Good afternoon, and welcome to the CytoSorbents Second Quarter 2023 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call for your questions. Please be advised that the call will be recorded at the company's request. At this time, I'd like to turn the call over to our moderator, Taylor Devlin. Please go ahead, Taylor. Thank you and good afternoon. Welcome to CytoSorbents Second Quarter 2023 Financial and Operating Results Conference Call. Joining me today from the company are Dr. Phillip Chan, Chief Executive Officer; Vincent Capponi, President and Chief Operating Officer; Kathleen Bloch, Interim Chief Financial Officer; Dr. Efthymios Deliargyris, Chief Medical Officer; Dr. Christian Steiner, Executive Vice President of Sales and Marketing, and Managing Director of Cytosorbents Europe, GmbH; Christopher Cramer, Senior Vice President of Business Development; Dr. Irina Kulinets, Senior Vice President of Regulatory. Before I turn the call over to Dr. Chan, I'd like to remind listeners that during the call, management's prepared remarks may contain forward-looking statements, which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today. The company claims protection under safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today, therefore, we refer you to a more detailed discussion of these risks and uncertainties in the company's filing with the SEC. Any projections as to the company's future performance represented by management include estimates today as of August 1st, 2023, we assume no obligation to update these projections in the future as market conditions change. During today's call, we will have an overview presentation covering the operating and financial highlights for second quarter of 2023 by Dr. Chan and Ms. Bloch. Following that presentation, we will open the line to your questions during the live Q&A session with the rest of the management team. Now it's my pleasure to turn the call over to Dr. Phillip Chan. Thank you very much, Taylor, and good afternoon. Today, I have the pleasure of being able to update you on our most recent operational progress. We recently announced that the pivotal STAR-T trial completed enrollment ahead of internal projections with strong performance amongst our 30 clinical centers in the United States and Canada. This followed the second independent Data & Safety Monitoring Board evaluation in June on unblinded safety data on 80 patients, where the DSMB recommended completion of the trial without modification. In the second quarter of 2023, we achieved total revenue of $9.4 million, including product sales of $8.1 million versus $7.3 million in product sales a year ago, representing the third consecutive quarter of sequential product sales growth. Product gross margins grew 700 basis points to 74% from 67% a year ago, and we have now exceeded 212,000 cumulative human treatments delivered across 75 countries worldwide. We announced the appointment of Alex D'Amico as new Chief Financial Officer to start next week, August 7, 2023. Alex brings 20 years of broad finance, SEC reporting, M&A, fundraising, and accounting experience to the company, and our outgoing Chief Financial Officer, Kathy Bloch, will stay on as a consultant and help to manage the transition. We also introduced Michael Bator as the new Chairman of the Board at the annual meeting in June. Michael has been a board director since 2015 and currently serves as a founder and partner of Quartz Advisory Group, a capital markets investment bank. Michael was also the former Managing Director of Healthcare Research at Jennison Associates, a very large family of funds with more than $175 billion in assets under management. Last, not least, we announced a theranostic collaboration with Humedics. Humedics is the manufacturer of the EU-approved LiMAx liver function test that is used in liver patients to evaluate the functioning of the liver. We announced a one year joint marketing agreement where their sales force and ours in respective territories will cross-market CytoSorb as a superior, extracorporeal liver support technology, and LiMAx as a unique liver function test for the treatment of liver disease. As we've discussed previously, we are focused on three major objectives for 2023. The first is opening the US and Canadian markets with DrugSorb-ATR. The second is a return to sales growth of CytoSorb, and the third is to reduce our cash burn and to have tight control over expenses. In terms of opening the U.S. and Canadian markets with DrugSorb-ATR, I would like to note again that DrugSorb-ATR and STAR-T, which stands for the Safe and Timely Anti-thrombotic Removal of Ticagrelor trial, remains the core focus of our clinical efforts and the vehicle expected to open the U.S. and Canadian markets. This leverages two FDA Breakthrough Device Designations for DrugSorb-ATR to remove blood-thinning medications in patients undergoing cardiac surgery. One of these Breakthrough Device Designations is for the removal of Brilinta, commonly known as Ticagrelor. Also the second one is for the direct oral anticoagulants, of which Eliquis and Xarelto are the leading ones in that category. In addition, following independent Data & Safety Monitoring Board review of the first 80 patient safety data in the STAR-T trial and recommendation to continue the trial without modifications, we are pleased to announce that STAR-T enrollment has now completed. This helps to validate the decision to forgo the interim analysis at 80 patients that we discussed on the last earnings call, and we expect that the trial to complete imminently following the last 30-day patient follow-up. We believe this sets us up for near-term milestones that are rapidly approaching, which is why I have this picture of a mirror that says, Objects in the mirror are closer than they appear. First, we expect to get the database lock in the next several months, followed by statistical data analysis. This should hopefully lead to top-line data targeted by year-end, and if positive, regulatory submission to U.S. FDA and Health Canada to follow. We also expect to present data at a major cardiovascular conference next year, and pending visibility, we plan to begin executing on our pre-commercialization strategy and begin building a direct sales and marketing infrastructure in 2024. One thing that we really haven't discussed extensively in the past are the dynamics that may actually help expand ticagrelor market share in the United States and Canada, but particularly in the United States. More ticagrelor use means potentially more drug or ATR use should we get approved. As we've discussed in the past, patients with acute coronary syndrome who come into the emergency room with signs and symptoms of having a heart attack often get dual antiplatelet therapy. This consists of aspirin plus one of the P2Y12 platelet inhibitors, such as Brilinta or ticagrelor, Plavix or clopidogrel, or Effient, also known as prasugrel. Brilinta has superior antithrombotic efficacy to Plavix, but Plavix is generic and cheap, and Brilinta today is still a branded drug. This is expected to change as Brilinta will go generic in 2024 to become just generic ticagrelor, with multiple competitors with tentatively approved abbreviated NDAs that have already been approved by the FDA. The price of ticagrelor is expected to fall, potentially enabling market share gains against clopidogrel and the more expensive branded Effient. Recent public, recent publication in the well-respected journal, JAMA Network Open, highlights U.S. prescribing physician preference for ticagrelor versus other antiplatelet agents following acute coronary syndrome and percutaneous coronary intervention. In other words, for example, stent placement. In more than 62,000 patients that were studied between 2010 to 2019. What you can see in the graph in the lower right is that during that period of 2010 to 2019, that ticagrelor has steadily gained in prescribing preference for physicians, following acute coronary syndrome and per, and PCI, to the point where now, or at least in 2019, 60.4% of patients who were intervened upon in the cath lab got ticagrelor or Brilinta, while the rates of Plavix prescription have been going down to only about 30% in 2019, and prasugrel is a distant third at 10% of prescriptions, leading the authors to conclude that tic... Ticagrelor has emerged as the most commonly prescribed P2Y12 platelet inhibitor. The approval of DrugSorb-ATR would make ticagrelor the only one of these anti-platelet drugs to be reversible during Plavix surgery, a potentially powerful marketing advantage to take market share. One can imagine, given that 5%-10% of patients are not eligible for stent placement and wind up in surgery, that being able to reverse the drug used in dual anti-platelet therapy would be an extremely valuable marketing advantage that we could confer to ticagrelor, and we believe that this will come to pass and be true. This sets us up for an initial market in the United States for removal of Brilinta in cardiac surgery patients of approximately $250 million. If you add Canada, this increases the total addressable market to roughly $300 million-$350 million. In additional share against Plavix and Effient, the numbers of patients on Brilinta or ticagrelor in the future could rise to give us an opportunity of about a $500 million total addressable market. As we told you in the past, once STAR-T completed, we are looking to resume the STAR-D trial, which is looking at the removal of the direct oral anti-coagulants, the Factor Xa inhibitors, Eliquis and Xarelto. If we are able to add on that indication, this could double our total addressable market to $1 billion. If we can now open it up for not just cardiac surgery, but to all kinds of surgeries, and also potentially being able to be used in the emergency room, we estimate that that could, again, double the total addressable market here in the United States. A second major goal for the company is a return to sales growth for CytoSorb. Again, this has been the third consecutive quarter of sequential product sales growth, with 10% quarterly product sales growth year-over-year in the second quarter. We're seeing continued gradual recovery of hospital markets post-COVID, with continued strong customer engagement and enthusiastic response to our new data and marketing strategies. Our product gross margins rose 700 basis points to 74%, reflecting volume production from our new Princeton manufacturing facility, a trend consistent with prior guidance of returning to 75%-80% product quarterly base year. The following messages, one that we need to be able to treat the right patient with the right timing and the right dose, and we also need to hit hard and hit early. This incorporates our evolving understanding of how best to treat patients with CytoSorb. In particular, when CytoSorb is used early and aggressively in documented hyperinflamed patients, we have seen some outstanding results. This includes the recently published CTC therapy registry results in the journal Critical Care, detailing the clinical outcomes in 100 critically ill COVID-19 patients with severe inflammation and refractory lung failure using CytoSorb with ECMO to achieve enhanced lung rest. Overall, 90-day survival was high at 74%, and in the post-hoc analysis, patients who were treated before the median treatment time of 87 hours had even higher survival at 82%, compared to 66% survival in patients treated after 87 hours. In addition, those treated in the early group had significantly shorter median duration times on mechanical ventilation. ECMO, ECMO on the, in the blue lower left-hand graph, mechanical ventilation in red, and ICU stay in green. Overall, our results compare favorably to the approximately 50% survival reported by ELSO, or the Extracorporeal Life Support Organization, and their COVID-19 registry survival data, where they looked at ECMO use alone in this population. Our data support the strategy of early combined use of ECMO to treat severe ARDS, or acute respiratory distress syndrome, and refractory lung failure, and is a prime example of our hit early, hit hard treatment philosophy. To this end, our current company-sponsored trials, such as the PROCYSS refractory septic shock randomized controlled trial and the International COSMOS Critical Illness Registry, incorporate our evolving understanding of how to achieve better and more consistent results with CytoSorb. We've also been working to drive earlier usage of CytoSorb in the appropriate patients through a number of different ways, including, for example, pursuing a theranostics strategy. In other words, using a diagnostic test to guide patient selection and timing of CytoSorb therapy, as we're doing in our collaboration with Humedics in the field of liver disease. Our use also local perfusion machine, as we're doing with the PureADJUST platform from Nikkiso, that can run CytoSorb quickly and efficiently without needing to wait for patients to develop kidney failure and go on dialysis. With that, I'd like to turn it over to Kathy to now cover financial highlights for the quarter. Kathy? Thank you, Phil, and greetings to everyone on today's call. Let's start with our first slide on second quarter revenues. For the quarter ended June 30, 2023, total revenue, which includes product sales and grant revenue, was $9.4 million, compared to total revenue of $8.5 million in the second quarter of 2022, which is an increase of approximately 11%. Product sales for the second quarter, 2023, were $8.1 million, compared to approximately $7.3 million for the second quarter of the prior year. Our second quarter, 2023, product growth margins were 74%, compared to 67% for the second quarter of 2022 and 68% in the first quarter of 2023. This predicted improvement in gross margins is expected to continue throughout the year as we fully complete all the start-up activities associated with our new manufacturing plant and continue to ramp up production. Our second quarter grant revenue was $1.3 million, compared to $1.2 million in the same quarter of the prior year. Next slide, please. For the six months ended June 30, 2023, total revenue was $18.9 million, an approximately 10% increase over the $17.2 million in total revenue for the same period of 2022. First half 2023 product sales were $16 million, compared with $15.3 million in the same period of 2022. Grant revenue was $2.9 million in the first half of 2023, compared to $1.9 million in the prior year. Next slide, please. This next chart depicts our trailing twelve-month product sales, and it's broken down into COVID-19 related and core non-COVID-19 related product sales. Our core product sales of $30.1 million in the trailing twelve-month period ended June 30th, 2023, they're just slightly behind core product sales of $30.7 million in the trailing twelve-month period ended June 30th, 2022. This was due to the difficult market conditions, including a shortage of healthcare workers, fewer hospital beds, less surgical procedures, as well as other factors that we have discussed in prior earnings calls. As Phil mentioned, we are continuing to see improvements in the marketplace, including our sales team's ability to better access healthcare workers in the hospital and a return to face-to-face discussions with physicians in the market. Next slide, please. This slide shows our quarterly product sales broken down again by COVID-19 related and non-COVID-19 related core product sales. As you can see, over the past five quarters, there have been no COVID-19 related sales. The most recent three quarters have demonstrated sequential consecutive quarter-over-quarter growth in product sales, with $8.1 million in quarterly sales. Q2 2023 represents the highest quarter of core non-COVID-19 related sales since the COVID-19 pandemic was contained. Next slide, please. I'd like to wrap up my remarks today with some comments about our cash position. As of June 30th, 2023, we had approximately $14.8 million in cash and cash equivalents, which includes $1.7 million of restricted cash. This includes $5 million of loan proceeds received from our debt facility in December 2022. Now, one of our key objectives for 2023 has been to reduce our cash burn and maintain tight control over expenditures, and I'd like to elaborate on our progress on this. Over the past year, we took strong actions to reduce our quarterly cash burn, such that our quarterly cash burn over the first half of 2023 averaged approximately $4.5 million, which is down significantly from the average quarterly cash burn in the first half of 2022, which was approximately $11 million. We continue to maintain tight control over cash, guided by a strict 2023 operating budget, prioritizing spend in key programs and pipeline products. Our spending is fully aligned with our strategic priorities, in particular, the completion of our STAR-T clinical trial designed to obtain U.S. FDA marketing approval. That will conclude my remarks for today, and at this time, I would like to turn the call back to Phil for concluding comments. Phil? As a reminder, if you do have a question, star one on your telephone. Make sure your mute button- I apologize. I apologize. Phil? Thank you. Yes, thank you very much, Kathy. I apologize for that. Today, CytoSorb drives our growth. CytoSorb forms the foundation of our company with an EU-approved product that is sold around the world, that has generated approximately $200 million in sales since launch in more than 200,000 human treatments around the world. It is a high-margin, razor blade business model with industry top-tier, 80%+ blended product gross margins, and it has had strong validation by customers, partners, and government agencies. With current sales that supports near breakeven, less clinical trial costs, which we believe helps to de-risk the company and the investment opportunity. We believe CytoSorb represents the fuel for strong future growth, anticipated growth, targeting the $20 billion-$30 billion worldwide total addressable market of major unmet medical needs in critical care, cardiac surgery, as well as liver and kidney disease. We believe this gives CytoSorb the potential upside of a biotechnology company with a lower risk profile of a high-margin medical device company with sales. Soon, we believe that the story could change, with CytoSorb and DrugSorb-ATR representing dual growth engines for the company. We are racing to the finish of STAR-T, where we are rapidly nearing the completion of the study, expected imminently, with top line data expected later this year. Should STAR-T be successful and DrugSorb-ATR achieves U.S. FDA and Health Canada regulatory approval, we intend to commercialize DrugSorb-ATR in both the U.S. and Canada, a potentially major second engine of growth working in tandem with CytoSorb to drive sales. DrugSorb may open an expected initial U.S. and Canadian total addressable market of $300 million-$350 million for Brilinta alone, which could expand should Brilinta go generic as ticagrelor, where we expect significant penetration given the major unmet medical need indicated by our FDA Breakthrough Device Designation. If successful, this could transform CytoSorbents into a dual U.S. and international growth company that current and prospective institutional and retail shareholders are excited about and have been waiting for, and that can create potentially significant value. With that, that the formal remarks, operator, please open the Q&A session. If you have questions, please press star one one [inaudible] telephone. Please make sure your mute button is turned off to allow your signal to reach our equipment. One moment. Our first question. Our first question will come from Joshua Jennings of TD Cowen. Your line is open. Hi, good afternoon. Thanks for taking the questions, congratulations on completing the enrollment for, for STAR-T. Kathy, congratulations on your retirement. Was hoping to just get a refresher, and I apologize for this basic question, but just, Phil, if, if you could help us remind us about the differences just in the devices, DrugSorb-ATR versus CytoSorb. The reason I'm asking the question is just the, you know, the study, I think, CytoSorb absorption during emergency cardiac, cardiac operations in patients in high risk of bleeding. I believe that, that Cytosorbents, sorry, EU approval or CE mark approval for the indication to remove kind of thrombotics prior to cardiothoracic surgery, and just with that data that's out there and trying to kind of use that as a signal for the prospects of success for, for STAR-T. Just wanna be reminded of the, the differences of those 2 devices. Yeah. Thanks very much, Josh. The DrugSorb uses an equivalent polymer technology to CytoSorb, but DrugSorb-ATR is more of a drug removal system with bloodlines and other things that allow it to connect to the heart-lung machine. From a technical perspective, what CytoSorb can do, DrugSorb can do. If that is helpful. Absolutely. Just thinking about the, the interim analyses and, and getting through those, any, any changes in, in the study protocol, I mean, I think that's a clear positive signal on the safety side. Is there any, any, I guess, clinical signals you would put forward, either from real-world experience with CytoSorb for this indication in Europe or, or clinical data, including that study that I, that I just referenced, in terms on the efficacy side for the, for the STAR-T data, the signals that investors should be really considering as they're trying to analyze the, the potential success of the, of the STAR-T study? I can turn that over to Makis. Makis, would you like to handle that? I can call it. Thanks. Thanks, Phil, thanks for the question. As Phil mentioned previously, we have announced on our last earnings call that we're gonna forgo the interim analysis based on the speed of enrollment. The fact that we completed a study so soon would not have allowed significant amount of time, sufficient amount of time, for the interim analysis to be performed. However, by foregoing that, we did not have, not us, nor the DSMB, any further insight into the efficacy side. Therefore, now the data remains fully blinded as they're being entered by the sites. They will undergo the process of being validated and cleaned, leading to database lock, as you heard earlier, and obviously after that, we will pursue the final analysis and the top-line results of the study. Until then, we only have the DSMB review on the safety information of the trial, which we already reviewed today. We had two of those reviews that were both unremarkable, without any findings and without any recommendations for changes in the trial. That's a long way to telling you that as of now, the data remain blinded, but we do have the positive feedback for the safety of the study. No, thanks. Sorry for classifying the safety reviews as interim analyses. Then maybe lastly, I mean, getting a little bit ahead of myself, thinking about the plans for STAR-D and potentially kicking that study off for Xarelto and Eliquis removal. I mean, will the catalyst be, the, I guess, the thing about the decision tree, will we need to see success in STAR-T prior to thinking about initiating the STAR-D trial? Thanks a lot. Okay. Let, let me try to respond to that 1 as well. The STAR-D trial is targeting an addressable population that's even larger than the ticagrelor population. And we've seen that not just on our own literature review and the numbers that are out there, but primarily from the direct feedback from the site. We believe that the opportunity for these two blockbusters, Xarelto and Eliquis, is even greater than for Brilinta. In that regard, it's definitely an opportunity worth pursuing. Now, in relations to STAR-D, you know, we are now in a, in a very good position that we have the full apparatus to execute and study in place, you know, from our clinical team, our internal clinical team, all our vendors and our partners that we're working to execute the study, most importantly, the site network from STAR-T. These are highly performing sites that did excellent in STAR-T, so we believe that STAR-D, once resumed, will actually be efficiently executed and be able to enroll fast. The results of STAR-T will be very helpful, of course, especially relating to the safety of the device, since the application is very similar. As you know, the STAR-D trial is targeting the same use of the device, intraoperatively, for patients undergoing cardiac surgery. There's a lot of similarities between the two trials that we've discussed previously, but more importantly, now, we have the playbook, the right partners and the right sites to execute briskly the STAR-D trial. Excellent. Thank you very much. One moment for the next question. Our next question will come from Yuan Zhi of B. Riley. Your line is open. Thank you for taking my questions. Maybe I can start with the high-level question first, and then I have a follow-up. First, during your market research field, can you remind us the trend of using antidotes for anticoagulants such as, you know, Andexxa, Praxbind in the U.S. and EU? Thank you. Sure. Actually, Mike, this is an ideal question for you. Sure. Yeah, thank you for the question. The, the use of these reversal agents, that are approved in the marketplace now, specifically Andexanet, that is indicated for the reversal of the drugs we referenced before, the direct oral anticoagulants like Xarelto and Eliquis, is approved in the, in the presence of severe life-threatening bleeding. Those drugs are used when somebody has suffered a life-threatening bleed, the usual measures are not successful in stopping the bleeding, and then they applied. The population that we are addressing is actually a much larger populations. These are patients at risk for bleeding. If you can imagine, these are patients who are coming in with a heart attack, they have their cardiac angiogram, they see that they need surgery, but because they receive these drugs, they're sitting, waiting for the drug to wash out, at risk for having a second heart attack, for example, but they're not bleeding. In that population, it's as of now, there are no available solutions to help them have a timely operation, a safe and timely operation. These patients now are waiting in the hospitals for a long time. The drugs that we're referencing would only be indicated if they were bleeding. Some case reports where these drugs were used in the setting of patients heading into surgery, especially relating to Xarelto and Eliquis, the reversal agent, Andexanet, can interfere with the necessary anticoagulation that are required when people are put on a heart-lung machine. It poses also a complicating factor that may put the operation at risk, and therefore are not widely used in this setting, and they're certainly not approved for that application. The reversal agent for the bigger trend, which has a very, very small piece of the pie or the market share for these anticoagulants, does carry an indication that can be used because it has been studied also in people heading to cardiac surgery. Having said that, there are so few patients on this drug, again, at least in our sites, we have not experienced any of the clinical teams using these drugs in the setting. They're all opting to just wait and let the drugs wash out, which is exactly unmet need that we believe can target by allowing the surgery to proceed, while at the same time removing the offending agent and reducing the bleeding risk. Yeah, got it. Thank you so much for the clarification there. As a follow-up here I have is, I'm curious about the U.S. market. When you have a third party or have third-party distributor, can you clarify how will you split the responsibility? Will you take on the responsibility of marketing and education, and then they do the face-to-face interaction with surgeon? Thank you. Vince, do you want to take that? Sure, Phil, I'll take that. Thanks. In the U.S., we plan to use a blended approach of direct sales and distributors. We, we have some strong distributors that we developed in during the COVID period when we were selling Cytosorbents or CytoSorb under the EUA. We will use those, we will use those distributors in those select regions, since they have very, very close relationships with the cardiac surgeons. The rest of the U.S., we intend to focus on direct sales, specifically with probably a sales force of about 19 people. Got it. Thank you for the clarification. One moment for our next question. Our next question will come from Christopher Campbell of Jeff, J-E-F. Your line is open. Hey, thanks for taking the question. This is Chris on for Mike. I was wondering if you could elaborate a little more on the trends you're seeing in the core German market and how that's trended so far through the third quarter? Yeah, we, thanks very much, Chris. We, Christian, would you like to comment on that? There's only so much we can say about third quarter results so far. Christian, feel free to try. Yeah, thank thank you, Christopher, for the question. As Phil said, we cannot obviously comment on the third quarter. As you have seen already in the first and second quarter, there's a significant improvement compared to last year. This is mainly because we have a much better access to the, to the hospital, but also will be, will be, I think, carried in the next half year by a number of publications we have received over the first half. All this together has to balance. There's still critical or complicated situation in the hospitals. There are still ICU capacities blocked because there's not, there's a shortage of staff, and there's still less cardiovascular interventions compared to before the pandemic. The charts which have been shown by Kathy show that we are already much higher with the core business compared to the business before the pandemic, but also considering the core business during the pandemic. I think it's a stable improvement and, yeah, the second half will, I think, show further stabilization. One moment for our next question. Our next question will come from Jim Moy of Alliance Global Partners. Hello, this is Laura Suriel calling in for Jim Moy. Thank you for taking my questions. With enrollment now complete for the STAR-T trial and, you know, and top line data set to be announced by the end of the year, what type of data are you specifically anticipating in order, you know, to submit your regulatory submissions to both, the FDA and Health Canada? Thank you, Laura. Makis and Irina, would you like to take that? Yeah, I can take that. At this point, we don't know the results of a clinical study, STAR-T, but it is a randomized control study, and data is blinded until the final analysis will be completed. This data would be sufficient to support regulatory filing in United States and in Canada. This data also might be used in some other territories, but at this point, the United States and Canada regulatory submissions would be relying on this data. Got it. Maybe, Makis, you can talk about the, Makis, maybe you could talk about the primary endpoint and the, and some of the secondary endpoints as well. Sure. Hey, thanks for the question. I think, like, with any regulatory review, the agency will have to perform a benefit risk analysis for this proposed new intervention. The STAR-T is designed to provide all that information. First of all, the safety, and we already talked about this on this call. We had some interim reviews, and we'll have a final review as well. Safety will certainly be supported by the data for STAR-T for the necessary review by the agency. For efficacy, we are looking at two specific things in STAR-T. First of all, we want to establish the mechanism of action. We're looking for the drug removal of the drug to actually be validated in vivo. We're going to be measuring the levels of the drug before surgery and after surgery. That's actually the key secondary endpoint of the trial, to show that the drug is effectively removed from circulation compared to the control arm, where the device is not used. The second piece of the efficacy, which is actually the primary endpoint of the trial, is a composite endpoint, looking at various events that cause the bleeding, perioperative bleeding. We're measuring things like transfusions. We're measuring things like the amount of blood that comes out of the chest after the operation, and that will give us a picture of the overall bleeding rates between the intervention arm and the control arm. I think, the overall information from the STAR-T trial will be sufficient to, for the agency to review, to, to come up with the benefit risk analysis as necessary, during this process. Understood. May you also go over the joint marketing agreement that you entered with Humedics and, you know, the LiMAx diagnostic tool? Then what might you expect in terms of, you know, increased customer awareness and use for both of the products involved? Yeah, why don't, Chris, why don't you take that one? Yeah. Thank you, Phil. Yeah, thank you for the question. As Phil had mentioned, Humedics has a, a really innovative, non-invasive liver function test, and basically what it helps physicians do is to assess how much liver function a patient may have. They got their start with pre-surgical planning, but I think ideally what we hope to do is to leverage the test, and as Phil had mentioned, use this as a diagnostic test to help stratify and identify the right patients who would ultimately be best suited for our treatment. That's I, I would categorize that as maybe a near, a mid to, to later objective of the partnership. Today, you know, we're leveraging the commercial organizations to get in front of key customers for our product, customers like hepatologists, hepatic surgeons, and others. I think the, the, the real near-term benefit of this is that the partnership could be valuable because it'll help introduce us to customers who may not yet be familiar with CytoSorb, but could be, you know, good buyers of the product. I think this is just another way for us to accelerate our commercial efforts in the field of liver therapy. Got it. Thank you for taking the question. One moment for our next question. Our next question will come from Sean Lee of H.C. Wainwright. Your line's open. Good afternoon, guys, and thanks for taking my questions. My first one is on the U.S. market, potential U.S. market for DrugSorb-ATR. You mentioned a, currently a $250 million opportunity. I was wondering, how many of these, cardiac surgeries per year that are kind of using ticagrelor, in patients using ticagrelor, that you, you believe, could be benefit from DrugSorb-ATR? Thanks, Sean. Makis, would you like to take that one? Sure. What Phil showed you today is that these acute coronary syndrome patients, which is about 1 million or more admissions as such in the U.S. every year, require the use of antiplatelet drugs. Aspirin is one, but they also require one of these P2Y12 inhibitors. The position of ticagrelor within that marketplace is constantly improving based on the very good efficacy data, especially over Plavix. The numbers of patients on ticagrelor have been growing over the past few years, and we believe that trend will continue to go up with the generic availability of the drug and obviously, hopefully, potentially, the availability of DrugSorb. From all those patients, about 100,000 of them out of this 1 million, about 10%, when they're presented with ACS, will require surgery. That surgery takes place in the hospital. These are not patients that are stable enough to be sent home, to be allowed to stop the drugs and then come back for surgery without risk of bleeding. They are staying in the hospital, being monitored, and currently, these hospitals are waiting, are waiting multiple days until they can be operated. The amount of patients from those 100,000 that are on ticagrelor, we estimate, like I said before, we have estimated in the past, that the market share for ticagrelor is approximately half of that market, and may potentially grow even more in the future. That those are the assumptions behind the number that Phil has quoted previously about the total mark, total addressable market with this device. To summarize, about 10% of patients presenting with an acute coronary syndrome need to go to surgery. These patients are on P2Y12 inhibitors and aspirin, dual antiplatelet therapy, and the percentage of ticagrelor patients within that population is high and will continue to grow, we believe, with the generic availability of the drug. Great. Thank you. Thank you for that. My second question is on your commercial planning in the U.S. and Canada. You mentioned that you expect to start building out a direct sales team starting next year. I was wondering, would you be pursuing entirely through direct sales or a hybrid model where, you know, you have some direct sales territory and some through distributors? And in terms of personnel, what's the size of this sales team that you're looking at? Yeah, Vince, would you like to cover that? Sure. Thanks, Sean, for the question. So we do plan to do a hybrid model, Sean. You know, we have some good distributors from the COVID EUA program that are actually are specialists in cardiopulmonary bypass equipment. So we will combine that with a direct sales force of about 19 people. I think with the distributors, they have the established relationships, so we would, you know, obviously, leverage their Rolodex to get into those accounts quickly to establish the use of DrugSorb-ATR. Then in the rest of country, we will go in with a direct sales force, and that will be roughly about 19 people. Does that answer your question? I think, I think the other thing to note is that, at the price points that we're talking about in the United States, we've talked about a number of about $5,000 per cartridge, compared to $1,000 for CytoSorb in the European Union. Our product gross margins for DrugSorb-ATR are expected to be well above 90%. With a highly profitable, high-margin, disposable device such as DrugSorb-ATR, the payback on sales of that product is very quick. I think I was telling someone the other day that we have a lot of experience in terms of commercialization experience based upon our, what we've been doing in Europe. We, again, have been in the market for 11 years with CytoSorb and have a full-fledged, fully operational sales and marketing commercialization team that has a gamut of sales and marketing folks, but also product support, clinical support, clinical and medical affairs, and application specialists, customer service, et cetera, et cetera. We look to replicate that here in the United States and know how to do this cost effectively, and so are looking forward to the opportunity to do that here in the U.S. Great. That's very helpful, and thanks again for taking my questions. Again, if you do have- Absolutely. Thanks. Again, if you do have a question, please press star one one on your touch tone telephone. Again, please press star one one on your telephone. Our next question will come from Tom Kerr of Zacks SCR. Your line is open. Hi, guys. I think most of my questions have been asked. Just a couple quick ones and some financial ones. You guys don't talk about those programs under development much anymore. Any comment on that? You know, the HemoDefend and the contrast and that sort of stuff. Are you still working on those efforts? Absolutely. The HemoDefend-BGA program is the beneficiary of more than $15 million in government grant funding, particularly from the Department of Defense. It is a priority, actually for our R&D program, outside of the work that we're doing on CytoSorb and other, other key programs. It is well funded. If you've seen a lot of the press releases we put out on these technologies, we have funding to really bring it to clinical studies and potentially even commercialization. We're active on that. I think we're making some outstanding progress. We are looking to address multiple different markets, including military markets, including civilian transfusion markets, as well as plasma processing markets with our technology, because we believe that universal plasma has a place in each of those verticals. We really look forward to the day when a bag of freeze-dried universal plasma is on every, you know, or multiple bags of freeze-dried plasma is in every ambulance, for example, in the world, given that plasma is a life-saving product with lots of beneficial components in it, such as coagulation factors and other things that are very useful for trauma patients and are much better at resuscitating patients than what they're using today, which is simple saline. You can imagine how large this opportunity could be worldwide, and it's one of the reasons why we're, we're very excited about that program. We don't talk about it much, but be very clear that we are making some nice progress. Okay, great. A couple quick financial questions, though. Does the burn rate expected to remain around $4.5 million? You guys stated in the press release you're funded through 2023, but you have substantial more liquidity than that. Just trying to get that out there and figure that out. Kathy, did you want to address that? Yeah, I'll take that. Thanks, Phil, and thank you for the question. So our, our cash burn moving forward is estimated to be around $4 million a quarter. That's just what we're expecting as, as, as we move out of 2023 and into 2024. Of course, when we begin to have sales in the U.S. of DrugSorb-ATR, Phil already mentioned that it's a very quick payback, and it is. We're targeting average selling prices of around $5,000 versus the $1,000 that we sell CytoSorb for currently. What are now up to 80% gross margins will be very high, 90% gross margins on those products, so, so they'll be very profitable. We do have an ATM in place. We do have the ability, to borrow additional debt, if need be, to extend the cash runway. Okay, I think I understand, it seems like with that amount of liquidity and a $4 million burn rate, you'd be funded beyond 2023 instead of through 2023. Maybe I'm reading into that too much. No, you're reading it right. It will be beyond 2023. Okay. Yeah. All right. That's all I have, that's all I have for today. Thanks. Thanks, Tom. Thank you. Well, if there are no... Okay, operator, sorry? I'm sorry, there are no further questions. I'd like to turn the call back to you, Phil, for closing remarks. Thank you, Tanya. Well, thank you everyone for joining the call today, and a special thanks to the analysts who asked some excellent questions. If you do have any other questions, please feel free to reach out to Kathleen Bloch this week at kbloch@cytosorbents.com, or me at pchan@cytosorbents.com, and we'll reply to your questions where possible. We look forward to our next quarterly call. Thank you everyone, very much. Have a great evening. Thank you. That concludes our conference for today. I'd like to thank everyone for their participation.