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spk10: Good day and thank you for standing by. Welcome to the NANUC's fourth quarter 2023 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Mike Cavanaugh, Investor Relations. Please go ahead.
spk17: Good morning, and thank you for joining us today. Earlier today, Nanox Imaging Limited released financial results for the quarter ended December 31st, 2023. The release is currently available on the Investors section of the company's website. Eris Meltzer, Chief Executive Officer, and Ron Daniel, Chief Financial Officer, will host this morning's call. 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 Eris Meltzer.
spk04: Thanks, Mike. And as always, thank you all for joining us today for our financial result call and corporate updates. Before we get started, I would like to take a minute to acknowledge the passing of our founder, Rand Polyakin, back in January. We all owe him our gratitude, and I'm proud to lead our team as we seek to realize his vision of making medical imaging more accessible to improve early detection and treatment to help people achieve better health outcome. My remarks will be a bit longer today than usual, and I will provide a lot of details on the various business aspects of NADoPS. As we share our fourth quarter update and review our financial results, I'm extremely proud of the progress our team made over the course of 2023, highlighted by the exciting milestone of FDA clearance for the NanoX Arc system, a clear validation of our technology and mission, and our first steps in the US commercialization. On today's call, we will be focusing on our fourth quarter activities, as well as some of our achievements in early 2024, a year which I expect will be transformational for NanoX. We are now in the process of expanding our commercialization of the Nano-X Arc system and are aiming for a steady increase in deployments as we raise awareness of the Nano-X solution. Nano-X is dedicated to accelerating the implementation of our commercial infrastructure and future strategic plans in the US. Our mission is to provide healthcare practices with a game-changing advantage through the Nano-X Arc an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care. I'd like to start our call with an update on our U.S. deployment activities. As we have disclosed in the past, we have already deployed the ART at the first location in the U.S. in New Jersey in the New York metropolitan area. Since then, we have launched across five states, marking an advancement in our U.S. deployment, which is going as planned. As of today's call, AHRQ systems have been installed at several medical imaging and diagnostic systems centers in New Jersey, New York, Florida, and Kansas, as well as the Georgia 626 Imaging Academy, which serves as a technical and training center the NANUC's AHRQ system began to scan patients. Clinical operation of the AHRQ system will begin in other sites pending certification from the corresponding states' regulatory bodies. As already indicated in our Investor's Day, back in December, one of the purposes of these installations is to validate our MSAS assumptions. Based on these initial deployments, it seems, that the model is indeed validated, and we are scanning around seven scans per day, as well as the indication for $30 per scan. As part of the establishment of our infrastructure, the Georgia site at 626 Imaging Academy serves as a technical and training center for technicians on the use of the system and they have successfully completed our engineers training program at the Atlanta 626 MIS Woodstock Training Center. We are in advanced negotiation with another installation, maintenance, and service provider in order to expand our service coverage. This is prior to scale. As we increase our footprint across the United States, we continue to expand our U.S. sales and technical teams. We are continuing to expand our professional team and have recruited additional personnel in the US. We aim to grow gradually as needed and are being judicious about our hires to ensure that additional expenditure generate a good return on the investment. At the same time, we are extending our sales network as planned. As we ramp up the deployment, I can share that we have begun realizing revenue streams from ARC imaging scans at the US deployed sites that are utilizing the EMSAS model. I'd like to address one final aspect regarding our commercial operation in the US. As per our standard procedures, NANUC has submitted certification requests to expand the placement of NANUC ARC units to various states across the country. I'm eager to keep you updated on the progress of these future installations. Turning now to our deployment effort in the rest of the world outside of the key U.S. market, as we disclosed in our last call, we are generating revenue from hardware deployments in Africa and have three installations as of the end of March. As previously mentioned, we have had a unit installed at the University of Ghana Medical Center Limited, UGMC, and which has received local regulatory clearance. I can now share that we have signed a Ghana multi-site agreement, which was done as part of our multi-site trial in Ghana. We are conducting the trial, aiming to generate continuous data and clinical evidence on the NanoxARC. I will describe this trial in a bit more detail later in my remarks. We have also made progress in expanding the Nano-X footprint in Latin America. One recent agreement is with a Peru-based medical equipment distributor, which has partnered with us to distribute the Nano-X Connect in that country. The partner has a strong presence in Peru with good reach into the key local health system and hospitals, and our cloud-based Connect solution should be a complementary product for the product offering as this partner is already actively marketing other healthcare solutions which enable remote patient exams by a clinician. I can also update you that our distributor in Mexico is seeking an import license for the NANUX Arc and preparing for the first installation. The partner has also received an import license for the NANUX Connect and we have shipped the first two systems. Similar to the ARC, the distributor has applied to obtain the required registration to sell this solution, and we also anticipate that Connect will also continue generating revenues in 2024. As a side comment, I will say that it is very gratifying to see that the ARC and Connect be marketed together as we have envisioned this complementary imaging solution from the very beginning. I'd like to provide an update on our hardware revenues, which Fran will review in more details shortly. While we have began generating revenues through our AI solutions in Q3, NanoX began to generate revenue outside of the US for the sales and deployment of its imaging systems. Now I'd like to provide an update on NanoX AI business which has had an increase of 250% in our client base compared to last quarter. We have an installed base of health system who use health CCS and AI-powered solution to detect levels of coronary artery calcium, a proven indicator of future cardiac events. We have digested our experience in the field with this and gathered feedback from users specifically cardiologists and radiologists, to upgrade the solution. Revisiting one of the AI product partners, Corwell Health, formerly Spectrum, which began using our population health solution in mid-2022 and is a large integrated health system. We have consistently received positive feedback from Corwell Health, which has fully integrated this into their standard of care, This has been a productive partnership, which has been extended for additional term. Many of you are aware that the NanoX solutions are available on Nuance Precision Imaging Network, a Microsoft company. More than 12,000 health care facilities and 80% of the U.S. radiologists will use Nuance PowerStribe for radiology reporting. I can share that Intermountain Health has signed on to deploy Health CCS and was part of Nuance Bundled. The go-live process started, including training activities and integration of the solution into internal systems. NANUCS also achieved another regulatory milestone last month when we received the 510 clearance by the U.S. Food and Drug Administration, FDA, for Health FLV. an artificial intelligence software that provides automated qualitative and quantitative analysis of liver attenuation from routine CT scans. Health FLD is intended to support clinicians in the detection of fatty liver correlated with hepatic steatosis, an early sign of metabolic dysfunction associated steatotic liver disease, MASLD, formerly referred to as non-alcoholic fatty liver disease. HealthFLD is a new and valuable tool for doctors, as it has traditionally been difficult to assess liver attenuation on contract-enhanced scans, which make up a large proportion of the CT scans. HealthFLD was designed to help clinicians in the assessment and the analysis of fatty liver in general population from routine CT scans. We believe that AI innovative solution and specifically health FLD may deliver substantial advantages to the biopharmaceutical industry to streamline the identification of candidates for clinical trials of much needed therapies for liver diseases, including mesh. This regulatory decision solidifies our leadership as a developer of automated AI software medical devices. We also announced last month early findings from the AI-enabled ADOPT study, which uses a Nano-AI solution, HealthVCF, the previous version of our current HealthLSP solution, to review routine CT scans and identify up to six times more patients with vertebral compression factor that the national average at national health services, NHS, hospitals in the UK. The study is being conducted at various national health service or NHS sites, including the Oxford University's hospitals. The ADAPT data shows that HealthVCF has clearly demonstrated the ability to identify vertebral compression factors in far more patients than previously possible with existing tools, enabling earlier intervention and potentially better patient outcomes. To date, the NANOX AI algorithms has identified over 2,400 patients with previously unknown vertebral compression fractures, and those patients have been designated for follow-up evaluation and treatment. As you can see, we have been very busy not only with this NanoX Arc system deployment, but also advancing the uptake of NanoX AI, which is an important component of the complete NanoX solution. Turning now to our OEM initiatives. After executive partnership kickoff meetings at Varix headquarters in Salt Lake City last year, the company's technical teams are actively engaged in validating the tube design and advancing the roadmap towards production and exploring future development. Expanding on our OEM-related activity, we have issued our first production purchase order to an industrial imaging equipment manufacturer and continue to work towards a multi-year tube supply agreement to ensure an adequate future supply of tubes. Additionally, Our collaboration with the U.S. government agency exploring Nano-XR technology for use in security application in progressing. After their acquisition of chips and tubes for evaluation, we are advancing to our collaboration on a novel tube based on our meter. Finally, as a means of increasing awareness and allowing access to our core technologies, we have created Nano-XR demonstration kits. containing a tube utilizing our emitter, and we have recently received the necessary safety and regulation certifications for the kit, and we'll be delivering our first few to interested parties in the coming weeks. Regarding the mass production as recently announced, due to the scale-up in commercialization, we continue as planned with our collaboration with Syssem, a chip maker located in Switzerland. As I mentioned earlier in my comments about Ghana, Nano-X is conducting multi-center clinical trial to enhance Nano-X Arc with the goal of expanding its use with chest and other indications. The trial is scheduled to begin patient recruitment shortly, and Nano-X Arc systems that are being used in these trials are already scanning patients. The system installed at Beilin Song Hospital is ready, The Institutional Review Board, IBR, has approved the trial and we are finalizing the remaining steps for integrating into multi-site. In Ghana, the IRB has been submitted and currently is under review. Additionally, the NanoxARC is being used to scan patients with abnormal lung conditions at Beilincon, one of the world's top academic medical center and an institution that has pioneered advancement in radiology. The system at EGMP is also currently being used to scan patients. Our pursuit of the CE mark in Europe is advancing in partnership with our notified body. Specifically, recently we completed a five-day audit by the notified body as part of the certification process for the CE certificates, the ISO, 13485 plus medical device regulations MDR certificate. During the inspection, hundreds of records, procedures, proofs, reports, and examples were presented. The MDR test was passed successfully. The ISO 13485 test was passed with a great success and without any adverse findings. Sometimes after the audit, the formal review process will begin, which includes examining aspects of the manufacturing process. And although we expect our application process to proceed in a timely manner, I would note the regulatory bodies worldwide are still working through a backlog of applications, which accumulated during the multi-year COVID pandemic and the adjustment for the new MDR regulations. However, as I said, we are well along in the process and will continue to prioritize the work with our partners necessary to complete the MIRA tasks required to bring the C-certification process towards the finish line. With that, I'd like now to turn the call over to Rand Daniel for a review of our financial results. Ron?
spk15: Thank you, Eric. We reported a gap net loss for the fourth quarter of 2023 of $10.2 million, which is the reported period, compared with a net loss of $52.8 million in the fourth quarter of 2022, which is the comparable period. The decrease was largely due to a goodwill impairment of $36.5 million and an accrual of $8 million in connection with the settlement of the class section, which were recorded in the comparable period. and a decrease of $4.4 million in the general and administrative expenses. Revenue for the fourth quarter of 2023 was $2.4 million, and gross loss was $1.7 million on a GAAP basis. Revenue for the comparable period was $2.1 million, and gross loss was $1.8 million on a GAAP basis. Non-GAAP gross profit for the reported period was $0.2 as compared to $0.8 million in the comparable period, which represents a gross profit margin of approximately 36% on a non-GAAP basis for the reported period, as compared to 39% on a non-GAAP basis in the comparable period. Revenue from the teleradiology services for the reported period was $2.3 million, with a gross profit of $0.3 million on a gap basis, as compared to revenue of $2.1 million with a gross profit of $0.3 million on a gap basis in the comparable period, which represents a gross profit margin of approximately 14% on a gap basis for the reported period, as compared to 13% on a gap basis in the comparable period. Non-GAAP gross profit for the company's teleradiology services for the reported period was $0.9 million, as compared to $0.8 million in the comparable period, which represents a gross profit margin of approximately 38% on a non-GAAP basis for the reported period, as compared to 40% on a non-GAAP basis in the comparable period. The decrease in the gross profit margin on a GAAP and non-GAAP basis is mainly due to an increase in the cost of the company's radiologists due to the increase in the read rates and payments of incentive payments which the company paid to the company's radiologists to engage in reading during the overnight and weekend shifts. During the reported period, the company generated revenue to the sales of its AI solutions in the amount of 84,000. as compared to revenue of $63,000 in the reported period. During the first quarter of 2024, Nanox AI sold its health CCS cardiac solution to a second IDN in the U.S. for an annual fee of $8,500 during the first year of the engagement and an annual fee of $75,000 from the first anniversary of the engagement and after. During the reported period, the company generated revenue through the sales and deployment of its imaging system, which amounted to $17,000, with a gross loss of $44,000 on a GAF and non-GAF basis. Those revenues stem from the sales and deployment of our 2D systems in Africa. Research and development expenses for the reported period were $6.8 million, as compared to $7.1 million in the comparable period. The decrease of $0.3 million was mainly due to a decrease in the company's development expenses. Sales and marketing expenses for the reported period were $1.0 million, as compared to $1.5 million in the comparable period. The decrease was mainly due to a decrease in the expenses related to our sales and marketing activities. General and administrative expenses for the reported period were $3.8 million, as compared to $8.2 million in the comparable period. The decrease of $4.4 million was mainly due to a decrease in our legal expenses in the amount of $4.0 million, largely as a result of the finalizations of the SEC investigation and the settlement of the class actions. a decrease in share-based compensation in the amount of $0.2 million, and a decrease in the cost of the director's and officer's stability insurance premium in the amount of $0.4 million. Other income was $2.7 million for the reported period, as compared to an expense of $7.8 million for the comparable period. Other expenses in the comparable period included an accrual for the settlements in connection with the class action lawsuit against the company, in the amount of $8 million, which was reversed by the amount of $3 million in the reported period since the company received that amount from its DNO insurance carrier under the settlement agreement in connection with the class action lawsuit against the company. Turning to our balance sheet. As of December 31st, 2023, we had cash, cash equivalents, restricted deposits, and marketable securities of approximately $82.8 million, and we had $3.5 million loan from a bank. We ended the quarter with a property and equipment net of $42.3 million. As of December 31st, 2023, we had approximately 57.8 million shares outstanding as compared to 55.1 million shares outstanding as of December 31st, 2022. The increase was mainly due to the sales of approximately 2.1 million shares and warrants to purchase up to 2.1 million shares in a registered direct offering in consideration of gross proceeds of 30 million dollars and a net proceeds of approximately 27.1 million dollars. and the issuance of approximately of 255,000 ordinary shares to the former shareholders of U.S. RAS under the amendment to the U.S. RAS Stock Purchase Agreement. With that, I will hand the call back over to Erez.
spk04: Thank you all once again for joining our call today and your continued support of NANUC's mission to make medical imaging more efficient, accessible, and affordable worldwide. It has been two years since I stepped into the CEO role, and when I came to here, Nano-X was in a very different place. In just this year, we achieved an important milestone of FDA clearance and are seeking to potentially expand the use case for AHRQ with the FDA. We are also deep into the process of pursuing CMARC designation in the European Union, and have received local regulatory clearances in other countries like Ghana. We've also begun commercialization. Earnest and Arc systems are now deployed for the use by imaging center and hospital systems in Israel, three countries in Africa, and as of today's call, we know we have numerous deployed systems in the U.S. Over these two years, we have integrated our AI strategy across the company. Our leading NanoX AI solution provides the ability to use AI to highlight and help identify patients with asymptomatic undetected chronic disease, initiating early diagnosis and preventative management. In this year, we also achieved two FDA clearances, a substantial clinical validation of our AI solution. We understand this has been a long road. but our progress is tangible, and we are very excited for even more progress in 2024. Before I end the call, I have one last piece of news to share, and this is something many of you have been anticipating. On Wednesday, April 10th, we will demonstrate the use of the installed ARC system at Dynamic Medical Imaging in Union, New Jersey. Beginning at 9.30 a.m., the demonstration will be followed by a roundtable discussion. Please contact our investor relations partners at ICR Westwick if you are interested in attending and note that space is limited. With that, I thank you once again and bring our fourth quarter and full year 2023 investor call at close.
spk10: We will now conduct the question and answer session. If you'd like to ask a question at this time, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster.
spk03: Just before we dive into the Q&A session, I would like to mention that we have updated our website with interesting clinical pathologies from the U.S. commercial site and chest from our clinical site. In the U.S. sample, we note enhanced visualization compared to traditional radiography. One example is cervical spine scan. Additionally, you can find a chest study from the Bellinson Critical Clinical Trial And in the chest body, while the X-ray only faintly shows a lesion, this lesion was clearly visualized on the NanoXARC images and in the CT scan of the patient's schedule for biopsy.
spk02: So take a look and feel free to see it as well.
spk10: Q and A. Our first question will come from the line of Ross Osborne. with Cantor Fitzgerald.
spk14: Hey, guys. Congrats on the progress, and thanks for taking our questions. So starting off with ARC, would you discuss how many systems in the U.S. are operational across the five states deployed in during the fourth quarter, and also provide us with how 2024 has progressed thus far in terms of placement and visibility into your pipeline or backlog of orders? Thank you.
spk03: Ross, we have already indicated that along the year we will add more details. So far, we have not informed exactly how many systems. We just say that we have systems installed right now in five states. The one thing I would say is that we have already manufactured a few dozens of systems. and the system is installed in the clinical facilities as indicated. Next, I would say that in the next meetings, I will probably mention and give you more numbers. The numbers that we gave so far are scans per day, the dollars per scan, and the few dozens that were already sold and shipped to the various locations.
spk15: Yes, and Ross, mind you that there's a difference between the amount or the number of the installed systems to the ones that are operated commercially since there's a gap of time due to the local or state registration requirements.
spk14: Understood. And then maybe could you provide some color on what types of centers are adopting ARC and how utilization has trended thus far and their level of comfort with $30 per scan?
spk03: Yes, we actually can. So we have small and medium-sized medical imaging centers right now. One of them is big. And the other thing that we can indicate is that the, where else do we have?
spk02: Yes, I think that most of them, yeah.
spk03: If I actually screen all of them, all of them are these type of clinical areas. The other one that we have is in the Georgia site of 626. And I would say, yeah, a few installations are in orthopedic clinical centers.
spk02: And yeah, that's the numbers.
spk14: Got it. And then lastly for us, would you remind us of the economics on Connect, given your agreements in Peru and Mexico, in terms of whether that's going to be a capital sale or MSAS? And if it is MSAS, how should we think about pricing?
spk15: Most of them are MSAS models in the same manner that we apply to the ARC. Sometimes we do a capital sales model with regards to the Connect. But as I said, most of them are MSAS models.
spk03: It depends on also, Ross, it depends also on the countries. In certain countries, especially in Africa, we make a decision to sell the system. In a few of them, we sell for... a partial amount and then that charge per scan. We have various models on the Connect.
spk13: Okay, got it. Thank you for taking my questions. You're more than welcome.
spk10: Our next question will come from the line of Jeff Cohen with Ladenburg-Thalaman.
spk05: Hi, how are you? Good, good.
spk06: I did want to follow up on a couple of Ross's questions. Could you talk about Connect a bit in a little deeper scale and give us a sense of Connect versus Arc and how you anticipate both those platforms to play out both in the US and OUS?
spk03: OK. Right now, the Connect is being sold outside of the US. Once the Connect is going to get the FDA in the US, we're going to sell it in the US as well. We have right now Connect in more than 10 countries right now and a lot of them are Africa, part of them are Latin America and in Israel. First of all, the purpose of the Connect was to expand or expand the line of products that we have. And the beauty of what we sell in the Connect is that we sell it not only as a piece of equipment, but bundled with AI system included in what we sell. So the system can analyze the image itself. In addition, we have systems that we're Sold in Morocco, for example, it was used in the earthquake by the customer that bought it there. It was used also in Israel in various extreme situations when you can do testing in the field or screening in the field. And the idea behind them is twofold. The first one is that we say that sometimes we get the connect and later on we get the arc. And second is the inclusion or the how do we build the AI system into the imaging itself. In terms of the process of the CONNECT, it's the same process. Sometimes they get the registration just before the ARC, sometimes after the ARC. If you take the CONNECT examples in Africa in one or two countries, we have achieved with the CONNECT One of the country's few days that the number of scans per day were above 120. And these are examples that can enable us actually to penetrate some clinics before. I will actually reemphasize the fact that for us it's really gratifying to see that the ARC and Connect, the fact that they are marketing together, marketed together, As we envisioned from the very beginning, it's basically complementary and very beneficial for what we do. The fact that we are very flexible in terms of the business model and the hybrid model, the MSUS and the CapEx-based Excel, this actually adds a lot of value for us as well.
spk06: So I guess, Eris, what you're saying is on clearances that you anticipate a lot of sites to, or maybe the majority of sites, to have both types of deployments, ARCs and CONNECs.
spk03: I would not say majority, because sometimes some countries would like to use CONNECs more than the ARCs. But I would say that in Latin America and in the U.S., it will be mainly ARC. In the rest of the world, we will see a lot of countries that will sell the Connect, sometimes as preparation to get access to medical imaging, because that's the mission that we took upon ourselves, and we're trying to get it in various ways as we do. By the way, we saw a few countries that the beginning was with the Connect, and then we were able to sign for the ARC.
spk06: Got it. And could you clarify a previous comment on manufacturing? Was that 2,000 systems manufactured?
spk03: No, no, no. We said that we have a few dozens. uh of systems that were already manufactured uh we are in the process of manufacturing a few dozens a few a few more dozens um and if you think about the long delete items and if you think about the availability of of a part this uh enabled us actually to cover the paste of the installation that we're doing right now if you remember in the in the investors' day, we said that we're going in a very conservative approach. We don't have a second chance to make a first impression, especially not in the US. So we are installing the systems. We are analyzing the data. We are adding and improving the process of the installation. We have been able to shorten the time that we install the systems. We are negotiating right now another service company that will have better coverage for the US. We have gained a lot of access or the ability to control the systems also from remote. We are opening the call center that will enable us to serve best these units Uh, we are, uh, increasing, um, exponentially the number of people that are in the sales and the service team. Um, and, uh, and we are continue to expand our professional teams, uh, and the, uh, and recruited the personnel last, but not least is that we have to, of course, to work on the referrals. and to ensure that people will be aware of the changes that we're doing in the standard of care and will do it professionally.
spk06: Cut. And lastly, Frost, any commentary on 2024 as far as first quarter, sequential revenue changes, et cetera, et cetera? Thank you.
spk03: Yeah. So, first of all, part of the indication that I gave are where we are so far. And so the number will be growing. We are focusing on generating more revenues, more installations, and more scans in the current installation in the system that we're going to install. And I believe that next quarter we'll be able to share more detailed update as well as numbers of where we are and what's the process that we're heading. As right now, we are making progress according to the plan and exactly according to what was presented in the investor's date. As you can imagine, we are right now, based on past experience, we are much more careful and conservative in what we say, what we indicate, and we're trying to ensure that whatever we promise will be delivered.
spk02: Super. Thanks for taking our questions.
spk10: As a reminder, that is star 1-1 to ask a question. Our next question will come from the line of Anthony Patrone with Mizuho.
spk16: Thanks and congratulations on the strong start to, strong into last year, strong start to this year. Maybe, Erich, just on the utilization per systems for Nano-X Arc, you mentioned 30 per scan. And some of the early systems are doing seven scans per day. Just on how you expect that to scale and which areas are you seeing utilization? Is it more on orthopedic side? Are you seeing it in chest x-ray? Just a little bit on where you're seeing the early use cases for Nanox ARC and how you see that scaling over the 2024. And then I'll have a couple of follow-ups. Thanks.
spk03: OK, no disrespect to the others, but great question. First of all, I can say that the seven scans per day is actually the model that we built. And it seems that from the early installations, that's what we see. I would say, however, more than that, that we had in medical imaging centers, which are, I would say, which are professionals, and there are people who really understand what we're doing. We had days with 15 scans per day. So this is the beginning. In terms of the dollars per scan, this is the $30. If you remember, compared to the $14 to $17, in the rest of the world, so U.S. is about $30. And this is in line of the CPT code and the reimbursement that can be generated, which actually leaves a lot of room for us, for the center, for the medical imaging center, and for the radiologist. With respect to the, so this is, these are the numbers that we see right now. with respect to clinical indications I'd like to remind the following okay in the US in the US we have right now the MSK FDA unlike the rest of the world that we do a lot in in in Israel, in Africa, in other places. We do chest, we do abdomen, we do scalp, we do all other kind of indications. Our 2024 FDA submissions will include other indications as stated in the comment that I made in the very beginning. Based on, for example, the hospital in Israel, we do pulmonology cancer screening. And this is actually part of the chest samples that we are taking. We actually uploaded on our website these examples and also the cervical spine scan that we do. I have to be very careful because of the regulation, because of the FDA, and because of all the clinical work that we do with other places. But right now, for us, it seems that we're going to have even more clinical indications as we move forward than originally anticipated. Even some of them are we're not part of the original plan.
spk16: That's helpful. And I have a couple of follow-ups on AI solutions and specifically health CTS for coronary artery calcification at Arrow Mountain. You know, it's deployed there and it looks like it's getting up and running. How do you see that progressing further? And when we think about Intermountain, you know, just in terms of the volume of patients they're seeing with coronary artery disease, how many cases do you think we'll actually see being analyzed in CCS, you know, over the next few months and how will it trend over the next few years as this collaboration with Intermountain Health evolves? Thank you.
spk03: Okay, so with AI, I suggest to read an article that our chief medical officer wrote and another one that I wrote in the Forbes about the usage of AI. It seems that right now, not only us, but other companies in the AI business have like engines with really high power But right now, because of the implementation and the deployment and the adoption by part of the, especially the US health economy, it's not fast enough, which will be able to generate more revenues to each one of the institutions. But people are afraid from this situation. By the way, I think that it is right for almost any other business elsewhere. But health is the adoption is slower than the ability to provide the services. With respect to the CCS, the calcium scoring, right now most of the experience that we have is mostly from Spectrum or from Corwell, which we gave these indications, and also from the UK. So if I talk about the cardiac solution, I would say that 60% of the patients in the study were undetected previously with the risk. And finally, they were with cardiovascular event from the chest test CDs that were not diagnosed. And the other experience that we had with a lot of people that were diagnosed, one of uh in the media is bellinson and israel and um in the uk which was uh mainly for the uh for the bones for the osteoporosis but what you can see is that the um um i think it we we published the uh the um the results of the adopt and the other one in our website yeah You can take a look at the website and see the indication that we gave there with the number of patients that were not detected or were not detected with cardiac diseases. And I think that this gives an indication of the ability to do. The one that was mentioned with respect to the bone solution is with the Oxford University. And this was published that they have identified up to six times more patients with vertebral compression fracture than that was indicated in the other CT scans that were there. So I think that the AI and what we do is they're getting a lot of attention. And we will provide, the more we go into the future, we will provide as much as we can, because this is under a lot of privacy restrictions. But the more we can share with the public and the more the institution, including, by the way, Intermountain, which is relatively new, the more they give us the ability to share, we'll definitely share with the public.
spk09: Thank you again.
spk01: This concludes today's conference call. Thank you for participating. You may now disconnect. you Thank you. Thank you. Thank you.
spk10: Good day and thank you for standing by. Welcome to the NANUC's fourth quarter 2023 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Mike Cavanaugh, Investor Relations. Please go ahead.
spk17: Good morning, and thank you for joining us today. Earlier today, Nanox Imaging Limited released financial results for the quarter ended December 31st, 2023. The release is currently available on the Investors section of the company's website. Eris Meltzer, Chief Executive Officer, and Ron Daniel, Chief Financial Officer, will host this morning's call. 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.
spk04: Thanks, Mike. And as always, thank you all for joining us today for our financial result call and corporate updates. Before we get started, I would like to take a minute to acknowledge the passing of our founder, Rand Paul Yakin, back in January. We all owe him our gratitude, and I'm proud to lead our team as we seek to realize his vision of making medical imaging more accessible to improve early detection and treatment to help people achieve a better health outcome. My remarks will be a bit longer today than usual, and I will provide a lot of details on the various business aspects of NADOS. As we share our fourth quarter updates and review our financial results, I'm extremely proud of the progress our team made over the course of 2023, highlighted by the exciting milestone of FDA clearance for the Nanux Arc system, a clear validation of our technology and mission, and our first steps in the US commercialization. On today's call, we will be focusing on our fourth quarter activities, as well as some of our achievements in early 2024, a year which I expect will be transformational for Nanux. We are now in the process of expanding our commercialization of the NANUX Arc system and are aiming for a steady increase in deployment as we raise awareness of the NANUX solution. NANUX is dedicated to accelerating the implementation of our commercial infrastructure and future strategic plans in the US. Our mission is to provide healthcare practices with a game-changing advantage through the NANUX Arc an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care. I'd like to start our call with an update on our U.S. deployment activities. As we have disclosed in the past, we have already deployed the ART at the first location in the U.S. in New Jersey in the New York metropolitan area. Since then, we have launched across five states, marking an advancement in our U.S. deployment, which is going as planned. As of today's call, AHRQ systems have been installed at several medical imaging and diagnostic systems centers in New Jersey, New York, Florida, and Kansas, as well as the Georgia 626 Imaging Academy, which serves as a technical and training center the NANUC's AHRQ system began to scan patients. Clinical operation of the AHRQ system will begin in other sites pending certification from the corresponding states' regulatory bodies. As already indicated in our Investor's Day, back in December, one of the purposes of these installations is to validate our MSAS assumptions. Based on these initial deployments, it seems, that the model is indeed validated, and we are scanning around seven scans per day, as well as the indication for $30 per scan. As part of the establishment of our infrastructure, the Georgia site at 626 Imaging Academy serves as a technical and training center for technicians on the use of the system and they have successfully completed our engineers training program at the Atlanta 626 MIS Woodstock Training Center. We are in advanced negotiation with another installation, maintenance, and service provider in order to expand our service coverage. This is prior to scale. As we increase our footprint across the United States, we continue to expand our U.S. sales and technical teams. We are continuing to expand our professional team and have recruited additional personnel in the US. We aim to grow gradually as needed and are being judicious about our hires to ensure that additional expenditure generate a good return on the investment. At the same time, we are extending our sales network as planned. As we ramp up the deployment, I can share that we have begun realizing revenue streams from ARC imaging scans at the US deployed sites that are utilizing the EMSAS model. I'd like to address one final aspect regarding our commercial operation in the US. As per our standard procedures, NANUC has submitted certification requests to expand the placement of NANUC ARC units to various states across the country. I'm eager to keep you updated on the progress of these future installations. Turning now to our deployment effort in the rest of the world outside of the key U.S. market, as we disclosed in our last call, we are generating revenue from hardware deployments in Africa and have three installations as of the end of March. As previously mentioned, we have had a unit installed at the University of Ghana Medical Center Limited, UGMC, and which has received local regulatory clearance. I can now share that we have signed a Ghana multi-site agreement, which was done as part of our multi-site trial in Ghana. We are conducting the trial, aiming to generate continuous data and clinical evidence on the NANOX ARC. I will describe this trial in a bit more detail later in my remarks. We have also made progress in expanding the Nano-X footprint in Latin America. One recent agreement is with a Peru-based medical equipment distributor, which has partnered with us to distribute the Nano-X Connect in that country. The partner has a strong presence in Peru with good reach into the key local health system and hospitals, and our cloud-based Connect solution should be a complementary product for the product offering as this partner is already actively marketing other healthcare solutions which enable remote patient exams by a clinician. I can also update you that our distributor in Mexico is seeking an import license for the NANUX Arc and preparing for the first installation. The partner has also received an import license for the NANUX Connect, and we have shipped the first two systems. Similar to the ARC, the distributor has applied to obtain the required registration to sell this solution, and we also anticipate that Connect will also continue generating revenues in 2024. As a side comment, I will say that it is very gratifying to see that the ARC and Connect be marketed together as we have envisioned this complementary imaging solution from the very beginnings. I'd like to provide an update on our hardware revenues, which Fran will review in more details shortly. While we have began generating revenues through our AI solutions in Q3, NanoX began to generate revenue outside of the US for the sales and deployment of its imaging systems. Now I'd like to provide an update on NanoX AI business which has had an increase of 250% in our client base compared to last quarter. We have an installed base of health system who use health CCS and AI-powered solution to detect levels of coronary artery calcium, a proven indicator of future cardiac events. We have digested our experience in the field with this and gathered feedback from users specifically cardiologists and radiologists, to upgrade the solution. Revisiting one of the AI product partners, Corwell Health, formerly Spectrum, which began using our population health solution in mid-2022 and is a large integrated health system. We have consistently received positive feedback from Corwell Health, which has fully integrated this into their standard of care, This has been a productive partnership which has been extended for additional term. Many of you are aware that the Nanux solutions are available on Nuance Precision Imaging Network, a Microsoft company. More than 12,000 health care facilities and 80% of the U.S. radiologists will use Nuance PowerStribe for radiology reporting. I can share that Intermountain Health has signed on to deploy Health CCS and was part of Nuance Bundled. The go-live process started, including training activities and integration of the solution into internal systems. NANUCS also achieved another regulatory milestone last month when we received the 510 clearance by the U.S. Food and Drug Administration, FDA, for Health FLV. an artificial intelligence software that provides automated qualitative and quantitative analysis of liver attenuation from routine CT scans. Health FLD is intended to support clinicians in the detection of fatty liver correlated with hepatic steatosis, an early sign of metabolic dysfunction associated steatotic liver disease, MASLD, formerly referred to as non-alcoholic fatty liver disease. HealthFLD is a new and valuable tool for doctors, as it has traditionally been difficult to assess liver attenuation on contract-enhanced scans, which make up a large proportion of the CT scans. HealthFLD was designed to help clinicians in the assessment and the analysis of fatty liver in general population from routine CT scans. We believe that AI innovative solution and specifically health FLD may deliver substantial advantages to the biopharmaceutical industry to streamline the identification of candidates for clinical trials of much needed therapies for liver diseases, including mesh. This regulatory decision solidifies our leadership as a developer of automated AI software medical devices. We also announced last month early findings from the AI-enabled ADOPT study, which uses a Nano-X AI solution, HealthVCF, the previous version of our current HealthLSP solution, to review routine CT scans and identify up to six times more patients with vertebral compression factor that the national average at national health services, NHS, hospitals in the UK. The study is being conducted at various national health service or NHS sites, including the Oxford University's hospitals. The ADAPT data shows that HealthVCF has clearly demonstrated the ability to identify vertebral compression factors in far more patients than previously possible with existing tools, enabling earlier intervention and potentially better patient outcomes. To date, the NANOX AI algorithms has identified over 2,400 patients with previously unknown vertebral compression fractures, and those patients have been designated for follow-up evaluation and treatment. As you can see, we have been very busy not only with the Nano-X Arc system deployment, but also advancing the uptake of Nano-X AI, which is an important component of the complete Nano-X solution. Turning now to our OEM initiatives. After executive partnership kickoff meetings at Varix headquarters in Salt Lake City last year, the company's technical teams are actively engaged in validating the tube design and advancing the roadmap towards production and exploring future development. Expanding on our OEM-related activity, we have issued our first production purchase order to an industrial imaging equipment manufacturer and continue to work towards a multi-year tube supply agreement to ensure an adequate future supply of tubes. Additionally, Our collaboration with the U.S. government agency exploring Nano-XR technology for use in security application in progressing. After their acquisition of chips and tubes for evaluation, we are advancing to our collaboration on a novel tube based on our meter. Finally, as a means of increasing awareness and allowing access to our core technologies, we have created Nano-XR demonstration kits. containing a tube utilizing our emitter. And we have recently received the necessary safety and regulation certifications for the kit, and we'll be delivering our first few to interested party in the coming weeks. Regarding the mass production as recently announced, due to the scale up in commercialization, we continue as planned with our collaboration with the system, a chip maker located in Switzerland. As I mentioned earlier in my comments about Ghana, Nano-X is conducting multi-center clinical trial to enhance Nano-X Arc with the goal of expanding its use with chest and other indications. The trial is scheduled to begin patient recruitment shortly, and Nano-X Arc systems that are being used in these trials are already scanning patients. The system installed at Bellington Hospital is ready The Institutional Review Board, IBR, has approved the trial and we are finalizing the remaining steps for integrating into multi-site. In Ghana, the IRB has been submitted and currently is under review. Additionally, the NanoxARC is being used to scan patients with abnormal lung conditions at Beilincon, one of the world's top academic medical center and an institution that has pioneered advancement in radiology. The system at UGMT is also currently being used to scan patients. Our pursuit of the CE mark in Europe is advancing in partnership with our notified body. Specifically, recently we completed a five-day audit by the notified body as part of the certification process for the CE certificates, the ISO, 13485 plus medical device regulations MDR certificate. During the inspection, hundreds of records, procedures, proofs, reports, and examples were presented. The MDR test was passed successfully. The ISO 13485 test was passed with a great success and without any adverse findings. Sometimes after the audit, the formal review process will begin, which includes examining aspects of the manufacturing process. And although we expect our application process to proceed in a timely manner, I would note the regulatory bodies worldwide are still working through a backlog of applications, which accumulated during the multi-year COVID pandemic and the adjustment for the new MDR regulations. However, as I said, we are well along in the process and will continue to prioritize the work with our partners necessary to complete the MIRA tasks required to bring the C-certification process with the finish line. With that, I'd like now to turn the call over to Ran Daniel for a review of our financial results. Ran?
spk15: Thank you, Eric. We reported a gap net loss for the fourth quarter of 2023 of $10.2 million, which is the reported period, compared with a net loss of $52.8 million in the fourth quarter of 2022, which is the comparable period. The decrease was largely due to a goodwill impairment of $36.5 million and an accrual of $8 million in connection with the settlement of the class section, which were recorded in the comparable period. and a decrease of $4.4 million in the general and administrative expenses. Revenue for the fourth quarter of 2023 was $2.4 million, and gross loss was $1.7 million on a GAAP basis. Revenue for the comparable period was $2.1 million, and gross loss was $1.8 million on a GAAP basis. Non-GAAP gross profit for the reported period was $0.2 as compared to $0.8 million in the comparable period, which represents a gross profit margin of approximately 36% on a non-GAAP basis for the reported period, as compared to 39% on a non-GAAP basis in the comparable period. Revenue from the teleradiology services for the reported period was $2.3 million, with a gross profit of $0.3 million on a gut basis, as compared to revenue of $2.1 million with a gross profit of $0.3 million on a gut basis in the comparable period, which represents a gross profit margin of approximately 14% on a gut basis for the reported period, as compared to 13% on a gut basis in the comparable period. Non-GAAP gross profit for the company's teleradiology services for the reported period was $0.9 million, as compared to $0.8 million in the comparable period, which represents a gross profit margin of approximately 38% on a non-GAAP basis for the reported period, as compared to 40% on a non-GAAP basis in the comparable period. The decrease in the gross profit margin on a GAAP and non-GAAP basis is mainly due to an increase in the cost of the company's radiologists due to the increase in the read rates and payments of incentive payments which the company paid to the company's radiologists to engage in reading during the overnight and weekend shifts. During the reported period, the company generated revenue to the sales of its AI solutions in the amount of $84,000. as compared to revenue of $63,000 in the reported period. During the first quarter of 2024, Nanox AI sold its health CCS cardiac solution to a second IDN in the U.S. for an annual fee of $8,500 during the first year of the engagement and an annual fee of $75,000 from the first anniversary of the engagement and after. During the reported period, the company generated revenue through the sales and deployment of its imaging system, which amounted to $17,000, with a gross loss of $44,000 on a GAAP and non-GAAP basis. Those revenues stem from the sales and deployment of our 2D systems in Africa. Research and development expenses for the reported period were $6.8 million, as compared to $7.1 million in the comparable period. The decrease of $0.3 million was mainly due to a decrease in the company's development expenses. Sales and marketing expenses for the reported period were $1.0 million compared to $1.5 million in the comparable period. The decrease was mainly due to a decrease in the expenses related to our sales and marketing activities. General and administrative expenses for the reported period were $3.8 million, as compared to $8.2 million in the comparable period. The decrease of $4.4 million was mainly due to a decrease in our legal expenses in the amount of $4.0 million, largely as a result of the finalizations of the SEC investigation and the settlement of the class actions. a decrease in share-based compensation in the amount of $0.2 million, and a decrease in the cost of the director's and officer's stability insurance premium in the amount of $0.4 million. Other income was $2.7 million for the reported period, as compared to an expense of $7.8 million for the comparable period. Other expenses in the comparable period included an accrual for the settlements in connection with the class action lawsuit against the company, in the amount of $8 million, which was reversed by the amount of $3 million in the reported period since the company received that amount from its DNO insurance carrier under the settlement agreement in connection with the class action lawsuit against the company. Turning to our balance sheet. As of December 31st, 2023, we had cash, cash equivalents, restricted deposits, and marketable securities of approximately $82.8 million. And we had $3.5 million loan from a bank. We ended the quarter with a property and equipment net of $42.3 million. As of December 31st, 2023, we had approximately 57.8 million shares outstanding as compared to 55.1 million shares outstanding as of December 31st, 2022. The increase was mainly due to the sales of approximately 2.1 million shares and warrants to purchase up to 2.1 million shares in a registered direct offering in consideration of gross proceeds of 30 million dollars and a net proceeds of approximately 27.1 million dollars. and the issuance of approximately of 255,000 ordinary shares to the former shareholders of U.S. RAS under the amendment to the U.S. RAS Stock Purchase Agreement. With that, I will hand the call back over to Erez.
spk04: Thank you all once again for joining our call today and your continued support of NANUC's mission to make medical imaging more efficient, accessible, and affordable worldwide. It has been two years since I stepped into the CEO role. And when I came to here, Nano-X was in a very different place. In just this year, we achieved an important milestone of FDA clearance and are seeking to potentially expand the use case for ARC with FDA. We are also deep into the process of pursuing CMARC designation in the European Union and have received local regulatory clearances in other countries like Ghana. We've also begun commercialization. Earnest and Arc systems are now deployed for the use by imaging center and hospital systems in Israel, three countries in Africa, and as of today's call, we know we have numerous deployed systems in the U.S. Over these two years, we have integrated our AI strategy across the company. Our leading NanoX AI solution provide the ability to use AI to highlight and help identify patients with asymptomatic undetected chronic disease, initiating early diagnosis and presentative management. In this year, we also achieved two FDA clearances, a substantial clinical validation of our AI solution. We understand this has been a long road. but our progress is tangible, and we are very excited for even more progress in 2024. Before I end the call, I have one last piece of news to share, and this is something many of you have been anticipating. On Wednesday, April 10th, we will demonstrate the use of the installed ARC system at Dynamic Medical Imaging in Union, New Jersey. Beginning at 9.30 a.m., the demonstration will be followed by a roundtable discussion. Please contact our investor relations partners at ICR Westwick if you are interested in attending and note that space is limited. With that, I thank you once again and bring our fourth quarter and full year 2023 investor call at close.
spk10: We will now conduct the question and answer session. If you'd like to ask a question at this time, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster.
spk03: Just before we dive into the Q&A session, I would like to mention that we have updated our website with interesting clinical pathologies from the U.S. commercial site and chest from our clinical site. In the U.S. sample, we note enhanced visualization compared to traditional radiography. One example is cervical spine scan. Additionally, you can find a chest study from the Bellinson Critical Clinical Trial And in the chest body, while the X-ray only faintly shows a lesion, this lesion was clearly visualized on the NanoXARC images and in the CT scan of the patient's schedule for biopsy.
spk02: So take a look and feel free to see it as well.
spk10: Q and A. Our first question will come from the line of Ross Osborne. with Cantor Fitzgerald.
spk14: Hey, guys. Congrats on the progress, and thanks for taking our questions. So starting off with ARC, would you discuss how many systems in the U.S. are operational across the five states deployed in during the fourth quarter, and also provide us with how 2024 has progressed thus far in terms of placement and visibility into your pipeline or backlog of orders? Thank you.
spk03: Ross, we have already indicated that along the year we will add more details. So far, we have not informed exactly how many systems. We just say that we have systems installed right now in five states. The one thing I would say is that we have already manufactured a few dozens of systems. And we have the system installed in the clinical facilities as indicated. Next, I would say that in the next meetings, I will probably mention and give you more numbers. The numbers that we gave so far are scans per day, the dollars per scan, and the few dozens that were already being sold and shipped to the various locations.
spk15: Yes, and Ross, mind you that there's a difference between the amount or the number of the installed systems to the ones that are operated commercially since there's a gap of time due to the local or state registration requirements.
spk14: Understood. And then maybe could you provide some color on what types of centers are adopting ARC and how utilization has trended thus far and their level of comfort with $30 per scan?
spk03: Yes. We actually, we can. So we have small and medium size medical imaging centers right now. One of them is big. And the other thing that we can indicate is that the, where else do we have?
spk02: Yes, I think that most of them, yeah.
spk03: If I actually screen all of them, all of them are these type of clinical areas. The other one that we have is in the Georgia site of 626. And I would say, yeah, a few installations are in orthopedic clinical centers.
spk02: And yeah, that's the numbers.
spk14: Got it. And then lastly for us, would you remind us of the economics on Connect, given your agreements in Peru and Mexico, in terms of whether that's going to be a capital sale or MSAS? And if it is MSAS, how should we think about pricing?
spk15: Most of them are MSAS models in the same manner that we apply to the ARC. Sometimes we do a capital sales model with regards to the Connect. But as I said, most of them are MSOS models.
spk03: It depends on also, Ross, it depends also on the countries. In certain countries, especially in Africa, we make a decision to sell the system. In a few of them, we sell for... a partial amount and then that charge per scan. We have various models on the Connect.
spk13: Okay, got it. Thank you for taking my questions.
spk02: You're more than welcome.
spk10: Our next question will come from the line of Jeff Cohen with Ladenburg-Thalaman.
spk05: Hi, how are you? Good, good.
spk06: I did want to follow up on a couple of Ross's questions. Can you talk about Connect a bit in a little deeper scale and give us a sense of Connect versus Arc and how you anticipate both those platforms to play out both in the US and OUS?
spk03: OK. Right now, the Connect is being sold outside of the US. Once the Connect is going to get the FDA in the US, we're going to sell it in the US as well. We have right now CONNECT in more than 10 countries right now and a lot of them are Africa, part of them are Latin America and in Israel. First of all, the purpose of the CONNECT was to expand or expand the line of products that we have. And the beauty of what we sell in the Connect is that we sell it not only as a piece of equipment, but bundled with AI system included in what we sell. So the system can analyze the image itself. In addition, we have systems that were Sold in Morocco, for example, it was used in the earthquake by the customer that bought it there. It was used also in Israel in various extreme situations when you can do testing in the field or screening in the field. And the idea behind them is twofold. The first one is that we say that sometimes we get the connect and later on we get the arc. And second is the inclusion or how do we build the AI system into the imaging itself. In terms of the process of the CONNECT, it's the same process. Sometimes they get the registration just before the ARC, sometimes after the ARC. If you take the CONNECT examples in Africa in one or two countries, we have achieved with the CONNECT One of the country's few days that the number of scans per day were above 120. And these are examples that can enable us actually to penetrate some clinics before. I will actually reemphasize the fact that for us it's really gratifying to see that the ARC and Connect, the fact that they are marketing together, marketed together, As we envisioned from the very beginning, it's basically complementary and very beneficial for what we do. The fact that we are very flexible in terms of the business model and the hybrid model, the MSUS and the CapEx-based Excel, this actually adds a lot of value for us as well.
spk06: So I guess, Eris, what you're saying is on clearances that you would anticipate a lot of sites to, or maybe the majority of sites, to have both types of deployments, ARCs and CONNECs.
spk03: I would not say majority, because sometimes some countries would like to use CONNECs more than the ARCs. But I would say that in Latin America and in the U.S., it will be mainly ARC. In the rest of the world, we will see a lot of countries that will sell the Connect sometimes as preparation to get access to medical imaging because that's the mission that we took upon ourselves, and we're trying to get it in various ways as we do. By the way, we saw a few countries that the beginning was with the Connect, and then we were able to sign for the ARC.
spk06: Got it. And could you clarify a previous comment on manufacturing? Was that 2,000 systems manufactured?
spk03: No, no, no. We said that we have a few dozens. uh of systems that were already manufactured uh we are in the process of manufacturing a few dozens a few a few more dozens um and if you think about the long delete items and if you think about the availability of uh of a part this uh enabled us actually to cover the paste of the installation that we're doing right now if you remember in the in the investor's day, we said that we're going in a very conservative approach. We don't have a second chance to make a first impression, especially not in the US. So we are installing the systems. We are analyzing the data. We are adding and improving the process of the installation. We have been able to shorten the time that we install the systems. We are negotiating right now another service company that will have better coverage for the US. We have gained a lot of access or the ability to control the systems also from remote. We are opening the call center that will enable us to serve best these units We are increasing exponentially the number of people that are in the sales and the service team. And we are continuing to expand our professional teams and recruit additional personnel. Last but not least is that we have to, of course, to work on the referrals. and to ensure that people will be aware of the changes that we're doing in the standard of care, and we'll do it professionally.
spk06: Got it. And lastly for us, any commentary on 2024 as far as first quarter, sequential revenue changes, et cetera, et cetera? Thank you.
spk03: Yeah. So first of all, part of the indication that I gave are where we are so far. And so the number will be growing. We are focusing on generating more revenues, more installations, and more scans in the current installation in the system that we're going to install. And I believe that next quarter we'll be able to share more detailed update as well as numbers of where we are and what's the process that we're heading. As right now, we are making progress according to the plan and exactly according to what was presented in the investor's date. As you can imagine, we are right now, based on past experience, we are much more careful and conservative in what we say, what we indicate, and we're trying to ensure that whatever we promise will be delivered.
spk02: Super. Thanks for taking our questions.
spk10: As a reminder, that is star 1-1 to ask a question. Our next question will come from the line of Anthony Patrone with Mizuho.
spk16: Thanks and congratulations on the strong start, strong into last year, strong start to this year. Maybe, Erich, just on the utilization per systems for Nano-X Arc, you mentioned 30 per scan. And some of the early systems are doing seven scans per day. Just on how you expect that to scale and which areas are you seeing utilization? Is it more on orthopedic side? Are you seeing it in chest x-ray? Just a little bit on where you're seeing the early use cases for Nano-X Arc and how you see that scaling over the 2024. And then I'll have a couple of follow-ups. Thanks. Thanks.
spk03: Okay, no disrespect to the others, but great question. First of all, I can say that the seven scans per day is actually the model that we built, and it seems that from the early installations, that's what we see. I would say, however, more than that that we had in in in medical imaging centers which are i would say can which are professionals and there are people who really understand what what we're doing we had days with 15 scans per day so so this is this is the beginning in terms of the dollars per scan this is the thirty dollars If you remember, compared to the $14 to $17 in the rest of the world, so U.S. is about $30. And this is in line of the CPT code and the reimbursement that can be generated, which actually leaves a lot of room for us, for the center, for the medical imaging center, and for the radiologists. With respect to the, so this is, these are the numbers that we see right now. With respect to clinical indications, I'd like to remind the following, okay? In the U.S., in the U.S., we have right now the MSK FDA. Unlike the rest of the world that we do a lot in Israel, in Africa, in other places, we do chest, we do abdomen, we do scalp, we do all other kind of indications. Our 2024 FDA submissions will include other indications as stated in the comment that I made in the very beginning. So based on, for example, hospital in Israel, we do pulmonology cancer screening. And this is actually part of the chest samples that we are taking. We actually uploaded on our website These examples and also the cervical spine scan that we do. I have to be very careful, you know, because of the regulation, because of the FDA, and because of all the clinical work that we do with other places. But right now, for us, it seems that we're going to have even more clinical indications as we move forward than originally anticipated. Even some of them are not, were not part of the original plan.
spk16: That's helpful. And I have a couple of follow-ups on AI solutions and specifically health CTS for coronary artery calcification at Arrow Mountain. you know, it's deployed there and it looks like it's getting up and running. Now, how do you see that progressing in 2024? And when we think about Erna Mountain, you know, just in terms of the volume of patients they're seeing with coronary artery disease, how many cases do you think we'll actually see being analyzed in CCS, you know, over the next few months and how will it trend over the next few years as this collaboration with Intermountain Health evolves. Thank you.
spk03: Okay, so with AI, I suggest to read an article that our chief medical officer wrote and another one that I wrote in the Forbes about the usage of AI. It seems that right now, not only us, but other companies in the AI business have like Engines with really high power, but right now they are because of the implementation and the deployment and the adoption by the by part of the, especially the US cell health economy. It's not fast enough. which will be able to generate more revenues to each one of the institutions. But people are afraid from this situation. By the way, I think that it is right for almost any other business elsewhere. But health, the adoption is slower than the ability to provide the services. With respect to the CCS, the calcium scoring, right now most of the experience that we have is mostly from Spectrum or from Corwell, which we gave these indications, and also from the UK. So if I talk about the cardiac solution, I would say that 60% of the patients in the study were undetected previously with the risk. And finally, they were with cardiovascular event from the chest test CDs that were not diagnosed. And the other one, the other experience that we had with a lot of people that were diagnosed, one of them, by the way, was in the TV, in the media, is Bellinson and Israel. And in the UK, which was mainly for the bones, for the osteoporosis. But what you can see is that the, I think we published the results of the ADOPT and the other one in our website. Yeah. You can take a look at the website and see the indication that we gave there with the number of patients that were not detected or were not were not detected with cardiac diseases. And I think that this gives an indication of the ability to do. The one that was mentioned with respect to the bone solution is with the Oxford University. And this was published that they have identified up to six times more patients with vertebral compression fracture than that was indicated in the other CT scans that were there. So I think that the AI and what we do is they're getting a lot of attention and we will provide the more we go into the future, we will provide as much as we can because this is under a lot of privacy restrictions, but the more we can share with the public and the more the institution, including, by the way, Intermountain, which is relatively new, the more they give us the ability to share, we'll definitely share with the public.
spk09: Thank you again.
spk01: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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