ENDRA Life Sciences Inc.

Good afternoon and welcome to the NDRA Life Sciences Incorporated fourth quarter 2022 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 Indra's fourth quarter 2022 Business Update and Financial Results conference call. Earlier today, Indra issued a press release on this topic, which is available in the Investors section of Indra'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, which is expected to be filed by the end of this week, for more information about risks and uncertainties related to the 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. With that said, I will now turn the call over to Francois Michelon. Francois?

Thank you, Yvonne. Good afternoon, everyone, and thanks for joining us today to discuss Endra's fourth quarter financial financial results, and business highlights. Let me start by saying that our top priority of the company is to complete the necessary TAIA scans in order to submit our de novo request to the FDA. I'm excited that we scanned over 100 subjects in 2022 and deployed our interactive software guidance tool to our global study sites last month. We're in the process of scanning the next cohort of subjects, and we're seeing significant improvements in intraoperator performance in the hands of independent clinical users. There's no shortcut here. We must have the most robust clinical data that our TAIS system is capable of achieving to enable a successful FDA submission and to support our global commercial adoption. Admittedly, it's taken longer than we expected, but Endra is developing a completely new and game-changing technology. which naturally comes with some challenges. We're excited about our active clinical evaluation sites, continuing to collect data with a newly deployed guidance tool and using this higher performance data to support our denominal submission as quickly as possible. As a reminder for any new listeners, Endra's Thermoacoustic Enhanced Ultrasound, or TEAS, is a proprietary technology platform with an initial application focused on measuring liver fat for the early assessment of non-alcoholic fatty liver disease, known as NAFLD. According to recent estimates, NAFLD affects over 2 billion people globally and is driven by a broad range of drivers, including obesity, diabetes, and genetics. There are currently no diagnostic tools for NAFLD that combine accuracy, safety, cost-effectiveness, and ease of use. Endros-TAIS is intended to enable non-invasive characterization of tissue in ways similar to an MRI, but at the point of patient care and at about one-fiftieth the cost. TAIS is approved for sale in countries that recognize the CE mark, including those in the European Union. In the U.S., we're diligently working towards submitting a de novo request to the FDA. Before I turn the call over to Mike Thornton for more color on the clinical data front, I want to highlight a few other areas that will resonate with investors. In parallel to our clinical data progress, we're maintaining a steady cadence of marketing activities, including participating in 11 clinical conferences in Europe and the U.S. last year, where we showed our TAIS system to hundreds of potential customers. We've built a great pipeline of sales leads that will be catalyzed with the clinical data we're collecting. Once we submit our FDA application, we'll synthesize the TAIS clinical data into a white paper to enable our commercial team in Europe to close sales, while in parallel, our clinical investigators submit their research to peer-reviewed publications. I'm also very proud to say we renewed our longstanding partnership with GE Healthcare in December of 2022 for two additional years. We've been partnered since 2016. GE is the ultrasound market leader, and we're energized by their interest in liver disease and emerging technologies like Endros. Finally, we continue to aggressively strengthen our intellectual property portfolio, to protect our technology from multiple indications. In 2022 alone, we had 19 patents issued, bringing our portfolio to 56 globally issued patents. Investors should know that this is a robust portfolio that includes a mix of U.S. and international patents balanced across method, system, and design claims with both defensive and offensive value for Andra. We have zero in licensing dependencies, and our average remaining patent life is over 16 years. When we benchmarked Endra against a dozen similar microcap medical technology companies, Endra had three times more issued patents than our peer group average. I think that's remarkable for a company of Endra's small size. As we mentioned on the last call, several Endra patents focus on novel cloud-enabled connectivity of medical devices including Andra's TAIS system, and we're actively pursuing potential licensing opportunities of this technology to help other companies collect data from their equipment, such as laboratory equipment, which may not have an internet connection. Okay, over to Mike Thornton now. Mike?