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spk03: Good afternoon, and welcome to Citrus Orbit's fourth quarter and full year 2021 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 would like to turn the call over to our moderator, Terry Ann Powers, Vice President of Investor Relations and corporate communications. Please go ahead, Ms. Bowers.
spk01: Thank you, Sherry, and good afternoon. Welcome to Cytosorbent's fourth quarter and full year 2021 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. Efthymios Deliorgieris, Chief Medical Officer, Dr. Christian Steiner, Executive Vice President of Sales and Marketing and Managing Director of Cytosorbents Europe, and Christopher Kramer, Vice President of Business Development. 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 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 today as of March 8, 2022, and we assume no obligation to update these projections in the future. During today's call, we will have an overview presentation covering the operating financial highlights for the fourth quarter and full year 2021 by management. Following that presentation, we will open the line to your questions with the management team. At this time, it's now my pleasure to turn the call over to Dr. Philip Chan. Phil, go ahead.
spk07: Thank you very much, Terri-Ann. Despite pandemic headwinds, 2021 was a good year with sales growth driven by increased Cytosar utilization and advancement of key objectives. Total revenue grew 5%, product gross margins improved to 80%, and we ended the year with a strong balance sheet with approximately $54 million in cash and no debt. We made significant progress on our U.S. antithrombotic removal clinical programs with the launch of two pivotal randomized controlled trials, the STAR-T and the STAR-D trials, evaluating the intraoperative use of DrugSorb ATR during urgent cardiothoracic surgery to remove certain blood thinners under two FDA breakthrough device designations. We also invested in key people and processes to ensure focus on our critical care and cardiac surgery application to position the company for sustained future revenue growth. Meanwhile, we continued to drive awareness of Cytosorb through company and investigator-initiated presentations and publications. And although it seems like we just recently celebrated the milestone of 100,000 cumulative devices utilized, as of the end of 2021, there have now been more than 162,000 cumulative cytosurge devices utilized, up 34% over the end of 2020. Finally, we have been extremely focused on allocating our capital towards priority programs, which include our company-sponsored clinical trials, our sales and marketing infrastructure, and our new manufacturing facility build out. As we've done in prior earnings calls, I'd like to provide our view of the COVID-19 pandemic, given the ebb and flow of its impact on our business. As you can see from the world maps on the new COVID cases in November of last year on the top left, and on the current map on the top right, the Omicron variant led to a dramatic surge in COVID-19 cases, particularly in the US, Europe, and the northern parts of Asia. However, as you can see on the bottom right, although there were high rates of COVID, the severity of illness has dropped significantly and sequentially with every new wave, with peak mortality rates of about 2.3% globally a year ago compared to only 0.4% now. This is likely due to the fact that on the lower left, approximately 65% of the world population has now had at least one vaccine dose, and 58% are fully vaccinated. Compare this to November 2021 when only 28% of the world population had one vaccine dose and only 14% were fully vaccinated. You can see in the table that in most major countries in Europe, like the United Kingdom, France, Spain, Italy, and Germany, the rates of full vaccination are very high in the range of about 73 to 83%. In terms of Germany, New cases of COVID-19 have only just recently peaked, resulting in many of the same trends we saw late last year to persist in the country, including hospital restrictions on sales reps and other outsider visits, decreased elective procedures, decreased ICU capacity, and other factors. What you see in this graph is that the peak mortality has dropped dramatically from early 2021, where 3% of patients who got COVID-19 died, to now only 0.1% peak mortality. This 0.1% mortality is typical of what we typically see with seasonal influenza. But we expect that new cases in Germany to drop rapidly soon, like you can see here with the other major EU countries, at which point we believe our core business will begin to pick up. Already Germany has announced its intent to lift most social restrictions this month. As with many companies, we are currently navigating through global uncertainty. The good news is that we expect that the COVID-19 pandemic will likely burn out in 2022. Are we out of the woods yet? Probably not. But we'll likely see minor spikes in COVID-19 as restrictions like masks are lifted. But we believe the pandemic is likely coming to an end this year due to the natural history of viral pandemics, the very high current rates of vaccinations and natural immunity, and the decreased severity of illness globally. Yes, they'll likely be other COVID-19 variants, but they'll more likely be like the seasonal flu, some worse than others, where most people have mild to moderate disease. From the perspective of the Russian-Ukraine war, we believe we currently have limited exposure with less than 4% of our 2021 product revenues coming from the region. Overall, we expect continued and progressive improvement throughout the year in our core non-COVID-19 business, with 20% or more growth, over 33.8 million in core non-COVID-19 sales in 2021, which assumes a recovery of normalized hospital activity and sales access in Germany and other key countries, no major economic slowdowns caused by new variants of COVID-19, and little to no sales from Russia, Ukraine, and neighboring countries. Also, because of the trajectory of the COVID-19 pandemic worldwide, we expect limited COVID-19-related sales in 2022, as the severity of COVID-19-related illness, hospitalizations, critical illness, and deaths have dropped significantly. That said, we are focused on driving our 2022 strategic priorities. As you'll hear in more detail from the management team momentarily, we have four key priorities. The first is to advance the high priority start T and start D US clinical trials in pursuit of US FDA marketing approval. The second is to manage our business and resources to achieve 20% or more growth in core Cytoserb sales in 2022. The third is to complete the build out and begin commercial Cytoserb production out of our new manufacturing facility in New Jersey by the second half of 2022. This is intended to increase Cytoserb production capacity to support annual product sales of up to 400 million a year and also to improve product gross margin. And finally, our fourth major priority is to expand both new and existing strategic partnerships to maximize the synergy between our technology and those of our partners while creating new opportunities for global growth. So with that, let me turn it over to Kathy to discuss our fourth quarter and full year 2021 financial performance. Kathy?
spk04: Thank you, Phil. And hello to everyone on the call. Today, I will briefly review Citus Urban's fourth quarter and full year 2021 financial results. In addition, I will provide an update around our working capital and financial focus for 2022. Next slide, please. Total product sales were $9.7 million, a 16% decline over total product sales of $11.5 million. in Q4 of 2020. Direct sales declined $475,000, or 6.2%, and distributor sales declined $1.4 million, or 35%. This decline in sales was due to decreases in sales to treat COVID-19 patients of approximately $900,000, as well as the impact of the imposition of hospital access restrictions, which impaired our Salesforce's ability to meet with physicians in the hospitals, particularly in Germany, our largest territory, which accounts for more than 50% of our sales. Notably, in Germany, Q4 2021 product sales were $5.3 million, which is an increase of 45% over the third quarter sales in Germany. third quarter of 2021. Grant income was $1.1 million versus $425,000 for Q4 of 2020. And product gross margin for the fourth quarter of 2021 remained strong at 78%, but compared to 81% for Q4 2020. The slight decrease in product gross margin in Q4 2021 is due mainly to our scheduled manufacturing shutdown. for planned maintenance and year-end inventory counts. Next slide, please. Next, we'll examine Q4 2021 relative to our historical quarterly performance. And this chart of historical sales shows our core non-COVID-19 product revenues, that's the blue part of the bar, and our estimated COVID-19 revenues, the light green part of the bar. Revenue attributable to COVID-19 treatments was $9.4 million in 2020 and $6.3 million in 2021. Next slide, please. Turning to our annual results for 2021, product sales were $40.2 million, a 2% increase as compared to $39.5 million for 2020. Core non-COVID-19 product sales were approximately $33.8 million, which is an increase of $3.8 million or approximately 13% over the prior year. Given the challenges our sales team faced, being unable to access physicians face-to-face in the hospital setting, we are very pleased that we were still able to grow our core sales in 2021. Grant revenue was $3.1 million for 2021 as compared to $1.6 million in the prior year. And product gross margin was approximately 80% in 2021 versus 76% for the prior year. Next slide, please. Reviewing annual sales growth, you can see the surge in sales that occurred as a result of COVID-19 revenue in 2020. We generated less growth in 2021 as a result of lower COVID-19 sales and greater access restrictions on our sales team. 2020 and 2021 were atypical years, impacted by the COVID-19 pandemic, but over a five-year period, total product sales grew at a compound annual growth rate, or CAGR, of 37%, while core non-COVID-19 sales grew 33% during the same period, which indeed is very strong growth. Product gross margins, which were impacted by costs associated with our 2020 ramp-up of production, improved in 2021 and are now at record levels, an overall 80% for the year 2021. Next slide, please. Turning to our working capital position, as of December 31st, 2021, we had a healthy cash balance of $53.8 million. This includes $1.7 million in restricted cash. Also, as of December 31, 2021, we have approximately 50.7 million shares outstanding on a fully diluted basis. Next slide, please. And finally, I'd like to provide some color on our 2022 outlook and our financial objectives. Despite some of the macroeconomic uncertainty and global complexity of our operations, we believe our business is very resilient. Specifically, as Phil mentioned, we expect core non-COVID-19 product sales to grow 20% or more over the prior year. We intend to continue to run a tight shift focused on the scrutinization of expenditures and prioritization of capital usage to ensure that our spending is fully aligned with our strategic priorities. Those are, of course, first, our robust clinical trial strategy with primary emphasis on our US Star T and Star D trials. Second, the strengthening of our sales and marketing organization. And third, the expansion of production capacity at our new manufacturing facility. We expect to be able to fund our operating needs and cash capital expenditure needs with cash on hand. And we also have financial flexibility if we need it. In the first quarter of 2022, we entered into a loan commitment with Bridge Bank, which provides us with the ability to access up to $15 million in debt financing. We believe this provides an optional source of cash should we require it in the future. In addition, in the first half of 2022, we expect to receive proceeds of approximately $0.7 million from the sale of our New Jersey 2020 net operating losses. In summary, We continue to prioritize our cash use and to fund initiatives that are expected to support near and longer term growth. Our balance sheet remains strong. We expect to be able to fund our operating needs and capital expenditures with cash already on hand, but we have financial flexibility if needed. That concludes my remarks for today. And at this time, it is my pleasure to turn the call over to our Executive Vice President of Sales and Marketing, Dr. Christian Steiner.
spk08: Thank you, Cathy.
spk09: Good afternoon to America and good evening here in Europe. Economies and societies are still suffering from the global pandemic. It's not over yet, though we are seeing light at the end of the tunnel. In Q4, several conditions have changed versus earlier in 2021. we were able to increase our sales visit frequency and in-person meetings. We could also exhibit and promote cytosol therapy at a number of congresses and symposia, which were canceled in the year before, although the number of attendees was significantly lower than what we were used to have before the pandemic. Based on that, we were able to significantly improve our sales compared to the Q3. Germany's sales increased 45% compared to the Q3 numbers and represented 55% of our overall product sales. The other direct sales markets delivered their best results ever and the emergency use authorization COVID business in the United States was contributing as expected. Orders from our distribution partners were on a good level but not the same volumes as a year ago since there was significantly less COVID business. However, approximately 1.7 million US dollars of the revenues was COVID related, either due to increased usage during the Delta wave or as preparation for the expected Omicron wave.
spk08: Next slide, please. Phil already pointed out the macroeconomic factors or conditions that are impacting our business.
spk09: COVID-related business will further decline due to lower severity of the disease, less ICU dependency of patients, and a much lower mortality compared to previous waves. However, health systems are still being significantly impacted by the number of patients, infected healthcare professionals, and otherwise limited capacity. This again leads to limited elective surgery programs, reserved or closed ICU beds, and we are still facing some restrictions in our ability to see our customers as well as for cancelled or unattended congresses. Despite these challenges, we are seeing a lot of positive developments, which will eventually come to full effect with the pandemic fading away. Our recently started initiatives in the cardiovascular field are starting to generate the necessary momentum to jumpstart our post-pandemic business. New additions to our team and the tactical adaptations are leading to much more efficient and fruitful sales and marketing efforts with important thought leaders and the major institutions. Increasing adoption of our therapy and the higher market penetration are expected to be the result of these efforts. We have started those initiatives in our strongest and most developed market, Germany, and we will roll them out to our other direct and major distributor markets in Q2. These efforts are also expected to be supported by new data and publications we are awaiting in this field. Similar projects are currently being prepared for the critical care indications and other therapeutic areas.
spk08: Next slide, please.
spk09: 2022 is an important year for us since we are celebrating the 10th year of providing CytoSorb therapy to our customers and their patients. CytoSorb is the pioneer and leader in new acute care blood purification. We started with CytoSorb as an experimental therapy in 2012 with a fresh CE approval, but with very limited data, almost no treatment experience, and only a limited idea of how the therapy could help patients. Nevertheless, we had a big vision to change medicine. Today, we have treated tens of thousands of patients with more than 160,000 treatments in several clinical application fields. There is a lively discussion about the opportunities and benefits of the therapy in medical communities, and they have generated several hundred publications and reports on Sideswap therapy in multiple compared to combined number of comparable technologic approaches. We furthermore extended our CE label to four other indications, including removing blood thinners in certain high-risk cardiac surgery patients. Cytosomes have started a movement to use new blood purification as an additional weapon in acute care, which is not stoppable. As you have heard before, And Michael will comment more on this in the clinical and medical section. We are currently focusing on a selected number of indications to reach standard of care status where we believe Cysozorb and our technology can provide the most clinical benefit. This slide shows you the invitation for the Cysozorb World Users Meeting in July. This is a key global event where the experts and thought leaders will present and discuss the current status and the future steps with an impactful therapy. I'm very excited about the opportunities we will pursue this year and for the years to come.
spk08: Next slide, please.
spk09: As I said before, the focus on selected clinical applications is defining our priorities for strong, sustained growth. We have and we will further increase the firepower of our commercial and medical teams. Experts in the field of clinical care and cardiovascular diseases and business are strengthening and streamlining our efforts. The further optimization and improvement of our German sales force is ongoing and increases the focus on key opinion leaders and key account management. We are implementing changes to support increased market penetration in our other direct territories to drive additional growth. Also, we are prioritizing the most important distributed markets, considering their potential and development possibilities. All these structural changes will be supplemented with new commercial tactics, including hybrid or virtual conferences, educational programs and trainings, as well as further development of highly efficient KOL relationship management. All these efforts and initiatives will be molded into consistent marketing and branding campaigns. We are already starting to see positive results of the laid-out initiatives, which fuel our confidence and optimism to get back on the growth path we were on before the pandemic. And now I'd like to turn the call over to our Chief Medical Officer, Dr. Artemios Deliargiris.
spk08: Michael, please. Thank you, Christian. And hello to everyone on the call.
spk02: Next slide, please. As you heard already, the theme for 2022 Cytosorbents is execution and focus. Accordingly, our updated clinical plan is now streamlined and comprises of seven programs. That includes three randomized clinical trials, three registries, and one pilot study. Three of the programs are executed in the United States, including our two top priority FDA randomized clinical studies, the STAR-T and the STAR-D trials, and also the cytosol therapy in COVID-19 registry under the emergency use authorization granted for use of cytosol in COVID-19. And the remaining four programs are executed in Europe, including the randomized process clinical study in patients with refractory septic shock, The pilot study HEP on fire in patients with acute and chronic liver failure, and our international registry is the STAR and COSMOS registry, respectively. As we're engaging with institutions around the world, we note that they continue to struggle with personnel shortages and fatigue in the aftermath of the pandemic. However, we're encouraged that we continue to see high levels of interest for participation in our clinical programs. There will be numerous data readouts in 2022, including data on COVID-19 from accepted abstracts from the CTC registry that will be presented at the International Symposium of Intensive Care and Emergency Medicine later this month in Brussels and the Euro-ELSO International Conference in London in May. This data will follow up on the original results presented and published last year showing high survival with the use of cytosorbine COVID-19, and now extending the observations to potentially additional valuable clinical benefits. We have also completed enrollment in the CDC registry, and we plan to publish the final results in 100 patients later this year. Later this year, we also intend to submit the first ever in vivo anti-thrombotic drug removal data to the European Society of Cardiology. If our abstract is accepted, This first ever results will be presented in the largest international cardiovascular conference later this year in August. We may even have potential early readouts from the starter registry later in 2022 or early 2023. To focus our resources to our top priority FDA STAR-T and STAR-D trials, we have also discontinued the following three clinical programs. First, the REFRESH-II AKI trial which will allow all our U.S. clinical team resources to now be focused on the STAR programs. We also discontinued the small single-arm studies, Tizer in the U.K. and Cytation in Germany, that were both evaluating ticagrelor removal, as they both now will be superseded by the much higher level of evidence that will be generated by the pivotal U.S. STAR-T randomized clinical study. It's important to note that in any of these three studies there were no safety concerns noted with the intraoperative use of our device in patients undergoing urgent cardiac surgery as confirmed by each independent DSMB in the three studies.
spk08: Next slide, please.
spk02: Moving on to our top priority FDA programs, namely the STAR-T and the STAR-D studies evaluating the use of the drugs or ATR device during urgent cardiac surgery in patients either on ticagrelor in the START-T study or apixaban or ibaroxaban in the START-T study. Both studies have now left the station, and they're actively recruiting patients. The majority of the U.S. sites participating in the studies have now been selected, with most of them, actually over 70%, noting that they will participate in both trials. Enthusiasm is very high for these two studies, despite pendant fatigue at these institutions. However, the site staff shortages are real, and we're seeing them across the board at US institutions. Based on the identical study design, the STAR-D startup times are moving faster by leveraging the synergies in the work already done to start up the STAR-T study. Importantly, in addition to the identical design, both studies have identical executional paths highlighted by three major milestones that are listed on the table below. The first milestone is the enrollment of 33% of the patients that will trigger the first DSMB safety review. The second milestone gets triggered after 67% of the patients are enrolled in the study and represents the second DSMB safety review, but also, importantly, the interim analysis of the trial. And finally, the third milestone represents the completion of the study with 100% enrollment, unless, of course, the study has been stopped for efficacy previously at the interim analysis. Now, specifically for the two studies, STAR-T is actively enrolling at multiple sites and is projected to hit milestone number one this summer. with enrollment of the study is expected to be completed within 12 months from today. For STAR-D, it is also actively recruiting at multiple sites. However, it's too early right now to project the enrollment pace of the study. We do believe, however, that enrollment will be completed within 12 to 18 months following the first patient entered in the study. Later this month, we'll have a major event for both studies, the Investigator Summit, which we believe will introduce significant levels of excitement across all the studies, all the study sites participating in both studies. And we plan to communicate the study progress for both of these studies in our future earning calls according to the progress they're making towards the milestones listed below.
spk08: Next slide, please.
spk02: Moving on now to our non-FDA programs, we have five clinical programs listed on this table. First, the CTC registry has completed enrollment with 100 patients now critically ill with COVID-19 requiring life support on ECMO. The database has been locked, and as noted previously, there will be multiple readouts later this year including presentations on international conferences and also publications of these data and the final results of the CDC registry. We believe this will inform beyond COVID-19, including the use with ECMO, an increasingly used platform around the world for patients suffering from severe respiratory failure. Next, the process of randomized clinical study in patients with refractory septic shock is now actively enrolling at multiple sites in Germany. We continue to bring more sites, hoping to have all sites for the study at the end of the second quarter. The next milestone is the interim analysis, which will be triggered after half of the patients are enrolled in the study, and we anticipate that to take place next year. The STAR Registry, an international registry in cardiac surgery, and specifically on antithrombotic removal, is actively enrolling patients in the UK and Germany, and we continue to expand to different countries around Europe that will be included in this registry. This registry will continue to enroll, and there will be data readouts once we have sufficient number of patients, and we expect those data readouts to be ongoing. Finally, the HEP on Fire and the COSMOS Registry have both received approvals in Germany, and we are beginning to activate sites. We anticipate that both the pilot study in acute liver failure will begin enrollment in the first half of this year, and our COSMOS registry, an all-inclusive registry among patients with critical care applications, will also begin enrollment in the first half of this year.
spk08: Next slide, please.
spk02: So in summary, we have focused our resources to ensure disciplined execution of our top priority START-D and START-D FDA programs. As we engage with institutions, both in the US and Europe, we know that they're still struggling with pandemic fatigue and staffing shortages, but we continue to see high levels of excitement for our studies. Both FDA programs are now actively recruiting at multiple sites, with STAR-T in the lead targeting first milestone this summer. PROCESS, our top priority randomized clinical study in critical care, is actively enrolling at multiple sites in Germany. As noted before, the CDC registry has completed enrollment and will be having multiple data readouts in 2022. And finally, both the International STAR and COSMIS Registry are making good progress and they are very important for supporting our data generation in the future as they both represent real-world evidence platforms in cardiac surgery and critical care.
spk08: And with that, I would like to turn it back over to Phil. Phil?
spk07: Thank you, Mike. In summary, we strongly believe that Cytosorbents has the potential to become a highly profitable medical device company with industry-leading operating profit margins while helping to solve some of medicine's most vexing problems. Our business is resilient, and while macro uncertainties continue, we remain well positioned to grow our core business in 2022 and beyond. We are heavily focused on being prepared to return to our normal sales and marketing activities, with the goal of driving strong, sustainable growth, not just in Germany, but worldwide. We firmly believe that FDA marketing approval will be a key catalyst for growth, and the company expects to complete enrollment of both the U.S. STAR-D and STAR-T pivotal clinical trial programs for antithrombotic removal, as Mike has mentioned, in the next 12 to 18 months. Meanwhile, with our strong balance sheet, we have the ability to fund key investments in growth with a focus on clinical studies, sales and marketing, and manufacturing capacity expansion. Thank you very much. That ends our formal remarks. Sherry, if you would, please open the call for the Q&A session.
spk03: Yes, thank you. As a reminder, if you have a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. And for a participant using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Please make sure your mute button is turned off to allow your signal to reach our equipment. We will take our first question today from Zach Weiner with Jefferies.
spk05: Please proceed. Hey, everyone. Thanks for taking the question. Two for me. First, just if you give some color on how things are trending in Germany through the first two months of 1Q, access for your reps to surgeons and whatnot. And then second, I just wanted to confirm you guys will not be communicating any milestones on Star D and Star T with the street beyond your quarterly earnings calls, or will you provide updates in your quarter? Thanks.
spk07: Yeah, thanks, Zach. You know, I think that we, as we spoke in our formal comments, the peak of COVID in Germany just recently passed. And so, you know, there are still high rates of COVID that has led to continued restrictions in German hospitals, increased difficulty in being able to see physicians by our sales reps, decreased ICU capacity, staffing shortages, and other issues that we faced in the second half of last year. So the quarter is not yet over. We're expecting that COVID cases, new COVID cases to drop significantly. in the next month or two, and a lifting of restrictions in Germany by the government. So I think that things will hopefully return to some new normal in the fairly near future. From a milestone perspective on clinical studies, I'll let Micah comment. Micah?
spk02: Yeah, thanks, Phil. Well, as we noted, we're going to be communicating progress based on the pre-specified milestones that were shown on the slide previously. So on earnings calls, we will be stating how the studies are tracking to those milestones. However, if any of those milestones are hit between earnings calls, obviously we will be announcing that. We will not wait for the earnings call, but we'll be announcing it as it happens.
spk05: Yeah, that's helpful. Thank you. Thanks, Zach.
spk03: Our next question is from Sean Lee with HC Wainwright. Please proceed.
spk10: Good afternoon, guys. I just have two quick questions. First, on anti-thrombotic removal. Now, the company received the CMR expression, I think, back in mid of 2020. So I was wondering, how big of an indication is this for you guys right now? Maybe a bit of color on what proportion of sales is coming from this indication? And do you expect it to be a big revenue growth driver in 2022, and where do you think it can get to?
spk08: Thanks. Yeah, thanks, Sean.
spk07: So, you know, as we've said before, COVID-19 has made it difficult to effectively market this particular application, which we just received approval on in 2020. And so I think that... We continue to face similar challenges of getting out there, but I think, as you heard from Christian, that new efforts to get out there with some new resources that we have have been successful and have been able to generate some momentum in this space. We think that the market in Europe is comparable in unit numbers as we would see in the United States. although given the ASPs of Cytosorb in Europe, the dollar value is less. And so, Christian, would you want to comment on that?
spk09: No, I think, sir, you have already described it very well. So, as you said, the COVID pandemic has hindered a lot of these developments, and they're still A lot of ground we have to make. But what we see over the last few months and also with the activities in the U.S. with the STAR-T and STAR-D studies, there's a lot of enthusiasm in the different cardiac surgery departments. And now we have to build it. And I think there's significant growth possible.
spk08: Great. Thanks for the additional, Carla. Thanks, Sean.
spk03: As a reminder to star 1 on your telephone keypad if you would like to ask a question. Our next question is from Justin Walsh with B. Reilly Securities. Please proceed.
spk06: Hi. Thanks for taking the questions. Your clinical trial efforts give some clarity related to the near and midterm indication targets. And given the large markets you're looking at there, that makes sense. But I wanted to ask you a couple questions about the published use case of Cytosorb to treat CAR-T-related neurotoxicity. My first question there is if you believe there's an opportunity for the company to leverage niche use cases to continue bolstering awareness of the product and how that might benefit the company as well as patients.
spk08: Yeah, thanks.
spk07: You know, the CAR T cell immunotherapy application is very interesting. When patients develop the complication of cytokine release syndrome and separately neurotoxicity from CAR T cell immunotherapy, it can be quite devastating, I think, to patients. It manifests very rapidly, often, you know, two to three days after the CAR T cell immunotherapy infusion. And when it happens, it can be a full-blown cytokine storm. Currently, it's being managed with steroids and some anti-cytokine inhibitors like tocilizumab. And the rates of CRS, they're getting better at helping to manage CRS. However, neurotoxicity, which they often call ICONS or CRES, is very difficult to control. And when it happens, it has been shown that steroids and cytokine blockers like tocilizumab do not help and can actually make it worse. And that was the case for this publication, landmark publication, actually, of the first case of severe neurotoxicity caused by CAR T-cell immunotherapy, and this was a case published in the United States. And so the fact that we were able to rescue this patient, and despite having failed many other interventions, with our therapy, this patient was salvaged and actually was able to recover from that neurotoxicity. If you recall, there's been some major CAR T-cell immunotherapy trials where neurotoxicity has killed patients and has closed down the studies. your point i think that uh our our business is a lot like this we have a lot of major indications right like sepsis and trauma and uh management of intraoperative and post-operative complications and other uh applications uh such as liver failure and pancreas treatment of pancreatitis now with the new data on ards i think this will become a major application for us as well in the future but What I think is so exciting about our therapy and what drives the interest globally is a lot of just broad usage in a lot of little indications where the effect is often very dramatic. So it is part of the reason why we've been able to drive really very strong growth in the usage and adoption of Cytosurf worldwide.
spk06: Got it. And maybe just a quick follow-up. I'm just curious if you see other opportunities for expansion as the immuno-oncology and cell therapy fields advance. And as you know, there are sort of very limited number of patients who currently receive these therapies, but if there's potential for movement to earlier lines or beyond some niche indications, wondering if you guys have sort of looked at that possibility and and if there might be, I don't know, partnership opportunities there or investigators who are interested in running those types of trials. Thanks.
spk07: Yeah, thanks. You know, the data are limited right now for the use of our therapy in the cancer field. However, we do acknowledge that it's actually a very large market. You know, one of the applications we had discussed previously and has kind of been on the back burner has been the complication of cancer cachexia. Cancer cachexia, as unfortunately many people are aware, is a wasting syndrome that happens in cancer patients that is actually caused by inflammation. In fact, the factor called cachexin that was identified as driving this muscle and fat wasting syndrome that depletes the patient of physical reserve is called cachexin, but the other name for it is tumor necrosis factor, which is a widely studied cytokine, for example. We have had a vision that perhaps cytosol could actually help treat cancer cachexia, which is often listed as the main cause of death for patients with cancer. It is an end-stage phenomenon in cancer, and it is a problem that prevents patients from being able to tolerate further immunotherapy or further cancer chemotherapy or radiation therapy, for that matter. So there is a vision that if we could potentially reverse cancer cachexia with our therapy, it may help buy patients time and give them reserve to be able to ultimately have more definitive therapies.
spk08: Got it. Thanks for taking questions. Sure.
spk03: And now I would like to hand the conference back over to management for any additional or closing remarks.
spk07: Well, thank you, everyone, for joining us today on today's earnings conference call. We appreciate your participation. If you do have any other questions, please feel free to reach out to TeriAnn Powers at tpowers at siteasservants.com, as you can see on the screen here. and we'll try to reply to your questions as soon as we can. Thank you everyone.
spk03: Thank you. That concludes our conference for today. I would like to thank everyone for their participation. Have a great evening.
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