Good day, ladies and gentlemen, welcome to the MDxHealth half-year release of results and business update conference call. As a reminder, this conference call is being recorded. Before we begin, I would like to remind everyone that the company will make forward-looking statements during today's call. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties. These risks and uncertainties are detailed in the company's most recent annual report. MDxHealth expressly disclaims any obligation to update any such forward-looking statements to reflect any change in its expectations with regard thereto or any changes in events, conditions, or circumstances on which any such statement is based, unless required by law or regulation. Now, at this time, I'd like to turn the conference over to Mr. Michael K. McGarrity, Chief Executive Officer of MDxHealth. You may begin your conference, and please go ahead, sir. Thanks, Cody. Thank you all for joining us for our 2021 mid-year release of results for MDxHealth. With me today is Ron Kalfus, Chief Financial Officer. We are encouraged by our expected progress in the first half of 2021. Our results reflect the key fundamentals of our business are now in place and will begin to drive sustained growth for MDxHealth. Our confidence is based on the following actual results and additional leading indicators. Volumes for our ConfirmMDx test increased for the third consecutive quarter, up 4% sequentially in Q2 over Q1, compounding on the 6% Q1 growth over the Q4 of last year. For our SelectMDx test, volume increased an even greater 16% sequentially over Q1, while year-over-year growth for Q2 was 82%. Also notable, we received a draft coverage decision on our SelectMDx test from Medicare. While we cannot be certain of the timing of a final coverage decision, we believe this is a clear indicator and validation that our SelectMDx test will be afforded coverage for our Medicare patient population on a national basis. Our compelling clinical data, broadening market adoption, healthcare economic value to payers and providers, and our inclusion in the NCCN guidelines support this expectation. Based on these positively trending results, I believe it is important to characterize what we are seeing in the market with regard to the pandemic dynamics and its influence on our volume trends. First, from a patient flow perspective, we see that there's likely a backlog of patients that deferred physician visits who will be coming back into the healthcare system as the pandemic lifts. These patients have put off important PSA screenings for prostate cancer, estimated to be down 48% in 2020, and associated biopsies based on PSA and risk factors. While we are still in the early days of this now very elastic return to normal patient flow, we are confident that our work and focus on adoption of both SelectMDx and ConfirmMDx in a diagnostic pathway of prostate cancer can and will become the standard in clinical urology practice. We believe our growth trend will clearly reflect that we are outperforming the pandemic, to best characterize it, and that the anticipated lift of patient flow over the coming quarters, however choppy it may be, will prove out these leading indicators. Further, despite the continued effect of the pandemic, together with the emergence of the Delta variant and the continued limitations on sales force access, our team has continued to engage and drive adoption of our menu into the diagnostic pathway of prostate cancer. Before I turn the call over to Ron, I would like to highlight that we have spoken to the restructuring of leadership, focus, and execution within our sales organization, and we will look to take advantage of what we believe we are building as a best-in-class sales team to drive additional channel opportunities into our urology customer base. In fact, the first of those opportunities has been realized as we have begun to introduce a urinary tract infection, or UTI test, as our first channel opportunity through our direct sales team into urology. I will comment further on this opportunity for MDxHealth and the advancement of our strategic initiatives, but first let me turn the call over to Ron Kalfus for a review of our financial and operating results for the first half of 2021. Ron? Thank you, Mike. The pandemic continues to impact sales rep access and the return to normal patient flow for not only MDxHealth but the healthcare industry as a whole. While various companies may be viewed as comparable to MDxHealth, it should be noted that each disease state in cancer diagnostics has a unique profile related to the impact from the pandemic and its associated recovery. While we have seen signs of recovery, evidenced by the sequential increases in volume and revenue for both of our products. We may continue to experience some fluctuations with expansion and contraction by geographic region, particularly with the emergence of the COVID Delta variant. Moving on to our results. Total revenue for the first half of 2021 was EUR 10.7 million, compared to total revenue of EUR 9.9 million for the first half of 2020. Revenue from ConfirmMDx and SelectMDx for the first half of 2021 amounted to EUR 10.5 million, an increase of 9% as compared to EUR 9.6 million a year earlier. Q2 2021 services revenue was up 43% from Q2 2020. Gross profit on products and services for the first half of 2021 was EUR 5.2 million as compared to EUR 4.7 million for the first half of 2020. Gross margins on products and services were 48.6% for the first half of 2021 as compared to 47.4% for the same period in 2020, representing a gross margin improvement of 120 basis points. Operating expenses in the first half of 2021 were EUR 17.7 million, consistent with the same period last year. Excluding non-cash expenses such as depreciation, amortization, and stock-based compensation, operating expenses for the first half of 2021 were EUR 15.7 million, an increase of EUR 0.3 million, or 2%, over the first half of 2020. Finally, following a successful equity raise of EUR 25 million, or approximately $30 million, by U.S. and European investors, including existing shareholders, we ended the half year with $31.3 million in cash and cash equivalents. Our cash burn remained comparable to the prior year at EUR 13.1 million for the first half. This concludes my brief overview of the results. I will now turn the call back to Mike. Thanks, Ron. I hope it is clear that even amidst the challenges presented by this environment, Ron and I, and our entire team across all of our operating functions, remain committed to and believe in our focus on execution and our clear path to build value. We expect the fundamental drivers of our business will become clear and obvious as we go forward. While we will not be providing specific guidance for the remainder of 2021, I would like to emphasize our expectations and what we will advance and deliver going forward. First, as urology group practices in general, and our customer base specifically, move towards standardization of menu and laboratory service providers, as well as adoption of clinical diagnostic pathways, we expect to leverage this trend into sustainable growth for MDxHealth. Second, the recent determination by MolDX that our SelectMDx test meets the necessary conditions to qualify for coverage for Medicare patients in its draft coverage LCD will not only catalyze our focused efforts to expand coverage among commercial and private payers. Will, most importantly, together with our inclusion in the gold standard NCCN guidelines, support our efforts to accelerate adoption by the urology community? Third, as I noted previously, we have refocused our R&D resources from product support and advancement of our existing menu to now investing in menu expansion that will supplement and contribute to our future growth. Our efforts here will expand our menu into active surveillance, where we believe we can deliver clinically actionable results for both selection and monitoring of patients for active surveillance. All of these initiatives are designed to put MDxHealth in the position to be the only company in the prostate cancer diagnostic space that can take a patient from an elevated PSA all the way through the diagnostic pathway. Lastly, but notably, as I commented earlier, we are commencing a limited market introduction of a UTI test into our urology channel, where approximately 20% of the 10 million cases in the U.S. market present annually. This market is one of the few remaining substantial opportunities for rapid and actionable multiplexed molecular diagnostics to convert from traditional culture methodologies. We believe that this conversion is now well characterized and that we can participate in this trend within our current and targeted customer base. It is important to note that this menu expansion is the result of a comprehensive and rigorous investigation over the last year to confirm market dynamics, competitive landscape, reimbursement, and clinical utility for our urology customer base. That diligence has informed our decision to take this initiative. We are confident that our assay design, which will incorporate a highly multiplexed panel of both organism and drug susceptibility markers or targets, will provide timely and clinically actionable results to our urology customer base for both diagnosis and treatment. While it would be premature to provide guidance on the impact to our growth and value creation, we are positive and optimistic that we can leverage this opportunity as the first of a number of potential channel opportunities to drive growth, and that revenue would be accretive to our P&L and gross margin when recognized. We will look to update our view and progress in this strategic initiative as we come into 2022. It is important to note that these initiatives are consistent with our building brand, which is based on a reputation for quality of people and diagnostics within the industry, and our mission at MDxHealth to provide highly accurate and clinically actionable urologic solutions to inform patient diagnosis and treatment while improving healthcare economics for payers and providers. As we look forward, we carry the highest sense of responsibility to this commitment of focus and execution. It is also important to note that these strategic initiatives take our total addressable market to over $4.5 billion in the U.S. alone. We believe this puts us in a unique and proprietary position in the urology space and will serve as the foundation for our growth and success. I would like to again communicate very clearly that throughout the coming year, our team will be singularly focused and dedicated to driving sustainable growth and that our commitment to focused execution will serve as the foundation for value creation for all of our stakeholders, including patients, customers, employees, and shareholders. Thank you for your interest in and support of MDxHealth. Now I'll turn the call back over to Cody for any questions. Thank you. If you'd like to ask a question, please signal by pressing star one on your telephone keypad. If you are using a speakerphone, please make sure that your mute function is turned off to allow your signal to reach our equipment. Once again, that is star one if you would like to ask a question. We'll take our first question from Lenny Van Steenhuyse from KBC Securities. Please go ahead. Hi. Good evening, gentlemen. I hope you can hear me well. Two questions from my side. You mentioned, indeed, a bit of a choppy patient flow, a bit of an elastic patient flow. Now, as the pandemic continues to linger, do you observe any changing behavior with urologists to adapt to this changing long-term, let's say, new normal as the patient flow continues to be choppy? Does this affect your approach to existing and novel customers? I'll have a follow-up to that. Thank you. Yeah, Lenny. We do likely see, as I commented, that this patient flow that has been or backlog that has been building will come back through the system, and we have clear visibility to the fact that—and I run the risk of overusing the pathway term, but I think it's important because previously, I think prior to my joining the company, there was always a question about, is this a Confirm company or a Select company? Hopefully our message is very clear that we have a prostate cancer menu and, when applied in the diagnostic pathways, just a very clear and straightforward adoption profile. As these patients come back through, I think that will become evident. Secondly, we've made the conscious decision, obviously, to continue to invest in Select as part of that pathway, as opposed to waiting until we have coverage. We think that as well will pay dividends. When you look at the growth rate for our Select in combination with the progress with Confirm on the pathway, we have a lot of leverage in our P&L and associated gross margin based on our confidence that we will be able to run coverage over our Select test. That investment, I think, in our patients there and focus will pay off. Our expansion into active surveillance as well puts us in a unique space. We are very positive. We probably just need a little bit more clarity as to the release of that patient flow. All right. Thanks for that. Perhaps zooming into the novel UTI test, I was wondering if you could elaborate a bit on, let's say, the process behind the addition of the test and how the financial dynamics of that test compare to Confirm and Select in terms of pricing and margin? Sure, Lenny. I commented briefly, but I think it is important to note that we've spoken to this, that we believe we're building a clear channel in the urology and a unique channel in the urology where that's our focus. Based on that, I think we're starting to become a little more obvious in that regard. We get opportunities that come our way for potential partnerships or distribution based on our access to this channel. I think it's very important to note that this is not like our tactics dictating our strategy, and we're going to try this. This is. We believe the exact opposite, right? We believe this fits with our strategy and our process within our sales organization, and I do want to emphasize the work that we did to confirm all of that. The dynamics from an economics perspective are actually pretty clear and de-risked. Again, I use the term well-characterized from a pricing perspective. It probably fits between our SelectMDx and ConfirmMDx, with potentially a EUR 1,500 type list price and coverage in the high hundreds. Then we have good visibility. I made the comment that as we recognize revenue in this opportunity, it will be accretive to our P&L and gross margin. Obviously, more detail is to come. We'd like to get a quarter or two of experience, and we want to be very focused in our launch, both from a quality and execution perspective, because in my experience, it would be reasonable to have a stumble here or there. We're very confident that we've done the work, and we'll look forward to giving you better visibility as we come into next year. All right. Many thanks for that. Thanks. Bye. Thank you. We'll take our next question from Kevin DeGeeter with Oppenheimer. Hi, this is Susan calling in for Kevin. Just a few questions. I believe the comment period for the new LCD ended in July. I was just wondering if you guys had any thoughts or any comments that you would call out. Susan, I probably have to lean on my difficulty in projecting the timing. I would just say that our confidence is very high in the data, the clinical utility. I think the inclusion in the NCCN guidelines is quite compelling, and we expect the comment period to reflect that. We are through that, and I think from my perspective, it's like the FDA and Medicare, we just can't and don't want to guide to a specific timing. We know over the coming months, we're very confident, between the fall and the spring, that we will be issued a final coverage decision. As I commented previously, we think that that provides a significant tailwind for the company and will prove out our focus on continuing to drive Select while we were not getting coverage. Okay. Thank you. Just actually another question on the other LCD, L37733. There was an update to that LCD, I think EPI is receiving expanded coverage. I was wondering how that might impact Select and if at all. Yeah. We don't view or have any particular comment on that. We believe that our Select reimbursement and clinical utility package stands on its own. Okay. One last question. I wanted to know what the impact of Delta is on the company's commercial organization, specifically in-person sales, travel, and things like that. Yeah. It's clearly had an impact, as it has on all sales organizations, particularly in the diagnostic space. I don't want to quantify it to some specific impact. I would just say that the biggest impact is probably on access. Our team is fully engaged and has been productive. Access will clearly open up, or we anticipate that. I think all the companies in our space are reporting 50% or so estimated management estimates. Those are minor. That's probably right from an access perspective. We've been, as I said, fully engaged. Great. Those are all the questions from us. Thank you. Thanks, Susan. Cody? Cody, can we move to the next question? Let's give it a minute. Cody? [inaudible] There might be some technical issues on the back end. All right. I do apologize for the inconvenience there. We will now take our next question from Laura Roba, from Degroof Petercam. Please go ahead. Yes. Many thanks for the clear presentation. Three questions on my side. What does your current development pipeline mean in terms of R&D expenses? Could you provide some guidance on that? Second question: how do you balance the focus between the commercial rollout of your existing products and the development of the new solutions? Finally, when do you expect to launch the UTI tests? Thanks, Laura. In order, from an R&D, OpEx perspective, our focus on the expansion of our menu into active surveillance will drive some investment in R&D. However, we feel like it's largely absorbed by the growth in our business. It's important to note this is not a significant expansion of fixed expenses related to headcount. It is more associated with clinical studies and samples that you would find to be common in a development project like this. We are very focused on, and I think it's coming through in our numbers and will continue to, on operating discipline with regard to operating expense and our cash management. That will continue. That's the way we view the R&D. On your second question with focus, we have paid significant diligence and respect to that process, right? Because I have emphasized focus and execution. It's a really important point to note that we think this is not contradictory to that; it's very, very consistent with that. It's based on the fact that our target customer—and when I say target customer, I don't mean all of urologists, I mean our focused, qualified customer for SelectMDx and ConfirmMDx —and with the introduction of our UTI test, is very consistent and complementary. We do not anticipate, and we've pressure tested this a number of different ways, that it will be dilutive to our focus. We believe it will be accretive from the perspective of the quality of our sales team and the standardization of the rep, company, and laboratory in the urology space. That's why I point to that EUR 4.5 billion total addressable market. Yes, that's large, and we're not selling that as anything other than we believe that we are the only company in the space that serves that market from front to back. Your final comment on this is that we're using market introduction, mainly because in my experience, we want to introduce this product in a highly focused and quality way with our customer base. That's what we'll be doing here over the next quarter or two. I would expect that we would be speaking to the full launch strategy, how it folds into our view going forward for the business. Obviously, as we build our internal models on value creation and work with you and the market, we're confident that it will provide good growth. We just don't want to get ahead of that. We're very confident in this fit. Okay. Very clear. Thank you. Thanks, Laura. Thank you. That does conclude today's question and answer session. I'd like to turn to And, as well as today's conference, we do thank you all for your participation, and you may now disconnect.