Nanox Receives FDA Clearance for Advanced AI Cardiac Imaging Solution

Nanox Receives FDA Clearance for HealthCCSng V2.0, Upgraded Version of Advanced AI Cardiac Solution Empowering Physicians in Assessment of Coronary Artery Calcium - Nano X Imaging (NASDAQ:NNOX)

HealthCCSng V2.0 introduces additional 'zero calcium' categorization of coronary artery calcium (CAC) and generates a numerical calcium score with corresponding CAC detection category output Marks second FDA 510(k) clearance of HealthCCSng product PETACH TIKVA, Israel, Aug. 21, 2024 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (("Nanox" or the "Company, NASDAQ:NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for HealthCCSng V2.0. HealthCCSng V2.0 is the upgraded version of Nanox.AI's cardiac solution, HealthCCSng, which has already shown tangible results in several healthcare systems, identifying patients at high risk of coronary artery disease while driving significant revenue to cardiology departments. It has also been seamlessly integrated with existing picture archiving and communication systems (PACS) and electronic medical records (EMR) systems, and enabled timely and appropriate preventive care. HealthCCSng utilizes medical imaging data from routine non-gated, non-contrast CT scans that include the entire heart of adult patients of ages 30-85 to automatically measure coronary artery calcium (CAC), which is the number one risk predictor for a future cardiovascular event. The product aims to leverage the high utilization of CT scans in the medical care environment, including lung cancer screening programs, to automatically detect calcification in the coronary arteries of patients in an opportunistic manner. Patients with the highest category of CAC levels are over 13 times more likely to suffer a cardiac event. The device output is available to radiologists as part of their standard workflow. A list of studies that received a successful algorithm analysis result will also be available for further clinical assessment by cardiologists, general practitioners and other medical professionals. HealthCCSng V2.0 introduces the following features that improve its ability to inform physicians and help them conduct the most appropriate risk assessment and subsequent preventative healthcare for patients: Zero CAC Category: HealthCCSng now enables clinicians to easily distinguish between patients with zero and low CAC levels. CAC levels of zero are associated with very low risk of cardiac events. The new zero CAC category joins the previously featured 'low', 'medium' and 'high' CAC categories.Numerical CAC Scoring: HealthCCSng now provides the numerical CAC score alongside the CAC category in its results interface, allowing clinicians to finetune their cardiac risk assessments of patients.CAC Category Configuration: HealthCCSng now enables users to adjust the lower and upper bounds for the low (1-99 Hounsfield units (HU) by default), medium (100-399 HU by default) and high (400+ HU by default) categories of CAC scores. This added customization allows users to finetune their cardiac risk assessments of patients. "We are pleased to receive another regulatory clearance from the FDA for our AI cardiac solution, with new updates that reflect our commitment to providing healthcare professionals with the tools they need," said Erez Meltzer, Nanox Chief Executive Officer. "The AI cardiac solution helps to bridge the divide between radiology and cardiology, two medical specialties that often use different terms and descriptions to assess imaging data, and catches patients who might otherwise fall through the cracks so that they can be directed to appropriate preventative healthcare. We will continue exploring opportunities to seamlessly integrate our AI solutions with healthcare systems and clinician workflows, and ultimately enhance patient care and outcomes." About Nanox.AI Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI technology, Nanox.AI helps clinicians extract valuable and actionable clinical insights from routine medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit https://www.nanox.vision/ai. About Nanox Nanox NNOX is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. Nanox's vision is to increase access, reduce costs and enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment, which Nanox believes is key to helping people achieve better health outcomes, and, ultimately, to save lives. The Nanox ecosystem includes Nanox.ARC -- a multi-source Digital Tomosynthesis system that is cost-effective and user-friendly; an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic disease (Nanox.AI); a cloud-based infrastructure (Nanox.CLOUD); and a proprietary decentralized marketplace, through Nanox's subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts; and a comprehensive teleradiology services platform (Nanox.MARKETPLACE). Together, Nanox's products and services create a worldwide, innovative, and comprehensive solution that connects medical imaging solutions, from scan to diagnosis. For more information, please visit www.nanox.vision. Contacts Ben Shannon ICR Westwicke [email protected] Investor Contact: Mike Cavanaugh ICR Westwicke [email protected] Market News and Data brought to you by Benzinga APIs

Nano-X stock gains on FDA nod for HealthCCSng (NASDAQ:NNOX)

Nano-X Imaging (NASDAQ:NNOX) shares traded higher premarket Wednesday after the company announced that its Nanox.AI subsidiary received the FDA's 510(k) clearance for an updated version of its cardiac imaging solution, HealthCCSng. Named HealthCCSng V2.0, the upgraded product adds new features to HealthCCSng, which is designed to use CT scans to automatically measure coronary artery calcium (CAC), the biggest risk factor for a cardiovascular event. Nano-X (NNOX) said that HealthCCSng V2.0's new features, such as Zero CAC Category and Numerical CAC Scoring, are expected to help physicians conduct risk assessments and plan preventative healthcare for their patients. "We are pleased to receive another regulatory clearance from the FDA for our AI cardiac solution, with new updates that reflect our commitment to providing healthcare professionals with the tools they need," CEO Erez Meltzer remarked. More on Nano-X Imaging Nano-X Imaging Ltd. (NNOX) Q2 2024 Earnings Call Transcript Nano-X Imaging: Optimism Is Premature Nano-X Imaging Ltd. (NNOX) Q1 2024 Earnings Call Transcript Seeking Alpha's Quant Rating on Nano-X Imaging Historical earnings data for Nano-X Imaging

Nanox.AI gains FDA clearance for advanced cardiac imaging tool By Investing.com

PETACH TIKVA, Israel - Nanox.AI, a subsidiary of Nanox (NASDAQ:NNOX), has received the U.S. Food and Drug Administration (FDA) 510(k) clearance for its updated cardiac imaging software, HealthCCSng V2.0, the company announced today. The software is designed to enhance coronary artery disease detection and assessment by utilizing routine CT scans. HealthCCSng V2.0, an AI-driven solution, now includes a 'zero calcium' category to identify patients with no detectable coronary artery calcium (CAC), indicative of a very low risk of cardiac events. This feature complements existing categories that classify CAC levels as low, medium, or high. The software also provides a numerical calcium score, which can be customized by clinicians to refine risk assessments further. The tool integrates with existing picture archiving and communication systems (PACS) and electronic medical records (EMR), aiming to assist healthcare providers in identifying patients at high risk for coronary artery disease opportunistically. According to the company, those with the highest CAC levels are significantly more likely to experience a cardiac event. Erez Meltzer, CEO of Nanox, expressed the company's commitment to equipping healthcare professionals with effective tools for preventative care. He highlighted the AI solution's potential to bridge the gap between radiology and cardiology, facilitating the identification of at-risk patients who may otherwise be overlooked. Nanox.AI's technology is part of a broader effort by Nanox to democratize access to medical imaging and improve early disease detection and treatment. The company's ecosystem also includes the Nanox.ARC digital tomosynthesis system, a cloud-based infrastructure, and a decentralized marketplace offering remote access to radiology and cardiology expertise. This advancement is based on a press release statement from Nano-X Imaging LTD. In other recent news, Nano-X Imaging Limited reported its Q2 2024 financial results, which included a reduced GAAP net loss of $13.6 million, down from last year's $17.4 million for the same period. The company's revenue for the quarter was $2.7 million, despite a gross loss of $2.9 million. These developments are part of Nano-X's ongoing efforts to expand its product offerings, notably the forthcoming Nanox.ARC X system, and secure several regulatory approvals, including a new FDA submission and a pending CE Mark for the EU region. Nano-X's recent progress also includes installations in three major U.S. healthcare chains and an increased manufacturing capacity in Israel. The company is awaiting state approvals in Delaware and California and an import license for Mexico. It is also making strides with the Nanox.AI cardiac solution, which recently received recognition at a scientific meeting. Looking ahead, Nano-X plans a production ramp-up for 2025, facilitated by a low-cost manufacturing arrangement. The company also plans to expand its U.S. sales force and use distributors in countries outside the U.S., Israel, and the UK. These are the latest developments in Nano-X Imaging Limited's ongoing efforts to enhance its position in the medical imaging field. Nanox (NASDAQ:NNOX), a pioneer in medical imaging technology, recently celebrated a milestone with FDA clearance for its cardiac imaging software. As investors consider the implications of this development for the company's financial health and stock performance, certain metrics and tips from InvestingPro provide deeper insights. InvestingPro Data shows that Nanox has a market capitalization of $417.08 million, reflecting the company's current valuation in the market. Despite challenges such as weak gross profit margins, indicated by a gross profit of -$7.12 million over the last twelve months as of Q1 2023, Nanox holds more cash than debt on its balance sheet, which could provide a cushion for operational needs and investment in further innovation. Two InvestingPro Tips for Nanox highlight the company's financial position and market performance: 1. Nanox's liquid assets exceed its short-term obligations, suggesting a stable financial footing in the near term. 2. The stock price has been quite volatile, with a 1-year price total return of -16.07%, which could indicate higher risk for investors seeking stable returns. It's also worth noting that analysts do not anticipate Nanox to be profitable this year, and the company does not pay a dividend to shareholders, which may influence investment decisions depending on individual risk appetites and income preferences. For investors interested in a more comprehensive analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/NNOX, which could provide further guidance on the potential risks and opportunities associated with Nanox's stock.