ENDRA Life Sciences Inc.

Good day and welcome to the NDRA Life Sciences third quarter 2023 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 touch tone 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.

Thank you, Operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to NDRA's third quarter 2023 Business Update and Financial Results Conference Call. Earlier today, NDRA issued a press release on this topic, which is available in the Investors 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 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 Michelon, Chairman and Chief Executive Officer will begin the prepared remarks, followed by Michael Thornton, NDRA's Chief Technology Officer. Mr. Thornton will be followed by Irina Pestrikova, Senior Director of Finance, to review the third quarter financial results. With that said, I'll now turn the call over to Francois Michelin. Francois?

Thank you Yvonne and good afternoon everyone and thanks for joining us today to discuss Endra's third quarter 2023 financial results and business highlights. I'm delighted by the momentum that's building for our thermoacoustic enhanced ultrasound liver system known as PEAS. This momentum checks a number of boxes including clinical, regulatory, and commercial along with a convergence of a number of factors that put NDRA in the right place at the right time. We spent the last few days of the liver meeting held by the American Association for the Study of Liver Diseases where we interacted with experts in the field, clinical users, prospective customers, and partners. Steatotic liver disease, known as SLD, is the umbrella term for a multifaceted metabolic disorder resulting in too much fat in the liver. Anything over 5% liver fat is of clinical significance, and this fat can irritate and inflame the liver, then scar it, and ultimately lead to irreversible end-stage liver disease. Steatotic liver disease is estimated to affect more than 2 billion people worldwide, and it's predicted to become the leading root cause of liver transplants in the U.S. by 2030. The American Association of Clinical Endocrinology and the American Diabetes Association have updated their guidelines over the past 18 months to include the screening for fatty liver in adults with obesity, prediabetes, and type 2 diabetes. The good news is that the new GLP-1 obesity drugs have demonstrated clinically significant reductions in liver fat, and a rich pipeline of targeted therapies to treat SLD in both obese and non-obese patients is approaching commercialization, with the first drug approvals expected in early 2024. This intersection of variables, a heavy public health burden, a lack of practical diagnostic tools and the near-term availability of the first treatments creates an opportunity to address the large unmet clinical need for a noninvasive, cost-effective tool to assist in identifying and monitoring patients. That's where NDRA intends to lead. As discussed on our last conference call, we submitted the TEIS de novo request to the FDA on August 14th of this year. And since then, the submission has entered the substantive review period. The de novo submission was a significant milestone for NDRA as this regulatory pathway should strengthen our competitive position with distinctive patent protected capabilities as a noninvasive point of care tool to aid in the characterization of liver fat. We look forward to working with the FDA during the review process. And the FDA's published goal is to make a decision on a de novo request within 150 review days. Since our FDA submission, we've had our second positive clinical dataset reviewed and accepted for presentation by the European Association for Study of the Liver. These clinical abstracts are available on ENDRA's website under the tab Research and Media. The most recent abstract includes 45 subjects comparing ENDRA's TEIS liver measurements to MRI, and we're very pleased with the results. We believe the data in these published abstracts and related presentations are crucial to building awareness of the TAIS system and its capabilities with clinical users and to supporting commercial adoption of our new technology. The clinical data is the most critical element for getting commercial traction with clinical customers. Mike Thornton will provide more detail on our clinical data in a moment. In terms of commercial activities, We've been actively showcasing our TEIS liver system at the key clinical conferences in hepatology, endocrinology, and radiology in our target markets of the UK, Germany, France, and the US. We've participated in eight clinical conferences this year, including five since September, namely, The British Association for Study of the Liver, European Association for the Study of Diabetes, French Society for Hepatology, Drei Lander Treffen, which is the annual meeting of the ultrasound societies in Germany, Austria, and Switzerland. And I've just returned with Mike Thornton from the American Association for the Study of Liver Diseases in Boston, which is the preeminent liver meeting in the US. We also sponsored a great multidisciplinary panel discussion on liver disease while at ASLD from the perspective of a hepatologist, the liver experts, an endocrinologist, the metabolic obesity and diabetes experts, and a radiologist, the imaging experts. Steatotic liver disease resonates with each of these specialties, and there's a growing interest in the primary care arena as well. Turning to intellectual property, we continued to bolster our portfolio and recently achieved a great new milestone of 70 issued patents, with three additional patents issued during the third quarter and three more patents issued in Q4 thus far. A portfolio with 70 issued patents and no in-licensing dependencies is a remarkable achievement for a company of our size and a testament to the innovation of Endra and the proprietary nature of our technology. These newly issued patents protect and further differentiate Endra's thermal acoustic systems in areas of high unmet clinical need, such as the early detection of steatotic liver disease. The company is also actively exploring licensing opportunities in non-core indications with outside partners to augment the value of our growing intellectual property portfolio. With that update, I'll turn the call over to Mike Thornton for more details on our clinical and regulatory progress. Michael?