Good morning, welcome to the Renalytix conference call to review fourth quarter results for fiscal year 2021. At this time, all participants are in a listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Peter DiNardo of Capcomm Partners for a few introductory comments. Thank you, Mary, and thank you all for participating in today's call. Joining me today from Renalytix are James McCullough, Chief Executive Officer, Tom McLain, President, and James Sterling, Chief Financial Officer. Before we begin, I'd like to remind you that management will make remarks during this call that include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. Examples of these statements include, without limitation, statements related to KidneyIntelX's ability to lower healthcare costs, improve patient quality of life, and set long-term standard of care, trends in our market and potential benefits of government policy change, the impact of COVID-19 on our business, our expectations for hiring, product development, strategic partnerships and collaborations, reimbursement decisions, clinical studies and regulatory submissions, and our business strategies and future growth. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our annual report on Form 20-F that was filed today, October 21, 2021, with the Securities and Exchange Commission. All forward-looking statements made on this call are based on management's current estimates and various assumptions. Renalytix disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, October 21, 2021. With that, I'll turn the call over to James McCullough. Thank you, Peter. Good morning and good afternoon, everyone. Over the past year, we have continued a methodical execution of the fundamentals for the Renalytix care model, which was designed to change outcomes, costs, and patient quality of life in chronic kidney disease. We believe the next 6-1 2 months will be event-filled with new hospital system partnerships, broad real-world evidence development and publications, expanded private and public reimbursement coverage, an FDA De Novo marketing authorization for KidneyIntelX, growing pharmaceutical partnership activities, and the build-out of our direct sales, marketing, and customer service capability. We expect revenue growth this fiscal year from three main areas. Our announced scale-up of KidneyIntelX testing in the Mount Sinai Health System, initiation of the KidneyIntelX program across the Veterans Administration health system, and expanding pharmaceutical partnership-related activity. Our KidneyIntelX EHR integration with Atrium Wake Forest is expected to go live this current quarter. The universe of KidneyIntelX insurance coverage has increased to 20 private commercial contracts, and we are pleased to announce today now includes our first Blue Cross Blue Shield coverage contract and a coverage contract from a major New York State insurance provider. We have also continued to build on our Medicaid strategy with 27 approved state provider contracts. For the kidney space, the stakes have never been higher, with close to 40 million Americans who have existing kidney disease. Most, fortunately, are in the early stages, where advanced risk assessment and active treatment can have the greatest impact on maintaining health and limiting social costs. Globally, the number of people living with kidney disease is estimated to exceed 850 million. This is a massive challenge that needs to be addressed assertively with education, early detection, prognosis, proactive treatment, all beginning right at the primary care physician level. The unsustainable health economics here are readily apparent. Kidney disease-related illness consumes more than 20% or $120 billion annually of the U.S. Medicare budget. For our U.S. veterans, the Veterans Health Administration spends an estimated $19 billion annually for non-dialysis kidney disease alone. Rapid growth in diabetes and obesity continue to fuel kidney function impairment across the global population. One in five Americans with kidney disease will suffer life-threatening complications in their lifetimes, with many progressing unchecked until an emergency room visit. The very good news here is the cost of preventable suffering has ignited a new era of accelerated drug and medical device innovation across the kidney spectrum. Recent government policy shifts have underscored the importance of early prevention to maintain kidney health and have started the migration from late-stage disease management. These policy changes and the growing awareness in the clinical and patient community have provided significant tailwinds for our KidneyIntelX early risk assessment and care management program. These converging economic, regulatory, reimbursement, and clinical dynamics have created the most opportunistic environment we have experienced in our collective diagnostic careers. We believe that will provide lasting benefits for patients, doctors, and investors alike. We believe the solution to kidney disease epidemic ultimately lies in the accurate risk assessment of large populations with early-stage kidney disease. Closely matched with corrective clinical actions that can be implemented by the estimated 210,000 practicing primary care physicians in the United States. To be effective, this clinical action must be guided by a patient's current biology as measured by active blood biomarkers. KidneyIntelX currently uses three well-established blood biomarkers for kidney status prediction. The preventable solution also needs to be deployed with physician education, advanced population health strategies, and a dedication to continuous real-world evidence development. This, in a nutshell, is our KidneyIntelX care model. In this current half year 2021, Renalytix is building on a national commercial launch strategy for KidneyIntelX. In less than 36 months from our first funding, the KidneyIntelX program is now scaling system-wide in the Mount Sinai Health System, which is currently caring for an estimated 250,000 patients with chronic kidney disease. We have been granted a 10-year U.S. General Services Administration agreement allowing us to initiate a comprehensive sales program into the VA health system, which is currently caring for a chronic kidney disease population that could exceed 2 million individuals. Additional program implementations are underway at the University of Utah in the Southwest region and Atrium Wake Forest in the Southeast that we expect to begin live testing this quarter. We expect KidneyIntelX will achieve payment by Medicare at the set national Medicare rate of $950 per reportable result by the summer of 2022. With GSA, Medicare, and other private and government reimbursement, we expect KidneyIntelX insured covered lives will exceed 10 million people with diabetic kidney disease in the United States. We are working on expanding the KidneyIntelX product capabilities to support a breadth of precision medicine diagnostic, therapeutic, and monitoring strategies, further expanding the potential eligible and insured market size for testing. On now to two key operational areas, our Mount Sinai Health System implementation and the VA health system launch that we've just announced. Both market categories will drive revenue for this fiscal year and growing into fiscal 2022. One of the remarkable value points to our hospital system implementations is engagement with population health, which brings the capability to coordinate care services across broad groups of treating physicians. With Mount Sinai, early success has triggered a system-wide scale-up with a target testing run rate of 300 patients per week in the near term. Mount Sinai expects to complete approximately 6,000 patients tested around the second calendar quarter of 2022, which will result in an important, large, real-world evidence demonstration. All testing conducted is set at the national Medicare and General Services Administration price of $950 per reportable result. To support this scale-up, we are deploying newly hired Renalytix sales, customer service, and medical science liaison personnel around Mount Sinai and other healthcare institutions we expect will bring the KidneyIntelX solution program online in coming months. We believe the real-world evidence emerging from Mount Sinai is validating our business model that integrating with KidneyIntelX within a population health management system can drive meaningful change in care for early-stage kidney disease patients. This KidneyIntelX pop health care model is also demonstrating a capital-efficient means to drive revenue growth by reaching regional bases of primary care physicians and at-risk patients quickly with a consistent, actionable message. I'd like to turn the conversation now to our president, Tom McLain, who will detail our launch into the Veterans Health Administration health system currently underway. Tom? Thank you, James. The Veterans Health Administration system is the largest integrated healthcare system in the United States. It represents a significant launch opportunity for KidneyIntelX because the VHA has a longstanding commitment to improve care and outcomes for veterans with chronic kidney disease. The VHA has established itself as the leader in clinical care for CKD. VHA implemented the first evidence-based clinical practice guidelines ahead of other guidelines for both nephrology, the KDOQI and KDIGO guidelines, and for diabetes care through the ADA. VHA's leadership in this space is built from knowledge and innovations in care delivery that they've developed from more than 20 years of kidney disease clinical trial experience. Recent examples of VHA-led advances in care include the deployment of digital platforms that can help guide CKD management and direct appropriate utilization of resources. They recently launched VA-REINS, a nationwide renal information system to inform and improve clinical care. The VHA demonstrated commitment provides a unique setting to implement KidneyIntelX risk assessment to improve the health of veterans with chronic kidney disease. A key factor that will accelerate the adoption of KidneyIntelX is a new VHA clinical directive, directive number 1053, that's titled "Chronic Kidney Disease Prevention, Early Recognition, and Management." It was issued in March 2020. In outlining the significant health challenge faced by VHA, the directive references that CKD is the fourth most common diagnosis in the VHA system. Of the 9 million veterans receiving VA healthcare, 960,000 of them, or 11%, meet the established criteria for CKD. The VA-REINS database estimates that with improved diagnosis, there could be as many as 1 million-2.5 million veterans using strict versus liberal definitions of CKD. The cost of caring for the CKD population is substantial, with annual VHA costs estimated to exceed $19 billion. That's 24% of the VHA healthcare budget each year. Directive 1053 specifies the VHA's strategy for prevention, recognition, management, and evaluation of CKD in the veteran population. It brings focus to kidney health by pushing CKD care upstream to prevent progression. That change in care focus is expected to reduce the incidence of kidney failure and premature mortality. Renalytix has just announced launching KidneyIntelX through a comprehensive commercial and clinical program focused at the national, regional, and local levels of the VHA system. Jed Falk, our VP Sales Government Accounts, has just completed the first sales training class this week for a team that will build to four regional directors and 40 account executives. Alison Trucillo, our new VP of medical affairs, is assembling a team of medical science liaisons who will partner with the account executives to introduce KidneyIntelX in the context of the CKD directive and share clinical insights, insights that are based on our experience with large integrated health systems like Mount Sinai. Our launch focus will be on supporting VHA primary care physicians on three key elements of the directive: early recognition, patient management, and the prevention of end-stage kidney disease. Our KidneyIntelX solution can leverage key elements of the directive, including the work of a newly formed kidney health committee, tele-nephrology consultations, initiatives focused on patients in rural areas, and importantly, the patient aligned care team, or PACT model that integrates the PCP, care coordinators, specialists, and the patient in advancing kidney health. Importantly for revenue recognition beginning this year, coverage for KidneyIntelX is provided under the company's General Services Administration, or GSA contract. This contract allows individual primary care physicians to order the test today, and larger purchase quantities can be committed through a simple purchase order process at the VA center or regional level. We expect to report initial revenues in fiscal quarter two and to drive significant revenue growth in calendar year 2022. Back to you, James. Thanks, Tom. Finally, a summary on regulatory and reimbursement. As has been experienced broadly across the diagnostic industry, KidneyIntelX has had a prolonged review since our De Novo submission in August of 2020 due to staffing challenges and continued prioritization of COVID-19-related emergency use authorizations. FDA is not currently meeting its 150-day De Novo review goal due to, "Considerable increases in COVID-19 activities." We're committed to working collaboratively and expeditiously with the agency and continue to provide additional information, clarification, and supplemental analyses as requested. While we will continue to decline to provide a forecast for FDA timing, we are confident that KidneyIntelX will receive FDA authorization given our interactive dialogue to date, and that fiscal 2022 commercial objectives remain on track. The recent government proposal to repeal the MCIT rule for national Medicare coverage was disappointing. However, our Medicare coverage program through different Medicare contractors has been ongoing, and we do not see a significant impact on our execution of our calendar 2022 business plan if MCIT is ultimately to be repealed. We believe Medicare payment for IntelX will be achieved in the summer of 2022. Our progress with private payer contracting, including the announcement today of our first Blue Cross Blue Shield coverage contract, has exceeded our expectations. We now believe additional Blue Cross Blue Shield coverage will be available in the near term and can provide significant insurance support for expanding KidneyIntelX deployment. Let me turn it now to James Sterling, our Chief Financial Officer, who will provide more detail on our financial results. James? Good morning, everyone. The earnings release we issued today presents our financial results for the fiscal year ended June 30, 2021. I'll review a summary of these results now. All figures are in US dollars, which is our reporting currency. In this summary, I'll present our US GAAP financials as reported on our Form 20-F filed with the SEC. You can refer to today's RNS press release for the IFRS financials and a reconciliation of IFRS to GAAP. During our fiscal year end to June 30, we recognized $1.5 million of revenue, which comprised nearly $1.1 million of services revenue related to our work for Mount Sinai and AstraZeneca, and just over $400,000 of testing revenue. These represent the commencement of revenue-generating activity for the company. We did not post revenue in the prior year period. We recorded $858,000 of costs attributable to those revenues. Our operating expenses were $32.5 million for the year, compared to $10.3 million for the prior year period. The increase was mainly driven by higher headcounts and infrastructure build-out as we scale the company for commercialization of the KidneyIntelX platform in the United States. Net loss was $34.7 million, or $0.49 per share on a GAAP basis, as compared to $9.8 million or $0.17 per share for the same period a year ago. We ended the fiscal year with cash and equivalents of $65.1 million on June 30, 2021. We will now turn the call back to James McCullough for final remarks before we open the call to questions. Thanks, James. In closing, with the payment and regulatory landscape solidifying for KidneyIntelX, we intend now to build a substantial sales, marketing, and clinical capability that allows us to expand baseline testing and monitoring of kidney health to the broader national market, and eventually globally. This includes a direct to any primary care physician capability in the United States. We expect growth opportunities for calendar 2022 and 2023 to be substantial, with few precedents that we have seen in the diagnostic space, and importantly, with few precedents in chronic disease management. This is a time and a place for step change innovation, which is driven by unsustainable social cost and a need to reduce unnecessary suffering. There are multiple near-term catalysts for value accretion to Renalytix. We will remain focused on measured execution to realize this potential. Thank you. Operator, we'd like to now open it up for questions. Thank you. As a reminder, to ask a question you will need to press star one on your telephone. To withdraw your question, press the pound key. Again to ask a question, press star one on your telephone. Please stand by as we compile the Q&A roster. Our first question comes from the line of Dan Arias from Stifel. Your line is open. Hey, guys. This is Dan Masek on for Dan Arias this morning. Thanks for the question. I guess first of all, is there an overall volume number or range that we should think about for fiscal 2022? I assume it's probably safe to say that Mount Sinai's 6,000 tests is maybe a starting point, but realizing that there's ramping opportunities in the VA and also Wake Forest and Utah. I was just wondering if there's some sort of volume number that we should be thinking about. Yeah. Thanks, Dan. I appreciate that. We're not going to give guidance just yet. We're getting close. We're giving ourselves a little bit of breathing room, which I think is appropriate as we're building out all these different segments. I do think that we're starting to give some specific clues. Mount Sinai with 6,000 patients tested is a pretty big chunk. We're also giving you some direction in terms of ramp rate with the 300 tests per week number. We would like to continue to translate that type of ramp rate and that type of volume into other systems that we're bringing online, recognizing that each of these systems is different. I think the important thing here in terms of the hospital ramp rate is this year, we're now getting direct experience in demonstrating how the business functions in different environments. This is key, because the United States is a lasagna plate in terms of healthcare provision. If we're really talking about generating long-term sustainable revenue growth, long-term sustainable changes in standard of care, increases in volume ramp rates, we have to understand and demonstrate it in different systems, in different environments, in different demographies. Your primary care experience here in Utah is going to be different than your primary care experience in New York City. I can speak to that directly because I spent 35 years in New York and I've been here in Utah now for three years. We're understanding all these dynamics, and that's going to help us to start to forecast much more reliably as we come into the end of 2022 and start to provide everybody with guidance. Certainly taking a look at the Sinai numbers that we put down should give you a good clue. We shall see how the VA health system ramps. There's no barriers for us at the moment. There's no regulatory barrier, there's no reimbursement barrier. We're fully paid moving into this very large market in the VA system. We're now putting all the personnel capacity in to start to implement in an assertive way starting this quarter. That's going to be very interesting to see the demonstration of testing growth and the experience that we're going to get as we start to launch into individual hospital systems, and we start to work at the business level as well. We'll be providing guidance hopefully soon. I hope that answers your question. Yeah. That's helpful. Thanks. You mentioned you expect initial testing for Wake Forest and Utah. First, I just want to make sure I heard that right. Was it in this fiscal 2Q, or was it in the fiscal year? I just want to make sure I heard that right. Where are you in terms of those ramps, in terms of implementation and integration, physician education. You mentioned how different every health system is, so I'm just trying to get a feel for the both of those. It's a very good question. I believe we're going to be live in November at Wake Forest Atrium. I said this quarter, the December quarter, because I want to give a little bit of room because these are complex implementations. What's become readily apparent is, we have learned an enormous amount on the technology side, the clinical workflow side, the education side, the behavioral economics, and some of the dynamics that are required to implement with these large systems. Each one of these systems that we bring on is a big deal. They treat large populations, they set standard of care in their regions, they're recognized nationally. With Mount Sinai Health System, it was a fabulous training ground, to work very closely in partnership to get the first implementation done. That provided us with credibility to go out to other institutions. Wake Forest Atrium actually had a very well-defined care pathway in place between population health and primary care. When we got to the point of implementation, it was actually a lot easier for us to implement KidneyIntelX in a broad manner, with electronic health record integration. We're very pleased with how Wake Forest is going. We think they're a very important partner for us, and we're going to be demonstrating a lot of real-world evidence development. I just want to warn everybody that actual revenue recognition from a group like Atrium Wake Forest comes as we build out insurance reimbursement around the system. We do have a $6 million testing contract with Mount Sinai Health System, which is providing us with direct revenue this year. We are going to have to wait for reimbursement to come in, which we believe will come in starting in the first half of next year before we start to recognize actual revenue with Wake Forest. The experience of being able to move in and do an integrated implementation, educate the physicians, create the IT infrastructure, ahead of the insurance reimbursement is invaluable. Right. Because we don't want to just show up with Medicare coverage and say, "Okay, let's go." As we move into Medicare coverage, we will have multiple systems online. The clinical pathways will be worked out. The IT integration is in place. We will have salespeople in place now. We will have medical science liaison support, customer service, all of the things that are required to start to drive significant adoption and uptake in a sustainable manner. This is the key. When we start generating revenue, what I don't want to do is have a sawtooth revenue generation. I want to have consistency, growth building, and we're able to do that now because of our experience with Mount Sinai Health System and some of the other systems. We're really starting to know what we're doing here. Okay. Appreciate that. Lastly, maybe just give similar thoughts in terms of the VA ramp. It's obviously early, but if you could just speak to the path toward ramping there. I'm wondering too, I think you said you plan on hiring, I forget the exact number, but I'm wondering if hiring may be a risk and if you just hired a person in charge there, and I'm just wondering how that's going and if there's risk to other hires potentially as well. I'm going to bring Tom McLain. The great news about the VA for us is we already have the government pay contract in place at the national Medicare rate of $950 per reportable result. The government is a wonderful payer. We don't have revenue recognition risk when it comes to driving testing. In the very beginning of the company, I do not want to build up fixed overhead until we have direct line of sight to reimbursed, recognizable revenue. When you see us starting to announce sales force build, that's something you can stand on in terms of the ability to recognize revenue with concrete reimbursement. That's very important. The VA is an extraordinary opportunity. Tom, do you want to come in and just talk a little bit? We just completed our first sales class training with the next one in December. This sales force build with medical science liaison is happening today. Thanks, James. The drive for test volume and revenue at the VHA systems needs to be driven in the PCP office. We already have the contract in place with the GSA contract and the form of contract that we were able to secure for VA and other government health systems. In order to get volume, we are deploying a trained sales force with MSLs who will call on the PCPs. This is the diagnostic commercial model that is deployed by all laboratory service providers. It's those relationships and education and the work that we will do with them, with the PACT teams on the care integration of KidneyIntelX's risk assessment, that is going to drive volume and therefore drive the revenue growth under the payment that we've secured with the GSA contract. Thanks, guys. Thanks, Dan. Our next question comes from the line of David Westenberg from Guggenheim Securities. Your line is open. Hi. Thanks for taking the question. Just a quick clarification on the FDA. I was reading through the press release and just wanted clarification in terms of the missing the 150 days. That's nothing new, right? I mean, when you're commenting there, that was just on the August date. Am I correct? There's no new delay or anything like that. That's just a quick clarification. Thanks, David. No new news. We're all waiting with the FDA process. I think the important thing is we see no showstoppers. I think the dialogue has been very prescriptive and very specific in terms of the process to date, which gives me a lot of confidence. Obviously, if there was a significant delay or if there was a showstopper, it's something we would let the market know. I'll let the statement stand where it is. The PDUFA dates were targets, and FDA has been under, as everybody knows, an enormous amount of stress. They are still, as I understand it, processing emergency use authorizations for COVID-19 diagnostic tests, currently now moving into the home testing market. The stress on the agency is significant. I think they're doing a remarkable job at getting through the process. We remain quite confident where we are with the application. Appreciate it. Just on reimbursement and private payers. How many private payers should we expect prior to the LCD? Is there any kind of snowball effect from signing the first Blue to maybe some of the other Blues? It seems like sometimes there is, and sometimes there isn't. I'd love to get your thoughts on that. It's a very good question. Tom, do you want to take that one? Sure. We continue to secure private payer coverage agreements. While Medicare coverage is helpful with that, already being on the Clinical Laboratory Fee Schedule for Medicare has given us a wind in our sails. Significant to our coverage efforts is the expanding numbers of health systems partnerships that we are putting into place. When you have a large health system in a region adopting KidneyIntelX, that accelerates the coverage process with the payers in those regions. That probably is as significant for us in expanding coverage as any factor could be at this stage of deployment of KidneyIntelX. Got it. David, I think a lot of people have heard me say this a long time, when we started Renalytix, reimbursement strategy was the number one item. We know how to run an FDA process. We know how to build an IVD. We know how to build marketing and sales. We know how to do all these things. The value generation here comes from obviously, ultimately revenue growth, which is a function of payment and reimbursement. We have had reimbursement as a complex strategy from the very beginning. We do not take any specific reimbursement pathway as a sole pathway. We always have multiple pathways that we're working on. This is critically important because different pathways happen at different times. As we just seen with MCIT, things change. I'd just like to remind everybody that MCIT was one part of the reimbursement strategy. It certainly was not a dominant part. In fact, when we created the entire Medicare focus, MCIT was not even a thing yet. MCIT didn't come in until January. That's why we can make the statement that ultimately we don't think that Medicare coverage is going to be off track with or without MCIT. I think the safety here and the de-risking is in the multiple pathways. We have been pleasantly surprised by the private coverage determination momentum. I think it's a reflection of the fact that in general, we got to do something to solve kidney disease cause and progression.Again, it's a time and a place where there are a whole sequence of factors, government policy. Since the Protecting Access to Medicare Act, there's been a wave of policy around reimbursement, which has opened up innovative pathways. It's just a time and a place where we actually feel very good about reimbursement, which has not always been the case in my diagnostic career. Having private pay come along like this, there are no guarantees about how this private pay momentum continues, but it is certainly very encouraging. Got you. Just my last question in terms of new hospital systems, integration goals, or, and I do apologize, we are tracking different companies that are reporting this morning, so sorry if I missed it. How do you feel you're tracking in terms of your new hospital system adoption goal and what's kind of the puts and takes in terms of hitting it, missing it, going over, going under, et cetera? I'm very confident where we are in terms of hitting goals that we've stated. I think actually our view is really how broad do we want to build it in calendar 2022? We are now, for example, getting into hospital network discussions. These are groups of hospitals that work together. This is aspirational, I want to make that clear, but I believe in calendar 2022 that we will actually be able to start to move into multiple deployment environment through networks. We're certainly having many discussions. Again, what's abundantly clear is everybody's looking for a solution. We'll talk a little bit more about value-based care coming up, but we offer a very interesting prospect to the hospital systems, which is we can bring the solution, we can invest in its implementation within the compliance legal framework, which is not trivial. We could do it at no cost to the hospital system. What we are enabling is population health management on a broad scale to treat large groups of patients with early-stage kidney disease to maintain their kidney health. This could be very profitable for the hospital system. It can enable a substantial standard of care. We see this now with the deployments that we're doing. The real-world evidence is showing that, in fact, we are improving things, which is what we're looking for. I think that the value proposition to the hospital is very compelling, and I think it's unique. It's unique because we are the only one with an advanced prognostic tool, because you need to take a blood draw, and you need to have biomarkers. If you don't do that, if you don't create an IVD strategy, you can't tap into reimbursement. We're the only ones at the moment doing that, and we're doing that in an integrated fashion in the care model with population health. By recruiting population health, it provides us with a considerable amount of capital efficiency. It provides us with the ability now to extend out to broad patients. It provides us with the ability to provide consistent education message out to broad groups of physicians. I'm very pleased with this approach, and I think it's bearing a lot of fruit. Not to mention now that we have set up a real-world evidence machine, and this is one of the core value components of Renalytix, which I also think is unique. This is a multi-center, demographically broad, real-world evidence machine where we can now start to look at a whole sequence of factors, not only that supports long-term reimbursement, supports multiple product categories running through a regulated IVD process, and gives us a lot of insights as we start to build out this precision medicine continuum at the front end of this huge disease class. Now we can start to look at real-world evidence around subtyping, therapeutic response, disease progression, primary care physician behavior change, education, all of the factors that are required in the ecosystem to start to bend the cost and outcome curve. Got it. All right. Well, thank you guys very much. Have a nice day. Thanks, David. Our next question comes from the line of Tycho Peterson from JP Morgan. Your line is open. Hi, this is Julia on for Tycho. Thanks for taking a question. Just want to follow up on the Mount Sinai ramp. I know you expect 6,000 total testing next year with a run rate of 300 tests per week, which equates to 15,000 tests per year versus the 250,000 total patients that you mentioned earlier. Just curious, how did you get to that run rate number, and what can drive that ramp faster or slower, versus your expectations? What key factors are at play? Is it the pace of your sales and service rep hiring? Is it timing of publications or LCD coverage? Just talk through kind of the moving pieces and upside and downside versus that run rate number. I know it's still a little early, but how should we think about the long-term ramp, beyond that 6,000 number you gave? Yeah. Great question. We could probably spend two hours on that. Tom, do you want to set the framework there? I'd be happy to. Within Mount Sinai, volume is actually driven through the care coordination and the care deployment at Mount Sinai. We have an individual who is supporting the effort at Mount Sinai, but the identification of patients, ordering of the tests, follow-up from the tests, that is a care initiative that is going on at Mount Sinai. It's not a question of resource scaling on the Renalytix side. It's a question of the training, the execution, the deployment of that care coordination program at Mount Sinai. That involves practice administrators, the medical directors. That informs training nurse practitioners, pharmacy managers, dietitians who are supporting this integrated care model at Mount Sinai. We are working with them on everything that they are putting in place, as well as helping to support them in the education of those resources that are so critical to patient care. Really, in our health systems deployments, it's the health system itself that sees the value in the risk assessment and the care that comes from that. So it's the health system that drives the piece of that volume growth. So w hat was important in the announcement that we made, what we were sharing with you based on the success Mount Sinai has seen thus far with KidneyIntelX, they were able to start projecting how that growth rate would begin to build as they deploy it system-wide. James, back to you on that. I think there are a couple key points here. I think that the fact we could put down a run rate, or we didn't put down a run rate, Mount Sinai did, of this significance, and we have not yet deployed a sales force. There are a number of ways you can grow business in the diagnostics space. The traditional way is you put a bunch of salespeople out, and you start knocking on doors. That tends to be a very expensive exercise. It drives up a lot of fixed overhead, and it can become very difficult to understand really what the connecting message is to drive utility. In other words, what are people saying to get those sales? How is it done? We arrived on this, and we knew we had a major challenge, which is how do you start to change some of the clinical workflow at the front end of the disease at primary care level? That's a big challenge. It requires a whole sequence of things to make that happen, a symphony surround sound around that primary care experience with these patients. The fact that we've been able to get to this type of a run rate, without a sales force, for me, is a new achievement. I think it bodes very well for how we can now add a sales force, add customer service, add medical science liaison, and continue to build out that surround sound concept at the front end of this disease in a capital-efficient manner. Ultimately, by 2025, we'd like to be out to most of the 210,000 practicing primary care physicians, many of whom are in systems. Partnering with population health provides us with the leverage to be able to do that. It was significant that we could put that type of run rate down, and we can now add resources to be able to support and expand that run rate. Let's see how we go here. It's been a significant step to get to this point. Got it. Thanks for that color. I'm sorry if I missed this, if you mentioned earlier. Did you say how many new systems are you looking to add in 2022? As we think about your broader commercialization effort, how would you say the relative focus is between adding new systems versus ramping the existing partners you have? Well, that's the million-dollar question, right? Because we always want to do this with quality. It's not just about adding systems. I think we've figured out how to add systems. There's always nuance as you move into new systems, but we've figured out the regulatory and compliance framework, which is first and foremost when you're partnering or collaborating with a major system like this. We've got a lot of legal advice to be able to structure these agreements. They are not trivial. I think we've got a very good handle on it. Certainly, we are simplifying the way that we can complete test ordering with an electronic health record data pull. That has been a learning experience. Now we've been reaching a consistency of what we need to do. Adding systems, I do not believe in 2022 will be a rate-limiting factor. Maintaining quality of execution is number one. How many systems would I like to add in 2022? I'd love to be able to add between 10 and 20. Let's see how it goes. I won't compromise the quality of the execution because already between the several systems we have announced, the private payer groups that we're working with who are also implementing, we're out to a considerable addressable market of diabetic kidney disease patients that could drive whatever revenue line we need to drive if we execute properly. Quality is number one, but this is without a doubt a scalable model. I think that's the key. Actually, your group at JPM asked that question a couple of quarterly calls ago, "How scalable is this?" That stuck in my head. I think we're now demonstrating this is scalable. Certainly, I know from an internal basis with the efforts to get the implementations going, it's getting easier and we're getting much smarter, which you only get with experience. I think this is imminently scalable to any integrated disease network health system in the country. I believe it's also scalable internationally. The key for us is to maintain quality. The data coming out now is critical for demonstration of utility impact, cost reduction in patient suffering, et cetera. We want that to be very high-quality data. This is not in trivial numbers. We're talking about thousands and thousands of patients. As we've added now systems in the Southwest, the Northeast, the Southeast, there will be others. This becomes a very comprehensive real-world evidence production that will tell us exactly how the KidneyIntelX integrated care model affects different patient populations. That's the type of evidence that you need to create a long-term standard of care. It's the type of evidence that you need to expand your regulatory pathway, and it's the type of evidence that you need to maintain and sustain long-term reimbursement coverage. Great. Thank you. Thank you. Our next question comes from the line of Anita Dushyanth from Berenberg Capital. Your line is open. Hi, good morning. Thanks for taking my question. I just wanted a little bit to talk about the approval timeline from the FDA. I know you mentioned earlier that they're kind of busy with the emergency use applications related to COVID-19, but as much as this year and the past has been sort of very unusual, in terms of keeping up timelines from the agency, how do you sort of feel about whether the approval is more like coming before end of this year or it's likely to get pushed out to next year? Yeah, fair enough. We're not going to call FDA timing, because as I've always said, that's a fool's game. Especially in this environment, we can't call it. What we're more interested in is how is the process. Is it prescriptive? Do we know exactly what needs to be done? Do we have good communication with the agency? Is the agency looking at KidneyIntelX with its full attention? Ultimately, you always want to make sure that there are no showstoppers, which are you need to run another prospective clinical trial, or you need to provide a data set that you can't provide. At this point, we're very pleased with where we are. Sure, would I have liked to have gotten FDA De Novo marketing authorization by now? Absolutely. I think this is an industry-wide issue. Most importantly, FDA is one component. We do not need FDA to commercialize. We do not need FDA to drive revenue. In fact, we are gaining a huge amount of experience now because we've set up the KidneyIntelX testing as a single-site IVD. We are commercially capable in 50 states. To me, the equation is not FDA, it's reimbursement. Right? The most important thing is we're generating real-world evidence because FDA De Novo marketing authorization timing notwithstanding, it's the use of KidneyIntelX, it's the use of KidneyIntelX in population health. It's the demonstration of can you start to bend the cost and utility and outcomes equation. That's what creates the business. I have high confidence we will have a beautiful FDA pathway, not just for KidneyIntelX, but for subsequent versions of KidneyIntelX. We've designed the program to do that because we think regulation is important and it's supportive. The heart of this business that drives value is demonstrating change and demonstrating utility. We're doing this now. This isn't a three-rat study that we're putting up as a laboratory-developed test. This is a very complex, multi-center, diverse real-world evidence database that we're building here, which is quite rare when you look at the history of diagnostic launches. We designed it that way because we knew that that was ultimately what was going to drive KidneyIntelX as a standard. I just want to make that clear. I'm going to be a little bit ambiguous on FDA because we just cannot call the timing. I think that that would be irresponsible. Yeah, that's understandable. Thanks for explaining the process. That's helpful. I just have one more question about the revenue ramps. Again, I'm sorry if I missed the earlier, if you had addressed it earlier. Getting to that 300 tests per week with Mount Sinai, something that they had come up with. How do we think about the ramp from VA and Wake Forest on a comparative basis? I know the systems are different, but is that something higher than 300 or less than that? How quickly can we get to that by maybe mid-year next year? Yeah, fair enough. I'm sorry, I'm still going to be a little ambiguous. Tom, you should chime in on this. The VA health system is its own animal. That's very important. Doing comparisons with integrated disease networks is difficult. We're not going to try to do that. There are advantages and disadvantages. The sales force that we're hiring to implement at VA is largely military. We have Black Hawk pilots and fighter jet pilots. My reports coming in from Baltimore and the folks that I've met, this is a really impressive, sophisticated group. I think is going to be a significant asset for the national VA system rollout. That's very different than what's going on with population health-driven integrated disease networks like Mount Sinai Health System. What is important is that the VA systems that we're looking at as the early adopters are co-located with the large integrated disease networks. Again, an overused word, but I'll use it here. There's a huge amount of leverage with our population health-driven integrated disease network deployments, like Mount Sinai Health System, and VA hospital systems that are geographically contiguous with those health systems. They're different, but there are many, for example, primary care physicians that practice on both sides of the fence at the VA system and at the hospital system. We do get a lot of benefit from education movement, et cetera, with the integrated disease networks that spills over into our ability now to start to implement KidneyIntelX in the VA hospital system. Tom, did I describe that correctly? Do you want to add to that? I think you did a great job, James. We are just training the first class of account executives this week. We're aware that there are unique features in the VA, both our contract and the chronic kidney disease directive that will be helpful to us as we commercialize. With this being initial launch, putting a sales force into the field, we need that experience, as James indicated, before we start to make very specific projections. That we feel comfortable when we get to the end of this fiscal year, that we'll have a much better idea and be able to be clearer on where we expect that volume growth to go in fiscal 2023. Okay. Thanks, Tom. Again, Anita, I think it's a function of building the fundamentals and putting them in place, and the rest will come. That is the diagnostic story. If you get all the fundamentals in place, you have the data, you've got the reimbursement pathway, you've got the sales and marketing strategy, and you have the need. The need here is significant. The growth and the ramp will come. Great. Thank you. Thank you, Anita, and I think we're out of time there. Operator, very good questions today. Thank you all for participating. There are no further questions at this time. I turn the call back over to James McCullough. Back again for one minute. Thank you all. Please stay safe, and we look forward to talking to you on the next quarterly call. This concludes today's conference call. Thank you everyone for joining. You may now disconnect.