Nanox to Present New Clinical Data on Nanox.ARC Advanced 3D Digital Tomosynthesis Imaging System at ECR 2025
Nanox (NASDAQ: NNOX) will present new clinical data for its Nanox.ARC digital tomosynthesis system at ECR 2025 in Vienna. The system recently received both CE mark certification for European marketing and FDA 510(k) clearance in December 2024.
Three key studies will be presented:
- A 19-patient clinical study showing diagnostic value in 17 cases for fracture detection
- A phantom study demonstrating superior lung nodule detection in simulated obesity conditions compared to standard X-ray
- A case series highlighting improved musculoskeletal imaging applications
The Nanox.ARC system features a proprietary digital X-ray source with cold cathode technology, providing 3D body views while reducing radiation exposure and reading time. Clinical results showed enhanced detection of occult fractures, improved cast imaging, and potential reduction in CT scan requirements.
Nanox (NASDAQ: NNOX) presenterà nuovi dati clinici per il suo sistema di tomosintesi digitale Nanox.ARC all'ECR 2025 di Vienna. Il sistema ha recentemente ricevuto sia la certificazione CE per la commercializzazione europea che l'approvazione FDA 510(k) a dicembre 2024.
Saranno presentati tre studi chiave:
- Uno studio clinico su 19 pazienti che mostra il valore diagnostico in 17 casi per la rilevazione di fratture
- Uno studio su fantomi che dimostra una superiore rilevazione di noduli polmonari in condizioni simulate di obesità rispetto alla radiografia standard
- Una serie di casi che evidenzia miglioramenti nelle applicazioni di imaging muscoloscheletrico
Il sistema Nanox.ARC presenta una sorgente di raggi X digitale proprietaria con tecnologia a catodo freddo, fornendo visualizzazioni corporee 3D mentre riduce l'esposizione alle radiazioni e il tempo di lettura. I risultati clinici hanno mostrato una migliore rilevazione di fratture occulte, un miglioramento nell'imaging dei gessi e una potenziale riduzione dei requisiti per le scansioni TC.
Nanox (NASDAQ: NNOX) presentará nuevos datos clínicos para su sistema de tomosíntesis digital Nanox.ARC en el ECR 2025 en Viena. El sistema recibió recientemente tanto la certificación CE para la comercialización en Europa como la autorización FDA 510(k) en diciembre de 2024.
Se presentarán tres estudios clave:
- Un estudio clínico con 19 pacientes que muestra el valor diagnóstico en 17 casos para la detección de fracturas
- Un estudio de fantomas que demuestra una superior detección de nódulos pulmonares en condiciones simuladas de obesidad en comparación con la radiografía estándar
- Una serie de casos que destaca las aplicaciones mejoradas en la imagenología musculoesquelética
El sistema Nanox.ARC cuenta con una fuente de rayos X digital propietaria con tecnología de cátodo frío, proporcionando vistas corporales en 3D mientras reduce la exposición a la radiación y el tiempo de lectura. Los resultados clínicos mostraron una mejor detección de fracturas ocultas, una mejora en la imagenología de yesos y una posible reducción en los requisitos de escaneos por TC.
Nanox (NASDAQ: NNOX)는 비엔나에서 열리는 ECR 2025에서 Nanox.ARC 디지털 토모신세시스 시스템에 대한 새로운 임상 데이터를 발표할 예정입니다. 이 시스템은 최근 유럽 마케팅을 위한 CE 마크 인증과 2024년 12월 FDA 510(k) 승인을 모두 받았습니다.
세 가지 주요 연구가 발표될 예정입니다:
- 19명의 환자를 대상으로 한 임상 연구로, 17건의 골절 탐지에서 진단 가치를 보여줍니다
- 표준 X선에 비해 비만 조건에서 우수한 폐 결절 탐지를 입증한 팬텀 연구
- 근골격계 이미징 응용 프로그램의 개선을 강조하는 사례 시리즈
Nanox.ARC 시스템은 냉음극 기술을 사용하는 독점적인 디지털 X선 소스를 특징으로 하며, 방사선 노출과 판독 시간을 줄이면서 3D 신체 이미지를 제공합니다. 임상 결과는 숨겨진 골절의 탐지 향상, 석고 이미징 개선 및 CT 스캔 요구 사항의 잠재적 감소를 보여주었습니다.
Nanox (NASDAQ: NNOX) présentera de nouvelles données cliniques pour son système de tomosynthèse numérique Nanox.ARC lors de l'ECR 2025 à Vienne. Le système a récemment obtenu à la fois la certification CE pour la commercialisation en Europe et l'autorisation FDA 510(k) en décembre 2024.
Trois études clés seront présentées :
- Une étude clinique sur 19 patients montrant la valeur diagnostique dans 17 cas pour la détection des fractures
- Une étude fantôme démontrant une détection supérieure des nodules pulmonaires dans des conditions d'obésité simulées par rapport à la radiographie standard
- Une série de cas mettant en évidence les applications améliorées de l'imagerie musculosquelettique
Le système Nanox.ARC dispose d'une source de rayons X numérique propriétaire avec technologie à cathode froide, fournissant des vues corporelles en 3D tout en réduisant l'exposition aux radiations et le temps de lecture. Les résultats cliniques ont montré une détection améliorée des fractures occultes, une amélioration de l'imagerie des plâtres et une réduction potentielle des exigences en matière de scanner CT.
Nanox (NASDAQ: NNOX) wird auf dem ECR 2025 in Wien neue klinische Daten für sein digitales Tomosynthesesystem Nanox.ARC präsentieren. Das System erhielt kürzlich sowohl die CE-Zertifizierung für den europäischen Markt als auch die FDA 510(k) Zulassung im Dezember 2024.
Es werden drei wichtige Studien präsentiert:
- Eine klinische Studie mit 19 Patienten, die den diagnostischen Wert in 17 Fällen zur Frakturerkennung zeigt
- Eine Phantomstudie, die eine überlegene Erkennung von Lungennodulen unter simulierten Adipositasbedingungen im Vergleich zu Standard-Röntgenaufnahmen demonstriert
- Eine Fallserie, die verbesserte Anwendungen der muskuloskelettalen Bildgebung hervorhebt
Das Nanox.ARC-System verfügt über eine proprietäre digitale Röntgenquelle mit Kaltkathodentechnologie, die 3D-Körperansichten liefert und gleichzeitig die Strahlenexposition und die Lesezeit reduziert. Die klinischen Ergebnisse zeigten eine verbesserte Erkennung von versteckten Frakturen, verbesserte Gipsabbildung und eine potenzielle Reduzierung der CT-Scan-Anforderungen.
- FDA 510(k) clearance and CE mark certification achieved
- 89.5% success rate in musculoskeletal diagnostic study (17/19 cases)
- Superior lung nodule detection in obesity conditions vs standard X-ray
- Potential to reduce costly CT scan requirements
- 2 cases showed no diagnostic value in musculoskeletal study
Insights
Nanox's announcement of new clinical data for its Nanox.ARC system represents a significant technical validation milestone following recent regulatory achievements. The dual regulatory clearances—FDA 510(k) in December 2024 and now CE mark certification—remove critical barriers to commercialization in the world's two largest medical device markets.
The clinical data being presented at ECR 2025 addresses several compelling use cases that could drive adoption. The 19-patient musculoskeletal study showing diagnostic value in 89% of cases demonstrates practical clinical utility, particularly for fracture detection and characterization. Most notably, the phantom study highlighting superior performance in simulated obesity conditions targets a growing clinical challenge—the declining diagnostic quality of standard X-rays in an increasingly obese population.
From a market positioning perspective, Nanox is targeting the sweet spot between traditional X-rays and CT scans. By potentially eliminating the need for some CT scans while offering superior diagnostic capabilities to standard X-rays, the technology could create a new market segment with compelling clinical and economic benefits:
- Reduced radiation exposure for patients
- Decreased radiologist reading time (efficiency gain)
- Improved diagnostic accuracy without requiring full CT
- Enhanced visualization through metal and casts
The proprietary digital X-ray source with cold cathode technology represents Nanox's key technical differentiation. This approach allows for a stationary (non-rotating) design that potentially offers reliability and maintenance advantages over conventional CT systems.
However, significant commercialization challenges remain unaddressed. The announcement lacks details on:
- Pricing strategy and capital equipment cost
- Reimbursement pathways and CPT coding status
- Manufacturing scale-up plans
- Sales and distribution partnerships
For investors, this announcement signals progress in validating the technology's clinical utility but doesn't yet provide visibility into the revenue timeline or market penetration strategy. With a relatively small market cap of $357 million, Nanox will need to demonstrate commercial execution to justify valuation expansion beyond the current levels.
The company's ability to navigate the complex medical imaging marketplace—dominated by giants like GE Healthcare, Siemens, and Philips—will be critical. Nanox must clearly articulate its value proposition not just to clinicians but to healthcare administrators who make capital equipment purchasing decisions based on return on investment calculations.
- 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, 2025 (GLOBE NEWSWIRE) -- 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 Contact
ICR Healthcare
NanoxPR@icrinc.com
Investor Contact
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ICR Healthcare
mike.cavanaugh@icrhealthcare.com
FAQ
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