All right, good morning, everyone. My name is Mike Sarcone. I'm an analyst on the U.S. Medical Supplies and Devices team, and this is day two of the Jefferies 2025 New York Healthcare Conference. This is a session with CytoSorbents. From the company, we've got CEO Phil Chan and CFO Pete Mariani. Gentlemen, thank you for joining us. Phil is actually going to kick it off with some prepared commentary, then we'll get into Q&A. Great. Thank you, Michael, and thank you very much for the invitation to present today. As a publicly traded company, please let me remind you of our safe harbor statement for forward-looking statements. CytoSorbents, at a glance, has a platform blood purification technology for removing toxins and harmful substances from blood. Our products are high-margin razor blade disposables that are plug-and-play into existing hospital blood pumps. Two main products leveraging the underlying polymer technology are our flagship product, CytoSorb, which is for the treatment of life-threatening conditions in the intensive care unit and cardiac surgery, with record core non-COVID product sales of $35.6 million in 2024 that grew 15% year over year. This is an EU approved product with more than 270,000 human treatments utilized cumulatively to date in more than 70 countries around the world. Our second product is an investigational product called DrugSorb -ATR, which is designed to reduce the severity of perioperative bleeding during CABG surgery due to blood thinners. It has two FDA breakthrough device designations, and we submitted late last year for FDA as well as Health Canada marketing approval and expect final regulatory decisions this year. If approved or cleared, we expect to rapidly commercialize this in these countries, targeting a significant unmet medical need in large U.S. and Canadian markets. Our technology is based on a highly hemocompatible, highly porous polymer bead technology platform that acts like tiny sponges to remove harmful substances from the blood by pore capture, surface adsorption, and concentration. We have excellent removal of a broad range of substances from whole blood and plasma. We have solid-state porous polymer chemistry that does not use ligands, biologics of any kind, antibodies, or cells. This is a highly patented technology with 22 issued U.S. patents and multiple patents issued and pending worldwide. We have been the beneficiary of approximately $50 million in grants and non-dilutive funding from NIH, DARPA, and the DOD. We are expanding the dimension of blood purification because CytoSorb removes a broad range of harmful substances that dialysis does not. On one hand, dialysis works like the kidney, removing highly water-soluble molecules, metabolic waste products, and electrolytes, while CytoSorb works more like your liver, removing macromolecules like cytokines, bacterial toxins, inflammatory mediators, and fat-soluble drugs. Notable for our technology is that dialysis, the membrane, only has about a surface area of three-quarters of a ping-pong table, while in a single one of our cartridges, we have seven football fields' worth of surface area in our cartridge to bind substances, which is one of the keys to our capacity. Now, turning to CytoSorb, our flagship product, CytoSorb targets massive inflammation, which is the heart of critical illness. Acute inflammation is the body's way of dealing with injury and infection. However, in severe inflammation driven by cytokine storm, it can cause a chain reaction of problems that can result in organ failure and death. These include causing shock, capillary leak, immune dysfunction, direct tissue damage, hypercoagulability, cell-mediated injury, microvascular dysfunction, just to name a few. It's really a system crash. Severe inflammation is the common threat amongst most critical illnesses and impacts up to 60% of patients in the intensive care unit and is directly correlated with the severity of illness and the incidence of morbidity and mortality in these patients. CytoSorb has the ability to control this deadly inflammation and has demonstrated reversal or prevention of many of these complications. CytoSorb is taking an integrated approach to critical care. By choosing the right patient at the right time with the right dose, we have the highest chance for a good clinical outcome that is designed to help break the cycle of deadly inflammation, reverse instability, and restore and preserve organ function. Just like antibiotics, the message here is treat early, treat aggressively, and complete the full course of treatment to have the best possible outcome. This year, we had some seminal research that was published on our technology. One came from Professor Berlot from Italy, where they demonstrated that early and intensive treatment with more blood treated works the best. What they did was that they analyzed at their center patients that were either started early or late with CytoSorb or with low or high intensity. What they were able to demonstrate is that in all comers, there was a significant reduction in mortality compared to expected mortality based on predictive scores of mortality in critical care. Importantly, high-intensity treatment led to statistically significant, even better improvement in mortality. Early starters with high intensity led to the overall best outcome. Importantly, what they demonstrated is that the amount of blood that you purify with our cartridge is actually important. In a single day, you can treat your entire blood volume more than 70 times. The more blood volumes you treat, the better you are able to control inflammation. This is exactly what their data demonstrated. A second study that was published this year was the first meta-analysis in septic shock. Now, septic shock is a dreaded complication of sepsis, resulting in a potentially lethal drop in blood pressure with high expected mortality. CytoSorb has demonstrated repeatedly the ability to reverse shock and reduce mortality. In this meta-analysis done at the famed hospital center of Charité in Berlin, they demonstrated that amongst patients evaluated in one RCT and eight observational studies between 2019 to 2024, CytoSorb was associated with a statistically significant reversal of shock with significant hemodynamic improvement and reductions in vasopressor need in CytoSorb patients. A significant reduction in in-hospital mortality with an odds ratio of 0.64, anything less than one, demonstrates a benefit that was statistically significant with a number of patients of 462 and a reduction in 28-day to 30-day all-cause mortality that cut it by half with an odds ratio of 0.49, highly statistically significant in approximately 250 patients. That is the CytoSorb story. We believe that there's tremendous potential and growth. We're already generating $35.6 million in sales from that product alone with a potential to grow double digits in the future. Now let me turn to a second product called DrugSorb-ATR that, again, is an investigational product in the U.S. This product is trying to deal with the prevalent problem of people on blood thinners during surgery, particularly open-heart surgery. Millions of people are on blood thinners worldwide to reduce their risk of heart attack and stroke. You probably know people in your family, colleagues, friends, et cetera, who are on these blood thinners like Eliquis, Xarelto, or Brilinta. Cardiac surgeons are frequently faced with patients on these blood thinners needing urgent surgery. If they go to surgery, they will bleed and often bleed potentially fatally. Guidelines recommend that such patients wait three to five days to wash out the drug to avoid bleeding complications. Frequently, the surgery cannot wait, and patients are operated on at very high risk of bleeding. Delaying surgery is also not optimal because during that interim period of while you're waiting for surgery, bad things can happen, like sudden cardiac arrest. It is also not very efficient for hospitals, given that when they're waiting in the ICU, for example, every day is $6,000 just to wash out the drug. There is no approved reversal agent for these specific drugs in the U.S. or Canada for cardiac surgery. In fact, CytoSorb is the only approved therapy that has this indication in the EU and the only option for cardiac surgery rest of the world. That brings us to DrugSorb-ATR, which uses an equivalent polymer technology to CytoSorb and installs easily into a heart-lung machine. As whole blood is pumped through the cartridge, it's designed to remove the free drug in the bloodstream to reverse the anti-thrombotic effect. FDA has granted two breakthrough device designations for DrugSorb-ATR, highlighting the major unmet medical need and lack of effective therapies and provides for priority review of marketing submissions. We received one for Brilinta removal in 2020 and one for the DOACs, the Direct Oral Anticoagulants, Eliquis, and Xarelto in 2021. Brilinta is our initial focus for the U.S. and Canadian market. Now, let me go over the use case of Brilinta. It is really meant for heart attack patients who wind up needing CABG surgery. If someone is having a heart attack, they go to the emergency room, and by standard of care, they typically get what's called dual antiplatelet therapy, aspirin and a super aspirin like Brilinta. All these patients will go to the cath lab, and 90% of them will get a stent. Five to 10% of patients will not be eligible for a stent and require urgent cardiac surgery. If they go to cardiac surgery, they will bleed. The only accepted solution for this is to wait, as I mentioned before, three to five days. If they're highly unstable, they're waiting in the intensive care unit or in the step-down ICU unit or on the hospital wards, but three to five days before they can actually get to surgery. What we do with DrugSorb is that we bypass all that. DrugSorb is able to get them, eliminate all of this waiting, and get them the critical surgery that they need without delay while reducing or preventing bleeding complications. Now, we evaluated this in the pivotal STAR-T randomized controlled trial, a 140 patient randomized controlled trial in the U.S. and Canada evaluating the safety and efficacy of DrugSorb-ATR to reduce the severity of perioperative bleeding in cardiac surgery patients when used within two days of having the last dose of Brilinta or Ticagrelor in the emergency room. The principal investigators of the study concluded that, one, that the primary safety endpoint was met. The primary efficacy endpoint was not met in the all-comer surgery population. However, in the main target population of CABG, the severe bleeding efficacy endpoint was met. This accounted for more than 90% of patients in the study. In isolated CABG patients, the intraoperative use of DrugSorb-ATR was also associated with a reduced bleeding severity by a major definition of perioperative bleeding in cardiac surgery called the UDPB, Universal Definition of Perioperative Bleeding, or by chest tube drainage. The number needed to treat was only six patients to treat prophylactically to prevent one serious bleed. That actually has tremendous value for hospitals, for patients, and for doctors. Overall, it had a very favorable benefit-to-risk profile. This was complemented in our submissions with real-world evidence from our STAR registry, Safe and Timely Anti-Thrombotic Removal Registry in Europe. This was in six countries, more than 600 subjects enrolled in different cardiac surgeries. The first analysis of patients on Brilinta or Ticagrelor of 102 patients is now published. Just recently, last month, our collaborators presented an updated cohort of 150 CABG patients at the Europe PCR Conference in Paris. We also had the first report of DOAC removal, so Eliquis and Xarelto removal in 62 CABG patients that has been now published. The results are consistently showing significant reductions in this bleeding risk, excellent safety with zero device-related adverse events reported to date, and the device is being used increasingly in the routine care of patients on blood thinners undergoing cardiac surgery at cardiac surgery centers around the world. Based on our experience, we believe our technology represents a compelling value to patients, surgeons, and hospitals in this application. Whoops. So importantly, this is just an example of the data that has been published on this. This was from a comparison of the STAR registry in blue compared to a large existing recently published cohort of patients who did not have our therapy but were on the blood thinner Brilinta. What you could see here is that there has been tremendous benefit in terms of reducing CABG related bleeding, the need for more than five packed red cell units within 24 hours after the surgery, and a revision of bleeding, having to go back to the emergency room to try to stop bleeding that is happening. This was highly statistically significant. Control number of patients were 644 patients, and those in the device group with CytoSorb were 150 patients. This brings us to our FDA and Health Canada regulatory update. Our de novo submission and medical device license application to Health Canada included STAR-T randomized controlled trial data as well as STAR registry real-world evidence. We had an interactive review with FDA that resolved many issues. However, a denial letter was issued on April 25, 2025. A subsequent meeting with FDA provided clarity on the remaining issues. We continue to believe that our submission package is strong and that the remaining issues can be resolved this year. We plan to file a formal appeal this month as the most expedited path forward. What this gives us is a prescribed process that includes a formal hearing with the company, our regulatory counsel, FDA review team, as well as senior FDA officials and testimony from external clinical experts such as cardiac surgeons. The appeal decision is estimated at 60 days after filing, so we expect to have a final decision sometime in August of this year with three potential outcomes. One is that the decision could be upheld. The second is that the decision would be reversed and marketing authorization granted for DrugSorb-ATR. The third one is that the initial decision would be reversed and that we would gain market authorization, but with certain post-market requirements. Meanwhile, our Health Canada submission is in advanced review. Although Health Canada has indicated that they're experiencing some delays in the review, they have assured us of their commitment to issue a decision as soon as possible. We continue to expect final regulatory decisions in the United States and Canada this year. This addresses a major total addressable market of about $300 million to start in the United States and Canada. As we gain more indications for more blood thinners and more types of surgery, not just cardiac surgery, this could grow to more than a $1 billion in total addressable market. Now, turning to our financial performance, this is our annual revenue. What you can see here is that historically, we've had a CAGR of about 25%-26% going into the pandemic. In blue are our core non-COVID sales. In purple are our COVID-related sales. You can see that last year, we grew 15% to $35.6 million in sales, which is the highest level of core sales that we've had. The drop between 2021 and 2022 was partially post-pandemic related at hospitals, but also heavily related to the devaluation of the euro, which most of our sales are based out of. We also have very healthy gross margins in our business of 71%. We've recently strengthened our balance sheet with the goal to drive our core business to cash flow breakeven by the second half of 2025. We raised in aggregate proceeds $7.85 million in a successful rights offering earlier this year that unlocked an additional $5 million in restricted cash on our balance sheet. We ended the first quarter with $13.1 million in cash, cash equivalents, and restricted cash. In April, we received another $1.7 million from the sale of our New Jersey NOLs and R&D tax credits in a program that New Jersey has. Importantly, we have a $5 million second tranche available on our term loan facility that is available to us if we get FDA approval. That will be very helpful in a potential market launch of DrugSorb in the United States. We can do that at our option. We are currently well capitalized through a combination of sales growth, improved product gross margins, and tight cost controls. We expect to drive the core business to cash flow breakeven in the second half of this year. Finally, we believe that we have a very clear and compelling value proposition, particularly at our current market cap. CytoSorb is the basis of our established international core business in critical care and cardiac surgery with more than $35 million in high-margin product sales, with expectations for growth due to a significant market opportunity targeting major unmet medical needs, a very clear message of treating the right patient at the right time with the right dose of CytoSorb, strong growth from direct sales outside Germany and distributor partner sales. Germany sale outside Germany direct sales was 28% growth last year. Distributor sales was 22% growth. This was offset by flat growth in Germany, but we have taken active measures to restore Germany back to growth. Our goal is an important one, to drive towards near breakeven of our core business and achieve financial independence without having to raise additional capital. We remain committed to bringing DrugSorb-ATR to the North American market and continue to believe that we can successfully work through the remaining questions on our application with FDA. We hope to hear from Canada soon and expect to have final regulatory decisions this year. While we are doing that, we are actively preparing as we wait for these regulatory decisions with market preparation. With that let me thank you very much for your attention. I think that we'll have a few moments for Q&A. Yeah, definitely. Thanks a lot, Phil, for the presentation. Much appreciated. I guess the key area of focus is getting DrugSorb through the regulatory process, both here in the U.S. and Canada. You talked about several of the outcomes or potential scenarios, and you expressed some confidence in addressing some of these FDA issues. I guess to any extent you can, can you share with us, even at a high level, what's remaining to be addressed? Also maybe comment on what's underlying your confidence that we can get this to clearance in the U.S.? Yeah, we haven't given public guidance on what those various issues are. However, in our meeting with FDA, we came out of that meeting feeling that we understood what those issues are and that they were addressable in a fairly short timeframe with the existing data that we have provided to the FDA. Importantly, the FDA did not ask us to do another trial, which is very important. We believe that in the appeals process, it is a good forum for us to be able to state our case again to the FDA, which we believe, again, is quite compelling, demonstrating a very favorable benefit to risk of our therapy. Great. Assuming we do get DrugSorb-ATR clearance in the U.S., can you talk about commercial strategy timelines? Yeah. If we do get approval, our goal is to begin with what we call a controlled market release, where we will be launching the product in our clinical trial centers that ran STAR-T. This is roughly 23 centers in the United States and seven centers in Canada. I think that our goal there is to test the various assumptions that we have on the marketing and adoption of this product such that we will be well prepared for a broader market launch in 2026, where we expect to generate material revenue. When you think about the commercial strategy, how heavily do you plan to rely on direct reps versus maybe any distribution? Yeah, it will be predominantly direct. It will be direct in Canada. In the U.S., we expect to have a mainly direct sales force, but complementing it with perfusionist distributors, distributors who run perfusion services for cardiac surgery centers in certain parts of the country. Got it. During COVID, I think DrugSorb was approved to be used in the U.S. You talked about having 23 U.S. clinical trial sites. Can you talk about the number of accounts in the U.S. that maybe had already been using DrugSorb? Yeah. Between our three randomized controlled trials in the United States that we've done, including STAR-T, including the centers where we sold under emergency use authorization our product under COVID, which was predominantly to cardiac surgeons and perfusionists because it was used predominantly with ECMO, and then with the additional network that we expect to gain from our key marketing and sales executives. Tom Shannon is one person that we brought in recently as the Head of North American Marketing, who brings with him a wealth of experience from companies like Medtronic, Getinge, as well as Fresenius, very deeply instilled within the cardiac surgery network. Between them and our perfusionist distributors, expect to have actually a very strong start with covering maybe 10%-20% of or at least having contact or experience with 10%-20% of the 1,000 or so cardiac surgery centers in the U.S. In Canada, in the STAR-T trial, we were in seven of the 32 adult cardiac surgery centers. We were at the highest volume centers actually in Canada. I think we are well positioned. Again, assuming we get to clearance and we are commercializing, are you going to be required to go through the VAC processes for each of these hospitals? Yeah. The value analysis committee process is one of the necessary things that medical device companies need to do to be able to demonstrate the cost-benefit of their therapy and demonstrate the value potentially to that hospital or hospital network. So often, big hospital networks have a centralized VAC value analysis committee that evaluates these things. We believe that we have a very strong health economic argument, not only demonstrating a benefit to patients by getting them to surgery faster, but also by reducing the log jam of having to wash out patients in the hospital of these drugs at very high cost. We think that we will, and we have been preparing this VAC pack that we will be ready to present to hospitals, provided that we get approval. Just to follow up there, is there any way you can share any quantification around pricing for the product and what those economic savings for the hospital could look like? Because we know length of stay is pretty important in determining cost. Yeah. Just to think about it, right? If you're washing out a drug in the intensive care unit because you're unstable, three to five days, $6,000 a day, that's $18,000-$30,000 of basically just cost to wash out the drug. Particularly, that patient with Brilinta and the heart attack story is still having a heart attack. They haven't fixed it and could suddenly die of a cardiac arrest, right? These are the problems that hospitals face today. We resolve that issue and believe that we can do that extremely cost-effectively at both high margin and that has an impact to drive our growth. Very helpful. I do want to loop Pete in here. Pete, maybe you can comment on the cash position today, how you're thinking about cash burn and what the runway looks like. Yeah, we've got, as Phil mentioned, $13 million of cash at the end of the third or first quarter. We've been burning in the $2.5 million-$3 million a quarter range. We noted that even with an adjustment in Q1, it's still in that range. We're committed, as Phil noted, that we can continue to take cost out of the business, continue to reduce burn. We're absolutely committed to getting the core business toward breakeven as we're exiting this year, which frees up money for us to do the initial launch of DrugSorb when we get approval. Got it. Have you shared anything around how you're thinking about the P&L impact, assuming we get DrugSorb to the U.S.? We haven't shared that publicly yet. As Phil mentioned, I think we've got the right strategy of initially focusing on our clinical sites and a few handful of sites. Other than that, we're going to learn pretty quickly in the three to, call it, three to six months after launch how quickly we can ramp these up in these hospitals. We will be able to titrate the launch investment once we understand that. Got it. That's helpful. Phil, back to you. I do have to ask, right? You laid out the three different potential scenarios. In the worst-case scenario where the denial is upheld, where do we go from there? What's the plan? Yeah. Again, we believe that we had a very strong submission to the FDA as well as Health Canada. Should they maintain the denial, we will be back very rapidly with a new de novo submission. It's already prepared. We will be focusing on those remaining issues that the FDA was not comfortable with and believe that we can resolve those again very rapidly. It is not the end of the story. Understood. I guess that implies if you do have to go the route of a new de novo submission, you still will not need to run any new trial to generate the data you need. We do not believe that will be necessary. Got it. On Germany, right? That is a pretty big market for you. You talked about making some organizational changes. Can you talk about what has been going on there and how you are thinking about the near-term growth prospects? Yeah. Germany is a very strategic market for us. It is the largest medical device market by far in Europe, third largest in the world, and accounts for about 40% of our revenue. As I mentioned in my comments, it's been flat growth because of a lot of macro factors for the last two+ years. What we have decided to do is actually do what we can. What we've done is realigned our sales force, split up territories to have them be more effective with the goal of driving deep into these accounts, right? There are so many different applications for CytoSorb. I think that what we could be doing a better job at is really driving accounts that use our therapy every day, believe in our therapy, to these other applications. That is one of the goals of this realignment that we expect to have a benefit in the second half of this year and have long-term dividends for that investment. Just to follow up there, you talked about some macro factors. I guess how do you think about making the organizational changes, going deeper into the accounts? What's within your control versus kind of what's outside of your control because it's impacted by macro? Yeah. I think that the market is so big, right, that we can continue to grow here. Particularly, Germany has enacted hospital reform where they are moving away from pay for procedure to actually pay for quality. Quality measures are get the patient out faster, improve outcomes, stop them from needing mechanical ventilation and other life support, getting them out of the ICU faster, right? These are all the things that our therapy does. Longer term, I think that the trends are there for Germany to recover. It's just that in the near term, we are realigning our organization to be able to take advantage of that opportunity. Understood. That puts us at time. Phil, Pete, thank you very much for your time today. For the audience, thanks for your interest. Yeah, thank you very much. Thanks.