Nano-X Imaging (US:NNOX)2025-06-23 07:58Business Updates - Nanox submitted a new 510k submission to the FDA to expand the intended use cases for the Nanox.ARC for general use, including chest[13] - Nanox advanced the US deployment program for the Nanox.ARC technology, with systems installed in eight states[14, 18] - 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[15] - Nanox is engaged with various OEMs and governments around the world to evaluate and/or develop X-ray tubes, industrial inspection applications, security systems, dental, veterinary and other novel medical devices[21] Commercial Strategy - Nanox employs a hybrid approach combining a usage-based MSaaS model with a CapEx model to help promote adoption[19] - Under the MSaaS model, for U.S. CPT Code 76100, the reimbursement range is $88–$109, with Nanox pricing at $30 for scanning and $20 for reading, resulting in a net to operator of $28–$49 (48%-62%) and $10 (33%) respectively[19] - Outside the U.S., Nanox prices scanning at $14–$17 and reading at $20, totaling $34–$37[19] AI Solutions & Clinical Performance - Corewell Health significantly increased their ability to detect coronary calcification by using Nanox.AI's cardiac solution, identifying nearly 3,721 new patients in 2023 compared to just 268 patients having CAC reported in the previous two years[37, 39] - Early findings in the ADOPT study show that Nanox.AI software improves the detection of spine fractures, an early sign of osteoporosis, outperforming UK National Health Service national average[41, 43] - Clinical Trial 08.2024: Preliminary Results for Chest DTS, Radiographically occult lesion (seen on DTS only. Not seen on CXR): 19/26[66] Nanox.ARC X - Nanox.ARC X is a future 3D digital multi-source tomosynthesis system with a smaller footprint[86, 88]