NANO-X IMAGING LTD

This time, all participants are in the listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Glenn Garmont of Investor Relations.

Thank you, Joe, and thanks to everybody for joining the Nano-X Imaging First Quarter 2021 Conference Call. On today's call, we will hear from Ron Polyakin, Chairman of the Board of Directors and Chief Executive Officer, and Itzhak Mayan, Chief Financial Officer. Before we begin, I'd like to remind everyone that management's remarks today may contain forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process, operations, the impact of COVID-19 on its business, and other matters. These statements are subject to risks, uncertainties, and assumptions and are based on management's current expectations as of today and may not be updated in the future. Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date. Factors that may cause such a difference include but are not limited to those described in the company's filings with the SEC. We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of non-GAAP to GAAP measures is provided in our press release, with the primary differences being stock-based compensation and class action-related expenses. With that, I would like to turn the call over to Nanox's Chairman and Chief Executive Officer, Ron Polyakin. Ron?

Thank you, Glenn, and thanks to everyone joining our first quarter update call. Also joining me on the call this morning is Yitzhak Maayan, our CFO. I would like to start with the FDA 510K clearance of Nanox CART X-ray system. The key highlight since our last quarterly update has been the FDA clearance for our single source system, which we now refer to by its cleared name, the Nanox CART X-ray system. This 510K clearance represents a significant milestone, for our company. It is the result of nine years of R&D and a very meaningful leap forward in X-ray technology. We believe that this clearance supports a similar regulatory pathway for the multi-source system. This clearance is an important stepping stone towards our designated commercial multi-source system, the NanoX Arc, that leverages our unique main chip low-voltage nanoscale cold cathode X-ray source technology. It is smaller and cheaper to manufacture the legacy hot filament technology that requires special cooling and rotating mechanics and we believe can replace analog X-ray technology that has been used for over 120 years. As we demonstrated live at RSNA, the NanoSarc can produce high-resolution clinical quality imaging in both 2D and 3D across a range of imaging procedure. We believe the results is a simpler, more cost effective machine with a smaller footprint. Moving now to the supply chain and manufacturing ramp-up update. So our supply chain and manufacturing ramp-up We continue to make important progress building our global supply chain, including scaling up our semiconductor fabrication plant in South Korea. The fab is currently in construction and will be built next to the SK Hynix Semiconductor Cluster in South Korea, the world's largest semiconductor center. The fab site is 12,000 square meters, including 1,200 square meters MEMS Cleanroom. This overall project cost is estimated at $45 million and the plant is expected to be operational mid-next year. In the meantime, we are currently operating out of a temporary manufacturing fab facility in South Korea for MEMS production, which will start contributing to our end-to-end chip production process during the second half of this year. The technology transfer from Japan to our South Korean subsidiary is progressing as planned. At this point, I would like to provide an update on the development of our multi-source NanoSARC, which will be our actual commercial device. Recently, we have experienced delays which were compounded by the COVID-19 pandemic with the first manufacturer of our second generation high-power ceramic tube. We are currently working with two alternative tube suppliers, for the multisource system. As a result, while we do not expect to meet our previously announced milestone of shipment of 1,000 units multisource Nano-X by the first quarter of 2022, we believe that we will be able to gain ground during the year to reach the shipment milestone of 1,000 Nano-X units during 2022 and possibly more if the multisource Nano-X arc is cleared by the FDA and authorized by other similar regulatory agencies. NanoX continues to expect submission of a 510K pre-market notification to the FDA with the multi-source NanoX Arc and the NanoX Cloud during 2021 and deployment of an initial wave of approximately 15,000 NanoX Arc units by the end of 2024. Moving to the commercial update. At this point, I would like to provide an update on our commercial activities. Recall that we have a unique business model, which we call MSAS, Medical Screening as a Service, which employs a paper scan approach. This is a key differentiator for us. It avoids the significant upfront investment associated with traditional X-ray technology. making the machine more affordable for healthcare facilities of all sizes. We believe this model has been key to our early success in entering into commercial agreements. Recall that we currently have contracts in place for the deployment of 5,150 nanoSARCs units with nine service providers in 13 countries. In addition, We have collaborations with USA RAD and SK Telecom for the deployment of an additional 5,500 units in the U.S., South Korea, and Vietnam. And following our live demo at RSNA, we've been experiencing increasing interest from service providers across many countries, resulting in a growing pipeline of potential opportunities to enter into additional MSAS agreements. The NANOX Arc is just one element of our potential value proposition. We believe that the medical imaging should migrate to a universally connected global cloud service with superior accessibility to medical data and its analysis for the benefit of preventive healthcare. Our vision is to provide a worldwide end-to-end medical imaging solution including remote services such as image repository, radiologist matching, online and offline diagnostic review and annotation, connectivity to medical imaging AI systems, and billing and reporting. As we move forward towards commercialization, we're continuously seeking opportunities to expand our capabilities through potential partnerships and acquisitions. Moving on to team additions. Before turning the call over to Yitzhak to review the financials, I'm turning now to our team. I'm excited to say that we've made a number of significant additions to our leadership, most recently with the addition of Moshe Stengel, our Chief Business Officer. Moshe has substantial experience in global and medical business, development, and sales executive. We also announced the additions of Jim Dera, COO, Ophir Koren, CTO, and Tamar Aaron Cohen, CMO. All of these individuals bring substantial experience to their roles. I believe this is an indication that we are building out a world-class team that best positioned us for long-term success. At this point, I will turn the call over to Yitzhak for a review of our financials. Yitzhak, please.

Thank you, Ram. Nanox reported a gap net loss applicable to ordinary shares for the first quarter of 2021 of $12.7 million, compared to a net loss of $7.4 million for the first quarter of 2020. Non-gap net loss applicable to ordinary shares for the first quarter of 2021 was $7.1 million, compared to a non-gap net loss of $2.6 million for the same period in 2020. A reconciliation between GAAP net loss and non-GAAP net loss for the three-month period ended March 31, 2021, and 2022 is provided in the financial results that are part of the press release we issued this morning. The difference between GAAP and non-GAAP net loss to ordinary shares is mainly due to share-based compensation and expenses associated with the secondary offering completed during the quarter. Non-GAAP research and development expenses for the first quarter of 2021 were $2.1 million, as compared to $689,000 for the comparable period in 2020, reflecting the increased development activities of our nanosystem. Non-GAAP marketing expenses for the first quarter of 2021 were $1.2 million, as compared to $651,000 for the comparable period in 2020, as we continue building our brand awareness and product marketing capabilities. Non-GAAP general and administrative expenses for the first quarter of 2021 were $3.7 million as compared to $1.2 million for the comparable period in 2020, as we are ramping up our investment in expanding our management team and the overall organizational infrastructure in addition to costs related to the company's secondary equity offerings. Net cash used in operating activities during the first quarter of 2021 was $4.4 million as compared to $2.3 million for the comparable period in 2020. As of March 31st, 2021, we had approximately 47.6 million shares outstanding. We ended the first quarter of 2021 with cash and cash equivalents of approximately $219.3 million including $13.6 million cash in transit which were paid soon after the quarter ended and with no debt. For the quarter, cash users included funding of our operating activities and investing $5.7 million in purchasing property and equipment. Nano's cash position increased versus the year end 2020 as our financing activities generated $15.9 million including $2.2 million from option and warrant exercises, and $13.6 million were filled by a trustee following share option exercises. We believe that our current cash is sufficient to fully execute on our plan of manufacturing, shipping, and installing 15,000 of our Nano-TARC units, which we are targeting by the end of 2024, while continuing to expand our delivery capabilities and invest in our clinical and product roadmap. And with that, We would like to open the call for questions. Operator, please start the Q&A session.

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your cell phone keypad, and a confirmation tone will indicate that your line is in the queue. If you would like to remove your question from the queue, please press star 2. If for anyone, for participants using speaker equipment, it may be necessary to pick up your handset before pressing the start keys. One moment, please, while we poll for questions. Our first question is from Kyle Mixon with Kendra Fitzgerald. Please proceed.

Thanks. Hi, guys. Congrats on the approval, of course. So just was wondering if you could provide a bit more detail on why the third-party tube manufacturer experienced the delay. Just wondering if that's a systemic kind of issue. Just as like a, you know, for background, I guess, on the last call, you mentioned two tube suppliers in Korea, but then stated that you wanted to bring that in-house eventually. So just wanted to understand if there was an update there. And also was wondering if the delay is indicative of any issues with the ability of the two components to withstand the temperature between the cathode and the anode. Thank you.

Okay, let me take that. Thank you. Thanks for the question. I would go back again just for the context in terms of our supply chain. So our unit is based on three main, I would say, critical components. One is the chip, the other one is the tube that's enclosed with the chip, and the other one is the system. I believe that in terms of the system, what we reported before is that given the limitations of traveling during COVID-19, we mitigate the risk and we successfully opened up a manufacturing plant in a subcontractor in Israel for the system integration, and I believe we also issued a press release on that. So that has not changed. In terms of the cheap manufacturing, what we've also, I believe, released is that we do have long-term investment in a beautiful facility in South Korea, and we are now migrating the technology from Japan to Korea to deliver that by the second half of this year, we will have a sufficient ability, we believe, to supply the chip component. In terms of the tubes, we are working currently with three suppliers. Actually, we had a supplier in Korea that was our leading supplier, and he simply had issues related to the final assembly and testing. They're still working on it. And when we saw that this is delayed, we just opened up two other suppliers, one of which already is in a good position to supply those tubes. And the second one is expecting to show some results later on. in this year, and we also believe that even the first supplier that experienced some delays will come around. So what we're doing, we're mitigating the risk of the delays by opening two additional suppliers, and also making sure that we have sufficient, I would say, sufficient access to suppliers that are not only in Korea. So we opened up another one in Italy. So that's really what we did. I believe that due to COVID-19, also traveling and making sure that everything is okay is not easy. So overall, that's why we felt that it would be prudent from the company's point of view to plan and to report that we're not going to ship those 1,000 units on the first quarter as previously announced.

That was perfect. Thanks a lot, Ron, for that. And it's positive, obviously, that the 15,000 placement goal remains in place, but could you just talk about your level of confidence that you'll be able to hit that? Because obviously it's a pretty kind of steep ramp in 22 and beyond. And then kind of related to that, is there any concern or risk about the X-ray carts being manufactured as well, according to the original plans?

I'm sorry, can you repeat the second one? Sorry, I got the first one, but what was the second one?

Any risk? Any risk to the carts being manufactured? We talked about tubes and chips, but just wondering about the carts themselves.

Ah, yeah, okay. Yeah, yeah. So I think, let me answer the first one first. I mean, the good news is that we have an, I think, unparalleled demand. I mean, we have... Already, as we reported, 5,150 units that are spoken for in over 13 countries based on the prototype that customers have seen. We also have collaboration agreements with USA RAD and SK Telecom for additional 5,500 units. And we have a very, very healthy pipeline following the RSNA show. So I think on the demand side, I don't see any reason why we couldn't meet our goal of first wave of 15,000 units. On the supply side, I think that the focus right now will be in two areas. One is to really complete the scaling up of manufacturing and getting units on its way to customers, and that's something that we do believe has very little risk in terms of validity, simply because we have the prototypes and we're just now getting things in line in terms of supply. of manufacturing and assembling. We do not see any reason that we cannot meet our numbers even with our facility in Israel. And as we reported before, we expect to open up the facility in Taiwan with Foxconn as soon as the world will open a little bit more. Now, all of that, the big caveat we have, and that's really, I think, I believe part of the reasons for our delays is really that While we feel that COVID-19 in some countries, especially in Asia, is kind of taken care of, in other countries it's much more difficult. Specifically in Korea, there have been a lot of restrictions, and that's something that we should pay attention to because it could delay somewhat, but not fundamentally, I think. So on the supply side, we don't see any long-term risks. We're just experiencing what I believe many other companies are experiencing, which is really the COVID-19 issues, as well as what you'd call a normal assembly issues that are all going to be taken care of.

Understood. Thanks for that. And just one last question for me. In the new expectation for the at least 1,000 placements in 2022, I guess, when do you expect to receive FDA clearance and CE-MARC approval? Because I know you want to submit those this year. Yeah, thanks.

Yeah, actually, that's actually the second part of your previous question. The second one that we need to make sure that is happening in order to meet the demand is really to get the clearances, not only for the FDA, for the U.S. market, but in all those countries that we signed contracts with. And our first step toward that was clearly the clearance of the NANOCs cart, which we got earlier this year. And the next milestone will be to submit the multi-source system, the commercial system, and we believe we will do that with the FDA still within this year. And in parallel, or shortly after, we will also submit in other countries. And that's a precondition, obviously, to start and operate the business in all those countries where we got contracts signed with. We do believe that when we deploy en masse in 2022, we should already have clearances in multiple countries, and that's what we're planning on.

Great. All right. Again, thanks again, guys.

Thank you.

Thank you. Our next question is from Ravi Mitra with Berenberg Capital Markets. Please proceed.

Hi, good morning, good afternoon, guys. So just one on the tubing and kind of how it applies to the multi-source system. Can you just kind of remind us, regarding your supplier contracts with the multi-source, is that based on a ceramic tube or, you know, or is a glass tube possible? Number one, from a contract perspective. Number two, from an engineering perspective. You know, say you have more unanticipated delays around putting in the ceramic tube. Is this something you can submit to the FDA at kind of the KVP range you've discussed in the past up to 120 from a glass tube? And then third, maybe... Just on the multi-source submission, what is the KVP that we're looking at when it comes to the filing that will be submitted for FDA approval? Thank you.

Yeah, okay. Thank you, Ravi. So I think it's a very good question, and the answer is both are possible. I mean, currently, most tubes in the world are based on glass, so there are no limitations in glass tube to reach KVP nor KVP. to meet any submission to the FDA. We are working in parallel on both ceramic and glass tubes. As I mentioned in previous calls, the ceramic tubes is mainly due to ease of manufacturing, and we do have confidence that in both technologies, ceramic and glass, one can achieve the required goals, which is, in our case, up to 120 kV in certain MA. And that's something that we feel very confident that we can do. And we demonstrated that at least so far with the glass tube. And we are in process of completing the ceramic tube stabilization, let's call it as we speak. So I don't see any real concern there. Both of them are totally adequate in order to submit to the FDA. That's something that will take it to the finish line. It's good that we have two alternatives and three suppliers, and we believe that that will not be an issue from that area. In terms of what we are planning to submit, as we mentioned before, we are planning to a submission that is either 100 or 120 kV. That's all related to the procedures that we will include in the submission, and that's something that we're reviewing right now. I want to assure you that the limitation will not be from technology point of view, but rather from procedures point of view. We will decide which procedures we want to submit with FDA or any other regulatory submission, and we'll take it from there. But from technology point of view, there is absolutely no limitation. to go the full range.

Great. And then just maybe on the manufacturing, I'm trying to kind of quantify the risk around your margin profile if this thing gets to market as a glass tube. You've said in the past kind of $10,000 to $12,000 kind of manufacturing cost. What kind of step up or... delta, you know, what we see here between a system that had that glass versus there's something that we should be contemplating there in our margin kind of ramp. Thank you.

Well, I don't think so. I think currently at least our suppliers with the glass tube quoted $200 in mass production. That was the initial quote, and we believe it's reasonable. It may be a little bit more than the ceramic tube, but remember, we have only five tubes in the system. So overall, I think the other component like the power supply detector mechanics are much more impactful in terms of meeting the $10,000 goals over time than the tubes themselves. So the answer is not going to have a big impact. The impact that we're mitigating is really scalability and how quickly can we make big quantities. and we now feel that both in the ceramic and the glass, there are ways to make a lot at one batch, and that's something that we felt very comfortable with when our glass suppliers actually showed us.

Thank you. Our next question is from Jeffrey Cohen with Leidenberg Thalmann. Please proceed.

Well, hi, Rand, and it's Cock. How are you?

Very good, thanks.

Hi.

So I wondered if you could expand upon your regulatory strategy for CE and some of the other territories. Do you plan to wait until the FDA has cleared the... the multi-source system and then pursue CE-MARC and other MARCs with the other agencies, or are you planning on taking the single source into other regulatory approvals as well?

Let me try and answer that. The first point is that we are not expecting currently to take the single source to be cleared in any other countries other than the U.S. So that's the first thing. The second thing is alongside the submission of the multi-source in the U.S. to the FDA, shortly after actually, we envision submitting it to other regulatory authorities. In terms of the CE, we also need to make sure that the company is compatible with a certain ISO standard in order to be able to submit to the CE, and that's something we're working on. Overall, the reason why we're waiting until the submission but not the clearance of the multisource to the FDA is simply because a lot of the testing and a lot of the laboratories testing that we are conducting for the FDA are very similar to what other countries are requiring when submission there. So that's the only reason we are doing it a bit after the submission of the multisource to the FDA.

Okay, got it. That's helpful. Can you talk about... software developments during the first quarter? It seems like most discussion has been around the hardware and the regulatory side. Was there any significant milestones on the software side this quarter?

No, not everything as planned. Our software had three components. One component really is the operating system for the for the machine itself, and that's fully functional, as you could also get the impression, I believe, from the demonstration at RSNA. So that's, let's call it the operating system. The second component has to do with what we call the reconstruction, or how we take multiple images from different angles and make sense out of them with algorithm and mesh technology, which is software that we developed in-house, and that's something that we are We have a version, but we're continuing to obviously to improve it. And the third one is really the cloud and the uploading and the cloud management. And that's something that we are in the cloud. We have the operational cloud and the clinical cloud. And that's all in progress as planned. We do believe that alongside with launching the commercial solution, all of that should come to a place where it's mature and stable and ready for scalability.

And then lastly for me, you mentioned opening a facility in Italy. Can you just review for my notification what activities are going to be going on there?

Yeah, actually we do have a supplier in Italy which is a leading supplier for tubes that we assign a mitigation plan to provide us with tubes that are including our chips. So we did a very, very quick... This quarter, actually, we did a very quick education for both sides, and it's possible to send people from Israel to Italy. So our engineers spent time there, and so far, so good. We have very good confidence that this supplier is able and capable to supply tubes with our chips, and we're doing it for... really for redundancy and in order to make sure that we will have tubes ready for our big vision to deploy many units. And that's happening as we speak. So that's the reason we did that. And again, as you know, we have two suppliers in Korea, but Korea is also going through some COVID-19 situation. or it's sometimes hard to predict when, you know, things will happen. So we took, as a mitigation plan, we opened another supplier, and he brought up to speed very quickly. So now we have three suppliers, and the Italian one is very, very much capable to give us what we need.

Okay, super. That's helpful. Thanks for taking the questions.

You're welcome.

Thank you. Our next question is from Suraj Kalia with Oppenheimer. Please proceed.

Hey, Ron. It's up. Can you hear me all right? Yes. Perfect. So, Ron, a lot has been discussed, and let me see if I can hone in on a few specifics. You mentioned parallel pathing the glass and ceramic tubes for the multisource. The single source, was it a glass or a ceramic tube? That would be my first question. And by definition, if the tube architecture is switched and your KVPs are changed, the change in tube architecture would mandate a certain level of stability and lifecycle testing. Just kind of walk us through, given the switch in suppliers, what you all are thinking about the multi-source submission, especially with your comment about parallel pathing glass and ceramic tubes.

Well, okay, so the first question is that the cart itself, the Nano-X cart, was using a glass tube. So that's to answer your first question. And I think in terms of the tube, I would say that there is no, I mean, it's the same KVP, Other than minor mechanics, maybe mechanics that we need to adjust, we can go either with ceramic or glass. We don't see any concern there. In terms of the electrical system, the housing system, the drivers, the digital driving, it's all the same, exact same. You're absolutely right that this supplier that is coming in line needs to meet qualification. of medical supplier, and that's why we're very happy to say that even the new supplier that we brought from Italy is very famous for tubes for medical equipment, and they need to meet ruggedized tests and acceleration tests, and there is a whole list of VNV, what we call validation and verification, that we need to go through before we qualify this tube, and that's something that is ongoing as we speak, and should not be a concern toward the submission of the application to the FDA. I would say, though, that given the basic fact that our first supplier in Korea failed to deliver on time, the tubes, by definition, the multi-source submission has been dragged a bit longer It's still within our guidance, so we're going to submit it within this year, but it will require us to work in parallel with multiple suppliers and do those tests in the few sites. But I don't think it's a major... From a risk point of view, I don't see that as a risk. We don't believe it's introducing a risk, other than the fact that the submission could have been done... earlier than later this year, and that's something that we are facing.

So, Ron, just to be clear, now that you all are switching suppliers for the ceramic tubes, prior to submission for your 510 clearance, Would I be right in saying that it is not possible to finish stability and lifecycle testing for this new? Every supplier has to undergo qualification, right? But you would not have conducted the requisite amount of stability testing. Is that the right way to think about it?

Yeah, I think it's absolutely right. So what you're doing, you're actually taking the final tubes, put them in a system, and run the system through a stability test and all kinds of testing of tube assembly and electrical testing and others. And that's something that normally takes between, I don't know, four to six weeks. And that's something that you need to do anyways. What we're thinking and what we're doing is doing that in parallel with all suppliers so we have redundancy again. And again, we're planning to mitigate all possible risk here. But it's true that when you're submitting, the system to the FDA, you need the system to be tested, and you need to go through the full testing of a system that includes the said tubes. So that's what you need to do, and we are totally prepared to do it, and we'll do it within time before the submission. So it's not a big change. It's anyways you need to do it.

Ron, I know I'm getting in the weeds here, so forgive me, just trying to understand. So your single source tube, it has a focal spot of 0.3 millimeter compared to the predicate and the reference devices, which have like 0.6 to 2 millimeters. So given the difference of the focal spot, there will be a difference for the required exposure times. So I guess maybe you could just kind of talk about the multi-source system. How should we think about it? You have five tubes. Will each tube be capable only of 40 kVp? Are there going to be any limitations in terms of exposure times and focal spots?

Yeah, well, I think, first of all, our multi-source system is designed to give way more than 49 kVp. simply because we're looking at a full body scan, and a full body scan requires sometimes 100 kVp or even more. So each one of the tubes is capable of moving all the way from 20 kV all the way to 120 kVp. That's how we plan it. So when you're looking at the soft tissue, you can reduce the kV to a penetration power that we look at soft tissue, and when you're looking through a bone, you can increase the penetration power to 90 kV or whatever you need in that specific procedure. So that flexibility that we have in our unique Nano-XA tube that is very unique to us. So that's one point. So every one of our tubes is capable of moving through the range of kVp from a very low, which is really soft tissue, all the way to very high, which is the hard tissue. Now, each one of them is operating separately, but in sequence, which means we can control each one of those five tubes. And as you recall, they are located in different angles to the target. And we can actually create what we call a recipe. And that's really a sequence of exposures that will be done specifically to a procedure. For instance, if we're doing a tomosynthesis test, If we're trying to do a tomosynthesis imaging for a chest, there will be one recipe. Or if we're doing something like we demonstrated in the RSNA, which can be a hand or wrist, it will be another sequence altogether. That's something that our system is fully capable of doing. Now, in terms of focal spot, you're right. In most cases, you don't need a 0.3 sensor. millimeter focus spot. I think the limitation comes from the thermodynamic and not from the, because you can go with focus spots as low as you want. At the end of the day, it's the question of thermodynamic, and we have a special design that we believe is optimizing what we need in order to go through procedures that are most popular in a full-body scanner, which are not necessarily going to be the same as the 0.3 millimeter focus port of the glass tube for the 49KV.

Got it. Final question, Ron, and I'll hop back in queue. I remember it. Please correct me if I'm wrong. Yola talked about building inventory for the multi-source in anticipation of 510K. There was some discussion, forgive me, I have to go back and check my notes about building some inventory. Could you give us a status update on that and have your partners that you'll have signed these contracts with, reached out and asked for renegotiations based on any of these delays? Thank you for taking my questions.

Yeah, well, I think for the first question, I mean, we do have the assembly line in Israel, and we're ready to populate those units, and we have no problem of scale there. So we do have... systems ready in our factory in Israel, waiting for the final integration of the tubes and what we call DNV. And that's something that has not changed from our last, I think, last calls that we had with you, Srad. So it's the same. And we don't see any problem of scaling that. And in terms of partners, I mean, we are in constant touch with each one of our partners. And the idea there is to send units as soon as we get them, even prior to regulatory approval just for them to get through the training session. I mean, to put a partner in a way that they can function, you need to train. You need to go through regulatory approval locally. We need to go through acceptance tests. So we are in very good touch with all the partners and also new partners that are trying to get in line. And everybody is expecting the units to be shipped. I think generally speaking, I think everybody expected to be able to start using our device commercially during 2022. So in that sense, we are not really in a delay mode. What is delaying that the submission of, I'm sorry, the shipment of the first unit right now seems to be delayed. But overall, 2022 will be a prime time year for us, and that's our communication to our partners, and they are very eager to start, obviously, like us, and using our technology.

Thank you.

Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad, and a confirmation cell will indicate that your line is in the queue. Our next question is from Rahul Rakit with LifeSide Capital. Please proceed.

Hey, can you guys hear me? Yes. Awesome. All right. Thank you for taking the questions. So I apologize if I missed this in the prepared remarks, but can you remind me of the regulatory requirements for the NANOX cloud? Is there going to be a separate 510K submission required?

Yeah, I mean, before going live, we're going to submit the cloud and the ARC, so two separate systems that need to go through regulatory clearance.

Got it. And is the timing of clearance for that application tied to that of the ARC, or do you expect the two to come separately?

Yeah, I mean, it all comes together to our prime time when we start operating the business. So we believe that we're going to submit everything in time within this year, and before we go live, everything will be in place so that we can not only in the U.S., but also in other countries, start to conduct business.

Understood. And then following 510K clearance, what does time look like for some of those ex-U.S. regulatory approvals? I know you touched on it a bit, but maybe you could help me better understand which regions outside of the U.S. do you view as low-hanging fruit, and which regions do you expect to have a bit lengthier of a regulatory process, just in terms of thinking about some of this earlier revenue?

Yeah, well, I think, first of all, as a reminder, again, we have agreements in 13 countries today I think it's very obvious that the U.S. market is a very important market for us, and therefore that's the first submission that we'll see. We're also looking at Korea, South Korea. We have a strategic partner there. It's a very important market, as well as Israel, which is a backdoor, a backyard for us. Other than that, the CE mark will give us access to, at least right now, two agreements that we have in Italy and Spain, Spain and Portugal, actually. And I would say that another indication that we're actually studying now is submitting in countries where we believe that the clearance will be short. And I think we also have some additional countries that will come in that category. But overall, I think USA market is a major market for us, South Korea, Israel, and all the other countries that we signed either within the CE or other than the CE mark. And all of that will start rapidly to submit once we submitted the multi-source to the FDA later this year.

Got it. Okay. So I guess just kind of pushing on that a little bit more, of the first 1,000 units that you expect to deploy, do you think the majority of those will be deployed in the U.S. as well as Israel, or do you think? you know, more of those systems will be, you know, ex-US or in the EU?

Yeah, at this point, I don't want to provide any specific numbers, but I think I gave you kind of where we believe the markets that we'll submit first will be, and we don't know exactly which units are going where because it's also depending on the timing of the regulatory pass. So, for instance, if we get a regulatory pass in the U.S., But none other countries, by definition, the 1,000 U.S. will go to the U.S. first. If, however, we get the clearance in the U.S. and in parallel in Israel, first, that will be the first countries we'll be operating in. The good news is that we have no problem of demand, and that's very good news for a company like Nanox, because we can really, we're sitting now on a very, very big backlog of orders that are subject to exception tests and regulatory process. That's why I think I cannot give you an accurate answer at this point for that before I get the clearance for the different countries.

Understood. No, that's still helpful. I appreciate it. All right. Thank you for the questions, guys.

Thank you. Ladies and gentlemen, we have reached the end of the question and answer session, and I would like to turn the call back to Ron Poliakhin for closing remarks.

Thank you very much. So I think that concludes our call for this morning. Again, we're very excited to receive FDA clearance of our single-source X-ray card system. We delivered on a key milestone this year. We believe this clearance supports a similar regulatory pathway to ultimately gain clearance for our multi-source device. We're working on submission of our 510K for our commercially designated multi-source nanosarcs devices here. Thank you again and have a good day.