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PETACH TIKVA, Israel - Nanox (NNOX), an innovative medical imaging technology company with a market capitalization of $287 million, has announced its receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Nanox.ARC X, a new digital tomosynthesis system. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet. This clearance allows the Nanox.ARC X to produce tomographic images for various medical uses, including musculoskeletal, pulmonary, intra-abdominal, and paranasal sinus indications for adult patients.
The FDA approval, which was granted in under 30 days from submission, represents a significant advancement in medical imaging technology. The Nanox.ARC X system is designed to deliver a more comprehensive, three-dimensional view of the body, enhancing visualization by reducing the superimposition of structures often seen in 2D X-rays. While the company’s gross profit margins remain challenged at -94%, analysts anticipate substantial sales growth in the current year, with revenue projected to more than double.
Erez Meltzer, CEO and Acting Chairman of Nanox, emphasized the importance of this milestone, stating, "By integrating our proprietary digital technology in this new imaging system, we’re making it easier for healthcare providers to adopt digital 3D imaging." He also highlighted the company’s commitment to expanding access to medical imaging technology and the potential for future enhancements through remote software upgrades.
The Nanox.ARC X features a sleek design with a smaller footprint compared to traditional systems, offering a ’plug and play’ installation process that can be completed in one day. It is built to operate in any standard X-ray shielded room, requiring minimal infrastructure and running on standard power sources. Its cable-free design aims to improve safety, ease of cleaning, and maintenance. InvestingPro analysis suggests the stock is currently undervalued, with additional insights available in the comprehensive Pro Research Report, which provides detailed analysis of this and 1,400+ other US stocks.
Nanox plans to launch the Nanox.ARC X later this year, expanding its product portfolio to cater to various customer needs. The company’s vision includes a full suite of affordable medical imaging technologies backed by advanced AI and proprietary digital X-ray sources, aiming to drive the transition to preventive healthcare. With a current ratio of 5.63, the company maintains strong liquidity to support its growth initiatives, though investors should note that profitability remains a key challenge, as highlighted by multiple InvestingPro metrics and analysis.
The information for this article is based on a press release statement from Nano-X Imaging LTD.
In other recent news, Nano-X Imaging reported its fourth-quarter 2024 financial results, revealing a revenue increase to $3 million, up from $2.4 million the previous year. This growth was primarily driven by a 23% rise in teleradiology services, which contributed $2.8 million. Despite the revenue increase, the company experienced a wider net loss of $14.1 million, compared to $10.2 million in Q4 2023. Cantor Fitzgerald maintained an Overweight rating on Nano-X Imaging but reduced the price target from $12 to $9, citing the company’s operating results and recent corporate updates. The firm remains optimistic about Nano-X’s future, highlighting potential U.S. deployments and anticipated FDA approval of next-generation devices. Nano-X Imaging also achieved significant regulatory milestones, including FDA clearance and CE Mark certification for key products, as part of its strategic market expansion in the U.S. and Europe. Additionally, the company is focusing on expanding its AI solutions client base and market education efforts.
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