Erez Meltzer
Analyst · Cantor Fitzgerald
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 Ran Poliakine 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 outcomes. My remarks will be a bit longer today than usual and I will provide a lot of details on the various business aspects of Nanox. As we share our fourth quarter update and review our financial results, I am 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, a clear validation of our technology and mission and our first steps in the U.S. 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 a transformation of Nanox. We are now in the process of expanding our commercialization of the Nanox.ARC system and are aiming for a steady increase in deployment as we raise awareness of the Nanox solution. Nanox is dedicating to accelerating the implementation of our commercial infrastructure and future strategic plans in the U.S. Our mission is to provide healthcare practices with a game-changing advantage through the Nanox.ARC and 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 ARC 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, ARC 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 Nanox.ARC system begun to scan patients. Clinical operation of the ARC system will begin in other sites’ spending certification from the corresponding state's regulatory bodies. As already indicated in our investors day, back in December, one of the purposes of these installations is to validate our MSaaS 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 U.S. 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 U.S. deployed sites that are utilizing the MSAS model. I'd like to address one final aspect regarding our commercial operation in the U.S. As per our standard procedures, Nanox has submitted certification requests to expand the placement of Nanox.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 Multisite Agreement, which was done as part of our multisite 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 Nanox footprint in Latin America. One recent agreement is with a Peru-based medical equipment distributor, which has partnered with us to distribute the Nanox 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 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 Nanox.ARC and preparing for the first installation. The partner has also received an import license for the Nanox 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 would like to provide an update on our hardware revenues, which Ron will review in more details shortly. While we have begun generating revenues through our AI solutions in Q3, Nanox begun to generate revenue outside of the U.S. for the sales and deployment of its imaging systems. Now I'd like to provide an update on NanoxAI 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, an 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, Corewell Health, formerly Spectrum, which begun using our population health solution in mid-2022 and is a large integrated health system. We have consistently received positive feedback from Corewell 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-serve facilities and 80% of the U.S. radiologists will use Nuance PowerScribe 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. Nanox also achieved another regulatory milestone last month when we received the 510(k) clearance by the U.S. Food and Drug Administration, FDA, for Health FLD, 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, formally referred to as non-alcoholic fatty liver disease. Health FLD is a new and valuable tool for doctors as it has traditionally been difficult to assess liver attenuation on contracts enhanced scans, which make up a large proportion of the CT scans. Health FLD 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 bio-pharmaceutical industry to streamline the identification of candidates for clinical trials of much needed therapies for liver diseases, including NASH. 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 the Nanox AI solution, HealthVCF, the previous version of our current health LSP solution. To review routine CT scans, have identified up to 6 times more patients with vertebral compression factor that the national average -- at National Health Services, NHS hospitals in the U.K. The study is being conducted at various National Health Service or NHS sites, including the Oxford University's hospitals. The ADOPT data shows that HealthVCF has clearly demonstrated the ability to identify vertebral compression fractures in far more patients than previously possible with existing tools, enabling earlier intervention and potentially better patient outcomes. Today, the Nanox AI algorithms has identified over 2,400 patients with previously unknown patients with previously unknown vertebral compression fractures and those patients have been designated for a 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 Varex 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 Nanox.ARC technology for use in security applications and progressing. After their acquisition of chips and tubes for evaluation, we are advancing toward 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 Nanox demonstration kit containing a tube utilizing our meter. And we have recently received the necessary safety and regulation certifications for the kit and will 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 the system, a chip maker located in Switzerland. As I mentioned earlier in my comments about Ghana, Nanox is conducting multicenter clinical trial to enhance Nanox.ARC with the goal of expanding its use with chest and other indications. The trial is scheduled to begin patient recruitment shortly, and Nanox.ARC systems that are being used in these trials are already scanning patients. The system installed at Beilinson Hospital is ready. The Institutional Review Board IBR, has approved the trial and we are finalizing the remaining steps for integrating into multisite. In Ghana, the IRB has been submitted and currently is under review. Additionally, the Nanox.ARC is being used to scan patients with abnormal lung conditions at Beilinson, one of the world's top academic medical center, and an institution that has pioneered advancement in radiology. The system at UGMC 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, 100s 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 regulation. 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 matter of tests required to bring the CE 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?