NNOX Nano X Imaging Ltd

NANO-X IMAGING LTD ("Nanox" or the "Company", Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it will present data supporting the Nanox.ARC performance at the 2025 European Congress of Radiology (ECR), taking place February 26 – March 2 in Vienna, Austria.

The Nanox.ARC is a stationary X-ray system featuring a proprietary digital X-ray source and advanced tomosynthesis technology with a cold cathode, providing a more comprehensive, sliced three-dimensional view of the body.

Earlier today Nanox announced that it has received CE (Conformité Européenne) mark certification to market the multi-source Nanox.ARC system in Europe, where the system is intended to generate tomographic images of human anatomy from a single tomographic sweep performed in recumbent positions of adult patients.

The CE mark, together with the FDA 510(k) general use clearance received in December 2024, marks a significant milestone in the global commercialization of the Nanox.ARC system.

“We take pride in our robust clinical performance. By prioritizing clinical needs and development efforts in collaboration with the medical community, we ensure that our innovations are not only advanced but also relevant to those we serve,” said Erez Meltzer, Nanox Chief Executive Officer and Acting Chairman. “Alongside our recent regulatory milestones, these latest Nanox.ARC data highlight several of our clinical efforts and reinforce our commitment to advancing patient care.”

Nanox representatives will be available for meetings throughout the congress. Schedule a meeting here: https://bit.ly/415jsjv.

New data will be presented across three abstracts at ECR:

• A clinical study evaluating digital tomosynthesis for musculoskeletal imaging
• A phantom study assessing the impact of obesity on chest imaging
• A case series demonstrating key applications in musculoskeletal diagnostics

More details are as follows:

Oral Presentation: Evaluation of the diagnostic potential of a Tomosynthesis system for MSK

• Presenter: Nogah Shabshin, M.D. (Medical Director, ARC Division at Nanox)
• Session: RPS 2410 - Imaging of musculoskeletal tumors
• Location: ACV, Research Stage 4
• Summary:
  • In a 19-patient study conducted by Shamir Medical Center, researchers compared standard X-ray, CT, and digital tomosynthesis (Nanox.ARC) for diagnosing fractures
• Conclusions:
  • Digital tomosynthesis provided diagnostic value in 17 of the 19 cases
  • The technology improved the detection of occult fractures and lesions, improved fracture localization, determined fracture age, and cleared suspected fractures

Poster Presentation: The Effect of Obesity on Chest Radiography and Digital Tomosynthesis – a Phantom Study

• Presenter: Nogah Shabshin, M.D. (Medical Director, ARC Division at Nanox)
• Location: EPOS Area, Level 2
• Summary:
  • In an internal Nanox study, a phantom simulating a human with lung nodules underwent scans by standard X-ray and digital tomosynthesis (Nanox.ARC). Gel layers were added to the phantom to simulate waist circumferences up to the 95th percentile of the U.S. population.
• Conclusions:
  • Nanox.ARC scans clearly demonstrated the simulated lung nodules and the image clarity was maintained through added gel layers.
  • In contrast, lung nodules were barely visible on standard X-ray scans, regardless of the number of added gel layers, suggesting potential benefits for early detection in a growing population affected by obesity.

Poster Presentation: Applications of Digital Tomosynthesis in the musculoskeletal system

• Presenter: Nogah Shabshin, M.D. (Medical Director, ARC Division at Nanox)
• Location: EPOS Area, Level 2
• Summary:
  • The versatility of digital tomosynthesis in musculoskeletal imaging is demonstrated in a series of clinical cases featuring scans taken by the Nanox.ARC.
• Conclusions:
  • Highlighted applications include improving visualization of overlapping bones, reducing dependency on patient positioning and coordination, and improved imaging of patients with casts.

About Nanox

Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by bringing a full solution of affordable medical imaging technologies based on advanced AI and proprietary digital X-ray source.

Nanox's vision encompasses expanding the reach of Nanox technology both within and beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, leveraging AI for more accurate diagnostics and maintaining a clinically driven approach. The Nanox ecosystem includes Nanox.ARC – a multi-source digital tomosynthesis system that is cost-effective and user-friendly; Nanox.AI LTD, a subsidiary of Nanox Imaging, is an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic diseases; Nanox.CLOUD – a cloud-based software platform that manages data collected by Nanox devices, and provides users with tools for in-depth imaging analysis; Nanox.MARKETPLACE – 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. By improving early detection and treatment, Nanox aims to enhance better health outcomes worldwide. 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, any statements 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 complete development of the Nanox 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 the 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 System and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces; (x) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xi) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xii) potential litigation associated with our transactions.

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.

Contacts

Media ContactICR HealthcareNanoxPR@icrinc.com

Investor ContactMike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com