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| Statement |
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| Corewell management reports that their team has successfully integrated the Nanox.AI HealthCCSng solution into their patient care flow, recognizing its significant value in identifying new patients with medium and high calcium levels on chest CT scans |
| In these units, by the way, I would say that the numbers of scans per day where they’re operational is actually - or the numbers are exceeding our original expectations |
| So, it's good |
| We have also received similar positive feedback from another healthcare system using Nanox.AI solutions |
| We are enhancing our US sales and service team, and I'm happy to announce we have signed an agreement with 626, a national healthcare technology and equipment management company |
| We are happy with it |
| With their ISO 13485 certification, national footprint, and over 160 field service engineers, they are an ideal company to partner with as we ramp up our commercialization efforts in the US |
| We are diligently navigating these challenges, prioritizing swift approvals, while ensuring accuracy and regulatory compliance |
| We have also made substantial progress in our home market, Israel |
| So, it's kind of a friendly environment for us to ensure that we're going to take all the benefits of the proof of concept, both for demonstration purposes and for operational |
| Ross Osborn Sounds good |
| We are pleased to announce that our local partner has obtained approval from the Ghana Food and Drug Authority, the GFDA, and it'll soon be operational for clinical scanning of patients |
| The agreements that we have, in each one of them we're making progress in terms of the regulation approvals |
| Thanks for taking our questions, and hope your loved ones and employees are safe as possible given the war |
| These updates are highly promising, and I look forward to providing additional updates on the Nanox.AI business throughout 2024 |
| So, just looking to understand the Nanox.ARC revenue a little bit better for the quarter |
| At the end of the quarter, we announced compelling study results which demonstrated that Nanox.AI product found that approximately 60% of patients unknowingly had moderate to severe level of coronary artery calcium, also known as CAC, proven indicator of future cardiac events |
| And some percentage, but we don't want to get into this just because the way we structure the agreement is very beneficial for us in terms of the way we want to manage our business |
| We are making significant progress toward deployment of the Nanox.ARC system at scale in both the US and other markets, and I'm looking forward to our Investor Day next week and our Q4 update call in early 2024 |
| To support these important efforts, our team and I have increased our presence in the United States over the last few months, and I'm currently in the US |
| Moving to the recent developments in deployments, I'm pleased to announce that we have established the first US-based commercial site and demonstration center for the Nanox.ARC, which is part of our initial wave in the US |
| I'm happy to announce that we have submitted our technical file for obtaining the CE mark |
| Ross Osborn Sounds great |
| And from the capacity point of view, they will be able to supply whatever we need going forward |
| Have a good day |
| While these revenues are currently small, they are growing |
| Good morning |
| On November 22, 2023, Nanox.ARC received AMAR approval from the Israeli Ministry of Health, and it is now registered as a medical device in the Israeli market |
| Headquartered in Boca Raton, Florida, 626 offers tools necessary for imaging centers to achieve maximum uptime and maintain better patient care |
| I don't want to give any - we have been saying all the time that regulation in medical equipment is something that is always challenging and very complicated and has a lot of facets, but we assume that with the quality of the information and the quality of the clinical trials that we have, and with the quality of the ISO that we passed, all of this, it'll be real reasonably faster than what (indiscernible), and I have an estimation, but I think that it would be better to wait until we get a better clarity when in 2024 we will get it |
| Statement |
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| Regarding our regulatory test, despite our efforts to gain regulatory approval in a number of markets across the world, sometimes our regulatory progress is slower than we would like, in some instances, such as with the FDA in the US |
| The decrease in the gross profit margins on a GAAP and non-GAAP basis is mainly due to an increase in the cost of the company's radiology - due to the decrease in the (revenue), and payments of incentive payments which the company paid to the company's radiologists engaged in the readings during the overnight and weekend shifts |
| Nevertheless, we have not stopped pushing ahead with our regulatory efforts, which continue to be of foremost importance to Nano-X |
| Goodwill impairment for the third quarter of 2023 was $7.4 million due to the goodwill impairment related to the teleradiology reporting unit in the amount of $7.0 million, and the Nanox.AI reporting unit in the amount of $0.4 million, largely due to the increasing discount rate, and management estimates that it would take longer than we originally expected to generate original growth of revenues, gross profit, and positive operating cashflow in the AI and teleradiology business segment |
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