Good afternoon, and thank you for joining us today. This is Mike Cavanaugh from ICR Westwicke. You are joining the Nanox virtual tour of the Nanox.ARC in a clinical setting. This tour was presented today at the RSNA, and we are delighted to share that with investors today. I'll turn the call over to Ran Poliakine for a few words, but I'd like to say we will be answering questions at the end of the call. If you'd like to ask the question, please use the Ask a Question function at the top right of your screen. You can ask a question at any time until the Q and A session begins. With that, I'd like to turn the call over to Ran Poliakine for a few words.
Thank you very much, Mike, and hello everyone. This is Ran Poliakine. I'm the Chairman and CEO of Nanox. I want to share with you our excitement and also what we're going to do today. Nanox made a huge progress from last year's RSNA. Today, actually, earlier today, we presented a virtual tour that I would like you to join as well. We're excited to share with you the latest development of our future Nanox.ARC 3D tomosynthesis system, as well as the integration of AI-enabled medical imaging software population health solution.
What we're going to do, we're going to replay the virtual tour of Nanox.ARC in a clinical setting, broadcast from Shamir Medical Center, which is a leading government hospital in Israel with advanced diagnostic imaging capability. The tour includes some of the new procedures of Nanox.ARC, introduced for the first time, actually, including pelvis and chest. The full range of six new procedures can be found in our virtual booth or on our YouTube channel. I'm very happy to invite you to join our journey together for better health. This is the time to move to the video, please.
Hello, everyone, and welcome to the Shamir Medical Center. My name is Dr. Osnat Levtzion-Korach, and I'm the CEO. As the fourth-largest government hospital in Israel, Shamir Medical Center provides for over 1 million residents in Israel's central region with state-of-the-art medical care and services. Serving an economically and socially diverse community, we are proud to be the medical home base for the cultural mosaic that is Israel. At the heart of our approach is the personalized and accessible care we deliver to all of our patients and their families and an unwavering commitment to the community we serve. I am proud to say that Shamir Medical Center is home to multiple centers of excellence, including an exceptionally advanced radiology department with world-class imaging capabilities. We always strive to be in the forefront of innovation in order to continue to increase accessibility of medical procedures and treatment for all.
Therefore, we find Nanox to be a natural partner, and we're delighted to highlight the Nanox.ARC features during this first time ever virtual broadcast from our medical center.
Thank you for joining us on our journey together for better health and for hosting us today here at the renowned Shamir Medical Center with its highly advanced medical imaging capabilities.
Thank you, Osnat, and welcome everyone to the Nanox tour at the RSNA 2021. We have been very busy since last year's RSNA advancing the Nanox.ARC system, which has the potential to improve accessibility and aims to drive a significant increase in the delivery of medical imaging all over the world. Besides greater availability and accessibility, we believe the Nanox.ARC system and its end-to-end ecosystem will enable healthcare providers to obtain crucial information, which has the potential to shorten diagnosis and treatment time and promote early detection. It is well known that earlier intervention is a key contributor to better health outcomes for patients. A more accessible medical imaging technology would not be enough to transform the global marketplace. We also decided to incorporate an AI capability to complement our technology.
Nanox.AI fulfills that need and provides the image analytics necessary to help locate a problem and begin the process of diagnosis and treatment. Today, we will unveil the Nanox.ARC features and introduce AI-enabled medical imaging software solutions. Buckle up and enjoy the ride as we walk you through the unveiling of the features of the Nanox.ARC. Today, we'd like to introduce you to the Nanox.ARC system, its operation, and use. The Nanox.ARC is installed in a standard X-ray room, just like other general radiography systems. As you can see, the Arc has three main components, the table assembly, an electrical cabinet, and the operation console. This arrangement enables simple room positioning and a quick installation. The Nanox.ARC design enables easy patient access from all sides.
The motorized patient table is large, flat, and with no cabling in the patient area for safety and cleanliness. It provides full patient coverage, and at the height of 48 cm or about 19 inches, it is easy for elderly or paraplegic patients to mount it. The large 17 by 17 inch or 43 by 43 cm flat panel detector located underneath the table provides high resolution images. We aim to design the Nanox.ARC to be a multi-source 3D tomosynthesis system. The Nanox.ARC will scan adult patients to produce 3D tomosynthesis images. Digital tomosynthesis is an imaging technique that combines a few dozens of low-dose images into a 3D X-ray image. It can potentially separate overlapping structures at a lower dose than that of CT and a greater clinical value than that of a 2D X-ray.
The Nanox.ARC is a multi-source system, and it contains five of our cold cathode tubes equally distributed above the patient table. Each Nanox tube contains a Nanox.SOURCE, the Nanox chip. This is disruptive. Nanox introduced a transformation for a 126-year-old technology. While the medical imaging market innovated, the X-ray source itself remained based on a hot cathode with a filament that generates extreme heat. The Nanox digital chip can maintain low temperature and power, releasing any number of electrons we want. We can create a small tube that costs much less. It is very small and light. This is the Nanox revolution, taking us from the analog world to the digital world. Moreover, Nanox has already received FDA clearance of our single-source Nanox Cart X-Ray System using our unique cold cathode tube.
This clearance is a key validation of Nanox's digital X-ray source and potentially holds many implications for imaging globally. Our cold cathode tubes have an advantage of being able to be connected in parallel and then switched rapidly. A feature that is heavily utilized by the Nanox.ARC system. Let's return to the Nanox.ARC, our multi-source system. The Nanox.ARC tilts from -18 to +18 degrees above the patient, producing several low-dose projections from each tube. The Nanox.ARC is controlled using a slick tablet device, running an easy-to-control and friendly UI. Patient intake is easy and straightforward, and so is the protocol setup. From here, the radiographer can select the body region to be scanned, adjust the imaging protocols, and view the results. Scanning is performed from this control area. The system has an integrated wide view camera that captures and monitors patient position and movement during scanning.
Once we position the patient, scanning is quick and easy. Each Nanox.ARC is securely connected to the Nanox.CLOUD via the Internet. During each study, the projection images are sent to the Nanox.CLOUD for conversion to a tomosynthesis image. A constant connection to this Nanox.CLOUD will enable us to deploy, update, monitor, and service the Nanox.ARCs. We believe that to protect the lives of us all, we must now work together to prevent the pandemics and health challenges of the future. By joining forces and making a coalition, we can make an impact. Nanox aims to build a global infrastructure for medical imaging and therefore provide accessibility and affordability to patients on a global scale. Now, let's unveil two of our new procedures filmed earlier at the Nanox X-ray room facilities.
This is a tomographic examination of a normal chest phantom with the Nanox.ARC. These sections provide us with a great degree of clarity in assessing structures all the way from the spine anteriorly through the lungs and seeing great detail in terms of the blood vessels as well as the central airways, the margins of the mediastinum, all the way anteriorly, where we see a very clear depiction of the sternum and the manubrium. This kind of demonstration is really an intriguing advance over standard projectional radiographs in offering an opportunity to provide greater clarity for subtle lesions within the chest that wouldn't be seen necessarily on a projectional radiograph.
Let's look at a pelvic tomosynthesis study. Let's start scrolling from posterior to anterior. At this level here, posteriorly, all the bones are blurred because we're at the level of the posterior soft tissues. As we move on forward, the spinous processes become sharp, as well as the sacrum and the coccyx. Look at the neural foramina here and the posterior most aspect of the right iliac bone. As we continue moving forward, these become blurred while the sacroiliac joints become sharp and also the ischial tuberosities. As we continue moving forward, now we can see the vertebral body is sharp and the hip joints. Now we're also at the level of the greater trochanters. There is a lytic lesion here in the femur of this phantom, and we can see very nicely the trabecula of the proximal femurs.
As we continue moving anteriorly, we're losing the sharpness of all of those parts of the pelvis. Now the pubic symphysis and the superior rami are sharp because they are anterior.
For more new features, please visit our virtual booth at the ARC section.
Hello, and welcome to the radiology department of Shamir Medical Center. We pride ourselves in utilizing the most advanced imaging equipment to ensure that all our studies are held to the highest international standards. I'm very excited about collaboration with Nanox as we are always looking to be in the front of technological innovation.
Medical imaging systems are an important diagnostic tool that we believe are key to increasing early detection and better patient outcomes around the world. At Nanox, we are truly striving to democratize medical imaging for all. We designed our system to be easy to deploy and train. This will help us to democratize medical imaging and promote early detection. As part of enhancing the early detection concept, we will showcase its AI-enabled medical imaging software population health solutions as part of its value-based care offerings for healthcare systems and payers expected to set a new standard in the medical technology sector. At Nanox, we believe that having more accessible medical imaging technology would not be enough to transform the global marketplace, but we also are in need of AI capabilities to complement our technology.
Nanox.AI fulfills this need and provides the image analytics necessary to facilitate the process of diagnosis and treatment. Nanox.AI has developed excellent data and machine learning platforms with which to create AI solutions, including eight FDA-cleared products and one pending, as well as numerous CE marks in Europe and regulatory approvals in other countries. We also have many research publications and granted patents in the field of artificial intelligence. The most valuable and unique asset we have is our data repository. We have a large, privately held data repository in the AI field with over 30 million patient records and 10 years of clinical patient histories. This rich data, accrued from several diverse sources, allows us to create a generalizable AI platform that is accurate and effective in different institutions across the globe and on a diverse patient population.
Our advanced natural language processing capabilities allow us to analyze radiology reports of those millions of studies in our data warehouse and easily pull out the ones we need for any given project, including the positive, negatives, and those cases in which the radiologists were unsure of the finding, which allow us to create rich datasets for training and testing our algorithms. Here, you can see the data labeling platform that we have designed and created in-house. We are able to create various data labeling exercises for our taggers to fine-tune our data and extract the details needed from the images to create our sophisticated AI algorithms. Here at Nanox.AI, we're focusing on chest CT scans. This is for two reasons. Firstly, many of the chronic health conditions that are significant world health problems can be identified with early biomarkers on these scans.
Secondly, chest CTs are commonly acquired for a variety of reasons, such as trauma, pneumonia, or COVID, providing imaging data which we can screen the population. Cardiovascular disease, pulmonary disease, liver disease, and osteoporosis all have biomarkers in chest CT scans. Identifying those biomarkers could be the key to unlocking the world of chronic medical conditions to enable early patient identification and preventative medical treatment. Cardiovascular disease, it's a worldwide pandemic. Even as we tackle the COVID pandemic, cardiovascular-associated diseases are still the leading cause of death worldwide. To make the situation even more challenging, people are typically asymptomatic in the early stages of the disease process. In fact, approximately half of patients who have cardiovascular disease only become aware of it as they experience their first heart attack. How can we screen the population? All chest CT scans acquired for any clinical indication is sent to the PACS.
The images from the PACS are then routed to our AI agent, which de-identifies the patient information from the images themselves. The anonymized images are sent to the Nanox.AI cloud, where our AI analytics agent runs the appropriate algorithm and returns results, which are then sent back to the medical center for re-identification, and the results get reconnected with the patient medical information. Together, they appear in the PACS, available for the radiologist within the study and as part of their regular workflow. The AI results act as a clinical assist tool, allowing the radiologist to easily validate and report the chronic medical condition identified by our AI. This workflow and platform are supported by all security certifications and are HIPAA compliant.
Once the patient gets to the preventative therapies, medical or interventional that they need, we will see the decreasing morbidity and mortality associated with cardiovascular disease, which will result in financial value by decreasing costs associated with this chronic later stage disease. Population health takes on a different dimension when you talk about the Nanox.ARC. The Nanox.ARC aims for efficient, affordable imaging with wide distribution throughout both the developing and the non-developed world. It will potentially increase the accessibility of the most common procedures such as chest and extremity X-rays. Now, why is that important? We live in the United States, and we're used to having a CT scanner or an X-ray machine at our disposal. But the reality in much of the world is quite different.
Two-thirds of the world have no significant access to medical imaging, and so increasing accessibility to imaging can impact population health throughout the world. However, the pool of radiologists worldwide is limited. Making imaging so accessible using the Nanox.ARC has the potential to create a radiology bottleneck and increase the work overload, and this is what we hope to solve using artificial intelligence. How do we plan to do that? Our idea is to use the vast and deep AI technology within Nanox.AI and train the algorithms on Nanox.ARC tomographic images to enable efficient and accurate radiology reporting of chest and extremity studies, as those study types cover the basics of imaging needs throughout the world. In many parts of the world, being able to get a chest X-ray or an X-ray of your wrist would be a leap forward in making basic imaging accessible to all.
Nanox plans to manage those images. How? We can prioritize and categorize the images appropriately by identifying and separating out all the normal cases that do not require immediate radiology evaluation and highlight cases with abnormal findings to make the throughput for the radiologists more efficient and reduce the workload. With the help of the teleradiology offering from USARAD, a company also recently acquired by Nanox, we hope to make imaging accessible, data management effective, and radiology reporting efficient and accurate. Nanox.AI is all about population health, whether it is by making imaging accessible worldwide or by promoting preventative health care with the algorithms we create for already existing imaging modalities.
As we believe artificial intelligence will unlock the world of medical imaging, making it accessible and affordable via the Nanox.ARC, while also enhancing the ability of traditional CT scans to make an impact on chronic medical conditions. We really hope you enjoyed the tour. I sure did. We must remember, many people around the globe lack significant access to medical imaging, which can help promote early detection and potentially save lives. This is why we founded Nanox, and every day we are getting a bit closer to our mission. Thank you very much and see you next year.
Hello, everybody, and thank you for joining us today. We will begin the question and answer session. Again, if you'd like to ask a technology-related question, please use the ask a question feature at the top right of your screen. We'll give you a few minutes to type in your questions. I'd like to start off. We've got several questions on the FDA submission. The company gave an update on the FDA submission and the status during the earnings call, and the company wants you to know that they intend to provide the FDA with a response within the regulatory timeframe. Moving on to the technology-related questions. The first question is for Ran.
Ran, can you provide any insight into possible applications for Nanox Source in areas outside of the healthcare sector?
Yes, Mike, absolutely. I mean, first of all, let's go back to the beginning and just to remind the audience that, you know, Nanox is X-ray generator. Basically, the best analogy to understand Nanox is the way lighting moved from Edison light to LED light. Both devices are generating light but in a different way. I mean, the idea of Nanox is really to generate X-ray in a more efficient way, which using cold cathode. Having said that, and for that reason actually, usage of X-ray in other industries is very much available for Nanox. It's true that Nanox is focusing its efforts on the healthcare market.
However, through our OEM partnerships and initiatives, Nanox is definitely looking to and can be available for the markets of security, the market of manufacturing, specifically semiconductors and automotive industry, the market of battery inspections, and even the market of food inspections. All of those are available simply because Nanox is an X-ray source, and those markets or industries are already using X-ray. We believe that in some modalities we have a huge advantage because of our cold cathode module, and we are working with partners through our OEM partnership program to explore those markets without losing focus on our main goal, which is obviously to provide universal with our Nanox.ARC system and focus on healthcare.
Okay, our next question is for Erez. Erez, could you talk a little bit about the new AI— Nanox AI product offering? Specifically, how do you see the AI product integrating into the Nanox-
Okay. First of all, the integration with formerly named Zebra and USARAD and MDW is taking place, and we're making a lot of progress. As you see or those who actually were visiting our booth at the RSNA, you can see that we're already presenting together, and it's part of what we are planning to do in the very near future. In terms of the AI part, this will be an integral part of every system that we're going to produce. The ability to get all the value chain from the Nanox.ARC itself, going to the Nanox.CLOUD, make the analysis using the USARAD capabilities and MDW as a marketplace, all of this together takes us one step closer to creating an end-to-end and global connected medical imaging solution.
We are already moving forward with the population health that will enable, once we are analyzing all the database that we have and the images that are going to be created as part of the deployment of the Nanox.ARC system. This will be analyzed and being provided to the IDNs in the U.S., but also to other organizations in the world. I think that these strategic transactions enable Nanox to maintain its strategic vision to make medical imaging affordable and accessible to all. Right now, we are even stronger positioned to significantly improve access and to reduce costs and enhance efficiency, and to dramatically improve the delivery of healthcare on a worldwide basis, fulfilling our vision.
Okay. The next question is for Ran. Ran, which version of the Nanox.ARC submitted to the FDA will Nanox sell once you receive approval?
Well, let me just start by saying that the version of the Arc we're using is multi-source Arc, which is capable of multiple procedures. I think what we showed today at the RSNA is for the first time actually that the same device, the Arc, actually can generate multiple procedures and that's very, very significant, and I will explain why. I mean, the idea that we have, other than selling the device in urgent care units and community center clinics, is also going after this two-thirds of the world population that do not have access to medical imaging systems.
Just imagine that we place those devices there and what we do, we enable a multiple number of scans in a very low cost of multiple procedures. The idea, once you have this cold cathode Nanox.ARC multi-source system, you can actually decide which procedure you go with, and this procedure will be vetted, of course, by radiologists and will be compared to the best-in-class radiography comparison to make sense clinically. Once you have that, you have a device that is can be used in multiple conditions, multiple indications, and that's very significant. I mean, in our submission to the FDA, we filed already few indications that that are very, very popular.
As we go, we envision us submitting more and more clinical indications or clinical procedures because we simply can do that in the setup of the multi-source Nanox.ARC. That's the beauty, I think, of the multi-source system and the impact that we may bring to the world because we can now, with one device that is, you know, based on our business model, really costs nothing to the customer other than paying per scan. We can cover the most popular and most needed procedures in the U.S., but not less important in many other countries.
Okay. The next question is for Erez. Erez, when is Nanox submitting for approval in other countries, and what is the timeline for approval in these countries?
As part of the deployment that we will start shortly. Actually, we are starting right now. We are planning to deploy the system or the initial countries in which we are going to deploy are not necessarily in the U.S. or in countries where the FDA is necessary to operate. In those countries, we have already started in the process of the regulation. As always in regulation, it takes time and you don't know exactly when you're going to get it. I think that the plan to deploy in these countries will enable us to make it happen in this coming year, in 2022 as planned, even if the FDA approval is going to take the time that it takes in order to get them.
Thank you, Erez. Thank you for joining us today, everyone. That's all the time we have for questions. We appreciate your attendance at this webcast and appreciate your support of Nanox. You may now disconnect. Have a great day.