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Nanox Receives FDA Clearance for HealthCCSng V2.0, Upgraded Version of Advanced AI Cardiac Solution Empowering Physicians in Assessment of Coronary Artery Calcium
Source: GlobeNewswire Inc.
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 (NASDAQ: 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
Media Contact:
Ben Shannon
ICR Westwicke
NanoxPR@icrinc.com
Investor Contact:
Mike Cavanaugh
ICR Westwicke
mike.cavanaugh@westwicke.com
abrooklyn
3 meses hace
Nanox Announces Second Quarter of 2024 Financial Results and Provides Business Update
Source: GlobeNewswire Inc.
NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, today announced results for the second quarter ended June 30, 2024 and provided a business update.
Recent Highlights:
Generated $2.7 million in revenue in the second quarter of 2024, compared to $2.6 million in the second quarter of 2023.
Submitted a new 510k submission to the FDA to expand the intended use cases for the Nanox.ARC for general use, including chest.
Advanced the US deployment program for the Nanox.ARC technology, with systems installed in seven states, and a robust sales pipeline.
Installed initial Nanox.ARC systems as part of three chain medical imaging service providers in the US.
Announces the development of system to be called Nanox.ARC X, that will be introduced in our next investor relations’ event
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.
Nanox.AI Cardiac Solution, HealthCCSng, was highlighted in multiple scientific presentations at the 2024 SSCCT annual meeting.
“The second quarter of 2024 was one of commercial advances as the Nanox team pursues its vision of making medical imaging more accessible worldwide,” said Erez Meltzer, Nanox Chief Executive Officer and Acting Chairman. “Our vision is to extend Nanox technology within and beyond hospitals, targeting underserved segments like urgent care and orthopedic clinics. We deliver a seamless scan-to-diagnosis solution, leveraging AI for smarter, more efficient healthcare, with a focus on aligning innovation with clinical needs to enhance patient outcomes globally. Nanox is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the U.S. Our mission is to provide healthcare practices with a transformative imaging advantage with the Nanox.ARC – an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care”.
Financial results for three months ended June 30, 2024
For the three months ended June 30, 2024 (the “reported period”), the Company reported a net loss of $13.6 million, compared to a net loss of $17.4 million for the three months ended June 30, 2023 (which is referred as the “comparable period”), representing a decrease of $3.8 million. The decrease was largely due to a decrease of $2.1 million in the research and development expenses and a decrease of $1.7 million in the general and administrative expenses and increase of $0.5 million in the Company’s financial income which was mitigated by an increase of $1.2 in the Company’s gross loss.
The Company reported revenue of $2.7 million in the reported period, compared to $2.6 million in the comparable period. During the reported period, the Company generated revenue through teleradiology services, the sales of its Imaging devices and services and the sale of its AI solutions.
The Company’s gross loss during the reported period totaled $2.9 million (gross loss margin of 106%) on a GAAP basis, as compared to $1.7 million (gross loss margin of (66%)) in the comparable period. Non-GAAP gross loss for the reported period was $0.2 million (gross loss margin of approximately 9%), as compared to Non-GAAP gross profit of $0.9 million (gross profit margin of approximately 34%) in the comparable period.
The Company’s revenue from teleradiology services for the reported and comparable periods was $2.5 million. The Company’s GAAP gross profit from teleradiology services for the reported and comparable periods was $0.4 million (gross profit margin of approximately 15%). A non-GAAP gross profit of the Company’s teleradiology services for the reported and comparable periods was $0.9 million (gross profit margin of approximately 37%).
During the reported period the Company generated revenue through the sales and deployment of its imaging systems which amounted to $68 thousand for the reported period, with a gross loss of $1.3 million on a GAAP and non-GAAP basis. The revenue stems from the sale and deployment of our 2D systems in Africa and our Nanox.ARC systems in the U.S.
The Company’s revenue from its AI solutions for the reported period was $113 thousand with a gross loss of $2.0 million on a GAAP basis, as compared to revenue of $53 thousand with a gross loss of $2.1 million in the comparable period. Non-GAAP gross profit of the Company’s AI solutions for the reported period was $57 thousand, as compared to a loss of 42 thousand in the comparable period.
Research and development expenses, net for the reported period were $4.8 million, as compared to $6.9 million in the comparable period, reflecting a decrease of $2.1 million. The decrease was mainly due to decrease of $1.2 million in salaries and wages and a decrease of $0.2 million in share-based compensation and $0.7 million in the expenses related to our research and development activities.
Sales and marketing expenses for the reported and the comparable periods were $0.8 million.
General and administrative expenses for the reported period were $5.9 million, as compared to $7.6 million in the comparable period. The decrease of $1.7 million was mainly due to a decrease in our legal expenses in the amount of $1.6 million, largely as result of the finalization of the SEC investigation and the settlement of the class action and a decrease in the cost of the directors’ and officers’ liability insurance premium in the amount of $0.4 million.
Non-GAAP net loss attributable to ordinary shares for the reported period was $8.4 million, as compared to $9.9 million in the comparable period. The decrease of $1.5 million was mainly due to a decrease in non-GAAP operating expenses of $2.2 million and an increase of $0.5 million in our non-GAAP interest income which was offset by decrease of $1.1 million in our non-GAAP gross profit.
Non-GAAP gross loss for the reported period was $0.2 million, as compared to a Non-GAAP gross profit of $0.9 million in the comparable period. Non-GAAP research and development expenses, net for the reported period, were $4.1 million, as compared to $6.0 million in the comparable period. Non-GAAP sales and marketing expenses for the reported period were $0.5 million, as compared to $0.6 million in the comparable period. Non-GAAP general and administrative expenses for the reported period were $4.3 million as compared to $4.7 million in the comparable period.
The difference between the GAAP and non-GAAP financial measures above is mainly attributable to amortization of intangible assets, share-based compensation, change in contingent earnout liability, expenses related to an offering and legal fee in connection with the class-action litigation and the SEC investigation. A reconciliation between GAAP and non-GAAP financial measures for the three and six months periods ended June 30, 2024, and 2023 is provided in the financial results that are part of this press release.
Liquidity and Capital Resources
As of Jume 30, 2024, the Company had total cash, cash equivalents, restricted deposits and marketable securities of $64.2 million, compared to $82.8 million as of December 31, 2023. The decrease of $18.6 million during the reported period was primarily due to negative cash flow from operations of $17.9 million.
Other Assets
As of June 30, 2024 the Company had property and equipment of $44.4 million, compared to $42.3 million as of December 31, 2023.
As of June 30, 2024, the Company had intangible assets of $75.3 million as compared to $80.6 million as of December 31, 2023. The decrease was attributable to the periodic amortization of intangible assets in the amount of $5.3 million.
Shareholders’ Equity
As of June 30, 2024 the Company had approximately 58.5 million shares outstanding. As of December 31, 2023, the Company had approximately 57.8 million shares outstanding.
Conference Call and Webcast Details
Tuesday, August 20, 2024 @ 8:30am ET
Individuals interested in listening to the conference call may do so by joining the live webcast on the Investors section of the Nanox website under Events and Presentations. Alternatively, individuals can register online to receive a dial-in number and personalized PIN to participate in the call. An archived webcast of the event will be available for replay following the event.
About Nanox:
Nanox (NASDAQ: 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.
Forward-Looking Statements:
This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, those relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to continue to develop of the Nanox imaging system; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iv) Nanox’s ability to realize the anticipated benefits of acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (v) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi) the market acceptance of the Nanox imaging system and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; and (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces, including the continuation and escalation of the military conflicts in Israel and current war between Israel and Hamas; (x) the costs incurred with respect to and the outcome of litigation Nanox is currently subject to and any similar or other claims and potential litigation it may be subject to in the future; and (xi) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things.
For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release.
Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations.
Non-GAAP Financial Measures
This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses and non-GAAP basic and diluted loss per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. These non-GAAP measures are adjusted for (as applicable) amortization of intangible assets, share-based compensation expenses, change in contingent earnout liability and legal fees in connection with class-action litigation and the SEC investigation. The Company’s management and board of directors utilize these non-GAAP financial measures to evaluate the Company’s performance. The Company provides these non-GAAP measures of the Company’s performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company’s results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non-GAAP measures are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, these non-GAAP measures should not be considered measures of the Company’s liquidity. A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release.
subslover
9 meses hace
Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver
Nanox’s HealthFLD is pioneering the use of a fully automated AI software for liver attenuation analysis from CT scans that has received FDA 510(k) clearance for use in general population
Expands Nanox’s offering in AI solutions, marking third product in Nanox AI’s suite of population health solutions to become commercially available
PETACH TIKVA, Israel, Feb. 13, 2024 (GLOBE NEWSWIRE) -- ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd., received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for HealthFLD, an artificial intelligence (AI) software that provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans in patients between the ages of 18 to 75. HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).
An estimated 24% of U.S. adults are living with MASLD or NAFLDi, a metabolic disease linked to obesity, cardiovascular disease and type 2 diabetes, all of which pose significant public health concerns. Adults with MASLD are not only at risk of developing severe liver complications, such as cirrhosis and metabolic dysfunction-associated steatohepatitis (MASH), but are also at risk of cardiovascular disease, which is the leading cause of death in people living with MASLDii. MASLD is commonly asymptomatic until it progresses to advanced liver fibrosis, and the current gold standard for diagnosis is a liver biopsy, which is invasive and costly. As such, early diagnosis of MASLD could benefit patients and the healthcare system.
While AI assessment of medical imaging offers a reliable, non-invasive, large-scale approach to support clinicians in the assessment of hepatic steatosis (fatty liver), it has traditionally been difficult to assess liver attenuation on contrast-enhanced scans – which make up a large proportion of CT scans – limiting the ability of clinicians to detect non-severe cases of MASLDiii. HealthFLD was designed to help clinicians in the assessment and analysis of fatty liver in the general population from routine CT scans.
Amidst rising obesity rates, the prevalence of liver-related disease is growing, and the need for an approved treatment for MASH has yet to be met. With several late-stage drug candidates for MASH in development and the availability of GLP-1 drugs for the management of type 2 diabetes and other metabolic diseases, identification of liver steatosis is especially relevant.
"We are proud to offer HealthFLD as the third product of Nanox AI’s suite of cutting-edge, AI-powered population health solutions designed to confront chronic diseases of great public health concern head-on and potentially improve health outcomes,” said Erez Meltzer, Chief Executive Officer of Nanox. “Furthermore, we believe that AI innovative solutions, and specifically HealthFLD, may deliver substantial advantages to the biopharmaceutical industry to streamline the identification of candidates for clinical trials of much-needed therapies for liver diseases including MASH. This regulatory decision solidifies our leadership as a developer of automated AI software medical devices.”
In a retrospective 2023 study of 2,917 patients, published in the American Journal of Roentgenology (AJR), the HealthFLD AI software demonstrated high performance in the detection of at least moderate hepatic steatosis in contrast-enhanced CT scans, with a sensitivity of 77.8% and specificity of 93.2% at less than 80 HU. Medical imaging offers the only reliable noninvasive method for quantifying liver fat. Integrating HealthFLD with widely used standard CT scans offers clinicians the potential to opportunistically screen for liver steatosis and possible signs of MASLD on a population level. “In recent years, automated, deep learning tools have offered an efficient, low-cost tool used to detect diseases in earlier stages,” said Perry J. Pickhardt, MD, of the University of Wisconsin School of Medicine & Public Health, and lead author of the AJR study. “We are now at a watershed moment when metabolic diseases are growing in prevalence and more effective treatment options are becoming available. It’s promising to have a liver solution available that may help evaluate early signs of illness from routine imaging.”
The HealthFLD clearance is the third product across the Nanox AI suite of population health solutions to receive FDA clearance. The FDA previously cleared HealthCCSng, a solution that detects coronary artery calcium (CAC) that presents a risk for coronary artery disease, and HealthOST, a solution that assesses vertebral compression fractures and bone mineral density to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine (such as osteoporosis).
About Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD), refers to a group of metabolic conditions linked to obesity, cardiovascular disease and type 2 diabetes. An estimated 30% of the adult population globally has MASLD,iv a major risk factor for chronic liver disease and for cardiovascular disease, which is the leading cause of mortality in this patient population.v
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 (NASDAQ: 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
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