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ENDRA Life Sciences Inc.
5/12/2022
Good afternoon, everyone, and welcome to the NDRA Life Sciences First 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 and then one. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I'd like you to turn the floor over to Yvonne Briggs with LHA. Ma'am, please go ahead.
Thank you, Operator. This is Yvonne Briggs with LHA. Good afternoon, and welcome to NDRA's first quarter 2022 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 otherwise required by federal securities laws, the company disclaims any obligation to update or revise any forward-looking statements. Please refer to the company's 2021 Form 10-K 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 Mike Thornton, Endra's Chief Technology Officer, followed by Renaud Meliberti, Endra's Chief Commercial Officer, and then Irina Pestrikova, Senior Director of Finance. With that, I will now turn the call over to Francois Michelon. Francois?
Thank you, Yvonne. Good afternoon, everyone, and thanks for joining us today for a discussion of UNDRA's 2022 first quarter financial results and an update on our business. We're very encouraged by the recent progress we've made in advancing our TA system toward global commercialization, and I'm delighted to share some of the highlights with you today. As many of you know, subsequent to the quarter close, we were able to raise $7.8 million through our at-the-market equity facility without the overhang of warrants or convertible debt. This fundraise bolsters our cash position to fund operations through several important milestones, including ramping up our commercial activities in Europe and advancing the TAIS system through the regulatory process in the U.S. What's more, I believe our ability to raise capital efficiently in this very challenging macro environment reflects investor confidence in our progress, our technology, and our market opportunity. The six weeks since our fourth quarter earnings call has been a very productive time for UNDRA, with several noteworthy accomplishments. First, we helped advance studies that are underway or being planned by our clinical research partners. These studies will support the commercial adoption of TEIS in Europe and will provide the additional clinical data needed for our FDA de novo submission in the U.S. We're leveraging the vast majority of our previous 510K application and are gathering data from a subset of our clinical partnerships to submit the de novo request as quickly as possible. We're on track to do so in the third quarter. Mike Thornton will provide more details in a few minutes. We're ramping up our sales and marketing efforts across Europe as pandemic restrictions continue to ease. Renaud will speak specifically about these activities in a minute. And third, we significantly strengthen our intellectual property portfolio, not only to protect our technology, but also to enhance out-licensing opportunities. Year-to-date, five patents were issued in the U.S., two in Europe, and four in China. These additions bring our global IP portfolio to 90 assets, including 46 issued patents. One of the issued U.S. patents we announced earlier this week has the potential to expand licensing and revenue opportunities for the company into a new space. The patent protects a proprietary method for acquiring, analyzing, and sharing data on equipment not connected typically to the Internet. Although this technology was developed specifically for Andrositea's system, based on our market research and industry discussions, it has broad applicability and out-licensing potential within the healthcare industry where it could help lower service and maintenance costs on things like laboratory equipment, thereby enhancing equipment uptime for laboratories and hospitals. I'll turn the call over now to Mike Thornton, our Chief Technology Officer, to provide updates on our clinical studies. Mike?
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