Erez I. Meltzer
Analyst · Cantor Fitzgerald
Thank you, Mike. Good morning, and thank you all for joining our second quarter 2025 call. As we enter the second half of 2025, the entire Nanox team remains focused on disciplined execution and expanding our commercial footprint across our entire ecosystem, including AI and teleradiology solutions as we pursue our vision of making medical imaging more accessible and thereby improving patient outcomes. In line with the commitments outlined during our May 2025 earnings call, we are making steady progress toward our goal of 100 Nanox.ARC systems installations. Expanding our commercial footprint remains a top priority, and our sales team continues to expand the pipeline of qualified leads and successfully convert those leads into systems being shipped to customers. While most leads and new customer activity is now being sourced from the U.S. market, we also continue to expand our network in different countries outside of the U.S., including various European countries such as Romania and Greece on the heels of obtaining the CE mark designation earlier this year. We are well on our way to meeting our target of 100 systems installed or being deployed by year's end. As previously indicated, revenues are expected to grow in the second half of 2025. We are also advancing our clinical strategy on multiple fronts as we seek to strengthen our position as a transformative force in medical imaging. To support this movement, we are acting on multiple fronts, clinical data and publication collaboration with global academic institutes, hands-on clinical education initiatives and expanding our key opinion leaders network. In other words, our commercial rollout involves bringing new technology to the market while also working to change the habits of health care providers. With respect to academic partners, supporting our transformative vision, we seek to partner with organizations that are leaders in medical imaging innovation. A prime example in our collaboration with researchers at Duke University Medical Center, which I'll tell you about later in my prepared remarks. Another example can be found in our recent announcement that Keiser University has established a flagship training and demonstration site, integrating the Nanox.ARC into the radiologic technology graduate program and enabling hands-on education for future imaging professionals. This is particularly exciting as the radiologists of the future are immersed in Nanox.ARC early in their careers. To raise awareness and drive education on the Nanox.ARC systems, we created a clinical education program. The clinical education specialists who run this program play a central role delivering structured customer onboarding and ongoing training through site visits, working with the referral physicians, training the site personnel through webinars and tailored educational plans. We recently launched the Nanox Academy digital platform tailored for our clients, partners and our Nanox network collaborators offering full product sales and clinical online training. Extending our clinical evidence, the ultimate output of these studies are peer-reviewed publications and white papers and academic publications derived from data generated by studies such as those currently being conducted with Shamir and Beilinson Medical Centers. These papers demonstrate the diagnostic potential of our cold cathode tomosynthesis system in imaging, offering a lower radiation cost-effective alternative to CT. Moreover, we are constantly expanding the number of images bank of case studies, which serves to help illustrate the capabilities of the Nanox.ARC system. This growing bank of scans also serves as a useful tool for our sales team when in discussions with imaging centers about the utility of the Nanox.ARC. The final leg of our clinical development platform is our key opinion leaders network. This strategy is evolving into structured segmented model that includes visionary leaders on our advisory board, clinical collaborators and show sites. This approach enable us to amplify our clinical voice, holding seminars and webinars talking about the clinical value in conferences while supporting presales activities and beta testing in targeted specialties such as orthopedic and lung cancer screening. Together, these efforts form a cohesive clinical narrative that supports commercialization, enhance credibility and drives adoption positioning Nanox as a category-defining innovator in low-cost 3D digital radiography. With that said, let's now move ahead to our operational highlights and updates. Turning now to our installation progress in key U.S. markets. I'm happy to report that our pipeline has grown substantially since our last call. We continue to install system in various facilities, primarily stand-alone multi-specialty, small- and medium-sized health clinics. These installations appear to be in line with the industry standard sales cycle. This increase in the sales pipeline is due to our investments in sales development representative initiatives, both internal and external, in order to increase the pipeline and conversion. These efforts are clearly resulting in traction with the medical imaging community and our commercial ramp will remain a primary focus. On another promising note, a growing number of customers with Nanox.ARC units installed are actively referring and scanning patients. Among the notable customers, the Nanox.ARC systems will soon be installed at Keiser University Sarasota campus for training health care professionals, including live demonstrations and incorporation into Keiser University Radiology Technology graduate program. We have also installed units in several imaging chains in California and New York. Of particular note, one of the largest medical imaging chains in the U.S. with hundreds of locations from which we recently generated revenues has completed installation of the ARC and began Nanox.ARC application training for its technicians in the last week of July. This is the final step before patient scanning begins, and we expect this chain to start scanning patients in the third quarter. The chain is also preparing to expand Nanox.ARC deployment to a second site within its network. As many of you are aware, we are supplementing our direct sales efforts via channel partnerships in select markets. And in the U.S. distributor partnerships we announced last quarter with ASI and Swiss Re are both fully completed and are off to good starts. Additionally, we are in advanced negotiation with large distributor and equipment reseller with a presence throughout the U.S. To support these partnerships, we provide comprehensive training and onboarding covering everything from system fundamentals and the clinical positioning to sales processes and contracting workflows. Our goal is to equip our partners with the tools and knowledge they may need to confidentially reengage their networks and promote the Nanox.ARC. As part of our efforts to expand our go-to-market strategy, we are working on developing a future project. Nanox is developing a mobile imaging solution that integrates the Nanox.ARC system into a commercial vehicle. The mobile Nanox.ARC vehicle will serve as a traveling medical imaging center visiting clinics to provide high-quality diagnostic imaging without requiring patients to travel to central hospitals. The goal is to expand access to high-quality imaging, improving patient reach and create new opportunities for service delivery and revenue growth. Turning to our rapidly growing Nanox.AI business. I'd like to share details of several product collaborations that we are working on. First, I'm pleased to announce that Nanox.AI and a leading provider of advanced AI-powered medical imaging solutions are collaborating to integrate Nanox.AI's liver and bone products with a provider's advanced visualization software. This new partnership will allow us to extend the benefits of Nanox.AI to a larger customer base, enhancing our collective offering and providing greater value to our users. Another commercial collaboration I can share is between Nanox.AI and a leading company, which provide an AI-powered health informatics with the aim of empowering breakthroughs in care through imaging. The collaboration leverages advanced AI for operational efficiency and improved clinical outcomes in lung. In another recent example, we have signed an agreement with deepc to incorporate cardiac, bone and liver products onto the deepc platform, and deepc is a multinational company, which markets an infrastructure platform, deepcOS designed to unify diverse radiology AI workflow across the enterprise. Having Nanox.AI solutions integrated within this platform will make our products available on a much larger potential customer base. Another collaboration that I'd like to share today is with CTIS, a leading provider of health informatics solutions with decades of experience partnering with clinical trial and research stakeholders, particularly in support of NIH projects. Nanox.AI and CTIS have joined to force to pursue 2 NIH grants aimed at analyzing gland cancer in young vapes users, which is acknowledged to be a looming health problem in the U.S. Needless to say, it is encouraging that a growing group of AI platform providers recognize the value of our technology and are taking the time to integrate the Nanox.AI solutions into their open architecture platform offering. Furthermore, as previously announced, we have finalized the collaboration between Nanox.AI and Ezra, a leading provider of full- body MRI screening services. Initially, the collaboration included Nanox.AI population health solution integrated to Ezra medical screening processes at 28 imaging center locations across the United States, which feature AI-powered full body MRI and CT scan to screen adults for early detection such as cancer and other serious conditions at their earliest and often most treatable stages. The solution is now integrated into 50 sites with both the number of installations and the volume of scans steadily increasing. To continue our updates for Nanox.AI, I'm pleased to report that the leading academic institution has launched a major collaboration with Nanox.AI, selecting 3 of our advanced artificial intelligence applications to power a new population health clinical study targeting asymptomatic individuals aged 70 and above. These marks another milestone in our ongoing academic collaboration. We continue to partner with leading academic institutions that are leveraging our AI solution. I can also report that we signed an agreement to provide Nanox.AI solution to customers of Radiology Diagnostic Group, RDG, a network of specialized senior radiologists offering rapid expert imaging interpretation, valuable second opinions and detailed explanation of imaging finding. In addition, we recently partnered with a reseller in India to market Nanox.AI solutions, securing 2 pilot projects and positions us to expand our footprint in the region. Moreover, we are strengthening our U.S. presence with the expansion of our service and sales infrastructure to support growing market demand. Turning to deployment and other activities outside of the U.S. We continue to advance along multiple fronts such as key EU market and where we feel that distributor model is an efficient way to make initial inroads into the various nations of the EU. We accelerated our efforts in the EU after Nanox.ARC was granted the CE mark designation under EU MDR standards earlier this year. Our team recently met with our partner in Romania, Medis Imaging, which is a leading medical equipment supplier in the country. It was a highly productive engagement, which included a training session for MEDDIC sales personnel. Next step is to launch the Nanox.ARC in the annual Radiology Congress in Romania with our new partner end of September. The system is ready for shipment for that purpose. This is an exciting step forward in making Nanox innovation and imaging solutions more accessible across Europe and promising start bringing next-generation medical imaging technology to Romania. We are currently working with our local partner in Greece to secure the required import permits and are engaged in advanced discussions with additional potential partners in the region. We will continue to focus on the large EU market and expect that our strong business momentum will continue in many other European countries in 2025 and beyond. In Latin America, we're also pursuing the import license to ship 2 demo units to distributor in Mexico, and I will provide an update when I have something material to share. The company notified the FDA of its intent to submit the TAP2D software module to the FDA through the 510(k) program. TAP2D submission purpose to receive clearance for 2D view image output for Nanox.ARC system, a practical tool for radiologists to enhance their diagnostic confidence as they become more experienced evaluating BTS images. TAP2D, once cleared, will be part of a wider vision held by Nanox to alleviate adjunctive use limitations in the future. Moving on to the clinical work that helps support all of our efforts by generating data supporting the use of our solutions. As I mentioned in my introductory remarks, we have several successes to share today, including our collaboration with Keiser University and our ongoing partnership with Duke University Center for virtual trials. We have mentioned the Duke partnership on previous calls, and I'm now able to share that this collaboration has resulted in the publication of a new paper that has just been published. In collaboration with Dr. Ehsan Samei's team at the Center for Virtual Imaging Trials, CVIT at Duke, we have seen promising results of the potential values of Nanox.ARC digital tomosynthesis, the DTS configuration in handling patient motion as opposed to standard linear configuration DTS system. Patient movement during image acquisition can adversely affect the quality of medical image, and the study shows the benefit that Nanox.ARC configuration has the potential to effectively manage this issue. The study addressed various types of patient motions and showed that the Nanox.ARC configuration is less susceptible to motion- induced artifacts. The data and conclusions of the study have now been published in Biomedical Physics and Engineering Express, making key opinion leaders aware of the value of the Nanox.ARC for sound mounting a common imaging challenge. Earlier, I acknowledge the value of bringing medical imaging experts and key opinion leaders onto the Nanox team. And with that goal in mind, we have recently strengthened our Medical Advisory Board with 2 new additions. Dr. Lawrence Tanenbaum is an active consulting in the medical imaging space. He is a long-term collaborator for the medical imaging industry and continues to chair advisory board for imaging, OEMs, pharma and AI concerns. He has interest in developing applications for AI and machine learning, concert agents, MR, CT and advanced rendering. Dr. Tanenbaum served as Vice President and Chief Technology Officer and Director of Advanced Imaging at RadNet Inc. from 2015 to 2024. Second, George [ Spire ] is a medical imaging executive with over 25 years of global leadership experience. He has held senior roles at [indiscernible] and Philips specializing in imaging technology and digital health transformation. He is an expert in bringing innovation to market and scaling customer-centric tech-driven health care solutions. We are excited to have these talented individuals join the Nanox team as we seek to innovate and change the medical imaging landscape. Our key opinion leader strategy is evolving into a structured segmented model that includes visionary leaders, clinical collaborators and show sites. This approach enable us to amplify our clinical voice while supporting presales activities and beta testing in targeted specialties such as orthopedic and lung cancer screening. Together, these efforts [indiscernible] cohesive clinical narrative that support commercialization, enhanced credibility and driven adoption, positioning Nanox as a category-defining innovator in digital radiology. We continue close collaboration with our OEM partners toward the supply of components needed as our ARC deployment continues. Furthermore, we are seeking partnership with additional providers of unique imaging equipment to develop new and innovative uses of our 3D tomosynthesis technology. Additionally, in Q2, we met with multiple companies across a handful of application areas we believe our technology provides unique and even disruptive technical benefits. These companies were approached based on an exhaustive review of their applications, market position, our perceived product fit and of course, the commercial opportunity potential. Having received several requests for additional data and/or testing results, we are now reviewing, prioritizing and formulating responses outline proposed next steps. New applications and business development efforts take time, but this activity level demonstrates our continuous probing for new use cases and applications for our differentiated imaging technology. I'd also like to follow up on my comments regarding Varex from our last call. We are sourcing glass tubes from Varex for our units as they are more economical than ceramic and advantageous for our application. At this time, I shared that Varex had delivered tubes for use in the newly developed Nanox.ARC and that Nanox has technical staff at Varex facility for validation and training on multiple source demo units. The ARC team in Israel began system integration of Varex tubes into the ARC X earlier this month, and we approached the time to start manufacturing the new ARC X at scale to meet anticipated customer demand. Also, delivery of the first multisource demonstrator from Varex is anticipated later this month. With regard to mass production, we have recently entered into a multiyear Volume Supply Agreement with Fabrinet, a leading global electronics manufacturing services provider to support the scalable production of Nanox.ARC X, Nanox Advanced Medical Imaging. Under this agreement, Fabrinet will provide contract manufacturing services, including assembly, testing, procurement and quality control, ensuring reliable and cost-effective product delivery aligned with [ Nanox.SOURCE ] specification. The long- term agreement will help to ensure stable and high-quality manufacturing as well as flexible production and forecasting to support our anticipated growth. In addition to manufacturing services, Fabrinet will support regulatory compliance, quality assurance and continuous improvement processes to help optimize the efficiency of the manufacturing process. We believe this collaboration will drive down our manufacturing costs over time and strengthen our global supply chain, which will, in turn, support our mission to expand access to innovative, affordable imaging technology worldwide.