Nano-X has the FDA's backing. Now it just needs to make some money.Nano-X Imaging (NNOX 15.00%), the Israeli X-ray imaging company that hopes to disrupt the medical devices market with a business model charging per X-ray delivered rather than simply selling X-ray machines, jumped in Thursday trading, rising 14.2% through 12:30 p.m. ET.Why? This morning, Nano-X announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to use its Nanox.ARC X technology to produce "tomographic i ...

First FDA clearance for Nanox.ARC X to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal and paranasal indicationsEnhanced imaging system features sleek design with smaller footprint; simplified ‘plug and play' installation processSystem design enables software upgrades and new capabilities to be added remotely following future regulatory clearances PETACH TIKVA, Israel, April 17, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD ((", Nanox", or the ", Company", , N ...

Financial Performance - As of December 31, 2024, the company reported working capital of approximately $64.7 million and shareholders' equity of approximately $189.1 million[35] - For the year ended December 31, 2024, the company incurred a net loss of approximately $53.5 million and negative cash flow from operations of $36.4 million[35] - The company has an accumulated deficit of approximately $378.7 million as of December 31, 2024[35] - The company reported net losses of $113.2 million, $60.8 million, and $53.5 million for the years ended December 31, 2022, 2023, and 2024, respectively[58] - As of December 31, 2024, the company raised $37.8 million under its Controlled Equity Offering Sales Agreement, with an aggregate offering price of up to $100 million[58] - The company operates in a capital-intensive industry and may need additional financing to support ongoing operations and development[60] Business Models and Strategies - The company is pursuing three business models: Subscription Model, CapEx Model, and Licensing for OEM Model, with the Subscription Model being the primary focus[37] - The success of the company's Subscription Model is critical for increasing early detection of medical conditions, but it faces numerous risks including manufacturing delays and market acceptance[61] - The company has not entered into any licensing agreements to date, which may hinder the implementation of its Licensing Model[63] Regulatory Approvals and Compliance - The company has received FDA clearances for the Nanox.ARC, a multi-source 3D digital tomosynthesis system, and has produced a few dozen systems to date[32] - The FDA granted clearance for the Nanox.ARC and Nanox.CLOUD, but third-party payor coverage and reimbursement are not yet widely approved, impacting potential revenue generation[42] - The company received FDA clearance for the Nanox.ARC (including the Nanox.CLOUD) on April 28, 2023, allowing it to market a multi-source 3D digital tomosynthesis system[174] - The company plans to seek additional clearances or approvals for further uses of the currently cleared Nanox System[174] - Compliance with EU Medical Devices Regulation (EU) 2017/745 is essential for selling products in the European Economic Area (EEA), requiring a conformity assessment procedure[178] Market and Competitive Landscape - The commercial viability of the Nanox System, including the X-ray source technology, is uncertain and requires significant sales and marketing efforts for successful deployment[43] - The company faces intense competition in the medical imaging industry, with over 700 FDA-cleared AI products currently available[69] - The healthcare industry is focused on cost containment, which may limit reimbursement for the Nanox System and affect its commercial success[42] Operational Risks - The company is highly dependent on the successful development and market acceptance of its X-ray source technology and related products[25] - The company is still in the early stages of commercializing the Nanox.ARC and Nanox.CLOUD, with ongoing efforts to seek additional regulatory clearances[56] - The company relies on third-party manufacturers for the production of its Nanox.ARC and has engaged multiple suppliers to mitigate risks associated with manufacturing[73] - The company may need to enhance or redesign its MEMs X-ray chip to generate licensing revenue or for specific medical imaging applications[81] - The company relies on third-party cloud service providers, such as Microsoft Azure, for its MSaaS products, which could adversely affect its business if there are disruptions[103] Financial and Legal Liabilities - The company may incur significant legal expenses and management attention due to ongoing litigation and investigations, which could adversely affect financial condition[124] - The company entered into a formal settlement agreement for $8 million related to two securities class action complaints, which was approved by the court on May 7, 2024[125] - The company paid a civil penalty of $650,000 to the SEC and is permanently enjoined from violating certain sections of the Securities Act and Exchange Act[125] Cybersecurity and Data Protection - Cybersecurity breaches could result in significant data losses, operational disruptions, and reputational harm, affecting business operations and financial condition[119] - The company must ensure that third-party manufacturers comply with applicable regulations to avoid delays in product delivery and potential sanctions[187] - The company expects to be subject to HIPAA and HITECH regulations, which impose strict standards for the protection of individually identifiable health information[194] Intellectual Property Risks - The company relies on a combination of patents and trade secrets to protect its proprietary technologies, but may face challenges in ensuring their protection[141] - The company may face costly litigation if claims arise regarding infringement of third-party intellectual property rights, which could distract management and impact financial resources[151] - Changes in patent laws or their interpretation could adversely affect the company's ability to protect its inventions and enforce intellectual property rights[146] Economic and Geopolitical Risks - Geopolitical tensions, inflation, and rising interest rates may disrupt global financial markets, impacting the company's ability to access capital[58] - The company is subject to geopolitical risks, including the ongoing military conflict between Russia and Ukraine, which may disrupt supply chains and impact financial markets[132] - The company may experience adverse effects from changes in general economic conditions, including high interest rates and constrained capital spending, which could impact financial performance[128]

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 [48] - 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 [49] - 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 [49][50] 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 [50][51] - Revenue from the sale and deployment of imaging systems amounted to $136,000, with a gross loss of $1.5 million, compared to revenue of $17,000 and a gross loss of $44,000 in the comparable period [52] - Revenue from AI solutions was $83,000 with a gross loss of $2.0 million, consistent with the previous period, indicating challenges in this segment [52] Market Data and Key Metrics Changes - The company is expanding its market presence in the U.S. and Europe, having received FDA clearance and CE mark certification, which are expected to enhance commercialization efforts [10][24] - The company has added Tennessee to its commercial coverage in the U.S. and is negotiating with new channel partners to accelerate market presence [11][19] - The company anticipates that initial sales in the EU will primarily be through a CAPEX model, with additional revenue from service contracts and AI solutions [28][29] Company Strategy and Development Direction - The company aims to accelerate the deployment of its imaging systems and AI solutions in the U.S. while expanding into the European market following regulatory approvals [17][30] - The focus remains on building a strong network of strategic partnerships and channel partners to enhance market penetration [22][30] - The company is committed to generating clinical validation and raising awareness of its technology among healthcare professionals [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growing interest from healthcare facilities and the potential for increased referrals and scans as the technology gains traction [20][21] - The company views 2025 as a pivotal year for growth, particularly in AI solutions and imaging systems, as it continues to build its sales and clinical support teams [92][106] - Management highlighted the importance of clinical validation and market education in driving adoption of their technology [26][106] Other Important Information - The company had cash and marketable securities of approximately $83.5 million as of December 31, 2024, providing a solid financial foundation for ongoing operations [54] - The company issued approximately 5 million ordinary shares during the reported period, raising gross proceeds of $38.8 million [56] Q&A Session Summary Question: Can you elaborate on the DME partners in the U.S.? - Management confirmed that there are options for both direct CAPEX sales and typical MSAS models for DME partners [63] Question: Can you provide insights on the U.S. market and expected placements in 2025? - Management indicated that the team is expanding rapidly and that early adopters are primarily small to medium-sized medical imaging centers and orthopedic clinics [66][70] Question: How many systems were deployed in the U.S. during the quarter? - Management refrained from providing exact numbers but noted that installations are in various stages and that the pipeline remains robust [78] Question: What is the pricing strategy for ARC in Europe? - Management stated that the majority of sales in Europe will be through CAPEX, with installations expected to begin in the next two quarters [80][83] Question: What is the outlook for 2025? - Management did not provide specific guidance but indicated that 2025 is expected to be a strong year for AI and imaging solutions [92][106] Question: Can you discuss the capital raised and its deployment? - Management confirmed that approximately $38 million was raised, which will be used to accelerate commercialization efforts for both imaging and AI products [104][105]

In its earnings release, Nanox attributed the deeper bottom-line shortfall to a one-time, $3 million income item that was booked in the third quarter. In more positive developments, Nanox provided a business update showcasing its two recent regulatory approvals. The first, earned in December, was the Food and Drug Administration's (FDA) nod for its Nanox.ARC, indicated for general use, and the second was the granting of a CE mark for the same system this past February. This is a quality designation required ...

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]

In a clinical study, it was found that the Nanox.ARC digital tomosynthesis enhanced musculoskeletal imaging, can improve the sensitivity and specificity of conventional radiography. In addition, can improve cast and metal imaging, eliminate the need for CT in some cases while at the same time reducing the patient radiation exposure and radiologist reading time.The Nanox.ARC outperformed standard x-ray in detecting lung nodules under simulated obesity conditions in phantoms PETACH TIKVA, Israel, Feb. 25, 202 ...

CE Mark is the first major regulatory milestone for Nanox.ARC Imaging System in the European market; follows recent general use FDA clearance in the U.S.New clinical data supporting use of Nanox.ARC to be presented at European Congress of Radiology (ECR) 2025.Nanox.ARC is an FDA, CE Marked, digital multi-source 3D tomosynthesis imaging system, providing advanced radiographic visualization.Nanox.ARC unlocks significant value for medical practices, providers, and their patients. PETACH TIKVA, Israel, Feb. 25, ...