Nano-X Imaging (NNOX)
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Nanox Announces Second Quarter of 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-12 12:00
Core Insights - Nanox Imaging Ltd. reported a net loss of $14.7 million for Q2 2025, an increase from a net loss of $13.6 million in Q2 2024, primarily due to higher gross loss and finance expenses [4][15] - The company generated revenue of $3.0 million in Q2 2025, up from $2.7 million in Q2 2024, driven by teleradiology services, imaging systems sales, and AI solutions [5][8] - Nanox is on track to meet its year-end deployment target for the Nanox.ARC system, with a growing commercial pipeline and a breakthrough in the European market [3][18] Financial Performance - The gross loss for Q2 2025 was $3.2 million, with a gross loss margin of 107%, compared to a gross loss of $2.9 million and a margin of 106% in Q2 2024 [6][8] - Non-GAAP gross loss for Q2 2025 was $0.6 million, compared to $0.2 million in Q2 2024, indicating a worsening trend in operational efficiency [16][47] - Research and development expenses remained stable at $4.8 million for both Q2 2025 and Q2 2024, while sales and marketing expenses increased to $1.2 million from $0.8 million [12][13] Business Developments - The company has expanded its customer base, including major medical imaging center chains in the U.S., and is preparing for the first system shipment to Romania [8][3] - Nanox has notified the FDA of its intent to submit the TAP2D software module for a 2D view image output, enhancing the functionality of the Nanox.ARC systems [8] - A multi-year Volume Supply Agreement was established with Fabrinet to support scalable production of Nanox.ARC X [8] Liquidity and Capital Resources - As of June 30, 2025, the company had total cash and equivalents of $62.6 million, down from $83.5 million at the end of 2024, with a negative cash flow from operations of $19.6 million during the reported period [19][20] - The total assets decreased to $184.2 million from $210.0 million at the end of 2024, reflecting a decline in cash and marketable securities [30][20] Shareholder Information - The company had approximately 63.9 million shares outstanding as of June 30, 2025, a slight increase from 63.8 million shares at the end of 2024 [21][20] - The accumulated deficit increased to $401.7 million as of June 30, 2025, compared to $373.7 million at the end of 2024 [30][20]
Nanox to Report Second Quarter 2025 Financial Results on August 12, 2025
Globenewswire· 2025-08-01 20:05
Core Viewpoint - Nanox Imaging Ltd is set to report its financial results for Q2 2025 on August 12, 2025, with a conference call scheduled for 8:30 a.m. ET to discuss these results and provide a business update [1]. Company Overview - Nanox is focused on advancing preventive healthcare through affordable medical imaging technologies that utilize advanced AI and proprietary digital X-ray sources [3]. - The company's vision includes expanding its technology's reach beyond hospital settings, offering a comprehensive solution from scanning to diagnosis, and leveraging AI for improved diagnostic accuracy [4]. Product and Service Ecosystem - Nanox.ARC: A multi-source digital tomosynthesis system that is cost-effective and user-friendly [4]. - Nanox.AI LTD: A subsidiary that provides AI-based algorithms to enhance routine CT imaging readings, focusing on early signs of chronic diseases [4]. - Nanox.CLOUD: A cloud-based platform for managing data from Nanox devices, offering tools for detailed imaging analysis [4]. - Nanox.MARKETPLACE: A decentralized marketplace through USARAD Holdings Inc. that provides remote access to radiology and cardiology experts, along with a teleradiology services platform [4].
Nanox Announces Clinical and Educational Collaboration with Keiser University Featuring the Nanox.ARC
Globenewswire· 2025-07-01 12:00
Core Insights - Nanox Imaging Ltd has announced a clinical and educational collaboration with Keiser University to deploy its advanced imaging system, Nanox.ARC, for training healthcare professionals [1][2] Company Overview - Nanox is focused on transforming healthcare through affordable medical imaging technologies, utilizing advanced AI and proprietary digital X-ray sources [6][7] - The company aims to enhance early detection and treatment of diseases, improving health outcomes globally [7] Product Details - The Nanox.ARC is a 3D digital tomosynthesis imaging system that offers improved sensitivity and specificity compared to traditional X-ray, while also reducing patient radiation exposure and radiologist reading times compared to CT scans [3][9] - The system features a proprietary digital X-ray source powered by cold cathode technology, providing a detailed, layered view of the body [3][9] Collaboration with Keiser University - The Nanox.ARC will be integrated into Keiser University's Radiologic Technology graduate program, allowing students and local medical imaging providers to access the technology for educational purposes [2][5] - This partnership is expected to enhance clinical education and empower future healthcare professionals with innovative diagnostic tools [5] Keiser University Overview - Keiser University is Florida's largest private, non-profit university, serving nearly 20,000 students across 21 campuses and online [4][10] - The university has awarded approximately 100,000 degrees since its establishment in 1977 and is recognized for its contributions to workforce talent in healthcare and nursing [4][10]
Nano-X Imaging (NNOX) Earnings Call Presentation
2025-06-23 07:58
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]
Nano-X Imaging (NNOX) Conference Transcript
2025-06-11 18:47
Summary of Nano-X Imaging (NNOX) Conference Call - June 11, 2025 Company Overview - **Company**: Nano-X Imaging (NNOX) - **Industry**: Medical Imaging Technology Key Points and Arguments Product and Technology Development - **Nanox ARC System**: A multi-source imaging device combined with a cloud-based platform, designed for 3D tomosynthesis images, enhancing early detection capabilities [6][7][8] - **Clinical Benefits**: Improved image quality, reduced false positives, and faster diagnosis compared to traditional X-ray and CT scans [10][11] - **Regulatory Approvals**: The Nanox ARC received FDA clearance for general use in December 2024 and CE approval for all body imaging in February 2025 [17][18] Business Model and Commercial Strategy - **Market Approach**: Direct sales in the U.S. targeting imaging centers and clinics, and indirect sales through distributors internationally [19][20] - **Economic Models**: Offers both capital sales and a pay-per-use model (MSAS) at $30 per scan, with a minimum of seven scans per day [21][22] - **Profit Margins**: Operators can achieve a margin of 43% to 54% using the pay-per-use model, creating a win-win situation for both the company and its clients [25] Financial Performance - **Cash Position**: As of Q1 2025, the company reported $72.9 million in cash and cash equivalents [43] - **Revenue**: Generated $2.8 million in revenue for the quarter, with a burn rate of approximately $3 million per month [43][44] AI and Teleradiology Divisions - **AI Solutions**: Focus on population health solutions, including bone health, cardiac, and liver solutions, with FDA and CE approvals [34][35] - **Teleradiology**: Operates through a network of certified radiologists using the cloud platform for efficient service delivery [40][41] Market Position and Future Outlook - **Competitive Landscape**: Collaborations with companies like Varex and CEI for component sourcing, while also leveraging partnerships for AI development [50][51] - **Growth Projections**: The AI division is expected to break even by 2026, while the hardware division aims for breakeven with 1,500 to 2,000 units deployed [47] - **Long-term Vision**: Emphasis on becoming a comprehensive medical device and AI solution provider, focusing on preventive and early diagnosis [56] Challenges and Market Perception - **Stock Performance**: The company’s stock price has declined from a peak of $90 post-IPO to lower levels, despite advancements in product development and market presence [53][54] - **Market Underappreciation**: The current valuation does not reflect the progress made in product offerings and regulatory approvals [54] Additional Important Information - **Installation Locations**: Devices installed in Israel and Ghana, with ongoing clinical trials [26] - **Future Developments**: Plans for software upgrades and additional capabilities for the Nanox ARC system [28][29] This summary encapsulates the key insights from the Nano-X Imaging conference call, highlighting the company's innovative technology, business strategies, financial health, and future growth potential in the medical imaging industry.
Nano-X Imaging (NNOX) Conference Transcript
2025-06-10 17:30
Summary of Nano-X Imaging (NNOX) Conference Call Company Overview - **Company**: Nano-X Imaging Limited - **Industry**: Medical Imaging Technology - **Key Product**: Nanox ARC, a proprietary imaging device that combines advanced imaging technology with a cloud-based platform for enhanced medical diagnostics [4][6][13] Core Points and Arguments - **Technological Advancements**: The company is focused on improving medical imaging and patient outcomes through innovative technologies, including the Nanox ARC and AI solutions [4][21] - **Regulatory Approvals**: Achieved FDA clearance for musculoskeletal (MSK) imaging in May 2023 and CE marking for all body imaging in February 2025, indicating significant progress in regulatory compliance [21][23] - **Market Strategy**: Targeting the U.S. market with a focus on imaging centers, multi-specialty medical centers, and urgent care facilities. The company employs a direct sales team and partners with distributors for broader reach [23][24] - **Business Model**: Offers a pay-per-use model charging $30 per scan, requiring a minimum of seven scans per day under a multi-year agreement. This model is designed to minimize capital expenditure for operators [27][28] - **Financial Position**: As of March 31, 2025, the company reported $73 million in cash and cash equivalents, with a quarterly run rate of $3 million [50] Additional Important Content - **Product Features**: The Nanox ARC system is designed to be smaller, lighter, and simpler than traditional X-ray systems, providing 3D tomosynthesis images with reduced radiation exposure compared to CT scans [12][18] - **Clinical Benefits**: The technology allows for better visualization and reduced false positives, expediting diagnosis while maintaining lower costs compared to CT imaging [17][19] - **Future Developments**: The company is working on an upgraded version of the Nanox ARC with a smaller footprint and enhanced capabilities, which will allow for more installations in space-constrained environments [31][32] - **AI Solutions**: The company has developed AI solutions for various medical applications, including vertebral compression fractures and coronary artery calcium measurement, with plans for future applications in orthopedics and body composition [45][46] - **Global Presence**: The company has installations in the U.S., Israel, and Ghana, with ongoing clinical trials and partnerships to expand its market presence [30][49] Conclusion Nano-X Imaging Limited is positioned to disrupt the medical imaging industry with its innovative technology and business model, backed by regulatory approvals and a clear market strategy. The focus on cost-effective solutions and advanced imaging capabilities presents significant growth potential in the healthcare sector [4][21][23][27]
Nanox Receives MDR CE Mark for HealthOST, an Advanced AI-Powered Software for Spine Assessment
Globenewswire· 2025-06-05 12:00
Core Viewpoint - Nanox Imaging Ltd has received EU MDR CE mark certification for its HealthOST software, enabling commercialization in Europe and ensuring compliance with regulatory standards for medical software [1][2]. Company Overview - Nanox is an innovative medical imaging technology company focused on preventive healthcare through affordable imaging technologies based on advanced AI [10][11]. - The company aims to enhance early detection and treatment of diseases, improving health outcomes globally [11]. Product Details - HealthOST is an advanced software solution that analyzes routine CT scans to assess vertebral height loss and bone mineral density, aiding in the evaluation of musculoskeletal diseases like osteoporosis [2][8]. - The software integrates with existing picture archiving and communication systems (PACS) and requires no additional imaging or patient time, making it a cost-effective screening tool [3][5]. Market Need - Osteoporosis affects over 25.5 million women in Europe, with a significant portion of vertebral compression fractures going undetected [4]. - The annual cost of osteoporosis-related fractures in Europe exceeds €56 billion, with cases expected to increase by 25% by 2034 due to an aging population [4]. Clinical Impact - In the ADOPT study, HealthVCF identified over 3,450 new patients with vertebral compression fractures, highlighting the software's effectiveness in detecting previously undiagnosed cases [6][7]. - The integration of Nanox.AI's solutions has shown to improve patient outcomes and reduce the burden on healthcare systems through preventive care [7].
Nanox to Participate in Sidoti Small Cap Conference
Globenewswire· 2025-06-03 12:30
Company Overview - Nanox Imaging Ltd (NASDAQ: NNOX) is an innovative medical imaging technology company focused on transitioning to preventive health care through affordable medical imaging technologies based on advanced AI and proprietary digital X-ray sources [3][4]. Upcoming Event - Nanox will participate in the Sidoti Small Cap Conference, scheduled for June 11-12, 2025, with management presenting on June 11 at 1:45 PM ET [1]. Technology and Solutions - The company aims to expand the reach of its technology beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, enhancing efficiency in routine medical imaging processes [4]. - Nanox's ecosystem includes several components: - Nanox.ARC, a cost-effective multi-source digital tomosynthesis system - Nanox.AI Ltd., which offers AI-based algorithms to augment routine CT imaging readings - Nanox.CLOUD, a cloud-based platform for data management and imaging analysis - Nanox.MARKETPLACE, a decentralized marketplace for remote access to radiology and cardiology experts [4]. Vision and Goals - The company's vision is to improve early detection and treatment of diseases, ultimately enhancing health outcomes worldwide [4].
Nano-X Imaging (NNOX) - 2025 Q1 - Earnings Call Transcript
2025-05-22 13:32
Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $13.2 million for Q1 2025, compared to a net loss of $12.2 million in Q1 2024, reflecting an increase of $1 million largely due to a $1.1 million increase in gross loss [29] - Revenue for the reported period was $2.8 million, with a gross loss of $3 million on a GAAP basis, compared to revenue of $2.6 million and a gross loss of $2.1 million in the comparable period [29][30] - Non-GAAP gross loss for the reported period was $400,000, down from a gross profit of $600,000 in the comparable period, indicating a gross margin of approximately 15% [30] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for the reported period was $2.6 million, with a gross profit of $400,000, compared to revenue of $2.4 million and a gross profit of $300,000 in the comparable period, representing a gross profit margin of approximately 17% [30] - Revenue from the sale and deployment of imaging systems and OEM services amounted to $33,000, with a gross loss of $1.6 million on a GAAP basis, compared to revenue of $47,000 and a gross loss of $400,000 in the comparable period [31] - The company's revenue from AI solutions for the reported period was $200,000, with a gross loss of $1.9 million on a GAAP basis, compared to revenue of $100,000 and a gross loss of $2 million in the comparable period [31] Market Data and Key Metrics Changes - The company has seen an increase in the number of scans performed by its systems, with an average target of seven scans per day for operational units [12] - The sales pipeline has doubled since January 2025, with the sales team handling over 1,000 leads, primarily from small and medium-sized health clinics in various countries [11][12] - The company is targeting over 100 ARC systems in various stages of deployment by the end of 2025 worldwide [12] Company Strategy and Development Direction - The company aims to improve medical imaging and enhance patient outcomes through strategic acquisitions and the integration of AI-powered imaging analysis [6][7] - The focus is on expanding the teleradiology business and AI solutions to create a comprehensive end-to-end medical imaging solution [8][9] - The company is preparing to ship its first systems to Puerto Rico and has made notable progress in forming distributor partnerships in the U.S. [15][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledges recent market uncertainties but remains encouraged by the growing base of early adopters of the Nanox Arc [13] - The company expects its AI business to break even in 2026 and the ARC business to break even in 2027, with an inflection point anticipated in the second half of 2025 [61][62] - Management emphasizes the importance of clinical validation and regulatory approvals in driving future growth [23][35] Other Important Information - The company had cash, cash equivalents, restricted deposits, and marketable securities of approximately $72.9 million as of March 31, 2025 [33] - The company continues to strengthen its sales and clinical teams to support its commercialization efforts in the U.S. market [14] Q&A Session Summary Question: Can you provide details on the fleet of units expected by the end of the year? - Management indicated that the majority of units will be in the U.S., with about 15-20% in Europe and 10% in other regions, depending on regulatory approvals [40] Question: What is the pricing and reimbursement status for the second opinion services? - The second opinion service is priced at approximately $300 and is primarily a retail model, with growing business [45][46] Question: How many units are currently deployed and operational in the U.S.? - More than 20 units are currently installed, with some awaiting regulatory approvals [52] Question: When can the company expect to reach breakeven? - The AI business is expected to break even in 2026, while the ARC business is projected to break even in 2027, with an inflection point anticipated in the second half of 2025 [61][62]
Nano-X Imaging (NNOX) - 2025 Q1 - Earnings Call Transcript
2025-05-22 13:30
Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $13.2 million for Q1 2025, compared to a net loss of $12.2 million in Q1 2024, reflecting an increase of $1 million largely due to a $1.1 million increase in gross loss [27] - Revenue for Q1 2025 was $2.8 million, with a gross loss of $3 million, compared to revenue of $2.6 million and a gross loss of $2.1 million in the same period last year [27][28] - Non-GAAP gross loss for Q1 2025 was $400,000, down from a gross profit of $600,000 in Q1 2024, indicating a gross margin of approximately 15% for the reported period [28] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for Q1 2025 was $2.6 million, with a gross profit of $400,000, compared to $2.4 million and a gross profit of $300,000 in Q1 2024, representing a gross profit margin of approximately 17% [28] - Revenue from imaging systems and OEM services was $33,000 with a gross loss of $1.6 million in Q1 2025, compared to revenue of $47,000 and a gross loss of $400,000 in the same period last year [29] - Revenue from AI solutions was $200,000 with a gross loss of $1.9 million in Q1 2025, compared to $100,000 and a gross loss of $2 million in Q1 2024 [29] Market Data and Key Metrics Changes - The sales pipeline has doubled since January 2025, with the sales team handling over 1,000 leads, primarily from small and medium-sized health clinics in various countries [9] - The company is targeting over 100 ARC systems in various stages of deployment by the end of 2025, with over 60 units currently in various stages of implementation [10][11] Company Strategy and Development Direction - The company aims to improve medical imaging and enhance patient outcomes through strategic acquisitions and the integration of AI-powered imaging analysis [6][7] - The focus is on expanding the commercialization of Nanox ARC and AI solutions, with a multi-pronged strategy involving direct sales, collaborations, and distributor engagements [8][12] - The company is also pursuing opportunities in the workers' compensation segment, which presents a significant potential market [14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged recent market uncertainties but expressed optimism about the growing base of early adopters for Nanox ARC [11] - The company expects its AI business to break even by 2026 and the ARC business to reach breakeven by 2027, with an anticipated inflection point in the second half of 2025 [57][58] Other Important Information - The company has received FDA clearance for the Nanox Arc X, enhancing its regulatory standing [20] - The company is actively engaged in clinical trials to generate data supporting the use of Nanox Arc, which is crucial for future growth [21] Q&A Session Summary Question: Can you provide details on the fleet deployment by the end of the year? - Management indicated that the majority of units will be in the US, with about 15-20% in Europe and 10% in other regions, depending on regulatory approvals [38] Question: What is the pricing and reimbursement status for the second opinion services? - The second opinion service is priced at approximately $300 and is primarily a retail model, with growing business potential [42] Question: How many units are currently deployed and operational in the US? - More than 20 units are currently installed, with some awaiting regulatory approvals [47] Question: What is the timeline for reaching breakeven across business lines? - The teleradiology division is already profitable, while the AI business is expected to break even in 2026 and the ARC business in 2027 [56][57]