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]