Welcome. To submit questions using the Zoom Q&A interface at the bottom of your screen. After the presentation, we'll open to your questions. With that, Ran, I'll turn it over to you.
Thank you, Alex, and good afternoon for everyone. Before we get started, I would like to remind everyone that I'll be making statements during this presentation that may be deemed forward-looking statements regarding our activities, commercializations, and any other matters. Computer is frozen. Anyway, I'm pleased to say that we are making progress in our mission to make progress in the medical imaging and improve patient outcomes. Our innovative technologies, including the Nanox. ARC and our AI solutions, are gaining traction in the market. I don't know why it's not going forward.
Okay, there you go.
Yeah, yeah, sorry. Just to be official, this is the disclaimer. Okay, we have developed the Nanox .ARC system, which combines a multi-source Nanox .ARC imaging device with our cloud-based Nano x.CLOUD platform. Our Nanox.ARC system, which you can see behind me over here, it's our own 3D digital multi-source systems, which combines our proprietary digital X-ray source to produce 3D tomosynthetic images with multi-stationary tubes arranged around the patient. I can show you over here. This is our chip. This is our tube, which goes together into our assembly house of the tubes which are positioned over here. One, two, three, four, five tubes. This is the overhead camera, and this is where the patient lies down. The assembly house of the tubes, or they are, just is stationary, and the bed is moving with the patient and stop to stop.
That depends on the particular or specific procedure that the patient moves. This system, together with our cloud system, is designed to streamline the medical imaging from scan to diagnosis, offering scalable, cost-effective solutions for early detection. Our Nanox.CLOUD centralizes all our AI solutions, AI diagnostic, radiologist machine, and reporting. We're using the IT infrastructure that you need, and we enable all this system to be operated remotely and as well as to support it. It also is being used as our billing systems. The only physical component of our solution that you see is actually our ARC. All the other, it's on the cloud. I want just to give an illustration of how exactly a tomographic sweep is being done. Here you see the technician, which has a regular iPad, programming the parameters for the patient and performing the overview. It's a chest scan.
You can see the bed is moving. The Arc is tilting 15-18 degrees to each side, creating the tomo effect. The machine, the device, is creating 30-60 images that are going to our cloud and being reconstructed to one 3D image with our reconstruction software. What are the clinical benefits for the tomosynthesis? First of all, the visuality of the image is much better, is enhanced. It also reduces the superimposition of normal structures that may reduce the false positive cases. It also contains many details. More details is more sensitive. It also has additional depth of views. Since most of our solutions, you may say it is an end-to-end solution, everything is being, it actually creates a speeder diagnosis and faster treatment, of course. We are tomosynthetic. Our technology is based on tomosynthesis. We are positioned between an X-ray and a CT.
The main difference is that CT produces hundreds of images, X-ray only one, and we create 30-60 images. The reading time is much closer to X-ray than CT, and the level of the dose is a little bit more than X-ray and far from the CT. A few examples of what is the difference between X-ray and Nanox.ARC . In this slide, you can see on the left side a patient with a cast. Usually, when a patient comes with a cast to take an X-ray, he needs to remove his cast. In our case, you can see that there's no need to remove the cast. Actually, our machine can read through the layers of the human body, and you get a clearer image with no need to remove the cast. This is a case of a hip fracture compared to a conventional X-ray.
This is my favorite example of an X-ray versus a digital tomosynthetic slice. You can see where you can find a needle over here, which cannot be seen in a regular 2D radiograph. What is the regulatory pathway that we have made through? Just as a reminder, some history about the company. The company was, this current form of the company was founded in 2018 by our founder, Ran Poliakine. Actually, our technology was developed by a group of scientists from the University of Japan. They were a spinoff from Sony itself. I'm sorry. Actually, they developed the chip, and we developed from 2020 and further on the tube itself. Today, the company is composed from three business divisions. The first one is the hardware with the flag product of the Nanox.ARC , as I explained before.
The second one is the AI division, which was acquired in 2021 from Zebra Medical Solution. We'll discuss it later. Our teleradiology division as well. We also have an OEM business, which is leveraging on the technology that we developed, the chip and the tube. What we have achieved regulation-wise, the ARC itself, the version that you see over here, was cleared for MSK use in May of 2023, for general use in December 2024. The next version of the ARC, the Nanox. ARC X, which I will show later, was cleared to be marketed in the US in April of 2025. We got the CE approval for all body in February of 2025. All our AI solutions are cleared by the FDA and the CE as well. Commercialization. We divide the world for two parts, in the ex-U.S. and the U.S.
In the U.S., we do a direct approach. We have our own sales force in the U.S. It's composed of sales personnel, market personnel, and clinical support personnel, which are very important to us because their job is actually to go from one customer to another and to show them the clinical value in our machine and to encourage them to use the machine. Outside of the U.S., we do an indirect approach. We have distributor agreements with various distributors all around the world. What we target in the U.S. market, we target imaging centers, orthopedic clinics, multi-special purpose medical centers, urgent cares, and etc. We have two economic models that we work in the U.S. market. The first one is capital sales, as we have in some other areas in the world.
You simply can buy and buy our machine outright and use it. Of course, you can add the maintenance component if you wish to. We also offer our devices on an MSaaS model. MSaaS means Medical Scan as a Service. It's simply our pay-per-use model. Sorry for that. We do charge $30 per scan, and we do oblige the customers to pay us seven scans as a minimum per day. Of course, it's a multi-year contract throughout most of the economic life of the machine. Sometimes we also offer a hybrid model, which means some of the down payment and some of it is the balance in the pay-per-use model. We also offer a third-party financing for the machine. What is the commercial strategy in the U.S.? We do have a hybrid approach that, as I said, is that combining the pay-per-use model with the CapEx model.
Why we think that our MSaaS model is innovative? First of all, when you offer someone to pay as he uses, you save him the need to invest a large amount of CapEx to acquire the machine. Coupled with the fact that our covered procedure with the established reimbursement is the CPT code 76100, which actually encompasses most of the usage of tomosynthesis, which is very simple because you have to deal with only one CPT code. As you can see from this schedule, the global amount for the 76100 in various areas in the U.S. varies between $90-$110 per procedure when the professional component is $30 per procedure, and the technical portion is $58-$79 per procedure. We charge $30 under our pay-per-use model per procedure. We also offer the client to use our teleradiology services and to pay us an additional $20.
The end result is that the net operator gains a margin of 43-54%, a very respectable margin. It's simply a win-win situation. Economically, the operator has an incentive to use the device more, and we, of course, enjoy from that usage. Other than what I said in the U.S., we also have a few installations in hospitals. We have three devices that are installed in Israel, two in Rabin Medical Center. One is this version. The other one is the next version that I'll explain later. I'll show later. We also have one device in Shamir, and we have another device in the largest hospital in Ghana. In all of them, we conduct some of our clinical trials, whether it's a specific trial or a general trial. I mentioned the Nanox.ARC . What is the Nanox.ARC ? It's actually our latest 3D digital multi-source tomosynthesis systems.
As I will show in the next slide, it has an improved design result in a smaller footprint. The new system is also designed to enable software upgrades and new capabilities. Today, as I said, the capability of this machine is to yield the 3D image. We are thinking of adding more capabilities to the machines on the top of the 3D image. Of course, we can run and control the machines remotely in both versions. This is how the Nanox.ARC looks like. I adhere everyone to go to our website for some more info about this new version. This new version, as I said, was cleared by the FDA in April of 2025. As I said, this is a small footprint. This version actually is a full span, and I hope that everyone can see that. It's a 15-foot device.
15-foot device is not always practical to go in smaller rooms just because in those types of customers that we target, sometimes real estate is expensive and the room is being used in a more effective way. Shortening this device by 6 foot gives us more opportunities to deploy more devices on the field. As the first version that you can see over here, the new version is multi-axis tomographic systems. It still works on the same source of energy called cathode, which is the chip and the tube. Just in the new version, this is a ceramic tube which we developed in our own fab in Korea. The tubes that we use in that version, it's actually glass tubes that are going to be manufactured by a few vendors. Of course, as you can see, it's an open and slick design.
It's very easy to access, very easy to use. It's a cable-free design. I don't know if you see, but in the first version, we also have an external electric cabinet. You can see it in the corner of the room. It's connected by cables on the floor. In this version, we actually condensed all the external parts into the device. It's one device. You simply come, install it, plug it, and play it. Very simple to use. Okay, I talked about the system design. I want to say a few words about our AI division. As I said, we have acquired the AI business from Zebra Medical Solution in November of 2021. We have several products that were actually cleared by the FDA and approved by the CE. Today, we are focused on three products that compose our suite of population health solutions.
The first one is the Bone Solution. It actually addresses vertebral compression fracture and low bone mineral density. The low bone mineral density version was actually cleared by the CE last week that we had PR about it. Our Cardiac Solution component, which goes on the coronary artery calcium measurement, and our Liver Solution. We work on additional products such as one for the ortho, another for full body composition, which is also going to be done with some collaboration with some universities in the U.S. Generally speaking, our AI solutions are, first of all, standing by themselves. Every IDN that uses PAC systems, every client that uses PAC system can install and use our AI solutions. It usually runs over CT scans. Of course, the second version of that is going to work on our own machines on the ARC.
In the future, we may develop some interfaces that are going to connect automatically our devices to our AI solutions, simply saying to have the option that we may automate the whole process. Today, we have a few customers in the U.S., namely Corewell Health, which is an IDN in the northeast of the U.S.. They entered into the fourth year of engagement with us. They also expanded the scope of the usage for those three solutions. We have also other customers such as Covera Health, Dandelion Health, Intermountain, etc. All of those customers are working with us on the basis of an annual license fee. Recently, we also started to work with our AI solutions also on a pay-per-use model. Namely, for example, we partnered with Ezra Medical to use our AI solutions. They actually use our solutions on a pay-per-use model. They offer cancer diagnostic services.
If they wish to, if they want to, they use one of those solutions, our chest solutions, for example, where we start with them, and they will pay for this solution. We have various options to work with our AI solutions and in various business models. In Europe, we had an installation of our bone solutions in the U.K. We had collaborations with the Minister of Health over there. That was a multi-year project. They also funded some of the development of those products. This year, actually, we transitioned this project into its commercial phase. Just as a reminder, I said it was acquired in November of 2021. When we acquired Zebra, we also acquired a database of over 500 million imaging CT scans, which facilitate the development of our AI medical imaging solutions.
Of course, as I said, everything is approved by the CE and the FDA. That is it. Let's see. Okay. A few words before I go to some financial highlights. We also have the teleradiology division, which we acquired also in November of 2021. That is USRAD. It is based in Florida. We have a network of certified radiologists in the U.S. They work, they do teleradiology, which means they also use our cloud platform to perform their job. Actually, our cloud platform connects all the stakeholders within our company, whether it is the AI solution, whether it is the ARC or our teleradiologist, to the customers, to the one who ordered the job. The whole process, besides the scan, is being done over the cloud and shortened the time to market. We also have the OEM business, as I explained. Our core technology, it is this chip and this tube.
Already in the earnings, we already mentioned a project that we have with Oak Ridge. It's a semi-government agency. We are past a few phases over there. We also have some other projects with other commercial companies with regards to our technology. As for the financial highlights, we finished the first quarter of 2025 with $72.9 million in cash and cash equivalents. We had a quarter revenue of $2.8 million. We have a big component of fixed assets and inventory on our balance sheet for two reasons. The first one is the fab that we established in Korea, which developed the chip and the ceramic tube. We also, all the devices that are being used for the pay-per-use model are being capitalized into our balance sheet. Our burn rate at the moment is approximately $3 million per month. That's it.
Ran, that was great. Thank you for sharing a lot of exciting information with us. We're getting some questions from the audience. There's a lot of ways to measure success in democratizing medical imaging. Is it the units installed, the AI licenses, the revenue, the clinical endpoints? Could you help us sort of think about where the company is today in terms of success as you define it? And then maybe help us understand the timeline for growing the install base and getting more success.
Okay. So we have touched this in a few points in our latest learning calls. I will divide it per our business divisions. As I said, we have three business divisions, and we'd like to measure each one on a standalone basis and the own company as a standalone basis. Of course, it depends on the interrelations between those three divisions.
On a standalone basis, we already said that we estimate that the AI division will be maybe break-even on a quarterly run rate sometime in 2026. We think that the hardware division will be break-even when we have somewhere between 1,500-2,000 units on the field. It is not an official guidance, but it is some kind of rule of thumb. We did guide the market in our latest earnings calls that we estimate that we may have 100 units or more deployed by the end of the year, this year, 2025.
Okay, great. Thank you. A question as well around partnerships. I think you mentioned Covera Health and Ezra Medical . What do you consider to be sort of competitive versus synergistic partnerships? Just a question around how Nano-X fits into the competitive environment.
I think it is a combination of both. Without getting into much details and technology, etc., our collaboration with Varex, CEI, and CSAM, where we actually outsource the chip and the tube itself, we developed ceramic tubes. Actually, with CEI and Varex, we are having glass tubes, which are cheaper, much more effective. Economic-wise, it makes more sense to use those tubes in our newer versions. Also, when you speak about, for example, in the AI business, if you talk about Corewell, or if you talk about Ezra, all of them are customers, but we also do collaborate with them because all the information that we gain in our AI tools together also with the ARC, when we accumulate this information, it simply helps us to develop a better version of the current products and even develop our future products.
Great. Ran, for folks kind of newer to the stock, if they're looking at the stock price over the last couple of years, what do you think are particular aspects of the business the street might be underappreciating?
That's a long question. Listen, I think that, and it's just my personal perspective, I think that when the company went public, there was an idea. There was some kind of momentum in the market. It was during the midst of COVID. Every med tech or healthcare that was related IPO was successful. We had no product. We had no FDA. We had no commercialization. The company was IPO at $18 per share, went up to $90, and today we are even in much lower price.
I think today, if you compare the share price and what we achieved and what we have right now, which is products, actually, it's a basket of products. Regulation-wise, we have CE and FDA to most of our products. We continue to develop our current products. We continue to develop our future products. We started commercialization in the U.S., and we're breaking the water in other markets in the EU. We had some installation in Africa. We have some clinical deployments in Israel, in Africa. We are in more advanced progress of the life of the company, but with much lower share price. I think it just says for itself.
No, I think that's a great answer because you started answering my next and last question, which was for folks who might be looking across medical imaging investment opportunities, how do you think Nano-X stands out? Yeah, I think you did a nice job summing that up.
I think that if you look a little bit for the long run and not on tomorrow, you see how we can become not just a medical device player, but we also can emphasize the AI and the whole trend of having an end-to-end solution. You know what? I would say end-to-end innovative solution because if you compare it to X-ray and CT, it's like we are, I think that we are more innovative. You can see where the future lies. It's AI, cloud, time to market, preventive to early diagnosis. All of those factors come into play. At some point, everything comes together, and you go into the next phase.
Makes sense.
With that, we are at time, but I'd like to thank you, Ran, for sharing the Nano-X story with us, and also thank everybody listening for spending time with us today. Thank you very much, Alex. Pleasure to be here.