ENDRA Life Sciences Inc.

Good day, and welcome to the Andrea Life Sciences, Inc. First 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 conference over to Yvonne Briggs. Please go ahead.

Thank you, operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to NDRA's first quarter 2023 business update and financial results conference call. Earlier today, NDRA issued a press release on this topic, which is available in the investor section of NDRA'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, including 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 are forward-looking statements. 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 2022 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 Michelin, 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 first quarter financial results. With that said, I will now turn the call over to Francois Michelin. Francois?

Thank you, Yvonne. Good afternoon, everyone. Thanks for joining us today to discuss Endra's first quarter 2023 financial results. and business highlights. I'm extremely pleased to report that we've completed the clinical data collection to support our de novo request to the U.S. FDA. Collectively, more than 100 subject scans have been performed with our interactive guidance tool, and we believe these scans will demonstrate the ability of TEAS to measure liver fat in the earlier stages of non-alcoholic fatty liver disease, known as NAFLD, at the point of patient care. We're analyzing the collected data and expect to make our de novo submission to the FDA mid-year. We believe this regulatory pathway will assist Endra in achieving the strongest market potential with TEIS-optimized claims as the de novo process is reserved for novel technologies without equivalents in the market. Mike Thornton will provide more detail on our clinical progress shortly. Thermoacoustic-enhanced ultrasound, known as TEIS, is an integral part of Ender's vision to provide better healthcare to more people by introducing point-of-care technology that addresses areas of high unmet clinical need. Non-alcoholic fatty liver disease affects over 2 billion people globally, and there are currently no diagnostic tools that combine accuracy, safety, cost-effectiveness, and ease of use. MRI is accurate, but it's also expensive and slow. Liver biopsy is painful and can only be performed by someone with surgical training. And traditional ultrasound derivatives can measure liver stiffness, but haven't yet demonstrated the necessary sensitivity to stage NAFLD patients in the early phases of the disease when it's most reversible. The annual liver disease diagnostic market opportunity is estimated to be $12.5 billion in size. The advent of the first targeted NAFLD drug therapies intensifies the need for clinicians to identify appropriate patients with practical diagnostic tools and then to monitor the response of those patients on the drugs. TAIS aims to fill that gap and help clinicians accurately characterize the liver noninvasively, at the point of patient care, and at one-fiftieth the cost of an MRI. Given these unmet clinical needs and TAIS's potential to assess liver fat at the point of care, we're very excited to have collected the data necessary for our de novo request, as it represents a significant milestone for the company. Turning to intellectual property, we've made some great progress here, too. increasing our patent portfolio with seven newly issued patents so far this year, bringing the total portfolio to 63 issued patents and 31 filed assets. This significant growth in patents not only protects our technology, but also creates opportunities for out-licensing. Finally, subsequent to the close of the quarter, we were able to strengthen the company's balance sheet with an upsized capital raise of $4.5 million in net proceeds despite the challenging capital market conditions. We'd like to thank the participation of long-term investors and company insiders for this capital, which positions Andrew to achieve key milestones such as FDA submission and commercial deployment. Okay, over to Mike Thornton for a detail on our clinical progress. Mike?