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spk07: Good afternoon and welcome to SIDO Sorbonne's third 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.
spk01: Thank you and good afternoon. Welcome to Cytosorbent's third quarter 2023 financial and operating results conference call. Joining me today from the company are Dr. Philip Chan, Chief Executive Officer, Vincent Caponi, President and Chief Operating Officer, Kathleen Block, Chief Financial Officer, Dr. Esfemios Deliajeris, Chief Medical Officer, Dr. Christian Steiner, Executive Vice President of Sales and Marketing and Managing Director of Cytosorbents Europe, GMBH, Christopher Kramer, Senior Vice President of Business Development, and 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. Therefore, the company claims protection under the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today, and therefore, we refer you to a more detailed discussion of these risks and uncertainties in the company's filings with the SEC. Any projections as to the company's future performance represented by management include estimates as of today, November 9, 2023, and 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 third quarter of 2023 by Dr. Chan and Ms. Block, as well as an update regarding the STAR-T clinical trial by Dr. Delia Hades. Following that presentation, we will open the line to your questions during the live Q&A session with the rest of the management team. And now, it's my pleasure to turn the call over to Dr. Philip Chan.
spk12: Thank you very much, Taylor, and good afternoon, everyone.
spk02: As I discuss in our earnings press release today, our core business is built upon our EU-approved flagship Cytosorb blood purification therapy, used in more than 221,000 human treatments, with more than 250 million in sales to date, including 31.4 million in the last 12 months alone. Cytosorb addresses multi-billion dollar markets in critical care and cardiac surgery in 75 countries worldwide by treating deadly inflammation and other life-threatening conditions. These are common everyday ICU conditions like sepsis, trauma, burn injury, respiratory failure, liver failure, and complications of surgery where mortality is high despite standard therapies. With the world struggling in the aftermath of the pandemic with war, natural disasters, and illness, we believe our life-saving therapy has never been more relevant. The DrugServe ATR antithrombotic removal system is our other focus, having completed the U.S. and Canadian Pivotal STAR-T trial that was designed to demonstrate a reduction in perioperative bleeding in patients undergoing cardiothoracic surgery on Berlinta, also known as Ticagrelor. Berlinta is increasingly the super aspirin blood thinner of choice for patients suffering from a heart attack or receiving a cardiac stent. should the data, which currently remain blinded, support U.S. FDA and Health Canada regulatory approval. It would open up an estimated $650 million total addressable market in these two countries alone, where we expect rapid adoption and strong user demand, reflecting our FDA breakthrough designation. We believe we've made excellent progress on both of these programs so far this year and are specifically pleased to report a 20% product sales growth in Q3 of this year versus a year ago, that Kathy will discuss in more detail, and our nearing database lock of the Pivotal US and Canadian STAR-T trial and data analysis before year-end. The goal for today is to provide brief commentary on these topics, but to leave enough time for the Q&A session with the team at the end.
spk12: Now I'd like to go over our recent operating progress. First, we completed the Pivotal STAR-T trial in August following the last patient follow-up.
spk02: The trial remains blinded, and the database lock is nearing, with completion of data analysis expected before year-end. The International Star Registry highlighted low rates of cabbage-related perioperative bleeding in patients undergoing isolated cabbage surgery with cytosol with two days of discontinuing Berlinta in the first and second analyses.
spk12: We also exceeded 221,000 cumulative human treatments across 75 countries worldwide to date
spk02: and have expanded our Anvisa registration of Cytosorb to treat shock in Brazil, which is Latin America's largest medical device market and the seventh most populous country in the world. We also highlighted how Cytosorb and ECOS 300CY are helping to shape the future of solid organ transplant by reducing inflammation during ex vivo organ perfusion, a strategy to potentially improve the quality and quantity of donated organs and improve transplant outcomes.
spk12: And last but not least, Kathleen Block resumed her role as full-time chief financial officer. I'd like to next cover the STAR-T pivotal trial update.
spk02: When we talk to investors, many are not aware of the use case of Berlinta, so I thought that we would present that here. If you can see the graphics, you can see a man hunched over having a heart attack. In this patient, when they go into the emergency room, they typically get loaded on aspirin and a super aspirin like Berlinta in something called dual antiplatelet therapy. These patients typically go to the cath lab to get a stent, which 90% of patients ultimately do. However, five to 10% will often need open heart surgery because they are not eligible for stent due to widespread cardiovascular disease, intractable ischemia and chest pain, or even complications of putting in a stent. If these patients go to surgery, however, with these blood thinners on board, they will bleed. The only accepted therapy today is to wait, and patients typically wait in the intensive care unit, in the step-down intensive care unit, or on hospital ward. At a cost of approximately $6,000 a day in the intensive care unit, at approximately $4,000 a day in a step-down ICU and about two to $3,000 a day in a cardiac monitored bed. And they typically wait for three to five days in the hospital costing anywhere from $6,000 to $30,000 just to wait and wash out the drug. Then these patients ultimately then go to surgery where they ultimately get the definitive procedure. Our value proposition for DrugServe ATR is actually to bypass this entire waiting period and to actually get patients the definitive surgery that they need without delay while reducing or preventing bleeding complications by actively removing the drug from blood during surgery.
spk12: So in terms of the STAR-T trial, what do we know?
spk02: The STAR-T trial was completed in August with follow-up on 100% of patients at 30 centers in the United States and Canada. Data monitoring is nearing completion with database lock to follow. The SART-T study data remained blinded to all parties and will not be unblinded until after database lock when the final statistical analysis will occur. The results of the study are currently unknown. As noted previously, there were no device-related safety issues with drugs or ATR raised in the first two scheduled data safety monitoring board data reviews, the last one at 80 patients. the final DSMB analysis will take place after database block. We expect to complete our initial STAR-T data analysis before year-end, and we intend to announce whether we believe the results from STAR-T can support an FDA marketing approval thereafter. Meanwhile, encouraging initial results from the International STAR Registry demonstrate low rates of serious perioperative bleeding when Cytosorb, which uses an equivalent polymer technology to drug-served ATR, is used for this indication. Remember, again, Cytosorb is approved for this indication in the European Union. With supportive data, our goal is to submit to the U.S. FDA and Health Canada for regulatory approval in early 2024 with the potential of a faster review with our FDA breakthrough device designation, targeting potential U.S. FDA marketing approval by late 24 or early 2025. For many discussions with cardiac surgeons in the United States, Canada, and abroad, we continue to validate the potential value proposition that DrugSorb ATR could have as successful and things that we're already seeing with Cytosorb in Europe. Some of these potential benefits include, for patients, the ability to get definitive surgery safely and without delay with low risk of bleeding complications. For surgeons, we solve the intraoperative and postoperative nightmare of bleeding due to blood thinners. We could also potentially reduce the need for costly and time-consuming re-exploration surgery. And we could also relieve the surgical scheduling log jam due to patients still recovering from bleeding complications in the cardiothoracic ICU, allowing new patients to be operated on. For hospitals, we have the potential to reduce or eliminate the three to five-day waiting period to wash out for Wnta that can, again, cost anywhere from $6,000 to $30,000 depending on where they wait. We also have the potential to reduce longer operative times due to bleeding costs, which can be more than $4,000 for every 30 minutes of extra time on the operating room table. We could also relieve the logjam of patients in the ICU who bleed, allowing more revenue generating surgeries for the hospital. And on top of this, we may also help to improve a hospital's quality star rating as defined by CMS or Medicare and Medicaid, by reducing serious adverse events like bleeding. This star rating helps hospitals differentiate themselves based on objective quality criteria, helping to drive patient traffic and procedural revenue, which is what all hospitals want.
spk12: So this is one of the reasons why we believe drug-absorbed ATR can be a potential win-win-win. Turning to Cytosorb,
spk02: We are proud to say that we have now received trademark designation for the term expanding the dimension of blood purification in Europe. What does that exactly mean? Cytosort is fundamentally different from but complementary to dialysis technology, which most people equate with blood purification technology. However, we're different because we remove a broad range of dissimilar toxins that dialysis does not remove well. Dialysis works like the kidneys. It removes small molecules and water-soluble substances, metabolic waste products, et cetera, that the body produces. However, you are aware that you have a second major blood detoxification organ in your body, which is your liver, and that is really what Cytosorb works to replace. It is capable of removing large molecules and fat-soluble substances, things like cytokines, inflammatory mediators, bacterial toxins, liver toxins, proteins and peptides, as well as fat-soluble drugs.
spk12: And because of this, we are able to target deadly conditions that afflict millions of people.
spk02: On the left-hand side, Cytosorb is helping to remove the fuel to the fire of massive uncontrolled inflammation that is often associated with organ failure and death in many, many common everyday conditions in the intensive care unit. And on the right-hand side, we're reducing inflammation in blood thinners in cardiothoracic surgery targeting reduction in complications of cardiac surgery like sepsis, bleeding, shock, and others. Now, one thing I want to revisit is our global marketing agreement with Fresenius Medical Care, because this is really where the expansion of blood purification comes in. Last year, as you recall, we announced a new expanded global marketing agreement with longtime partner Fresenius Medical Care, the market leader in dialysis worldwide, with a massive installed base of blood purification machines in ICUs around the world. Fresenius has now begun marketing Cytosorb as the feature technology for cytokine, bilirubin, and myoglobin removal on its critical care platforms worldwide, excluding the United States, but is expected to officially launch a more comprehensive effort next year through its Salesforce website, conferences, marketing literature, social media, and other platforms. The partnership, again, expands the dimension of blood purification with excellent synergy between the two companies. Fresenius dominates kidney replacement blood purification technologies with its rival Baxter. We're addressing 10% to 15% of patients in the ICU that have failed kidneys. What we do, however, is that we strengthen and broaden the focus on the lucrative critical care segment as Cytosurf helps to address deadly inflammation and toxin overload that afflicts an estimated 40% to 50% of patients in the intensive care unit. Citus Orbis benefits from the global endorsement and push on Fresenius' massive sales and marketing platform, and in return, we've agreed to subsidize this effort with a 0.9% royalty to Fresenius on ex-U.S.
spk12: Citus Orb sales, making it a win-win for both organizations. To highlight that Fresenius and Citus Orbis are well aligned, I wanted to
spk02: draw your attention to a Capital Markets Day presentation that Fresenius made earlier this year in April, and in particular, highlight this slide. On the slide, they're talking about their assets in the company and basically categorizing them based on the Y-axis, their strategic value to Fresenius, and on the X-axis, their potential to drive growth at Fresenius. And what you can see here in the red box is that critical care represents a major focus of the company that can drive both growth potential and strategic value for Fresenius. On the right-hand side, you can see that that circle represents roughly 500 million to a billion in euros worldwide, with roughly half of that in the United States. So at 31 million in trailing 12-month sales,
spk12: we actually represent a significant portion of Fresenius' overall critical care sales ex-US.
spk02: So with that, let me turn it now over to Kathy Block, our Chief Financial Officer, to go over our financial highlights.
spk12: Kathy?
spk04: Thank you, Phil, and greetings to everyone on the call today. For the quarter ended September 30th, 2023, Total revenue, which includes product sales and grant revenue, was $8.8 million as compared to total revenue of $8.1 million in the third quarter of 2022, an increase of approximately 9%. Product sales for the third quarter of 2023 were $7.8 million as compared to approximately $6.5 million in the third quarter of the prior year. representing an increase of approximately 20%. Third quarter 2023 product gross margins were 72% compared to 55% for the third quarter of 2022. This predicted improvement in gross margins is expected to continue as we ramp up production at our new facility in Princeton, New Jersey. Our third quarter grant revenue was $1.1 million, compared to $1.6 million in the same quarter of the prior year. It's lower because of the recent completion of several grants. Next slide, please. For the nine months ended September 30th, 2023, total revenue was 27.7 million, an increase of approximately 9% over the $25.3 million in total revenue for the same period of 2022. Product sales for the nine months ended September 30th, 2023 were $23.7 million as compared to approximately $21.7 million in the first nine months of 2022. And grant revenue was $3.9 million in the first nine months of 2023 compared to $3.6 million in the same period of 2022. Next slide, please. Now this chart depicts our trailing 12 months product sales broken down into COVID-19 related and core non-COVID-19 related product sales. Core product sales are 31.4 million in the trailing 12 months ended September 30th, 2023, which is slightly higher than core product sales of 29.4 million in the prior year. And while it is gradual, we are continuing to see improvements in the marketplace, including our sales team's ability to better access healthcare workers in the hospitals, a return to face-to-face discussions with the physicians in the market as well. Next slide, please. This slide shows our quarterly product sales, also broken down by COVID-19-related and non-COVID-19-related core product sales. And as you can see, Over the past six quarters, there have been no COVID-19 related sales. Three of the most recent four quarters have demonstrated sequential quarter-over-quarter growth in product sales. Q3 2023 core product sales, while lower relative to Q2 2023 product sales, are up 20% over Q3 2022 product sales. And we note that sales in the third quarter of the year are historically low due to seasonality as surgical procedures in the EU are lower during the summer months of July and August. Next slide, please. I'd like to wrap up today's remarks with some comments about our cash and cash run life. As of September 30th, 2023, we had approximately 10 million in cash, which includes $1.7 million of restricted cash. Our average quarterly burn for 2023 has been approximately $4.6 million. This is down significantly from our average quarterly burn of $9.9 million in the same period of 2022. We will need to raise additional capital to support our ongoing operations in the future. As we disclosed in our Form 10-Q and earnings press release, we initiated an equity offering but terminated this process after determining that current market conditions and the terms of an offering would not be in the best interest of our shareholders. We are currently focused on a number of alternative sources of capital, including less or non-dilutive debt financing, royalty financing, strategic or direct investment, equity financing, and or some combination thereof. We hope to have an update on this front for our shareholders very soon. Meanwhile, we are continuing to maintain tight controls over cash and are continuously identifying and implementing cost reduction opportunities in our operations. And that concludes my remarks, and I'd like to turn the call back to Phil.
spk02: Thank you, Kathy. As I've mentioned before, I'd like to reiterate our value proposition. Today, Cytosurf drives our growth. Cytosurf forms the company's foundation with an EU-approved product that's sold around the world that has generated approximately $205 million in sales since launch. It's a high-margin razor blade business model with historically high blended product gross margins that makes higher margin direct sales with lower margin distributor and partner sales. We have strong validation by customers, partners, and government agencies, and current sales supports near break-even, less clinical trial costs, which we believe helps to de-risk the company and the investment opportunity. We believe Cytosorb represents the fuel for future strong anticipated growth targeting the $20 to $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. That said, Cytosorb and DrugSorb could soon be dual growth engines for the company. STAR-T has now completed and is heading to database block with initial data analysis expected this year. International usage and trial safety to date gives us confidence. 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. DrugServe ATR is expected to have a higher ASP and product gross margin than Cytosorb and would open an expected U.S. and Canadian PAM of $600 to $650 million for Prolintha alone, where we expect significant penetration given the major unmet need indicated by our FDA breakthrough device designation. And with Cytosorb and DrugServe ATR driving sales, we expect to drive accelerated sales growth of the company with the goal of profitability soon thereafter. With that, that ends our formal remarks. Operator, please open up the line for the Q&A session.
spk07: Thank you. If you would like to ask a question, please press star 1 on your touchtone phone. Please make sure your mute button is turned off to allow your signal to reach our equipment. Again, that is star 1 if you would like to ask a question, and we will pause for just a moment to compile the Q&A roster. And we will take our first question from Yuanzi with B. Riley. Your line is open.
spk11: Thank you for taking our questions and congrats on a good culture. On the STAR-T trial endpoints, the components two of the complete endpoint, can you talk about how did you arrive at the assumption of 40% UDPB class two events in the control arm? versus 24% in the drugstore bar. Was it based on data from the open-label trial, or was it from real-world experience? Thank you.
spk02: Yes, Wuhan, thank you very much, and thanks again for your recent analysis of the potential success of the STAR-T trial that you published recently. Let me turn that over to Micah. Micah?
spk08: Yes. Thank you, Phil, and thank you, Juan, for the question. So as we have previously shared, the baseline risk for bleeding complications in patients undergoing surgery while on Ticagrelor without completing the washout period exceeds 50% as shown in the PLATO trial. Therefore, we started from that number and took a discount in relation to the control arm bleed rate that we're assuming for the STAR-T trial, and as you correctly noted, that is at 40% of the protocol state. Regarding the treatment effect size with the use of drug-served APR, we had to rely on the existing literature, which at the time represented the experience as published by Hassan et al., which showed reductions exceeding 50% in some of the components of the UDPB primary endpoint, including transfusions, and chest tube drainage. On that effect size, we again took a discount and assumed for the purposes of the trial a 40% reduction, which has led to a very adequately powered trial with a power of exceeding 98%.
spk11: Got it. And then a follow-up question on the STAR-T trial. So for the analysis timeline, can you talk about how long does it take for the database log, the analysis. Basically, can you talk about your confidence to share the data by year end, which is very important to the stock?
spk08: Yes. Thank you for the question. I think as Phil presented in the prepared remarks, the process leading to database loss is progressing well. And as we already stated, we think the lock is actually dealing. Once that happens, then the analysis process begins, which by itself requires time. It's not an instantaneous process that leads to results. During this time, all the parties remain blinded. Regarding the release of the data, we plan to follow the conventional road of reviewing the data internally, but also considering the submission for a major cardiovascular conference. Should we proceed that route, we would have to then obey the requirements relating to the embargo and the silent period of these conferences when they consider original results for presentation. However, as still again stated in the prepared remarks, we believe that by the end of this year we will be able to provide to the public, make a public press release with our initial assessment of whether we believe the data will allow us to proceed to the next step, which is basically the submission to the FDA.
spk11: Got it. That's all from me. Thank you. Thank you.
spk07: And we will take our next question from Tom Kerr with Zaxxon Investment Research. Your line is open.
spk09: Good afternoon, guys. Any update on the European ICU bed market, particularly in Germany? Has that opened up anymore?
spk02: Thanks, Tom. Let me have Christian address that issue. Christian? Christian, I think you may still be on mute. Well, Tom, let me... let me try to address that question. So if you, we follow very closely what's called the DV registry, which is published by the German intensive care unit society in Germany, where they actually look at open beds, free beds, occupied beds and beds that are still reserved for emergency purposes for COVID. And what we have seen is that the, Availability of ICU beds continues to be low, which I think speaks to the muted markets in Germany. I think that it is much better than it had been, particularly during COVID, where there was very tight ICU bed availability, but limited ICU beds overall. And I think that this is helping to drive our recovery in terms of German sales. But also, I think this phenomenon is happening around the world, which is why we believe that our sales have stabilized this year and are in a phase of recovery with the potential to help grow next year.
spk09: Okay. Thanks for that, Keller. And a couple of financial questions. the quarterly burn weight expected to be around the same in the mid-$4 million range, or does that go up or down in the next, let's say, two to three quarters?
spk02: Kathy, would you like to answer that?
spk04: I would. You know, I think that right now as we're wrapping up our STAR-T trial, for the fourth quarter, it's probably going to be similar to what we've experienced in the early quarters because we have a lot of invoices from our CRO with whom we're working, et cetera, for the closing processes. I think that we have been taking cost containment measures at site assortments across our organizations and that you should see lower burn rates beginning with the new year 2024. That will change again when we start up our SARD trial later in 2024. because that will add additional clinical costs.
spk09: But the submission on the START-T doesn't maintain or increase the burn rate in the first couple quarters, or is that a low-cost type activity?
spk04: No, that's not as expensive as the clinical study itself, and that will be done.
spk09: Right. Okay. One more financial one. Why would you guys look for an equity offering if you have a – ATM equity program in place? Or is that the same thing you're talking about?
spk04: We're really talking about... Yeah, any typos. Go ahead, Phil.
spk02: Oh, sorry. No, I think that, you know, I think one of the values of doing a standard equity offering is to bring new investors around the table and introduce the story to new investors. And so I think that was part of the goal to try to do that. I think with the ATM program, It is a very useful and good vehicle that we've used previously very successfully, but the goal here was in front of data to basically have more investors focused on near-term catalysts. But I think, as Kathy mentioned, that we decided to not pursue that avenue and focus more on less or non-dilutive investments forms of financing for the moment, given market conditions.
spk09: Got it. And there's still roughly 23 million availability on the ATM, if I recall, if necessary.
spk02: That's correct. That's approximately correct.
spk09: Yeah. Okay. That's all I have for now. Thank you.
spk02: Thank you.
spk07: We will take our next question from Sean Lee with HC Wainwright. Your line is open.
spk10: Good afternoon, guys, and thanks for taking my questions. My first one is on the start T. So with the potential for data by the end of this year and a regular submission next year, what needs to be done before you can file for submission? And in terms of commercialization, have you started building up any structures in the U.S.? ?
spk02: Irina, would you like to try to take that?
spk03: Yes, sure. In terms of submission to Food and Drug Administration, it is quite a sensitive document, which would be based on a result of a clinical trial, start clinical trial, as well as all extensive preclinical and manufacturing package, which we are developing as we speak. The last piece of information, of course, would be a clinical study report, which will be at the heart of that submission. It will be submitted at some point early in 2024, based on availability of clinical study reports. Phil, would you take the second part of the question?
spk02: Yes, Sean, if you could repeat that second part, please.
spk10: Yes, I was just wondering what preparations have you made so far in terms of for commercialization in the U.S., assuming that the study and the submission goes well?
spk02: Yeah. So, Vince, would you like to take that question?
spk06: Sure. Thanks, Phil. Thank you for the question. So there's a couple areas that we've already started preparation in. One is in the manufacturing facility. So we're preparing that facility to meet all the requirements within FDA. So any potential inspections, et cetera, that we're up to snuff with everything. And we're completing, obviously, all our validations, et cetera, necessary to produce drugs or ATR. On the commercial side, We've hired Jim Combs under Vice President of Sales and Marketing and Scott Brown, our Director of Marketing and Senior Director. And we've already developed a go-to-market plan with phase gating with respect to bringing on the resources to build the infrastructure. Of course, we'll work on back office first, you know, which is, again, building all the, you know, essentially customer services that are in training. and the like, and then we'll focus on sales as we near closer to approval. We've not pulled the trigger on those additional hires yet, obviously, and we're waiting until we get the readout, and then based on that, we'll determine when we'll start bringing those hires in. Does that answer your question?
spk10: Yep, that's very helpful. All right, so as a follow-up for the start piece, I know you guys have... CE mark approval for ticagrelor removal already in Europe. Would the results from STAR-T be useful for you to secure reimbursement in the major European countries?
spk02: Absolutely, Sean. I think that that is part of the goal. I think, you know, we talk about opening up this $650 million TAM in the United States and Canada. But, in fact, the data, given that drug-absorbed APR uses an equivalent polymer technology to cytosol, that data would be directly transferable potentially to the world market with high-quality randomized controlled trial data that should hopefully support not only clinical usage but also reimbursement as well. And so I certainly believe that will be the case.
spk10: Great. That's all I have. Thanks again for taking my questions. Thanks, Sean.
spk07: And as a reminder, it is star one if you would like to ask a question. And we will take our next question from Josh Jennings with P.D. Cowan. Your line is open.
spk05: Hi, good afternoon, thanks for the questions. Wanted to ask about potential reimbursement for DrugSorb and how you envision coverage during the early commercial period after approval. Will that be reimbursed through a DRG and with breakthrough designation? Are you anticipating filing for an NTAP and potentially having the technology add-on payment in place for launch or shortly thereafter?
spk02: Yeah. No, thanks, Josh. That's a good question. You know, as we've discussed in the past, at a very base case, we could certainly fall under the DRG because what we are trying to do is actually reduce significant costs from either waiting in the intensive care unit or in the hospital to wash out the drug or by reducing significant bleeding complications that are common in cardiac surgery patients undergoing surgery with these blood thinners on board. I think that we, however, seek line item dedicated reimbursement for this. And as you say, because of the breakthrough device designation, it gives us the ability to file for the NTAP or new technologies add-on payment as a separate reimbursable payment for hospitals. And we are currently pursuing that with consultants. There's also another program that we've discussed in the past called the TSET program or the Transitional Coverage for Emerging Technologies program. And this is a program that was proposed by CMS or Medicare and Medicaid and just actually put out for public commentary. And that commentary period is over and we're waiting for the final version of that program. But that program is designed for breakthrough device-designated devices that are applicable to Medicare patients, right? So elderly patients, essentially, which Cytosorb and DrugSorb absolutely is, given that it's typically the elderly population that are having heart attacks and are having open-heart surgeries, right? for that problem. And that is designed to guarantee coverage of breakthrough device-designated product devices that qualify for at least three years after FDA approval. So, we are actually tracking all of these areas currently.
spk05: Great. Great. Thanks for that. And just thinking about, I think the press release, your team has called out a TAM for drug sore for the tricagular removal indication. The U.S. and Canada around $650 million. That seems like a little bit of a tick up. Is there any new market analysis or is that the addition of Canada into that TAM? But just wanted to just regroup on the TAM that you guys are putting forward for tricagular removal indication. Thanks so much.
spk02: Yeah, that absolutely is. And I'll have Micah's comment on this because it was his team that actually led that market analysis. But, you know, it's very interesting. Canada is a country that uses Ticagrelor very frequently. Even though Canada has a smaller population than the United States, it represents a substantial market. Effiant, which is one of the competitors... is no longer distributed in Canada. I think Eli Lilly was the company that was initially distributing it. And Plavix, and the Canadian guidelines has highlighted that Berlinta is the preferred drug over Plavix based on clinical outcomes in these surgical patients. So So ticagrelor is actually used quite widely in Canada, and in particular, the use of dual antiplatelet therapy is widely used as well, given that it's often used as a temporizing measure to help try to improve clinical outcomes while patients are traveling from faraway distances to major cardiac centers in major cities within Canada. So it does represent a very exciting market for us, Maybe I'll turn it over to Micah to comment and maybe even comment on contribution to the STAR-T trial. Micah?
spk08: Yes. Thank you, Phil. Yeah, just exactly as Phil said, the system of care in Canada is very harmonized across the country. National protocols, the national guidelines tend to be universally followed, which is a little different than a very regional system. kind of practice that we see here in the U.S. where you can see variability in different geographic regions between academic versus non-academic centers. In Canada, it tends to be a more universal treatment approach, and with Tocagrelor carrying the highest recommendation that has been adopted in the treatment protocols of acute coronary syndrome. So very high penetration, dominant position of Tocagrelor in Canada. And then what we knew was happening based on this information, we validated in the STAR-2 trial the enrollment rate. And if you follow the trial closely, you saw that we hit a really very high pace towards the end. And we finished the trial actually with extra patients ahead of our own internal projections. That was because of the numbers that came in from Canada. So those patients are abundant. The institutions have very high volumes. so they encounter them almost on a daily basis. They have patients like these that they need to work around these delays. So the trial was very popular, the patients were abundant, and the enrollment rates were very good from there. We think the addition of Canada to our initial TAM analysis brings a substantial upside that you see in the subject that you noted.
spk05: Appreciate it. Thank you.
spk07: And we have no further questions at this time. I will now turn the call back to Dr. Philip Chan for closing remarks.
spk02: Well, thank you everyone for taking the time to get on this call today. Hopefully it was a productive session for you. We look forward to the next update on the next call. Thanks so much everyone. Have a good night.
spk07: And ladies and gentlemen, this concludes today's call and we thank you for your participation. You may now disconnect.
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