ENDRA Life Sciences Inc.

and welcome to the Endure Life Sciences fourth quarter 2023 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the call over to Yvonne Briggs. Please go ahead.

Thank you, operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to Endra Life Sciences' fourth quarter 2023 Business Update and Financial Results conference call. Earlier today, Endra issued a press release on this topic, which is available in the Investors section of Endra's website. Before we begin, please note that today's discussion will include forward-looking statements. All statements by management, other than statements of historical facts, are forward-looking statements. These include statements regarding the company's strategies, financial condition, operations, costs, plans, and objectives, as well as anticipated results of development and commercialization efforts, the timing of clinical studies, potential partnership opportunities, and expectations regarding regulatory processes, receipt of required regulatory clearances, and product launches. Except as required by federal securities laws, the company disclaims any obligation to update or revise any forward-looking statements. Please refer to the company's Form 10-K for the 2023 fiscal year and subsequent SEC filings for more information about risks and uncertainties related to forward-looking statements. In terms of the structure of today's call, Francois Michelon, Chairman and Chief Executive Officer, will begin the prepared remarks, followed by Michael Thornton, Endra's Chief Technology Officer. Mr. Thornton will be followed by Irina Pestrikova, Senior Director of Finance, to review the fourth quarter financial results, and then we'll take your questions. I'll now turn the call over to Francois Michelon. Francois?

Thank you, Yvonne, and thank you for joining us today to review Endra's fourth quarter 2023 financial results and key business developments. We're advancing our mission to revolutionize metabolic health through the practical detection and monitoring of liver disease. We've made significant progress in the following five areas. Number one, activating new clinical partner sites in our target markets to build our body of clinical evidence at the local level, which is the foundational element to achieving regulatory and commercial success. Number two, advancing our FDA de novo application for TEAS through close collaboration with the agency. Number three, strengthening our commercial position by developing new and nurturing existing relationships with clinicians, as well as maintaining a steady cadence of awareness-building activities. Number four, leveraging the rapid and positive evolution of key industry building blocks for diagnosing and treating liver disease which strengthen endless position and commercial opportunity. And number five, looking beyond our current markets and technology to new opportunities to license our intellectual property. Now, I'll elaborate on each of these elements. Recently, we achieved a key milestone in one of our target markets by installing the TAIS system in the United Kingdom. King's College Hospital in London, a prestigious national health service institution is leading the introduction of Endra's liver system in the UK market. This partnership entails a clinical study comparing TEIS's liver fat assessment accuracy to MRI, the recognized research standard. The study is expected to include approximately 75 subjects and aims to provide crucial data for evaluating the TEIS technology's performance. Moreover, the findings will be submitted for publication in a peer-reviewed medical journal. We're excited about this collaboration as it'll strengthen our base of clinical evidence and potentially opens doors to strategic opportunities within the UK's extensive national health service network. Mike will provide an update on Endra's active and pending clinical sites. And these sites are crucial for generating the body of clinical evidence needed to support our business strategy in three fundamental ways. First, clinical evidence from these sites supports our current and future regulatory filings and reimbursement claims. Second, the clinical sites enable commercial traction, serving as reference sites in key markets. They bolster our commercial endeavors by demonstrating Endra's technology in real-world settings and help us develop compelling clinical and economic value propositions in our target segments, endocrinology, hepatology, and other segments in each target market. And third, the clinical sites enable the ongoing enhancement of Endres technology through customer feedback, leading to future product improvements. Gaining commercial traction and additional regulatory approvals for Endres innovative technology hinges on continuing to build the base of clinical evidence. The clinical abstracts we presented at the European Association of Study of the Liver last year mark encouraging progress. These presentations highlight impressive clinical performance of our technology compared to the MRI gold standard. Yet, to convince potential users in our target market of our technology's value, we must further expand our pool of real-world evidence and do so at the local level. As you're hearing, we're accelerating these efforts by activating new sites such as King's College in the UK and others we'll announce in the second quarter. Clinical evidence is essential for the successful global adoption of new innovative technologies like Endres. Looking ahead into 2024, in addition to the foundational work of building clinical evidence, we're also advancing in other key areas. First, and importantly, we're advancing our FDA regulatory submission in the U.S. market. Since our de novo submission in the third quarter of 2023, we've received an additional information request from the FDA, and we're closely engaged with the agency. We've confirmed a meeting with the FDA to be held in the second quarter of this year to address open items and ensure a predictable regulatory pathway for our technology. And Mike Thornton will elaborate on this in a minute. The second area is we expect to achieve commercial sales with early adopters in Europe this year in our initial target markets of Germany, the UK, and France, leveraging our CE mark and our growing base of clinical data from King's College and other sites to showcase our technology's clinical and economic value propositions. In parallel to these activities, The ENDRA team's been proactive in generating awareness for Arteas technology and engaging with key stakeholders by attending major clinical conferences. Notably, at the liver meeting hosted by the American Association for the Study of Liver Disease, ENDRA hosted a panel discussion with multidisciplinary key opinion leaders in hepatology, endocrinology, and radiology. And this platform enabled the sharing of unique perspectives on managing metabolic dysfunction-associated steatohepatitis, also known as MASH. Endra's participation in eight industry conferences in 2023, such as the European International Liver Congress and the Diabetes Professional Care Meeting in the UK, contribute to raising awareness of Arteas technology. Plans are in place to attend the most critical European and American conferences this year, And the cadence of visibility underscores Endra's commitment to fostering relationships with potential customers and partners, highlighting our technology's potential. The third area, in alignment with our FDA initiatives, is we're exploring an intriguing new opportunity in the US bariatric and obesity management market. Because of the popularity of the GLP-1 drugs, This market is rapidly evolving from a surgery-centric approach to a broader mandate as metabolic disease management centers. Our research so far indicates that the obesity management market is characterized by high patient self-pay and relative price inelasticity with highly motivated patients who demand clinically relevant services to support their weight loss journey with three to four monitoring visits per year. This aligns really well with Endra's technology since liver fat is a key biomarker for metabolic syndrome. And this potentially expands Endra's addressable market beyond hepatology and endocrinology and holds promise for revenue streams based on patient self-pay per scan. On a broader market basis, three crucial building blocks for diagnosing, treating, and managing liver disease are rapidly advancing, providing hope for the millions affected and opportunities for companies like Endra. The first building block is that leading clinical societies have already updated their screening guidelines for fatty liver. As an example, the American Diabetes Association and the American Association for Clinical Endocrinology now recommend screening of fatty liver disease for pre-diabetic, diabetic, and obese patients. Those guidelines alone encompass 50% of the adult US populations with either diabetes or prediabetes and 41% of the US population who are obese. That's approximately 150 million people in the US alone. The second building block is that the World Health Organization has issued a new ICD-10 CM code specifically for fatty liver disease. The ICD-10-CM is a global coding system that indicates a diagnosis for reimbursement purposes, and it facilitates standardized billing and documentation for insurance processes in the U.S., Europe, and other markets. Endra believes the ICD-10-K76 code issued specifically for the diagnosis of fatty liver represents a significant opportunity for innovation as healthcare providers now have a more straightforward path to integrate advanced diagnostic technologies like endres. And the third building block involves the FDA's recent approval of resdifra, Madrigal Pharmaceuticals' pioneering drug therapy for NAFLD-NASH, marking the beginning of a whole new chapter in liver disease management. This therapy, along with other emerging targeted treatments for liver disease, will significantly impact both healthcare providers insurers, and patients. Major insurers like Blue Cross are requiring adherence to nine specific authorization criteria for res diffra, including an MRI, PDFF, liver fat exam, which can only be performed by the most advanced subset of the world's estimated 58,000 MRIs. This underscores the complexity of managing NAFLD-NASH and highlights the need for precision in diagnosing and treatment. Resdifra and similar drugs will consequently drive demand for more accessible point-of-care diagnostic tools, like Endrosteus, that are capable of facilitating the screening and monitoring of liver disease, which affects over 2 billion people. Finally, We're actively exploring collaborations and strategic pathways to expand the applications of our TEIS platform beyond the liver. By leveraging our intellectual property and engaging in strategic partnerships and out licensing opportunities, we aim to capitalize on the potential of TEIS in new therapeutic areas. We've engaged Patentvest, a leading intellectual property advisory firm, to spearhead the valuations of Endra's IP, competitive landscape analysis, and M&A outreach efforts. This collaboration will strengthen our position in the rapidly evolving medical technology landscape and enable us to explore a new set of opportunities for the TEAS platform. To that end, we've been aggressively expanding our global intellectual property portfolio with the issuance of 16 new patents in the U.S., China, and Europe in 2023 and two patents issued so far this year, With these additions, Endra's patent estate has reached an impressive 75 issued patents worldwide. These patents safeguard key innovations that are integral to the TEA system and reinforce our competitive edge in the market. I'll now turn the call over to Mike Thornton, our Chief Technology Officer. Mike?