Nano-X Imaging Ltd. Q1 FY2021 Earnings Call

Greetings, and welcome to Nano-X Imaging Ltd's First Quarter 2021 Earnings Call. All participants are in a listen-only mode. A question and answer session will follow the formal presentation. 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 Rand Poliakine, Chairman of the Board of Directors and Chief Executive Officer; and Itzhak Maayan, 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 differences 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 Nano-X’s Chairman and Chief Executive Officer, Rand Poliakine. Rand?

Thank you, Glenn, and thanks to everyone joining our first quarter update call. Also joining me on the call this morning is Itzhak Maayan, our CFO. I would like to start with the FDA 510(k) clearance of the Nanox Cart X-ray system. The key highlights since our last quarterly update have 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 510(k) clearance represents a significant milestone for our company. It is the result of nine years of R&D and is 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, which leverages our unique mesh chip, low voltage, nanoscale cold cathode X-ray source technology. It is smaller and cheaper to manufacture than 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 Nanox.ARC can produce high-resolution, clinical quality imaging in both 2D and 3D across a range of imaging procedures. We believe the result is a simpler, more cost-effective machine with a smaller footprint. Moving now to the supply chain and manufacturing ramp-up update. 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 under construction and will be built next to the SK Hynix semiconductor cluster in South Korea, the world's largest semiconductor center. The site is 12,000 square meters, including a 1,200 square meter MEMS cleanroom. This overall project cost is estimated at $45 million, and the plant is expected to be operational by 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 Nanox.ARC, 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 multi-source system. As a result, while we do not expect to meet our previously announced milestone of shipment of 1,000 multi-source Nanox units 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 Nanox units during 2022 and possibly more, if the multi-source Nanox ARC is cleared by the FDA and authorized by other similar regulatory agencies. Nanox continues to expect submission of a 510(k) premarket 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 MSaaS, Medical Screening As a Service, which employs a pay-per-scale approach. This is a key differentiator for us, as it avoids the significant upfront investments 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 Nanox.ARC 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. 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 MSaaS agreements. The Nanox.ARC is just one element of our potential value proposition. We believe that 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 connection to medical imaging AI systems and billing and reporting. As we move forward towards commercialization, we are continuously seeking opportunities to expand our capabilities through potential partnerships and acquisitions. Moving on to team additions. Before turning the call over to Itzhak to review the financials, I want to share our team updates. I'm excited to say that we have made several significant additions to our leadership, most recently with the addition of Moshe Shtengel, our Chief Business Officer, who has substantial experience in global medical business development and sales. We also announced the additions of Jim Dara, COO; Ofir Koren, CTO; and Tamar 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 positions us for long-term success. At this point, I will turn the call over to Itzhak for a review of our financials. Itzhak, please?

Thank you, Ran. Nanox reported a GAAP 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-GAAP net loss applicable to ordinary shares for the first quarter of 2021 was $7.1 million compared to a non-GAAP 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 months 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 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 Nanox system. 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 offering. 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 31, 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 was paid soon after the quarter ended, and with no debt. For the quarter, cash uses included funding of our operating activities and investing $5.7 million in purchasing property and equipment. Nanox's cash position increased versus year-end 2020 as our financing activities generated $15.9 million, including $2.2 million from option and warrant exercises and $13.6 million received 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 Nanox.ARC 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.

Our first question is from Kyle Mikson with Cantor Fitzgerald. Please proceed.

So I just was wondering if you could provide a bit more detail on why the third-party manufacturer experienced the delays. Just wondering if that's a systemic kind of issue. Just a bit of 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's an update there. And also, I was wondering if the delay is indicative of any issues with the ability of the two components to withstand the temperature between cathode and diode.

Okay. Let me take that. Thanks for the question. I would go back again just for the context in terms of our supply chain. So our units are based on, let's say, three main, I would say, critical components. One is the chip, the other one is a tube that encloses 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 travel during COVID-19, we mitigated our risk and successfully opened up a manufacturing plant with a subcontractor for the system integration, and I believe we also issued a press release on that. So that has not changed. In terms of the chip manufacturing, I believe we have communicated that we do have a long-term investment in a facility in South Korea. 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 currently working with three suppliers. Actually, the supplier in Korea was our leading supplier, and we simply had issues related to the final assembly and testing. They are still working on it, and when we saw that this was delayed, we opened up two other suppliers, one of which is already in a good position to supply those tubes, and the second one is expecting to show some results later on this year. We also believe that even the first supplier that experienced some delays will come around. So what we are doing is mitigating the risk of the delays by opening two additional suppliers and also making sure that we have sufficient access to suppliers that are not only in Korea. So we opened up another one in Italy. 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 it would be prudent from the company's point of view to plan and report that we are not going to ship those 1,000 units in the first quarter as previously announced.

It's positive, obviously, about 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 steep ramp in '22 and beyond. And then, kind of related to that, is there any concern or risk about the X-ray Cart 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.

Okay, yes, yes. So I think let me answer the first one first. I mean the good news is that we have, 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 U.S. 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 the 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 their 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 are now getting things in line in terms of manufacturing and assembly. We do not see any reason that we cannot meet our numbers even with our facility in Israel. As we reported before, we expect to open up the facility in Taiwan with Foxconn as soon as the world opens a little bit more. Now all of that, the big caveat we have, and that's really, 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 taking care of, in other countries, it's much more difficult, specifically in Korea, where 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 risk. We're just experiencing what I believe many other companies are experiencing, which is really the COVID-19 issues as well as the normal assembly issues that are all going to be taken care of.

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

Yes. Actually, that's actually the second part of your previous question. The second one that we need to make sure that it's 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 have contracts with. Our first step toward that was clearly the clearance of the Nanox.Cart, which we got earlier this year. The next milestone will be to submit the multi-source system, and we believe we will do that with the FDA still within this year. 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 have contracts signed. We do believe that when we deploy in mass in 2022, we should already have clearances in multiple countries. And that's what we're planning on.

Our next question is from Ravi Misra with Berenberg Capital Markets. Please proceed.

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 is glass possible, number one, from a contract perspective? Number two, from an engineering perspective, say you have more unanticipated delays around 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?

Yes. 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 tubes to reach kVp nor 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 are mainly due to ease of manufacturing. 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. 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 the process of completing the ceramic tube stabilization as we speak. So I don't see any real concern there. Both of them are totally adequate to submit to the FDA. And 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. Now in terms of what we are planning to submit, as we mentioned before, we are planning to submit 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 are reviewing right now. I want to assure you that the limitation will not be from a technology point of view, but rather from a procedure point of view. We will decide on which procedures we want to submit with the FDA or any other regulatory submission. And we'll take it from there. But from a technology point of view, there is absolutely no limitation to go the full range.

Regarding manufacturing, I am trying to understand the risk associated with your margin profile. If this product is marketed as a glass tube, you previously mentioned a manufacturing cost of around 10,000 to 12,000. What kind of increase or difference should we anticipate between a system using glass and another option we should consider in relation to our margins?

I don't think that will be the case. Currently, our suppliers have quoted $200 for the glass tube in mass production, which we consider reasonable. It may be slightly higher than the ceramic tube. However, we only have five tubes in the system, so I believe the other components, like the power supply and detector mechanics, will have a more significant impact on achieving the $10,000 target over time than the tubes themselves. Therefore, the cost of the tubes won't have a substantial effect. The main concern we've been addressing is scalability and how quickly we can produce large quantities. We're now confident that both ceramic and glass tubes can be manufactured in significant volumes at one bench, which our glass suppliers have demonstrated to us.

Our next question is from Jeffrey Cohen with Ladenburg Thalman. Please proceed.

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

Okay. Let me try and answer that. So 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. Secondly, alongside the submission of the multi-source in the U.S. to the FDA, we will shortly submit it to other regulatory authorities. In terms of the CE mark, we also need to make sure that the company is compatible with certain ISO standards in order to be able to submit to the CE mark, and that's something we're working on. Overall, the reason why we're waiting until the submission, but not the clearance of the multi-source to the FDA is simply because a lot of the testing and many of the laboratories' tests that we conduct for the FDA are very similar to what other countries require when submitting there. So that's the only reason. We are doing it shortly after the submission of the multi-source to the FDA.

And 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?

Everything is planned. Our software consists of three components. The first is the operating system for the machine, which is fully functional as demonstrated at RSNA. The second component involves our reconstruction technology, which processes multiple images from different angles using our in-house developed algorithms and mesh technology. We have a version available, and we are continuously improving it. The third component is related to cloud operations, including uploading and cloud management, which encompasses both operational and clinical aspects. Everything is progressing as planned, and we believe that with the launch of the commercial solution, all components will reach a mature, stable state ready for scalability.

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

Yes. Actually, we do have a supplier in Italy, which is a leading supplier for tubes that we signed as a mitigation plan to provide us with tubes that include our chips. A very, very quick education for both sides has already occurred. We were able to send people from Israel to Italy. Our engineers spent time there. So far, so good. We have very good confidence that the supplier is able and capable to supply tubes with our chips. We're doing it 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 still going through some COVID-19 limitations. So it's sometimes hard to predict when things will happen. So we took as a mitigation plan and opened another supplier, and we brought them up to speed very quickly. So now we have three suppliers, and the Italian one is very capable of giving us what we need.

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

Ran, can you hear me all right?

Yes. Yes.

Perfect. So Ran, 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 multi-source. The single source, was it a glass or a ceramic tube, Ran? 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 life cycle testing. Just kind of walk us through, given the switch in suppliers, what you are thinking about the multi-source submission, especially with your comment about parallel pathing glass and ceramic tube.

The first question is regarding the Nanox Cart, which uses a glass tube. To address your question, we are using the same kVp, with only minor mechanical adjustments needed. We can use either ceramic or glass tubes, so there are no concerns there. The electrical and housing systems, including the drivers and digital components, remain unchanged. It's important that our new supplier meets the qualifications of a medical supplier, and we are pleased that our new Italian supplier is well-regarded for manufacturing medical equipment tubes. They must pass rigorous tests, including ruggedness and acceleration tests, as well as a comprehensive Validation and Verification process before we can qualify this tube. This process is ongoing and should not affect our application submission to the FDA. However, due to our first supplier in Korea failing to deliver on time, the delay in receiving tubes has prolonged the multi-source submission. We are still on track to submit within this year, but this requires us to work simultaneously with multiple suppliers and conduct tests at various sites. From a risk perspective, I don’t consider this a significant issue. While it would have been preferable to submit earlier, we are managing the circumstances we currently face.

So Ran, just to clarify, now that you are changing suppliers for the ceramic tubes, before submitting for your 510(k) clearance, would I be correct in saying that it is not possible to complete stability and life cycle testing for this new supplier because every supplier has to be qualified? But you would not have conducted the necessary amount of stability testing. Is that the correct way to look at it?

Yes, I agree with you, Suraj. You are placing the final tubes into a system and conducting stability tests along with various tests for tube assembly and electrical performance. This process typically takes about four to six weeks and is necessary regardless. We are carrying out these tests in parallel with all suppliers to ensure redundancy and mitigate any potential risks. However, when submitting the system to the FDA, it is essential for the system to undergo thorough testing, including the mentioned tubes. We are well-prepared for this and will complete it in time before the submission. So, this is not a significant change; it is something we must do.

Ran, I know I'm diving deep here, so please bear with me as I try to understand. Your single source tube has a focal spot of 0.3 millimeters, while the predicate and reference devices have focal spots ranging from 0.6 to 2 millimeters. Given this difference in focal spot, there will be an impact on the required exposure times. Can you discuss the multi-source system? How should we view it? With your five tubes, will each tube only operate at 40 kVp? Are there any limitations regarding exposure times and focal spots?

Our multi-source system is built to operate at settings greater than 49 kVp because it is designed for full-body scans, which often require 100 kVp or more. Each tube can adjust from 20 kV to 120 kVp. This allows us to lower the kV for soft tissue and increase it to around 90 kV for bones, depending on the procedure. The flexibility in our Nanox X-ray tube is something distinct to us. Each tube operates independently but in sequence, allowing control over all five tubes positioned at various angles. We can develop specific exposure sequences tailored to each procedure, such as a particular recipe for chest tomosynthesis imaging or another for hand or wrist imaging, as demonstrated at RSNA. Regarding the focus spot, while a 0.3-millimeter focus spot may not always be necessary, limitations are determined by thermodynamics rather than just the focus size. Our design is optimized for popular procedures in a full-body scanner, which may not align with the 0.3-millimeter focus spot typical of certain glass tubes at 49 kV.

Final question, Rand, and I'll hop back in queue. I remember, please correct me if I'm wrong, you talked about building inventory for the multi-source in anticipation of 510(k). There was some discussion, and 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've signed these contracts with reached out and asked for renegotiations based on any of these delays?

Yes, we have the assembly line in Israel ready to begin populating those units, and there are no scaling issues. Our factory in Israel has systems prepared, waiting for the final integration of the tubes and what we refer to as VNV. This situation is unchanged since our last call with U.S. RAD; we do not foresee any scaling problems. Regarding partners, we maintain regular communication with each of them. Our plan is to ship units as soon as they are ready, even before obtaining regulatory approval, to allow them to begin training. To effectively partner, training is essential, alongside local regulatory approval and acceptance tests. We are in close contact with both our existing partners and potential new ones, all of whom are eager for the units to be shipped. Generally, there has been an expectation to commence commercial use of our device in 2022. Hence, we are not in a delay mode, although the shipment of the first unit is currently being delayed. Overall, we anticipate that 2022 will be a significant year for us, and we have communicated this to our partners, who are enthusiastic about beginning to use our technology.

Our next question is from Rahul Rakhit with LifeSci Capital. Please go ahead.

Can you guys hear me?

Yes.

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 510(k) submission required?

Yes. 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.

And then the timing of that clearance for that application tied to that of the ARC? Or do you expect the two to come separately?

Yes, it all comes together as we approach our prime time for starting the business operations. We believe we will submit everything on time this year. Before we launch, we will ensure that everything is ready so we can conduct business not only in the U.S. but also in other countries.

And then following 510(k) 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. you view as low-hanging fruit? In 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?

Yes. 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. 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 backyard for us. Other than that, the CE mark will give us access to at least two agreements that we have in Italy and Spain, Spain and Portugal, actually. 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. I think we also have some additional countries that will come in that category. But overall, I think the U.S. 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. All of that will start rapidly once we submit the multi-source to the FDA later this year.

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 more of those systems will be ex-U.S. or in the EU?

Yes. At this point, I don't want to provide any specific numbers, but I think I indicated where we believe the market will submit first. We don't know exactly which units will go where because it also depends on the timing of regulatory approvals. For instance, if we receive regulatory pricing in the U.S., then by definition, the 1,000 units will go to the U.S. first. However, if we obtain clearance in the U.S. and Israel first, those will be the initial countries where we operate. The good news is that we have no issues with demand, which is positive for our company. Like Nanox, we currently have a significant backlog of orders that are pending acceptance tests and regulatory approval. That's why I cannot provide an accurate answer at this point until we receive clearance for the different countries.

Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the call back to Rand Poliakine for closing remarks.

Thank you very much. So I think that concludes our call for this morning. Again, we are very excited to receive FDA clearance of our single source X-ray Cart 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 the submission of our 510(k) of our commercially designated multi-source Nanox.ARC device this year. Thank you again, and have a good day.