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]

Recorded noted regulatory successes with FDA general use clearance and granting of CE Mark in the EU Advanced commercialization globally, signing new customer and channel partner agreements for Nanox.ARC and Nanox AI Management to host conference call and webcast Monday, March 31, 2025 at 8:30 AM ET PETACH TIKVA, Israel, March 31, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (NASDAQ:NNOX) ("Nanox" or the "Company"), an innovative medical imaging technology company, today announced results for the fourth quar ...

Core Insights - The ADOPT study highlights the effectiveness of Nanox.AI's technology in improving fracture detection and reducing healthcare costs [1][2][3] Study Findings - The ADOPT study evaluated HealthVCF across four NHS trusts and identified over 3,450 new patients with vertebral compression fractures, significantly exceeding the national average [2] - AI-enabled Fracture Liaison Services led to a reduction in patient refracture rates by up to 10% and cost savings of up to £50,000 per healthcare organization [3] Technology Development - Nanox AI's HealthOST, an FDA-cleared AI bone solution, enhances fracture measurement precision and identifies low bone mineral density in routine CT scans without additional imaging [4] Upcoming Conferences - Nanox will present findings at major medical conferences, including the British Institute of Radiology AI Congress and the WCO-IOF-ESCEO Congress, showcasing the clinical value of AI in bone health assessment [5] Company Overview - Nanox focuses on preventive healthcare through affordable medical imaging technologies, leveraging AI for improved diagnostics and patient care pathways [8][9]

Core Insights - Nanox Imaging Ltd will report its financial results for the quarter and fiscal year ended December 31, 2024, on March 31, 2025, before market open [1] - The conference call to discuss these results will be hosted by CEO Erez Meltzer and CFO Ran Daniel at 8:30 a.m. ET [1] Company Overview - Nanox is focused on transitioning the world to preventive health care through affordable medical imaging technologies utilizing advanced AI and proprietary digital X-ray sources [3] - The company's vision includes expanding its technology's reach beyond hospital settings, providing a comprehensive solution from scan to diagnosis, and leveraging AI for improved diagnostic accuracy [4] Product Ecosystem - Nanox.ARC is a multi-source digital tomosynthesis system designed to be cost-effective and user-friendly [4] - Nanox.AI LTD offers an AI-based suite of algorithms that enhance routine CT imaging readings to identify early signs of chronic diseases [4] - Nanox.CLOUD is a cloud-based platform for managing data from Nanox devices, providing tools for in-depth imaging analysis [4] - Nanox.MARKETPLACE is a decentralized marketplace that offers remote access to radiology and cardiology experts, along with a comprehensive teleradiology services platform [4]

Core Viewpoint - Nanox Imaging Ltd is advancing its innovative medical imaging technology, particularly the Nanox.ARC system, which has received CE mark certification and FDA clearance, marking significant milestones for its commercialization in Europe and the U.S. [3][4] Group 1: Product and Technology - The Nanox.ARC is a stationary X-ray system that utilizes a proprietary digital X-ray source and advanced tomosynthesis technology, providing a comprehensive three-dimensional view of the body [2] - The system is designed to generate tomographic images from a single sweep, enhancing diagnostic capabilities while reducing patient radiation exposure and radiologist reading time [5][10] Group 2: Clinical Performance and Studies - New data will be presented at the 2025 European Congress of Radiology, highlighting the diagnostic potential of the Nanox.ARC in musculoskeletal imaging and its effectiveness in detecting lung nodules under simulated obesity conditions [5][10] - A clinical study demonstrated that digital tomosynthesis improved the detection of occult fractures and lesions, providing diagnostic value in 17 out of 19 cases compared to standard X-ray and CT [6][10] Group 3: Regulatory Milestones - The receipt of the CE mark and FDA 510(k) clearance signifies a major step in the global commercialization strategy for the Nanox.ARC system, allowing it to be marketed in Europe and the U.S. [3][4] Group 4: Company Vision and Ecosystem - Nanox aims to drive the transition to preventive healthcare by offering a comprehensive suite of affordable medical imaging technologies, leveraging AI for enhanced diagnostics [8] - The Nanox ecosystem includes various components such as Nanox.AI, Nanox.CLOUD, and Nanox.MARKETPLACE, which collectively aim to improve early detection and treatment of diseases [8]

Core Viewpoint - Nanox Imaging Ltd has received CE mark certification for its Nanox.ARC system, marking a significant step in its global expansion efforts, particularly in Europe [3][9]. Group 1: Product Overview - The Nanox.ARC is a stationary X-ray system designed to generate tomographic images from a single sweep, enhancing visualization through advanced tomosynthesis technology [1][2]. - It features a proprietary digital X-ray source that provides a three-dimensional view of the body, reducing the limitations of traditional 2D X-rays [2]. - The system is intended for use in professional healthcare settings and is designed for easy integration into existing clinical workflows [4]. Group 2: Market Impact - The CE mark certification is expected to accelerate the commercial introduction of Nanox.ARC in Europe, where several units are already in various stages of deployment [3][9]. - The company aims to broaden its commercial expansion globally, leveraging existing distributors and pursuing strategic partnerships [3]. Group 3: Clinical Applications - Nanox is conducting clinical trials to demonstrate the system's capabilities in detecting lesions and fractures that conventional radiography may miss [6]. - New clinical data supporting the use of Nanox.ARC will be presented at the European Congress of Radiology (ECR) 2025 [6][9]. Group 4: Vision and Strategy - Nanox's vision includes expanding its technology beyond hospital settings, providing a comprehensive solution from scan to diagnosis, and enhancing early detection and treatment through AI [8]. - The company is focused on driving the transition to preventive healthcare with affordable medical imaging technologies [7].

Core Insights - Nano-X Imaging (NASDAQ: NNOX) is a small innovation-focused biotech company that has gained attention in the biotech industry over the past two years [1]. Company Overview - The company operates within the healthcare sector, which has been experiencing significant developments and changes [1]. Investment Perspective - The company has been identified as a potential investment opportunity due to its focus on innovation in the biotech field [1].

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $13.6 million for Q3 2024, a decrease from a net loss of $21.4 million in Q3 2023, primarily due to a reduction in impairment-related expenses [48] - Revenue for Q3 2024 was $3.0 million, compared to $2.5 million in the same period last year, with a gross loss of $2.8 million on a GAAP basis [49] - Non-GAAP gross loss for the reported period was $0.2 million, compared to a non-GAAP gross profit of $0.9 million in the comparable period, indicating a significant shift in profitability metrics [50] Business Line Data and Key Metrics Changes - Revenue from teleradiology services reached a record $2.6 million in Q3 2024, with a gross profit margin of approximately 15% on a GAAP basis, up from $2.2 million and 11% in Q3 2023 [51][52] - Revenue from AI solutions increased to $0.4 million in Q3 2024 from $0.1 million in the same period last year, attributed to the completion of installation projects [54] - Revenue from imaging systems sales was minimal at $29,000, with a gross loss of $1.5 million, reflecting ongoing challenges in this segment [55] Market Data and Key Metrics Changes - The company has deployed 47 Nanox.ARC units across the U.S., with a focus on small and medium imaging centers, as well as some hospitals and clinics [68] - The company is actively pursuing regulatory approvals in various international markets, including Mexico and Chile, to expand its footprint [21][80] Company Strategy and Development Direction - The strategic growth plan includes doubling the pipeline and expanding sales, service, and support teams in the U.S. to enhance market penetration [8][15] - The company aims to secure CE Mark designation in the EU and is working closely with the FDA for additional clearances, which are expected to significantly expand the total addressable market [24][62] - The focus on innovation and strategic partnerships is expected to drive shareholder value, with recent collaborations with prestigious institutions like Oxford University Hospitals [10][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the transformative potential of Nanox.ARC technology and its ability to make advanced medical imaging accessible and affordable [13][62] - Positive feedback from healthcare providers and ongoing clinical trials are seen as critical to driving broader adoption of the company's solutions [63] - The company is preparing for significant milestones in 2025, including regulatory approvals and product launches, which are anticipated to enhance revenue growth [95] Other Important Information - The company has a cash position of approximately $57.1 million as of September 30, 2024, with a loan of $3.4 million from a bank [59] - The Nanox.AI solution has been recognized in Time's Best Inventions of 2024, highlighting its impact on the healthcare industry [11] Q&A Session Summary Question: How many systems were deployed in the U.S. during the quarter? - The company deployed a total of 47 systems, primarily in small and medium imaging centers, with some in hospitals and clinics [68] Question: How has average utilization trended for ARC? - Average utilization remains around seven scans per day in operating locations [69] Question: Any updates on FDA conversations and ARC-X? - Conversations with the FDA are positive, and the company plans to submit for ARC-X approval early next year [70][71] Question: What are the plans for Europe post-CE Mark? - The company plans to utilize distributors for sales in Europe, with a go-to-market strategy already in place [76][78] Question: What about regulatory efforts in LATAM? - Regulatory approvals in Mexico and Chile are being pursued by distributors, with ongoing communication to facilitate the process [80] Question: When should we expect an inflection point in revenue? - The company anticipates multiple milestones that could serve as inflection points, including regulatory approvals and product launches [94][95]

Financial Performance - The company generated $3.0 million in revenue for Q3 2024, a 20% increase from $2.5 million in Q3 2023[3] - The net loss for Q3 2024 was $13.6 million, a decrease of $7.8 million compared to a net loss of $21.4 million in Q3 2023[6] - Revenue for the nine months ended September 30, 2024, increased to $8,283,000, compared to $7,508,000 for the same period in 2023, representing a growth of 10.3%[36] - The net loss for the nine months ended September 30, 2024, was $(39,455,000), compared to $(50,528,000) for the same period in 2023, showing an improvement of 21.7%[36] - The company reported a basic and diluted loss per share of $(0.68) for the nine months ended September 30, 2024, compared to $(0.90) for the same period in 2023[36] - The company reported a basic and diluted loss per share of $0.43 for the nine months ended September 30, 2024, compared to $0.53 for the same period in 2023[45] Revenue Sources - Revenue from teleradiology services increased to $2.6 million in Q3 2024, up from $2.2 million in Q3 2023[9] Expenses - Gross loss margin for Q3 2024 was 93%, compared to 67% in the comparable period[8] - Research and development expenses decreased to $4.7 million in Q3 2024 from $6.0 million in Q3 2023[13] - Total operating expenses for the nine months ended September 30, 2024, were $34,052,000, down from $47,026,000 in the same period of 2023, a decrease of 27.6%[36] - Research and development expenses for the nine months ended September 30, 2024, were $14,781,000, compared to $19,237,000 for the same period in 2023, a decrease of 23.2%[36] - Share-based compensation for the nine months ended September 30, 2024, was $5,845,000, compared to $4,981,000 for the same period in 2023, representing a 17% increase[45] Cash and Assets - The company had total cash and equivalents of $57.1 million as of September 30, 2024, down from $82.8 million at the end of 2023[20] - Total current assets decreased to $930,000 as of September 30, 2024, from $1,092,000 as of December 31, 2023, a decline of 14.8%[34] - The total accumulated deficit increased to $309,985,000 as of September 30, 2023, from $288,582,000 at the beginning of the period[39] Liabilities and Equity - Total liabilities decreased to $20,054,000 as of September 30, 2024, from $23,134,000 as of December 31, 2023, a reduction of 13.3%[34] - Shareholders' equity as of September 30, 2024, was $163,887,000, down from $195,514,000 as of December 31, 2023, a decrease of 16.2%[34] Regulatory and Strategic Initiatives - The company is working with the FDA and EU regulatory bodies to secure approvals for its technologies, which is expected to expand its total addressable market[5] - The company has expanded its US sales and support teams and deployed dozens of units globally as part of its growth strategy[3] - The company aims to enhance health outcomes worldwide through its innovative medical imaging technologies and AI solutions[25] Non-GAAP Metrics - The company reported a non-GAAP net loss of $8.7 million for Q3 2024, compared to $9.4 million in the comparable period[17] - Non-GAAP net loss attributable to ordinary shares for the nine months ended September 30, 2024, was $25,155,000, down from $29,821,000 in the same period of 2023, reflecting a 16% reduction[45] - Non-GAAP gross profit margin improved to 1% from a GAAP gross loss margin of (93%) in the latest period[47] - Non-GAAP research and development expenses decreased by 34% from GAAP figures, indicating cost management efforts[47] - Non-GAAP sales and marketing expenses showed a reduction of 34% compared to GAAP expenses, reflecting efficiency improvements[47] Other Financial Information - The company experienced a net cash used in operating activities of $26,066,000 for the nine months ended September 30, 2024, an improvement from $32,263,000 in the same period of 2023[41] - The company issued 2,142,858 ordinary shares and warrants during the period, raising $27,139,000 net of issuance expenses[39] - The weighted average number of ordinary shares increased to 58,182,000 for the nine months ended September 30, 2024, compared to 55,900,000 for the same period in 2023[45]

Core Viewpoint - Nanox Imaging Ltd is set to report its financial results for Q3 2024 on November 21, 2024, with a conference call scheduled for 8:30 a.m. ET to discuss the results and provide a business update [1]. Company Overview - Nanox is focused on transitioning the world to preventive healthcare through affordable medical imaging technologies that utilize advanced AI and novel digital sources [3]. - The company's vision includes expanding the reach of its technology beyond hospital settings, providing a comprehensive solution from scan to diagnosis, and leveraging AI for enhanced diagnostics [4]. Product Ecosystem - Nanox.ARC: A multi-source Digital Tomosynthesis system that is cost-effective and user-friendly [4]. - Nanox.AI: An AI-based suite of algorithms that enhances routine CT imaging readings to identify early signs of chronic diseases [4]. - Nanox.CLOUD: A cloud-based platform for managing and storing data from Nanox devices, offering tools for detailed imaging analysis [4]. - Nanox.MARKETPLACE: A decentralized marketplace providing remote access to radiology and cardiology experts, along with a teleradiology services platform [4]. Business Strategy - By improving early detection and treatment, Nanox aims to enhance health outcomes globally [4].