NANO-X IMAGING LTD

Good day, and thank you for standing by. Welcome to the Nano-X Q3 2023 earnings conference 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 that session, you'll need to press star 1-1 on your phone. 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, and I would now like to hand the conference over to your speaker today, Mr. Mike Kavanagh, Investor Relations. Sir, please go ahead.

Good afternoon, and thank you for joining us today. Earlier today, Nanox Imaging Limited released financial results for the quarter ended September 30, 2023. The release is currently available on the investor section of the company's website. Erez 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. Management will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of each non-GAAP financial measure to the nearest GAAP financial measure is provided in the company's press release issued today. The non-GAAP financial measures include 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, non-GAAP other expenses, and non-GAAP gross loss per share. With that, I'd now like to turn the call over to Erez Meltzer.

Thanks, Mike. And as always, thank you all for joining us today for our financial results call and corporate updates. As previously noted, we have intensified our efforts and focus on the U.S. market to jumpstart our commercialization effort in the region. To support these important efforts, our team and I have increased our presence in the United States over the last few months, and I'm currently in the U.S. We have engaged in discussions with potential customers clinical partners, particularly U.S. healthcare sector professionals, focusing on reimbursement and medical workflow, and other key stakeholders. We aim to expedite the implementation of our commercial infrastructure and advance our future strategic plans. Moving to the recent developments in deployments, I am pleased to announce that we have established the first U.S.-based commercial site and demonstration center for the Nanooks Arc, which is part of our initial wave in the U.S. A Nanooks Arc system has been installed in the New Jersey-based imaging center, which marks the beginning of Nanooks' commercial expansion into the U.S. market. The system passed all necessary tests conducted by a licensed and certified physicist enable us to commence scanning of patients to acquire medical imaging using the NANUX Arc, a stationary x-ray system intended to produce 3D tomographic images of the MSK system. The clinic staff will manage the operational, professional, and administrative services, allocating human resources and equipment for the efficient operation of NANUX system in the imaging center. This center will also serve as a demonstration center for our medical professionals, offering them an opportunity to familiarize themselves with the system and facilitate the implementation process. More updates on the progress on installments in the U.S. are expected on the investor on December 4th. We are enhancing our U.S. sales and service team, and I'm happy to announce we have signed an agreement with 626, a national healthcare technology and equipment management company. They will provide services for the Nanooks Arc, including warehousing, installation, training, maintenance, and customer support. Headquartered in Boca Raton, Florida, 626 offers tools necessary for imaging centers to achieve maximum uptime and maintain better patient care. 626 has expertise in modalities and medical imaging equipment and provides customized services tailored to their clients' needs. With their ISO 134085 certification, national footprint, and over 160 field service engineers, they are an ideal company to partner with as we ramp up our commercialization efforts in the U.S. In addition to them supporting installations, maintenance, and services in the field, we intend to install an ARC system in their suburban Atlanta 626 imaging academy for training and demonstration purposes. Turning now to our deployment efforts in the rest of the world. Outside of the key US market, we have begun to generate revenues from hardware deployment in Africa. While these revenues are currently small, they are growing. Additionally, as previously announced, Anamux Art Unique has been installed in the University of Ghana Medical Center Limited, UGMC, one of the largest and most advanced hospitals in Ghana. We are pleased to announce that our local partner has obtained approval from the Ghana Food and Drug Authority, the GFDA, and it will soon be operational for clinical scanning of patients. In the meanwhile, we have received an order for additional units in Ghana. We're also actively working on establishing a presence in Latin America. One of our distribution partners is in the process of securing an import license for NANUC's ARCS, as well as laying the groundwork for a demonstration center. The potential location for the demo site has been identified as a large hotel offering this very space and expertise both in the Nanak's Arc. We will provide further detail on this development as we make substantial progress. Turning to our OEM initiatives. To meet the anticipated demand of our system, as previously announced, We entered into original equipment manufacturing agreement with Varex, a leading global manufacturers of imaging component based in Utah. We have since held formal partnership kickoff meetings at Varex headquarters in Salt Lake City, where the company's executive and technical teams came together to continue final tube design efforts and map out all the roadmaps towards production. Expanding on our own related activity, We're currently engaged with an industrial imaging equipment manufacturer on a tube development and manufacturing program we expect to formalize by the year end to ensure an adequate future supply of tubes. Additionally, our collaboration with the U.S. government agency exploring technology for use in security screening application is advancing with the acquisition of tubes and further testing and evaluation. Finally, a leading global medical technology company has purchased amateurs for internal testing and application development projects. We are not in our regulatory task. Despite our efforts to gain regulatory approval in a number of markets across the world, sometimes our regulatory progress is slower than we would like in some instances, such as with the FDA in the US. Each jurisdiction has its independent set of regulations contributing to the complexity of the process. We are diligently navigating these challenges, prioritizing swift approvals while ensuring accuracy and regulatory compliance. Nevertheless, we have not stopped pushing ahead with our regulatory efforts, which continue to be of paramount importance to NANUCS. As previously communicated, we partnered with BSI Group and a credible notified body based on the United Kingdom for eventual CE marking review and approval. I'm happy to announce that we have submitted our technical file for obtaining the CE mark. BSI's formal review will begin in the first quarter of 2024, according to the planned timeline. and I look forward to providing updates upon the conclusion of this process. We have also made substantial progress in our home market, Israel. The medical device division of the Ministry of Health, known as AMAR, A-M-A-R, is the regulatory body that oversees medical devices. On November 22nd, 2023, Nanook's Arc received Amar approval from the Israeli Ministry of Health, and it is now registered as a medical device in the Israeli market. Following this approval, the Israeli Ministry of Health granted Nanook's Arc a free cell certificate, which is a requirement for regulatory submission in some markets. Turning to our clinical efforts. As previously disclosed, the second phase of collecting clinical sample images of multiple human body anatomies with a Nano-XR system deployed at Shamir Hospital in Israel is continuing. Additionally, Nano-XR reached an agreement with Baylinson Hospital, a part of the Kralit Health Services, the largest health service organization in Israel and one of the largest in the world. According to this agreement, a human trial designed to assess diagnostic capabilities of the non-XR in detecting chest and lung diseases will be launched at the hospital. All required Israel Ministry of Health approval and institutional ethics committee has been obtained, and the trial is scheduled to commence by the end of 2023. Now I would like to provide an update on our NANUX-AI business segment. We generated $141,000 in revenue during this quarter, and Ron will review it in more detail shortly. At the end of the quarter, we announced compelling study results which demonstrated that NANUX-AI product found that approximately 60% of patients unknowingly had moderate to severe level of coronary artery calcium, also known as CAC, a proven indicator of future cardiac events. The study was sponsored by Nanox AI and conducted by Bellinsville Hospital utilizing Nanox AI Health CCS, an FDA cleared and CMR tool designed specifically for cardiac health assessment. Health CCS solution utilizes medical imaging data from routine chest CT scans to automatically quantify and analyze TAC, potentially offering an early detection mechanism for cardiovascular calcium and preventing cardiac care. In other NanoxIA news, a 510K submission for Nanox FETI liver detection known as Health FLD was submitted in September and is pending FDA 510 clearance. HealthSLD is designed to detect early signs of fatty liver diseases from routine chest and abdominal CT scans, not specifically for fatty liver assessment. These updates are highly promising, and I look forward to providing additional updates on the NanoxAI business throughout 2024. Before turning the call over to Ren, I'd like to revisit one of the AI products agreement that we have announced previously. In mid 2022, we announced a strategic agreement with Spectrum Health, now known as Corwell Health, one of the leading integrated delivery system IDNs to use our AI population health solutions. Coldwell Management reports that their team has successfully integrated the NanoSAI HealthCCS solution into their patient care flow, recognizing its significant value in identifying new patients with medium and high calcium level on chest CT scans. We have also received similar positive feedback from another healthcare system using NanoSAI solutions. And with that, I'd like to now turn the call over to Ran Daniel to review our financial results. Ran?