NEVE ILAN, Israel–(BUSINESS WIRE)–NANO-X IMAGING LTD (“Nanox” or the “Company”, Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its medical imaging analytics subsidiary of deep learning, Nanox.AI, has received FDA 510(k) clearance for the HealthOST device, an AI software that provides qualitative and quantitative analysis of the spine from CT scans to help clinicians in the assessment and evaluation of musculoskeletal diseases. Measurements of vertebral fractures and low bone density have been shown to increase the identification of patients with musculoskeletal diseases of the spine, such as osteoporosis, a disease that affects more than 10 million people in the United States.1
This is the tenth FDA clearance for Nanox.AI in its innovative portfolio of AI clinical decision support tools and the second FDA clearance for its spinal compression fracture device. HealthOST offers more detailed assessment, including the ability to measure fractures more accurately, potentially helping clinicians assess risk factors for osteoporosis. The Company’s Latest AI Solution Automatically Identifies Findings Suggestive of Compression Fractures and Low Bone Density, Allowing Further Examination and Treatment of Patients Diagnosed with Osteoporosis to Prevent Major, Life-Changing Osteoporotic Fractures , such as a broken hip. Nanox.AI previously received FDA clearance in May 2020 for AI software that identifies vertebral compression fractures.
“With FDA clearance for HealthOST, we are excited to offer radiologists a new tool that provides deeper analysis of medical images to help identify patients at risk of developing prevalent musculoskeletal conditions such as osteoporosis, to help promote deeper labor. and treatment of these patients,” said Pini Ben Elazar, CEO of Nanox.AI. “Our new product reflects our vision to create solutions to improve population health, building on our strong background in developing AI applications to help identify chronic disease risk factors.”
According to the World Osteoporosis Congress, 75% of compression fractures are missed or unreported. According to the CDC, approximately 10.2 million adults in the United States have osteoporosis while another 43.3 million have low bone density.1 Evidence suggests that there is a reported 25% mortality rate within one year of a patient’s hip fracture.2
“This FDA clearance is another step in our commitment to providing technologies that promote population health and value-based care,” said Erez Meltzer, president and CEO of Nanox. “AI technologies like HealthOST are poised to support routine clinical decision-making and potentially improve patient health outcomes.”
HealthOST provides qualitative and quantitative analysis of the spine, including labeling of T1-L4 vertebrae, measurement of height loss in each vertebra (T1-L4), and measurement of Hounsfield Unit (HU) average in volume of interest in the vertebra (T11-L4). HealthOST is indicated for use in patients 50 years of age and older undergoing CT scans for any clinical indication that includes at least four vertebrae in the T1-L4 portion of the spine (for spinal height loss) and the T11 portions -L4 (for bone attenuation) of the spine.
Nanox.AI’s portfolio also includes HealthCCSng, an FDA-cleared AI cardiac imaging solution that quantifies coronary artery calcium (CAC), to identify patients potentially at risk for a cardiovascular event, to promote further investigation. and a possible treatment for heart disease.
Nanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable around the world. Nanox’s vision is to increase the early detection of medical conditions that can be discovered by X-ray based medical imaging technologies, which we believe is essential to increase early prevention and treatment, improve health outcomes and ultimately saving lives. We are developing a holistic imaging solution, which includes the Nanox system, consisting of the Nanox.ARC using our new MEMs X-ray source technology, and the Nanox.CLOUD, a companion cloud software, integrated with AI solutions and teleradiology services. Our vision is to increase the early detection of medical conditions that are detectable by x-rays by improving access to imaging, reducing imaging costs and improving imaging efficiency, which, according to us, is essential to increasing early prevention treatment, improving health outcomes and ultimately saving lives. . For more information, visit www.nanox.vision.
Nanox.AI is the deep learning medical imaging analysis subsidiary of Nanox. Nanox.AI solutions are developed to target high prevalence chronic and acute diseases affecting large populations around the world. Leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that might otherwise go unnoticed, potentially initiating additional medical assessment to establish individual preventive care pathways for patients. For more information, visit www.nanox.vision/ai.
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, all statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing and marketing activities with respect to its source technology. technology and the Nanox.ARC, the ability to realize the expected benefits of acquisitions, and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by words such as “may”, “could”, “believe”, “may”, “estimate”, “continue”, “anticipate”, “have the intention to”, “should”, “plan”, “should”, “could”, “expect”, “predict”, “potential”, or the negative of these terms or other similar expressions. Forward-looking statements are based on information available to the Company at the time such statements are made or on the good faith belief of management at that time regarding future events, and are subject to risks and uncertainties. which could cause actual performance or results to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to (1) the inability to successfully integrate the businesses of the acquired companies, (2) the inability to achieve the anticipated benefits from acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of acquired companies to grow and manage growth profitably and retain key employees, (3) costs acquisition-related and/or unknown or invaluable liabilities, (4) changes in applicable laws or regulations that impact the operations of acquired companies, (5) failure to achieve planned technology development goals, ( 6) the inability of the acquired companies to effectively scale end-to-end medical imaging solutions around the world, (7) changes in global forces, political, economic commercial, competitive, market and regulatory, and (8) (i) Nanox’s ability to successfully demonstrate the feasibility of its gy technology for commercial applications; (ii) Nanox’s expectations regarding collaborations with third parties and their potential benefits; and (iii) Nanox’s ability to operate globally, among others.
For a discussion of other risks and uncertainties, and other important factors, each of which could cause Nanox’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the report. Annual Report of Nanox on Form 20-F for the fiscal year ended December 31, 2020 and subsequent filings with the United States Securities and Exchange Commission. The reader should not place undue reliance on the forward-looking statements included in this press release.
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1 Osteoporosis or low bone mass in older adults: United States, 2017-2018. Centers for Control and Prevention of Disasters. Updated March 31, 2021. Accessed April 26, 2022. https://www.cdc.gov/nchs/products/databriefs/db405.htm
2 Schnell S, Friedman SM, Mendelson DA, Bingham KW, Kates SL. The 1-year mortality of patients treated in a hip fracture program for the elderly. Geriatric Orthop Surg Rehabilitation. 2010;1(1):6-14. doi:10.1177/2151458510378105