis in pulmonary nodule detection and applications in the musculoskeletal system [5][6] - A cocktail event discussing the future of radiology and AI will be hosted by Dr. Lawrence Tanenbaum on December 1, 2025 [6][7] Company Vision - Nanox's vision is to expand its technology's reach beyond hospital settings, providing a comprehensive solution from scan to diagnosis, enhancing health outcomes through early detection and treatment [9]

Business Updates - Nanox submitted a new 510k submission to the FDA to expand the intended use cases for the Nanox.ARC for general use, including chest[13] - Nanox advanced the US deployment program for the Nanox.ARC technology, with systems installed in eight states[14, 18] - Nanox.AI Receives FDA 510K Clearance for HealthCCSng V2.0, upgraded version of the cardiac solution, introduces additional 'zero calcium' categorization of coronary calcium (CAC) and generates an exact calcium score with corresponding CAC detection category output[15] - Nanox is engaged with various OEMs and governments around the world to evaluate and/or develop X-ray tubes, industrial inspection applications, security systems, dental, veterinary and other novel medical devices[21] Commercial Strategy - Nanox employs a hybrid approach combining a usage-based MSaaS model with a CapEx model to help promote adoption[19] - Under the MSaaS model, for U.S. CPT Code 76100, the reimbursement range is $88–$109, with Nanox pricing at $30 for scanning and $20 for reading, resulting in a net to operator of $28–$49 (48%-62%) and $10 (33%) respectively[19] - Outside the U.S., Nanox prices scanning at $14–$17 and reading at $20, totaling $34–$37[19] AI Solutions & Clinical Performance - Corewell Health significantly increased their ability to detect coronary calcification by using Nanox.AI's cardiac solution, identifying nearly 3,721 new patients in 2023 compared to just 268 patients having CAC reported in the previous two years[37, 39] - Early findings in the ADOPT study show that Nanox.AI software improves the detection of spine fractures, an early sign of osteoporosis, outperforming UK National Health Service national average[41, 43] - Clinical Trial 08.2024: Preliminary Results for Chest DTS, Radiographically occult lesion (seen on DTS only. Not seen on CXR): 19/26[66] Nanox.ARC X - Nanox.ARC X is a future 3D digital multi-source tomosynthesis system with a smaller footprint[86, 88]

Core Insights - Nanox Imaging Ltd has received FDA 510(k) clearance for its new multi-source digital tomosynthesis system, Nanox.ARC X, in under 30 days from submission, allowing for tomographic imaging for various medical indications [1][7] - The Nanox.ARC X system features advanced technology that enhances imaging capabilities, reduces physical footprint, and allows for easy installation, making it suitable for diverse healthcare environments [2][3] Product Features - The Nanox.ARC X utilizes proprietary digital technology and cold cathode tomosynthesis to provide a comprehensive 3D view of the body, improving visualization and reducing structural overlap seen in traditional 2D X-rays [2][7] - The system is designed for minimal infrastructure requirements, operates on standard power, and has a cables-free design for improved safety and maintenance [3] Strategic Vision - The company aims to expand access to essential medical imaging technology, enhancing early detection and treatment capabilities through a seamless end-to-end solution that integrates AI and cloud-based data management [5][6] - Nanox plans to introduce the Nanox.ARC X later this year, expanding its product portfolio to cater to various customer needs and use cases [4]

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $14.1 million for Q4 2024, compared to a net loss of $10.2 million in Q4 2023, primarily due to an increase in gross loss and other expenses [53][54] - Revenue for the reported period was $3.0 million, with a gross loss of $2.9 million, compared to revenue of $2.4 million and a gross loss of $1.7 million in the comparable period [55] - Non-GAAP gross loss for the reported period was $0.3 million, compared to a gross profit of $0.9 million in the comparable period, indicating a significant decline in gross profit margin [55] Business Line Data and Key Metrics Changes - Revenue from teleradiology services was $2.8 million with a gross profit of $0.6 million, up from $2.3 million and a gross profit of $0.3 million in the comparable period, reflecting improved gross profit margins [55] - Revenue from the sale and deployment of imaging systems amounted to $136,000, a significant increase from $17,000 in the comparable period, driven by sales of 2D systems and OEM projects [56] - Revenue from AI solutions was $83,000, consistent with the previous period, but with a slight decrease in non-GAAP gross profit [56] Market Data and Key Metrics Changes - The company has expanded its commercial coverage in the U.S. to seven states, with a focus on small and medium-sized medical imaging centers and multi-specialty medical centers [19][77] - The company is actively pursuing entry into the European market following the CE mark certification, with new distribution agreements signed in Romania and Greece [31][92] Company Strategy and Development Direction - The primary focus remains on accelerating the deployment of the Nanox. ARC and AI solutions in the U.S. while expanding into the European market [17][24] - The company aims to enhance its market presence through strategic partnerships and channel agreements, particularly in the durable medical equipment space [22][23] - The company is committed to generating clinical validation and raising awareness of its technology among healthcare professionals [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2025 being a strong year for AI solutions and emphasized the importance of regulatory milestones and market education [103][118] - The company is focused on building a robust pipeline and converting installations into revenue-generating scans [89][118] - Management highlighted the positive feedback from customers and the potential for the Nanox. ARC to transform the medical imaging market [123] Other Important Information - The company ended the quarter with approximately $83.5 million in cash and cash equivalents, indicating a solid financial position to support ongoing operations [58] - The company issued approximately 5 million ordinary shares, raising gross proceeds of $38.8 million under its sales agreement [60] Q&A Session Summary Question: Can you elaborate on the DME partners in the U.S.? - The company will offer both CapEx direct sales and traditional models through DME partners [66][67] Question: How many systems were deployed in the U.S. during the quarter? - Exact numbers were not disclosed, but the company indicated that installations are in various stages and that the pipeline remains robust [85][86] Question: What is the pricing strategy for ARC in Europe? - The company expects most sales in Europe to be CapEx sales, with installations likely starting in the next two quarters [90][92] Question: What is the outlook for 2025? - Management refrained from providing specific guidance but indicated that 2025 is expected to be a meaningful year for growth, particularly in AI and imaging solutions [96][104] Question: Can you discuss the capital raised and its deployment? - Approximately $38 million was raised, which will be used to accelerate commercialization efforts for both imaging and AI products [116][118]