Core Viewpoint - The FDA has granted 510(k) clearance for TAP2D, a new cloud-enabled image enhancement capability for Nanox's digital tomosynthesis systems, marking a significant step in the company's regulatory strategy to establish its systems as primary diagnostic solutions [1][4]. Group 1: Product Development and Features - The TAP2D capability provides radiologists with an additional 2D view generated from digital tomosynthesis scans, enhancing evaluation while maintaining workflow efficiency [2]. - Nanox.ARC and Nanox.ARC X systems utilize advanced 3D imaging technology, offering enhanced diagnostic capabilities at a lower cost and radiation dose compared to traditional systems [3]. - Software upgrades and new capabilities like TAP2D can be added remotely to the Nanox.ARC systems following regulatory clearances [3]. Group 2: Company Vision and Strategy - The company aims to remove the adjunctive use of its systems in the U.S., allowing Nanox.ARC to function as a standalone primary imaging solution, similar to its status in Europe under CE Mark certification [4]. - Nanox is focused on delivering innovations that improve patient care and expand access to high-quality imaging globally [4]. - The company's vision includes expanding medical imaging access beyond traditional hospital settings by providing a seamless solution from scan to interpretation [6]. Group 3: Ecosystem and Services - The Nanox ecosystem includes various components such as Nanox.ARC, Nanox.AI for AI-driven analytics, Nanox.CLOUD for data management, and Nanox Health IT for healthcare IT solutions [7]. - By integrating imaging technology, AI, cloud infrastructure, and clinical expertise, Nanox seeks to lower barriers to adoption and advance preventive care worldwide [8].

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 [32] - Revenue for Q3 2025 was $3.4 million, an increase from $3.0 million in the comparable period [32] - 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% [33] 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 [34] - Revenue from the sale and deployment of imaging systems and OEM services amounted to $175,000 for Q3 2025, with a gross loss of $1.7 million [35] - Revenue from AI solutions for Q3 2025 was $0.1 million, with a gross loss of $1.9 million, compared to revenue of $0.4 million and a gross loss of $1.6 million in the comparable period [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][14] - 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, increasing revenues, and accelerating its path to profitability [4] - The strategy includes reinforcing its position in the medical AI sector and deepening its foothold in the U.S. healthcare system [4] - The acquisition of VasoHealthcare IT is intended to enhance the company's AI capabilities and customer service [10][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over $35 million in revenues for 2026, driven by current business trajectory and new partnerships [5][30] - The company anticipates that the AI business segment will achieve EBITDA break-even on a quarterly basis in 2026, while the overall company expects to reach EBITDA break-even in 2027 [31] Other Important Information - The company is preparing to launch its next-generation platform, the Nano-X ARC X system, which is designed to meet diverse customer needs and expand the addressable market [8] - The company has entered into a multi-year volume supply agreement with Fabrinet to support scalable manufacturing of Nano-X ARC systems [30] Q&A Session Summary Question: How many systems were in the field and performing scans that resulted in your revenue of $175,000? - The revenue was generated from a combination of scans and OEM services, with a few dozen systems actively scanning [43][45] Question: What types of agreements should we be thinking about in terms of those being lease versus capital sales? - The majority of agreements are expected to be MSES, with some CapEx sales anticipated [47][48] Question: Could you talk about how OpEx could look over the next four to six quarters? - Investment in deployment efforts will increase, while R&D expenses are expected to be more controlled as focus shifts to commercialization [56] Question: Could you talk about Vaso and the types of customers they currently have? - Vaso's customers are primarily medical-related, serving hospitals and imaging centers, presenting cross-selling opportunities for Nano-X [58] Question: Could you reiterate the break-even targets for the AI business and ARC division? - The AI business is expected to reach quarterly break-even in 2026, while the ARC division aims for break-even in 2027 [61][63] Question: How should we think about the cadence of the $35 million revenue target for 2026? - Revenue is expected to start slowly in Q1 and ramp up over the quarters, achieving the target by Q4 [70]