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ENDRA Life Sciences Inc.
11/14/2022
Good day and welcome to the INDRA Life Sciences Third Quarter 2022 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 telephone keypad. And 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 Miss Yvonne Briggs. Please go ahead.
Thank you, Operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to Endra's third quarter 2022 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, 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. Acceptance 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 2021 fiscal year and subsequent Forms 10-Q 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, NDRA's Chief Technology Officer. Mr. Thornton will be followed by Renaud Malaberti, Endra's Chief Commercial Officer, and then Irina Pestrikova, Senior Director of Finance, will review the third quarter financial results. With that said, I will now turn the call over to Francois Michelon. Francois?
Thank you, Yvonne. Good afternoon, everyone. Thanks for joining us today to discuss Endra's third quarter financial results and business highlights. Today we'll review the progress we're making on many fronts to advance our thermoacoustic enhanced ultrasound system known as TEAS. I'd like to start by underscoring that the collection of high-quality clinical data that validate the TEAS system is the top priority for NDRA. These data will enable a compelling U.S. regulatory submission and will also support global commercialization. In the meantime, We're continuing to build awareness of our TAIS system with a steady cadence of marketing activities in Europe and the U.S., and importantly, our balance sheet remains strong to enable the achievement of several significant milestones. As a way of background, TAIS is a proprietary technology platform with an initial application focused on accurately measuring liver fat for the early assessment of non-alcoholic fatty liver disease, known as NAFLD, which affects over a billion people globally. TEIS allows for the non-invasive visualization of tissues in ways similar to an MRI, but at the point of patient care and at about one-fiftieth the cost. TEIS is approved for sale in countries that recognize the CE mark, including those in the European Union, and in the U.S. we're diligently working towards submitting a de novo request to the FDA. Admittedly, it's taken longer than we expected to achieve our clinical milestones, partly because COVID restricted or even halted work at our partner clinical sites for the better part of two years, and also because Endra is developing a completely new and game-changing technology, which naturally comes with some challenges. But as you'll hear from Mike Thornton in a minute, we're making strong progress on the clinical data front. And as you'll hear from Renaud Malaberti, we're maintaining an excellent cadence of marketing activities to build awareness of Artea's fatty liver technology among prospective customers in Europe and the U.S. We also continue to enhance our intellectual property portfolio to protect our technology from multiple applications. In the third quarter, we had eight patents issued and now have a total of 56 patents issued globally. Several recent Andra patents focus on novel cloud-enabled connectivity of medical devices, including Andra's TAIS system. And we're pursuing potential licensing opportunities for this technology to help other companies collect data from their equipment, such as laboratory equipment, which may not have a direct Internet connection. On a separate point, we recently announced a special shareholder meeting to approve a reverse split of our stock. and I want to make it very clear. The reverse split is proposed to maintain compliance with NASDAQ listing requirements, and there is no capital raise connected with Endra's reverse split. Okay, now, over to Mike Thornton. Mike?
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