ENDRA Life Sciences Inc.

Good day and welcome to the End Your Life Sciences first quarter 2024 financial results conference call. All participants will be in a 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 touchtone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Yvonne Briggs Thank you, operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to Endra Life Sciences first quarter 2024 business update and financial results conference call. Earlier today, Endra issued a press release on this topic, which is available in the investor sections 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, We'll 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 first 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 thanks for joining us today to review Endra's first quarter 2024 financial results and key business developments. We're advancing on our mission to revolutionize metabolic health through the practical detection and monitoring of liver disease, and we've made good progress in the following areas. First, activating new clinical research sites and target markets to build our body of clinical evidence at the local level across a range of sites, users, and patient types. This clinical data is a foundational element to achieving commercial success in the future. Second, working closely with the FDA to align on clinical requirements for Artea Systems' de novo application. A pre-submission meeting is scheduled with the FDA in suburban Washington, D.C. this quarter. Third, leveraging the accelerating market developments in the detection and treatment of liver disease to strengthen Endra's position. And fourth, looking beyond our current markets and technology to new opportunities to license our intellectual property. I'll elaborate on each of these elements. In the first quarter, we achieved a milestone in one of our target markets by installing the first 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 TAIS's liver fat assessment accuracy versus MRI, the recognized research standard. The UK, along with other active clinical study sites in the US, are crucial for generating the body of clinical data needed to support the commercial adoption of our technology across radiology, hepatology, and endocrinology in global markets. The clinical abstracts we presented last year at the European Association for the Study of the Liver were a great start, highlighting the impressive clinical performance of our technology compared to the MRI gold standard. But we need to continue to expand this pool of real-world evidence to demonstrate our clinical and economic value to potential users in our target markets at the local level. In addition to the foundational work of building our clinical evidence, Endra is working closely with the FDA to achieve alignment on clinical requirements for our TEA Systems de novo application. Endra has had several interactions with the agency since Q4 of 2023, and we've provided additional information about our technology and historical clinical tests. To advance a review process and further align expectations with the aim of ultimately achieving a successful regulatory outcome, Endra has scheduled an in-person pre-submission meeting with the FDA this quarter focusing on clinical requirements. Mike will elaborate on this in a minute. On a broader market basis, key building blocks for diagnosing, treating, and managing liver disease are rapidly advancing, providing hope for the millions who are affected and opportunities for companies like Andra. Leading clinical societies such as the American Diabetes Association and the American Association for Clinical Endocrinology have updated their guidelines and now recommend screening for fatty liver disease for pre-diabetic, diabetic, and obese patients. That's over 100 million people in the U.S. alone who need to be evaluated, and MRI is not a practical solution for a population this large. A second building block relates to the FDA's recent approval of ResDifera, Madrigal Pharmaceuticals' pioneering drug therapy for NAFLD-NASH, marking the beginning of a new chapter in liver disease management. This therapy, along with other emerging targeted treatments for liver disease, will significantly impact healthcare providers, insurers, and patients. Major insurers like Blue Cross are requiring adherence to nine specific prescribing authorization criteria for res diffra, including an MRI PDFF liver fat quantification exam, which can only be performed by the most advanced subset of the world's MRIs. This underscores the complexity of managing this disease and highlights the need for precision in diagnosis and treatment. Res diffra and future drugs will consequently drive demand, we believe, for more accessible point of care diagnostic tools like Endres TEIS that are capable of facilitating the assessment and monitoring of liver disease affecting over 2 billion people globally. 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 initiatives, We aim to capitalize on the potential of Arteus platform in new therapeutic areas. We've engaged Pat Invest, a leading intellectual property advisory firm, to spearhead Endra's IP valuation, competitive landscape analysis, and licensing efforts. To that end, we're aggressively expanding our global intellectual property portfolio with the issuance of eight new patents so far this year. With these additions, Endress Patent Estate has reached an impressive 80 issued patents worldwide. These patents safeguard key innovations that are integral to the TAIS system and reinforce our competitive edge in the marketplace. I'll now turn the call over to Mike Thornton for an overview of our clinical and regulatory advancements. Mike?