Nano-X Imaging (NNOX) Q3 2024 Earnings Call Transcript

Nano-X Imaging (NNOX 4.58%)
Q3 2024 Earnings Call
Nov 21, 2024, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Nanox third-quarter 2024 earnings call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session.

[Operator instructions] Please be advised that today’s conference is being recorded. I would like now to turn the conference over to Mike Cavanaugh, investor relations. Sir, please go ahead.

Mike Cavanaugh — Investor Relations

Good morning, and thank you for joining us today. Earlier today, Nanox Imaging Ltd. released financial results for the quarter ended September 30, 2024. The release is currently available on the Investors section of the company’s website.

With me today are Erez Meltzer, chief executive officer and acting chairman; and Ran Daniel, chief financial officer. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements regarding the company’s financial results, research and development, manufacturing and commercialization activities, regulatory process operations, and other matters. These statements are subject to risks, uncertainties, and assumptions that 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 Securities and Exchange Commission. We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of the non-GAAP to GAAP measures is provided with our press release, with the primary differences being non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, and non-GAAP gross loss per share. With that, I’d now like to turn the call over to Erez Meltzer.

Erez Melzer — Chief Executive Officer

Thank you for joining us today for our financial results call. I’m happy to share the progress we have made deploying our innovative Nanox.ARC technology, as well as further progress with Nanox.AI and the other components of the full Nanox solutions. Since its commercial deployment at the beginning of this year, there are now 47 units, almost 50, that are in various stages of shipments and deployments for both commercial and clinical use. In the U.S., we are deployed across seven states.

Our strategic growth plan is well underway, and we are committed to accelerating our efforts to expand our footprint and enhance our technology. This is a multipronged effort, which includes doubling our pipeline, expanding our sales, service, and support teams on the ground in the key U.S. market to drive sales to raise awareness with imaging centers and hospitals, as well as supporting our growing customer base and the installations and ongoing use of Nanox solutions. Hand in hand with these efforts, we are also continuing to advance our regulatory efforts with the U.S.

FDA for additional clearances and securing the CE Mark in European Union, while also continue to generate trial data supporting the use of the Nanox.ARC. The positive feedback from healthcare providers and patients alike reinforce our belief in the transformative potential of Nanox.ARC. We are confident that our continued focus on innovation and strategic partnership will drive significant value for our shareholders. We also signed several new deals for Nanox.AI solutions, including Oxford University Hospitals, NHS Foundation Trust in the U.K.

I will share more detail on this and other agreements later in my remarks. But I will say that all of the Nanox.ARC are excited to partner with such prestigious institutions. We at Nanox were also humbled and proud to have Nanox.AI selected for a special mention in Times Best Inventions of 2024 List. This annual list highlights groundbreaking products that are transforming industries, and Nanox.AI is certainly beginning to change how we diagnose and manage population health.

I’m also pleased to report that our USARAD teleradiology business continued to produce meaningful revenue for our organization, generating $2.6 million in revenues, which is a quarterly record. And we anticipate its continued growth to complement our business lines. These milestone across all our business segments are a testament to our team’s dedication and the growing demand for our cutting-edge medical imaging solutions globally. As we look ahead, we remain confident about the opportunities that lie before us.

Our mission to make advanced medical imaging accessible and affordable is more critical than ever, and we are poised to lead the industry with our pioneering solutions. Thank you for continued support and confidence in our vision. I look forward to discussing our financial performance and future plan in more detail. Now, let’s dive right into some details around our deployment of the Nanox.ARC in the U.S., a highly sophisticated and competitive market.

I’m proud of our market penetration, a notable job demonstrating the benefits of introducing the Nanox.ARC to imaging and medical centers in the U.S., which are by nature sophisticated buyers and are exposed to the latest technology the world has to offer. Our accelerating commercial traction demonstrates not only the skill and the tenacity of our sales team, but also the value that Nanox.ARC brings to healthcare providers, as our customer base increases, along with rising awareness of the Nanox.ARC within the medical community, we will add to our team accordingly. As a result, during the quarter, we strengthened our sales team with representative, as well as expanded our clinical team along with enhancements to our operational team. As we accelerate our U.S.

commercialization, we doubled our sales and service personnel in the U.S. to support our expanding client base along with various channel partners. Our team on the ground will be critical to our accelerated rollout, and we will steadily but carefully continue to add to this team. We have an internal target of 30 to 40 sales service marketing and support personnel in place by the end of 2025 in alignment with our commercial progress.

Additionally, we are focusing on expanding our network of strategic collaborations and distributors. I mentioned on our last call that we have engaged with three prominent imaging groups in the U.S. And during Q3, we continued to gain traction with additional imaging groups. Our sales team continues to actively engage imaging groups across the U.S.

in consultative discussions, demonstrating the added clinical utility to be gained by adding the Nanox.ARC to their practices. It is our aim as more stand-alone imaging groups adopt our technology that the Nanox.ARC will eventually be viewed as a standard equipment alongside traditional X-ray and CT technologies. We are also working with multiple distributors in Europe charged with expanding our footprint in the EU. This is important as we anticipate receiving the CE Mark designation for the Nanox.ARC in the coming months.

To further assist our commercial core technology OEM rollout, we have created the demo kits to more effectively educate potential buyers on the Nanox value proposition. We have now shipped several demo kits to the prospective clients to more easily allow them to experience our unique technology. Clearly, we have been ramping up our activity in the U.S., and we know we must continue with this momentum and drive even greater adoption going forward. While we view the key U.S.

market as a strategic priority, we continue to advance commercialization efforts in the rest of the world. In Mexico, where we have already made commercial inroads, we are waiting for the import license needed to deploy the Nanox.ARC. The system allocated for the Mexican market has been manufactured and tested and is today ready for shipment. And our partner has already designated the first two sites for the Nanox.ARC in Mexico.

In Chile, the Nanox.ARC is in registration process after a successful site visit in our demo center in the U.S. Also in Europe, we were excited to showcase the Nanox.ARC technology at MEDICA 2024 in Dusseldorf, Germany recently in November. Medica is one of the largest medical B2B trade fairs in the world. Our team was well prepared and did an excellent job raising awareness to the 3D digital tomography as a key tool in the future of medical imaging.

Turning to the regulatory front. We have maintained ongoing communication with both the U.S. FDA and the European regulatory bodies. As you are aware, we have pending 510(k) applications to the FDA for the general use of Nanox.ARC, which could cover general use, including chest.

We continue to work closely with the FDA and provide any supporting information as needed in a timely manner, including in recent weeks. In the EU, we continue to work with our notified body in the process aimed to securing the CE Mark designation for the Nanox.ARC. Both new designations when secured would be, in our view, a considerable expansion for the Nanox.ARC technology and help to make it standard part of medical imaging equipment worldwide and result in a significant increase in our total addressable market. We are not able to comment specifically on timing, but we are doing everything we can to assist in both review processes and hope to receive the clearances in the coming months.

Turning to our clinical update in Beilinson Hospital, more than 40 patients were already recruited for both the CHEST trial and the multisite trial. Together with the staff of Beilinson, we have reviewed more than 25 of the patients’ data sets, and the results are impressive, continued the trend we have published in a recent white paper from the first 12 patients. In Ghana, the multicenter trial site is actively recruiting, and the Nanox.ARC system is actively scanning patients, both for the clinical trial as well as part of the clinical practice. Furthermore, Nanox is in active discussions with a prominent site in Europe for incorporation into the multisite clinical trial.

I’d like now to discuss the Nanox AI business segment, which is generating revenues and is also gaining commercial tractions worldwide. As previously announced, during the quarter, we secured a new 510(k) clearances from the U.S. FDA for Nanox.AI Health CNG version 2.0, the upgraded version of Nanox.AI cardiac solution, which has already shown clinical utility in several healthcare systems by identifying patients at high risk of coronary artery disease and enabling earlier intervention. The solution is also easy to use, being seamlessly integrated with existing picture archiving and communication systems and electronic medical record systems.

As we know, AI has been the forefront of the news worldwide for some time, highlighting its groundbreaking benefits to many industries and myriad use case, much of which is largely hypothetical at this point. Conversely, the Nanox.AI application has been fully developed into a practical tool with significant clinical utilities in many imaging and diagnostic uses. Its advanced algorithm and robust data processing capabilities have been trained on thousands of images and enable healthcare providers to identify health problems in much earlier stage than was previously possible. With that, let’s look at some recent Nanox.AI being used in the real world.

Corewell, formerly Spectrum Health, one of the early U.S.-based adopters of the Nanox.AI solution. After two years of successful collaboration and having seen the clinical utility of the Nanox.AI HealthCCSng cardiac solution, the system will implement the HealthOST bone solution into its clinical system. The HealthOST algorithm automatically detects vertebral compression fractures and low bone mineral density to help identify patients at risk of MSK disease with a focus on osteoporosis without a need for discrete imaging. We are looking forward to another exciting and productive collaboration with Corewell, and it is very gratifying to see sophisticated health systems validate the use of Nanox.AI solution.

As previously reported, the U.K. National Health Services initiated the DAPT trial to evaluate the use of Nanox.AI bone solution. Through this study, the NHS discovered that it was able to identify six times as many patients with osteoporosis in routine CT scans as they were without Nanox.AI. Following on those powerful results, one of the national health services sites, Oxford University Hospitals NHS Foundation Trust, decided to secure a three-year contract for the HealthOST bone solution.

ADOPT will continue into Q1 2025, but it’s already decided to secure the solution plus the new RealPlus bone management tool for three years. This is the first time the RealPlus bone management tool has been mentioned, and I’d like to take a few moments to describe this exciting new offering. We have developed this application for use either as a stand-alone application or alongside the HealthOST solution, and it is specifically designed to support fracture liaison service clinics in managing the entire patient life cycle more effectively from initial detection, whether through AI or other diagnostic means, RealPlus bone management tool will facilitate the comprehensive management of treatment and ongoing disease management, including follow-up exams, update letters, and medication management. These are the latest examples of prominent health systems, validating the utility of our Nanox.AI solution and that is, not just a concept, but a real value-add solution.

We expect many more to come. In other AI business news, Dandelion Health extended its cooperation with Nanox.AI solution available on its clinical AI marketplace. Dandelion Health is a healthcare data platform that focuses on AI analytics. It offers life science companies the ability to leverage Nanox.AI products to extract clinical insights from their multimodal longitudinal patient data set of over 10 million patients.

During the quarter, we also signed a new reseller agreement with SpinexMedical Inc., a distributor of medical equipment based in Florida. Spinex will distribute the Nanox.AI solution in the large Florida market, and we look forward to a productive partnership. Looking to the future of Nanox.AI, the strong validation of these solutions by multiple health systems around the world drives us to develop additional algorithms that can identify more health problems. We are now working on a pulmonary solution, which is expected to be the first AI application designed specifically for the Nanox.ARC.

The algorithm aims to automatically identify patients with pulmonary nodules with a goal of identifying chest diseases, essentially lung cancer through routine chest scans. The Nanox team will provide timely updates on the development of these exciting new AI solutions as we advance its development. Turning to our OEM efforts, which will help to ensure we have the manufacturing capacity for our expected client base of the future. As mentioned in the past, we finalized the establishment of our technology development centers based in our headquarters.

The primary purpose of the center is to consolidate our core assets and knowledge and to advance the development of the chips and the tubes and to lead our future road map. This center has eight R&D labs and is manned by a highly credentialed team of engineers and researchers who are also advancing Nanox chip and tube technology from the robust technology patent library. The library includes dozens patents families for Nanox and Nanox.AI. The team at the center is tasked with the ongoing work on Nanox future technology innovations, as well as the development of our next products in our road map, and I know our future development is in very capable hands.

I’d now like to provide an update on our OEM partners who will play an important role in ensuring that we have the supply of systems to meet our accelerating growth trajectory over the coming years. There are many manufacturing agreements in place, as well as multiple development projects in motion at various stages and sites globally, an increased pipeline of potential leads, and I’d like to provide a high-level overview of some of these activities. Varex has completed assembly of the first ARC tubes with Nanox proprietary emitter, and we have taken delivery of them at our manufacturing facility. We are now performing systems integration and pre-FDA submission testings on the tubes, which will be used in the Nanox.ARC.

Varex is also engaged in development of a multisource modules utilizing the aforementioned Nanox emitters. Testing of this unit should commence in Q1 2025. As part of our efforts to raise awareness of Nanox value and security applications such as screening, a Nanox team attended the International Security Expo in September in London, where over 300 international exhibitors showcased products and solutions from across the entire security spectrum. As a result of this event, we are following up on multiple opportunities to expand our penetration in the security vertical.

A leading global medical and diagnostic solution provider is assembling the first prototype tubes utilizing the Nanox emitter. We are working closely with them and have delivered a Nanox.ARC demo kit to serve as a test bench for a prototype under development. We have been partnering with the U.S. government security application projects to develop noninvasive screening applications.

The team has successfully completed component build, assembly, and testing. We have since received the follow-on purchase order to finalize two unique tube designs for advancing prototyping, which are to be delivered in the first half of 2025. We also delivered in Q3 a Nanox demo kit to Vieworks, a global X-ray imaging solution provider for assessment of our technologies. Vieworks recently completed their assessment, issued their findings, and have since requested to acquire Nanox tubes toward specific application testing and development.

We are pleased that our demo kit, inclusive of our emitter tube high-voltage power supply and software, has already enabled multiple global solution providers to more easily experience our technology. Additionally, the first tube utilizing CSEM chips have been successfully built, and the initial fab of production quality chips is scheduled to commence in Q1 2025. This is another example of the Nanox team’s dedication to security manufacturing agreements to ensure the supplier of Nanox.ARC system can meet our expected demand. That concludes my business update, and I would like now to turn the call over to Ran Daniel for a review of our financials.

Ran?

Ran Daniel — Chief Financial Officer

Thank you, Erez. We reported a GAAP net loss for the third quarter of 2024 of $13.6 million, which I will refer as to the reported period, compared with a net loss of $21.4 million in the third quarter of 2023, which I’ll refer as to the comparable period. The decrease was largely due to a decrease of $7.4 million in expenses related to impairment of goodwill, which were recorded in the comparable period and not in the reported period. Revenue for the reported period was $3.0 million, and gross loss was $2.8 million on a GAAP basis, compared to a revenue of $2.5 million and a gross loss of $1.7 million on a GAAP basis for the comparable period.

Non-GAAP gross loss for the reported period was $0.2 million as compared to a non-GAAP gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 6% on a non-GAAP basis for the reported period as compared to a gross profit margin of 37% on a non-GAAP basis in the comparable period. Revenue from the teleradiology services for the reported period was $2.6 million with a gross profit of $0.3 million on a GAAP basis in the reported period, which represents a gross profit margin of approximately 13% on a GAAP basis for the reported period. Non-GAAP gross profit of the company’s teleradiology service for the reported period was $0.9 million, which represents a gross profit margin of approximately 35% on a non-GAAP basis. Revenue from the teleradiology services for the comparable period was $2.2 million with a gross profit of $0.2 million on a GAAP basis, which represent gross profit margins of approximately 11% on a GAAP basis.

Non-GAAP gross profits of the company’s teleradiology services for the comparable period was $0.8 million, which represents a gross profit margin of approximately 36% on a non-GAAP basis. The increase in the company’s revenue from the teleradiology services was mainly attributable to customer retention and increased volume of the company’s reading services during the weekdays shifts. During the reported period, the company generated revenues through the sales of its AI solutions in the amount of $0.4 million as compared to a revenue of $0.1 million in the comparable period. The increase was mainly due to a completion of the project of the installations of our AI solution.

During the reported period, the company generated revenue through the sales and deployment of its imaging systems, which amounted to $29,000, with a gross loss of $1.5 million on a GAAP and non-GAAP basis. Those revenue stems from the sales and deployment of the Nanox.ARC systems in the U.S. and the sales of our 2D systems in the rest of the world. Research and development expenses net for the reported period were $4.7 million, compared to $6.0 million in the comparable period.

The decrease of $1.3 million was largely due to a decrease of $0.3 million in salaries and wages, decrease of $0.4 million in share-based compensation, and a decrease of $0.6 million in expenses that are related to other research and development activities. Sales and marketing expenses for the reported period were $0.9 million, compared to $1.1 million in the comparable period. General and administrative expenses for the reported period were $5.7 million as compared to $5.0 million in the comparable period. The increase of $0.7 million was mainly due to an increase of $0.5 million in share-based compensation, increase in our legal expenses in the amount of $0.5 million, which was offset by a decrease in the cost of our D&O liability insurance premium in the amount of $0.3 million.

Our non-GAAP net loss attributable to our ordinary shares for the reported period was $8.7 million as compared to a non-GAAP net loss of $9.4 million in the comparable period. The decrease of $0.7 million was mainly due to a decrease in our non-GAAP operating expenses of $1.8 million, which was offset by a decrease of $1.1 million in our non-GAAP gross profit. Turning to our balance sheet. As of September 30th, 2024, we had cash, cash equivalents, restricted deposits, and marketable securities of approximately $57.1 million, and we had $3.4 million loan from a bank.

We ended the third quarter of 2024 with a property and equipment net of $44.7 million. As of September 30th, 2024, we had approximately 58.5 million shares outstanding. With that, I will hand the call back over to Erez.

Erez Melzer — Chief Executive Officer

As we conclude our discussion today, I’m filled with confidence about the future of Nanox, our initial deployment of the Nanox.ARC technology across multiple states in the U.S., along with our expanding footprint in international markets, as being a testament to our unwavering commitment to making advanced medical imaging accessible and affordable worldwide. The positive feedback from healthcare providers and patients reaffirm their transformative potential of our solution. Coupled with a robust infrastructure we have established this past year, we are well positioned to accelerate our progress in 2025. On the regulatory front, we are diligently working with the FDA and European Union bodies to secure the necessary approvals, which will further solidify our position in the market.

Our ongoing trials and collaboration with leading health system demonstrates the clinical utility and the value of our AI solutions, paving the way for broader adoption of groundbreaking advancement in medical imaging. We take pride in our robust clinical performance. By prioritizing clinical needs and development efforts in close collaboration with the medical community, we ensure that our innovations are not only advanced but also deeply relevant to those we serve. Our commitment to providing advanced diagnosis imaging capabilities continues to elevate market needs and utilization, setting new standards in the industry.

Moreover, we’re constantly working to improve and innovate with solutions designed to meet and exceed market expectations. Thank you for your continued support and confidence in our vision. Together, we will drive significant value for our stakeholders and make a lasting positive impact on global healthcare. As always, we welcome your feedback and are happy to meet with the interested investors.

Please contact our investor relations partner at ICR, and they will assist. With that, operator, let’s now open the call for questions.

Questions & Answers:

Operator

Thank you. [Operator instructions] Our first question will come from Ross Osborn with Cantor Fitzgerald. Your line is open.

Ross Osborn — Cantor Fitzgerald — Analyst

Hi, guys, thanks for taking our questions, and congrats on the progress. So, starting off, how many systems did you deploy in the U.S. during the quarter? And how many were operating? And as a follow-up, what types of imaging centers are adopting ARC?

Erez Melzer — Chief Executive Officer

I think it was mentioned altogether, the number was 47. The — I would say majority of the medical centers are imaging centers, small and medium. Another part are imaging — imaging — medical imaging chains that we mentioned, and we added a few right now. And we have a few in hospitals or I would say, multifunctional medical centers and some chiropractors’ clinics or orthopedic clinics.

[Inaudible] Altogether, in terms of the locations and the place, by far, our pipeline and deal flow is far bigger than what we have indicated, and we continue to work.

Ross Osborn — Cantor Fitzgerald — Analyst

OK. And then looking at placements to date, how has average utilization trended in terms of scans per day or month for ARC?

Erez Melzer — Chief Executive Officer

I think it’s similar to what we reported last time that in the operating — in the places which are operating, this is around the number that we’ve indicated in the past in working days, seven days — seven scans per day.

Ross Osborn — Cantor Fitzgerald — Analyst

OK. And then lastly for us — I’ll jump back in queue. You mentioned ongoing conversations with FDA, but could you parse out how those conversations are going? And any updates on ARC-X and then the label extension for full body?

Erez Melzer — Chief Executive Officer

So, as you know, Ross, we don’t give any indication on something that is not in our hands. We — from our point of view and the best we can judge the — all the information, all the answers — all the questions were answered. From our point of view, the indication is positive. And from the FDA point of view, I don’t see a reason why it will not be in the short future.

In terms of the ARC-X, this is something that we are going to submit in a few months, next — early next year. And the ARC-X is anyhow scheduled to be deployed sometime during the next year. I would say probably second half if everything goes well. But from the FDA point of view, right now, the process seems to be in line.

Ross Osborn — Cantor Fitzgerald — Analyst

Great. Thanks for taking our questions.

Operator

And our next question comes from Jeffrey Cohen with Ladenburg. Your line is open.

Jeffrey Cohen — Analyst

Good morning, Erez and Ran. How are you?

Erez Melzer — Chief Executive Officer

Good.

Jeffrey Cohen — Analyst

So, a few questions from our end, and congrats on the progress. I know you called out MEDICA that you were at — can you talk about Europe, generally speaking, how that may play out throughout the first year or two of commercialization after a CE Mark? Are you anticipating that that will also become 30 or 40 or 50 commercial folks on the ground across Europe? Or do you imagine that will be more clinical and related to agreements by country as far as distribution?

Erez Melzer — Chief Executive Officer

So, if you remember from what we presented as a strategy for the company for sales and distribution, Europe — maybe with the exception of the U.K., Europe will be based on distributors. We have already a few agreements with the distributors that were signed. MEDICA actually indicated a very high interest from other countries, new distributors. And based on the — right now, the current indication, I think that — I don’t want to give a number, but it will be hopefully similar to the one that we currently have and we’re going to deploy.

We have already a few purchase orders which are concrete. And once we get the CE, I think we have already a plan, or the action plan for the go-to-market is already in place, and we’re going to start. The one other thing which is important with respect to the Europe, we have indicated that we are planning to do another clinical trial in a prominent institution in Europe, which will help us to get clinical samples and have a lot of clinical data to help us to work in Europe. But in terms of the salespeople, our channel management directors, the agreement with the distributors and the contract and the promotion and the marketing, we are already in place, and we are running fast forward.

Bear in mind that another country that is related to the EU CE is Australia, which we have already an agreement over there.

Jeffrey Cohen — Analyst

Got it. And, Erez, carry that over for a moment to APAC and LATAM as far as those territories and walk us through plans there and also talk about the regulatory and who’s carrying that burden and where that’s being pursued currently besides Mexico and Chile.

Erez Melzer — Chief Executive Officer

OK. So, LATAM is also going to be based on distributors. The process is already in place in these countries — in Mexico and Chile. So, the request for the regulation approvals was already submitted and — submitted by the distributors.

They carry actually the process. We are in touch with them. Actually, with Mexico, just now, I finished another call. And it’s going to be similar in terms of the efforts that we do there.

We have a channel manager that is responsible for this area. The beauty of what we can do is we bring people from Latin America to see the demos that we have in the U.S. in order to take them all the way to Israel. So, it’s good for them to make a short trip and see the system operating, see the clinical value that we had, discussed the economic value that we can contribute, etc.

Jeffrey Cohen — Analyst

OK. That’s helpful. And then lastly for us, a quick one. I didn’t hear any mention about the Nanox.CONNECT.

Was there any update there or any anticipation for that platform for ’25?

Erez Melzer — Chief Executive Officer

The — we’ll probably have more clarity on 2025. But right now, I think the next one on the agenda will be Mexico and that we’re going to get orders once we get the approval. And we have submitted already a request for regulation approvals in a few other countries for the CONNECT as well.

Jeffrey Cohen — Analyst

Perfect. Erez and Ran, thanks for the color.

Erez Melzer — Chief Executive Officer

Thank you.

Operator

[Operator instructions] The next question comes from Scott Henry with Alliance Global. Your line is open.

Scott Henry — Analyst

Thank you, and good afternoon. For starters, when we think about Europe and the rest of the world, how should we think of that opportunity relative to the U.S.? I know you used to think of all of that comparable to the U.S. as far as potential revenues. But I just wanted to get your thoughts on that.

Erez Melzer — Chief Executive Officer

I cannot say that we don’t have any internal thoughts about it, an indication, what’s the split between the U.S. and the rest of the world and especially Europe. But I would say that I will be smarter to indicate or to give an answer to your question once we get the CE approval. And we know that we can move fast forward.

In terms of strategy and the go-to-market, we have definitely — as we have mentioned a few times last year in 2023 and in 2024, in the beginning when we started the deployment in the U.S., we have put the U.S. as a priority, mainly because of the FDA approval and the fact that we can get easier access to customer and customer base and to generate big deal flow and the pipeline. And so, right now, U.S. would be a priority, and Europe will follow — will follow after.

Ran Daniel — Chief Financial Officer

But, Scott, in terms of modeling, you should think about it like the way that we did with the U.S. Just — we have learned more lessons from the past, so you can think about a more efficient thought process.

Scott Henry — Analyst

OK. Great. And then I noticed revenues for AI solutions were higher than the trend line. Is that a signal that AI solution’s revenue should continue to be higher? And is there a little bit of seasonality? Because I know they were strong in third quarter of last year as well, just trying to get a sense of that line.

Ran Daniel — Chief Financial Officer

OK. So, as —

Erez Melzer — Chief Executive Officer

So, the first question — I will start, then Ran will continue. The first question is yes, you can anticipate that the number will continue to grow. In terms of seasonality, it usually relates to the budget-related decisions, especially in the U.S., in the public health market. But since part of it is in the U.K., and it’s not necessarily related to the U.S.

budget processes, then I wouldn’t say that it’s a seasonality — there is a seasonality impact on this. Ran, would you like to add anything else?

Ran Daniel — Chief Financial Officer

Yes. Thank you. So, as we explained in the PR, this — the increase in the revenue of the AI division was due to a completion of a project of — where we installed our solution. As for what the second part of your question, we do continue to build up our customer base and backlog, whether it’s existing or expand the scope with existing customers.

So, it’s not related to seasonality and there’s no linear expansion over here, but you do — with these, we do see some expansion in the scope of the businesses in the AI division though.

Scott Henry — Analyst

OK. Thank you for that feedback. A final question, which is very much a big-picture question. When we think about the revenue trajectory, when do you think we would start to see an inflection point? Would that be the expanded indication? And then obviously, we get Europe coming in.

I mean, are we thinking kind of middle of 2025, we should start to see kind of that hockey stick upward turn? Just trying to get your sense of when we should look for the inflection point. Thank you.

Erez Melzer — Chief Executive Officer

Ran?

Ran Daniel — Chief Financial Officer

Yes. So, without specifying any specific point of time, it’s connected for various factors. Of course, it’s first of all unveiling our — the clinical value of our devices, the commercialization. It’s — of course, it’s also related to expanding the clearances for the general use in the U.S.

and the CE mark, so it’s really a combination of many things, which we hope that will come to fruition in the near future.

Scott Henry — Analyst

OK. Thank you —

Erez Melzer — Chief Executive Officer

I would actually look at it more not as an inflection point, but more of a kind of milestones that each one of them can make and be a game changer. So, one will be the chest and the full body. Another one will be the CE later on sometime in 2025. The FDA approval of the ARC-X — the ARC-X launch.

So, we have a lot of milestones along the way that each one of them will be a game changer. That’s the way at least we see it internally.

Scott Henry — Analyst

OK. Thank you. That — that is helpful. Thank you for taking the questions.

Erez Melzer — Chief Executive Officer

Thank you.

Operator

I am showing no further questions at this time. And I do want to thank you for participating in today’s call. [Operator signoff]

Duration: 0 minutes

Call participants:

Mike Cavanaugh — Investor Relations

Erez Melzer — Chief Executive Officer

Ran Daniel — Chief Financial Officer

Erez Meltzer — Chief Executive Officer

Ross Osborn — Cantor Fitzgerald — Analyst

Jeffrey Cohen — Analyst

Jeff Cohen — Analyst

Scott Henry — Analyst

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