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spk07: Good afternoon and welcome to the Cytosorbent's third quarter 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'd like to turn the call over to our moderator, Terri-Ann Powers, Vice President of Investor Relations and Corporate Communications. Please go ahead, Ms. Powers.
spk03: Thank you, Dave, and good afternoon and evening to everyone that is listening. Welcome to the Cytosorbents Third Quarter 2021 Financial and Operating Results Call. Joining me today from the company are Dr. Philip Chan, Cytosorbents Chief Executive Officer, Vincent Caponi, our President and Chief Operating Officer, Kathleen Block, our Chief Financial Officer, Dr. Estimios Mikas Delirgiris, Chief Medical Officer, Dr. Christian Steiner, Executive Vice President of Sales and Marketing and also Managing Director of Cytosorbents Europe. And finally, 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 Securities and Exchange Commission. Any projections as to the company's future performance represented by management include estimates today as of November 4th, 2021, and we assume no obligation to update these projections in the future. During today's call, we will also have an overview presentation covering the operating and financial highlights for the third quarter by management. Following that presentation, we will open up 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. Go ahead, Phil.
spk05: Thank you very much, Torianne. As we have discussed in a number of recent press releases, the past several months have brought us, for sure, challenges, but also opportunities. We'll have more detail in the upcoming slides, but here's a quick overview. As we disclosed earlier last month, total third quarter 2021 revenue was $9.8 million, including product sales of $8.9 million, with healthy blended product gross margins of 82%, combining higher direct sale margins with lower distributor margins. We closed the quarter with a solid cash balance of $61 million and no debt. On the operational side, we opened the U.S. STAR-T pivotal trial with the first patient enrolled into the study from the University of Maryland just recently. We also received our second breakthrough device designation, this time for the removal of the direct oral anticoagulants Eliquis and Xarelto during cardiothoracic surgery and received full FDA approval to initiate the STAR-T pivotal trial for this application in the span of only three months. In September, we announced top-line data from our U.S. Cytosorb Therapy in COVID-19, or CTC, registry, reporting high survival among 52 consecutive patients on Cytosorb and ECMO from five major U.S. ECMO centers. Last month, preliminary results from the long-awaited remove endocarditis study evaluating the use of Cytosorb in infective endocarditis were neutral, but showed a favorable adverse event profile and, again, validated the ability of Cytosorb to remove cytokines. We are pleased to report that Cytosorb is now distributed in more than 70 countries with the recent expansion to Thailand and the Ukraine. And overall, more than 152,000 cumulative Cytosorb treatments have been utilized to date, up 38% year over year. As we've done since the pandemic began, I would like to now give a quick overview of what we're seeing with COVID-19 since the second quarter earnings call in early August. This is particularly relevant this quarter due to the impact of COVID-19 on our financial results, especially in Germany. In the United States, COVID-19 has migrated from the southeast where the Delta variant drove the second worst surge in the country to date, now the western US and Alaska. According to the CDC, Delta continues to account for 99% of new US infections. To date, of those eligible 12 years of age or older, 68% of people are fully vaccinated, with 78% with at least one dose. Overall, 58% of the entire population is vaccinated. With the recent FDA approval and CDC recommendation of the lower dose Pfizer vaccine for children 5 to 11 years of age, representing about 8% of the U.S. population, the total vaccinated population is expected to go up significantly. What I'd like to point out on this slide are the lower right-hand figures on new daily COVID-19 cases in red, And then how the graphs of hospitalizations and deaths mirror new cases from a relative proportion standpoint. The graphs look very similar. High new cases yields high hospitalizations and deaths. And we'll come back to this as it relates to Germany. That said, in terms of worldwide COVID-19 cases, COVID-19 continues to migrate, now impacting countries like the UK and Germany, as well as Eastern Europe and Russia. Remarkably, after lagging the U.S. in terms of vaccinations in early August, the percentages of fully vaccinated people in major EU countries has generally surpassed the U.S., as you can see in the lower left corner. And again, in the lower right, you can see the relative proportionality of new cases and deaths. Finally, turning to Germany, I'd like to point out a few things that highlight what happened to us in the third quarter and where we are today. The top chart shows new cases of COVID-19 in Germany and the bottom graph shows deaths in Germany. First, at the purple vertical line, you can see where we were when we provided guidance in early August, where the rates of new COVID-19 cases and deaths were very low. Coupled with an initial lifting of restrictions in Germany and increased sales meetings, we were optimistic for a return to our core non-COVID-19 business in Germany. However, Rapidly over the course of weeks, the rates of new cases jumped significantly, prompting hospitals to continue or reinstate restrictions on elective procedures, limit outside visitors, including sales reps, and to reserve ICU resources already stretched thin by staffing shortages for pending critically ill COVID-19 patients. But during Q3, the numbers of critically ill patients expected did not materialize. Looking at these graphs, you can see something very different compared to the U.S. In the major surge in Germany in the fourth quarter of last year, the death rates were proportional to these new cases, as you can see from these two graphs, and as we've seen in the United States as well. However, in the subsequent surge earlier this year in Germany, the numbers of deaths were disproportionately low. And then with this last wave, the numbers of deaths reflecting ICU patients and severity of illness was very low. despite the third largest peak in new cases in Germany. In fact, this dissociation of high numbers of new cases but low numbers of deaths is the same trend we observe in other major EU countries, including the UK, France, Italy, and Spain. This is likely partly attributed to increased vaccination rates and the lower severity of illness among those vaccinated, as well as the age of those getting sick. So how did this dynamic affect us in Q3? As we have previously discussed, during the pandemic, core sales lost to COVID-19 restrictions were typically replaced by COVID-19 sales in Germany. However, in the third quarter, because of increased restrictions that decreased core non-COVID-19 sales and the low severity of COVID-19 illness, which decreased COVID-19 related sales, all happening in a traditionally seasonal third quarter, it led to weakness in Germany. In the past month, there's been a sudden spike in COVID-19 cases in Germany, with ICUs starting to fill up with COVID-19 patients and deaths increasing sharply. We're monitoring the situation closely to assess what impact, positive or negative, this may have on our business in Q4. But let me turn it over to Christian to give more color on what happened in Germany in the third quarter and how we're managing around the uncertainty related to COVID-19 this quarter.
spk06: Christian? Thank you, Phil, and good afternoon to the US from Berlin, Germany, and good evening to Europe. First slide, please. So the third quarter is traditionally a challenging one due to vacation time in Europe, and this year especially due to still existing COVID-related restrictions. Despite this, at the time of our second quarter earnings report, we were really confident that we would show good growth within our core business and some additional, although declining, COVID business. However, a new COVID wave started in August in Europe and particularly in Germany. This led to increased restrictions in hospital and customer access and to another slowdown or stop of elective surgical programs. As Phil explained earlier, due to less disease severity, the increasing number of infections did not result in more critically ill patients eligible for cytosol therapy at that time. Because of this situation, the resulting sales growth in our core business across all geographies was only 3%, and there wasn't enough additional COVID-related business compared to the Our business in Germany was particularly impacted with a 24% decrease in sales. Markets outside Germany were either not affected or not to the same extent.
spk09: Next slide, please.
spk06: In the current fourth quarter, the macro environment remains challenging in Germany. As Phil also indicated, currently we are seeing an increase in COVID-19 cases and rising number of ICU patients. As a result, we are starting to see increase in cytosol orders for those COVID-19 patients. We have a similar situation in many markets, but the impact to cytosol has been most relevant in Germany. We expect the environment to get better over time, but the pace of improvement is difficult to predict. Based on what we are currently seeing, we believe that we are on track to meet our fourth quarter product revenue guidance. Several medical conferences have been conducted by different organizers in September and October, although with relatively low attendance. This led to a moderate increase of our marketing efforts and activities. Next slide, please. In this context, I want to highlight the sizes of users meetings we have prepared for our customers and potential sizes of users, one for our international audience in October and one for our German-speaking users in November. Next slide. The eighth international sizes of users meeting was conducted here in Berlin, Germany, one week ago. We had a fantastic lineup of more than 20 international opinion and thought leaders in critical care medicine to give their lectures and discuss the benefits of using Cytosorb in different indications. More than 400 doctors and healthcare professionals from around 60 different countries attended our hybrid event. Key opinion leaders stated that based on their experience and the current body of evidence, Cytosorb has a favorable safety profile. In addition, they suggested that benefits and therapeutic effects are reproducible when patient selection, timing, and dosing are appropriate. It was really an excited and inspiring atmosphere, and everyone was focused on how to bring Sides of Use to the next level. Next slide, please. Thalassomes is tackling the current uncertain environment by applying a two-track strategy. At one, we are targeting the critically ill COVID patients with another promotional campaign, which particularly focuses on the right patient selection and appropriate timing and dosing of the treatments. And second, at the same time, we are pursuing the continued development and expansion of our core indications in the fields of critical care, cardiovascular, and liver support therapy. We are also increasing and adjusting our marketing and promotional efforts to address the current additional challenges. We do this by facilitating non-traditional customer meetings to see doctors and Cytosol users where they are available. This can be, for instance, outside the hospitals after work at scientific seminars, journal clubs, roundtable discussions, and others. We are also holding additional educational meetings and trainings both virtually and in person to ensure appropriate attendance. All these efforts are in direct response to the current pandemic situation in which we still must operate. At the same time, we are also continuing to invest in our business to drive medium and long-term growth. We are pursuing initiatives to optimize our sales force, not only in Germany, but also in other geographies. We work to increase utilization in existing clinical applications and launch new ones. And we also intend to expand our reach into additional direct territories over time. Enthusiasm and interest in ScienceDrop remain high, and we are absolutely focused on bringing back our German business to our usual growth rates while implementing measures to drive longer-term developments. With that, I will turn the call over to our Chief Medical Officer, Dr. Eftimius Mikus Delagiris, for an update on our clinical program. Mikus?
spk08: Thank you, Christian, and good afternoon and good evening to everyone on the call. In the next few minutes, I will be providing an update on the progress of our global clinical programs. Next slide, please. As you have seen from our recent press releases, we have made significant progress in our clinical trials in support of FDA marketing approval. The STAR-T study on ticagrelor removal received full FDA approval in July, triggering study startup activities. Site activation has begun in September, and we already enrolled the first patient in October. Our primary focus now is to continue bringing up study sites and we currently have six sites activated. We plan to provide enrollment updates in future earnings calls. The START-D study on apixaban and rivaroxaban removal moved in a very rapid manner from the application for breakthrough designation that was submitted in July and was granted by FDA in August to immediate submission of the IDE application and full FDA approval of the protocol in October. This accelerated timeline is consistent with the efficiencies we expected to observe based on the similarities of the STAR-T and STAR-D studies. The first central IRB approval has already been received, and we are now focused on engaging with sites, many of which are already part of STAR-T, with the target of enrolling the first patient in the study early next year. The Refresh2 AKI study has resumed enrollment with 15 sites activated. The momentum we saw in enrollment over the summer has slowed significantly in September and October as surging COVID-19 numbers have led to deferrals of elective cardiac surgeries. As of today, the study has enrolled 178 patients with 111 of them in the randomized cohort. The timing to interim analysis is entirely dependent on enrollment and as such may be delayed as a result of the COVID-19 impact. As we have previously disclosed, we continue to view the antithrombotic removal indications as the most expedited and lowest risk paths to FDA approval.
spk09: Next slide, please.
spk08: we have also made significant progress in our remaining clinical programs listed on this slide. The studies highlighted in green are already active, and we anticipate that the two studies in light blue will be active by the end of the first quarter next year. The German PROCESS randomized controlled multicenter study in patients with refractory shock is a top priority program evaluating hemodynamic stabilization in patients with severe sepsis. We are happy to report that the trial is now actively recruiting, and that next steps include continued site activations and enrollment. The German single-center citation study on tachycardia removal is also actively recruiting at all three German sites, and we recently added a fourth site in Luxembourg. Next steps include continuing enrollment in the study. The HEP on fire study in patients with liver failure is also a German multicenter study that recently received ethics approval. Next steps include activation of study sites with a target of first patient enrolled early next year. The next three studies listed on the slide are all registries. First is the USCTC registry that includes critically ill COVID-19 patients on ECMO treated under the FDA emergency use authorization. Top line results were presented in August and will be discussed in more detail on my next slide. We expect the data outputs from CTC to continue in 2022. The STAR registry is an international registry capturing real-world evidence on antithrombotic removal. Currently, the study is active in the United Kingdom and Germany, with the first patients already enrolled. We plan to expand the registry in additional EU countries in 2022, including, but not limited to, Austria, Belgium, the Netherlands, and Sweden. The final program listed on the slide is the International COSMOS Registry, designed to capture real-world evidence with the use of Cytosorb among a broad range of critical care applications. The protocol has been finalized, and next we will be seeking ethics approval in Germany with other EU countries to follow. The target completion dates for these programs are listed on the last column. However, as noted on the bottom of the slide, we continue to experience significant COVID-19 related challenges that add uncertainty to our timetables. What's worth noting is that in addition to the acute effects associated with limited hospital capacity or restricted access to research personnel, we're also seeing evidence that many institutions around the world are also suffering from the long effects of the pandemic that includes staff fatigue, high rates of turnovers, and difficult difficulties in hiring new staff. Next slide, please. Since our last earnings call, new Cytosorb data were released in COVID-19 and endocarditis. First, in COVID-19, the top line U.S. multicenter CTC registry results were presented at the International Symposium of Intensive Care and Emergency Medicine. The data were on 52 consecutive patients treated with Cytosorb while on life support with ECMO at five major U.S. centers and showed high 90-day survival rates of 73%. For context, the 90-day survival in the North American cohort of the International ECMO ELSA Registry is 50%, and that is in over 5,000 patients as of October 30th this year. The CTC data have been very well received and are expected to drive cytosorb usage in COVID-19 plus ECMO worldwide. Future CTC analysis will aim at better defining the optimal use of cytosorb with ECMO and identify potential additional clinical and economic benefits. Second, two data sets on endocarditis were presented at the European Association of Cardiothoracic Surgery less than a month ago. The results presented at the meeting were mixed. First, the German removed randomized study in 282 all-comer endocarditis patients did not meet the primary endpoint of change in SOFA score with the use of Cytosorb. However, a second observational study from Nuremberg, Germany in 195 patients with left-sided endocarditis showed reduction in sepsis-related mortality with Cytosorb. Importantly, Both studies declared that the intraoperative use of the device was safe with the same adverse event rates as the state of care, meaning the control arm where the device was not used. We intend to work closely with the investigators of both studies to further analyze the data and potentially inform future endocarditis studies. We do believe that the safety data for both studies bode well for the same exact intraoperative device use in our FDA trials.
spk09: Next slide, please.
spk08: In summary, in the past 12 months, we have scaled up our clinical capability significantly to support execution of our global clinical plan, comprising of nine company-sponsored clinical studies. We have made significant progress on our path to U.S. marketing approval that is focused on the antithrombotic removal opportunity with the two FDA-approved randomized controlled double-blind STAR-T and STAR-D trials. Outside the U.S., we are focused on generating data in several critical care applications, including sepsis and liver failure, among others. Finally, we expect to have seven of these programs actively recruiting by the end of this year, with all nine being active and recruiting by the end of the first quarter of 2022. And with that, I'd like to turn the call over to our Chief Financial Officer, Kathy Block. Kathy?
spk02: Thank you so much, Micah, and greetings to everyone on the call today. Today, I'll be providing a summary of Cytosurban's third quarter 2021 financial results. I will also reiterate our fourth quarter and full year 2021 guidance. And then finally, I'll provide an update around our working capital and cash runways. So let's start with product sales for the third quarter, which were approximately $8.9 million, a decrease of 13% as compared to $10.2 million last year. This outcome was driven by lower COVID-19-related sales and slower year-over-year growth in our core non-COVID-19 sales of approximately 3%. Product sales in Germany were $3.7 million, down 24% compared to product sales of $4.8 million in Germany last year. This, of course, a matter upon which Phil and Christian have already provided substantial color. Changes in the euro to dollar exchange rate had little impact on year-over-year product sales. Our income from grants was approximately $859,000, this an increase from prior year grant revenues of $301,000. And our total revenue, which includes both product sales and grant revenue, decreased by 7% to $9.8 million in the third quarter, compared to $10.5 million in the third quarter of last year. Our product gross margins remained a robust 82% in Q3 2021, compared to 74% for Q3 2020. Next slide. Here we'll have a look at quarterly product sales trends over time. And for this analysis, we've broken out our COVID-19 product sales from our core non-COVID-19 product sales. For the third quarter of 2021, our COVID-19 sales were estimated to be approximately $1.1 million, which is, in fact, the lowest quarterly COVID-19 sales we've reported since the beginning of the pandemic in the first quarter of last year. Our core non-COVID-19 sales were $7.8 million, growing 3% compared to last year's $7.5 million in sales. Next slide, please. With this slide, we'll take a look at our trailing 12-month product sales. And as you can see from the chart, overall, our annual product sales growth continues to be very strong, with $41.9 million in sales for the trailing 12-month period ended September 30, 2021. which is a year-over-year increase of 21%. COVID-19 sales were approximately $7.1 million in the trailing 12 months ended September 30, 2021, versus approximately $6.8 million in the prior period. So the main driver of year-over-year growth was a result of our poor non-COVID-19 product sales. Next slide. Turning to our guidance. Today, we reiterate the guidance we previously provided for the fourth quarter and full year 2021. We expect fourth quarter product revenues to be similar to third quarter 2021 product revenue of $8.9 million. Full year 2021 product revenue is expected to be at least $39.3 million, which is roughly flat compared to 2020 product revenue of $39.5 million. And while it is difficult to predict, 2021 core non-COVID product revenue is expected to be approximately $33 to $34 million for the current year versus $30.1 million in 2020. And based on what we are seeing so far this quarter, we remain confident that these results are achievable. Next slide, please. As of September 30th, 2021, we have approximately $61 million in cash on hand. During the third quarter of 2021, we continue to invest in mission critical activities, including a planned increase in spending on our clinical trials, as well as activities associated with the build-out of our new manufacturing plant. We are also preparing to invest in the U.S. commercialization build-out, which will be required to support sales and marketing activities once FDA marketing approval is received. We believe we have sufficient liquidity to support these investments, which are expected to drive our growth in the future. And now I'd like to turn the call back to Phil. Phil?
spk05: Thank you very much, Kathy. Despite the complexities of COVID-19 on our business, we believe we are well positioned for long-term growth within the outstanding therapy Cytosorb, that when used on the right patients at the right time with the right dose, works to help save lives. We're boldly trying to solve some of the most complex medical problems in medicine today that claim the lives of millions each year. It's not simple. But with every study, we move closer to unlocking the key. In addition, we believe we have an excellent business model bolstered by strong product gross margin, broad international physician and partner support, a growing body of clinical data, and a solid safety profile with now more than 152,000 treatments utilized across more than 70 countries. We remain confident in our core business both in Germany and internationally and are excited about our pivotal trials in the U.S. that have the potential to open the significant U.S. market and make our therapies available to help even more people. Given the resurgence of the Delta variant, our efforts in the near term will be to increase the international awareness of the positive data using Cytosorb in critically ill COVID-19 patients and drive utilization of Cytosorb for this application. In parallel, we continue to press on our core applications with the goal of returning to growth in our German business and driving our longer-term worldwide growth potential. To this end, we have a strong cash balance that, as you've heard today, we are continuing to direct towards key investments in growth that span clinical studies, sales and marketing infrastructure, and manufacturing capacity expansion. Meanwhile, we're accelerating our U.S. clinical program focused on the removal of antithrombotic blood thinning medications during cardiac surgery, a potential major future growth catalyst. We want to take the opportunity to thank the entire Cytosorbent community, including all of the healthcare workers on the front lines, our partners for making the therapy available to help patients, our employees for making all of this possible, and to our investors who, despite the near-term volatility, continue to support the company and share our vision of healthier and longer lives ahead in changing medicine. Thank you again. That ends our formal remarks. Dave, if you would, please open the call for Q&A for the Q&A session. Thank you.
spk07: Certainly, Anne. Thank you. As a reminder, if you do have a question, that is 1-4 on your touchtone phone. Please make sure you're muted. to allow your signal to reach our equipment. Once again, that is 1-4 on your touchtone phone. Our first question comes from the line of Danielle Antalfi with SVB Lyric. Your line is open.
spk04: Hi, guys. This is Priya on for Danielle. I've got two questions here. I think first, you know, since preannouncing, can you guys talk about some of the trends you've seen OUS and even within the U.S. in the first few weeks of the quarter as it relates to COVID. And appreciate that you guys can't give guidance, but directionally, how are things tracking as we head into 2022?
spk05: Yeah, I think that Christian had commented on Europe and in particular Germany, where the rising rates of COVID had translated into increased ICU usage. and more ICU patients and beginning of an increase in sales of Cytosorb related to those COVID-19 patients. I think that it depends really on where in the world you're talking about and where COVID has been increasing. We've been seeing increased Cytosorb sales for COVID-19. In the United States, last quarter, Just to give you maybe some perspective, when we gave our guidance back in August on the remaining year in terms of COVID-19 sales, we estimated that we would likely do less than a million in sales that were COVID-19 related. In the third quarter, we did 1.1 million in sales already. So we can't really predict exactly what that number will be for the fourth quarter. although we are seeing COVID-related sales both in the United States as well as in many countries around the world. But again, it's very country-specific.
spk04: Great. Thanks. That was helpful. And just another one here for me, if that's okay. You know, congrats on the STAR-D ID approval and then the first patient for STAR-T. But just curious, you guys did call out a little bit of an impact to refresh enrollment. Have you seen any impact thus far to the STAR-T enrollment, and just how are you guys leveraging those sites that are enrolling now for STAR-T when you do anticipate launch for STAR-D? Thanks.
spk05: Sure. Thanks, Priya. Let me turn that over to Mikus. Mikus?
spk08: Thanks, Phil, and thank you, Priya, for the question. So you're correct. The major headwinds relating to enrollment we're experiencing are refreshed, too, because it's targeting elective surgeries. and those tend to be postponed and deferred at the times where the pandemic is surging. However, as I stated in my prepared remarks, we're also seeing long-term effects among multiple institutions, irrespective of the surge in place or not, due to the staff being exhausted, sometimes retiring early, and then having difficulty rehiring. So in that regard, We do see that even, you know, in the Start T and our Start D startup activities. Having said that, we're progressing. We're making progress. As I mentioned, we already have six active sites, and we'll continue to move forward activating more and more. So we're uncertain what the exact impact on enrollment will be. We'll have better visibility when we have more sites active, and we'll be able to track the rates of enrollment. And as stated on the prepared remarks, we plan to announce on future earnings calls, you know, the trends in enrollment. To your second point, there's a great overlap between STAR-T and STAR-D on every level, including participating sites. So we do believe that we'll be able to deliver, you know, the start of the study in the first quarter of next year as we have previously targeted for STAR-D. We do believe we'll get the first patient in early next year.
spk04: Great.
spk09: Thank you. And our next question comes from Josh Jennings with Cowan.
spk07: Your line is open.
spk01: Hi, this is Brian for Josh. Thank you for taking my questions. I wanted to start with a clarification question on the COVID conditions in Germany and the guidance. Are you assuming that more normal ICU conditions return fairly quickly in November in order to achieve the sequentially similar product sales in the fourth quarter and I'm asking because visually the fourth quarter already looks similar to what you faced in the third quarter in terms of COVID impact, and I assume there could be pressure again in December following what's normally the flu season. So that's my first question. I have a follow-up if I can.
spk05: So I'll turn it over to Christian in a moment, but I think the fourth quarter differs from the third quarter in that the third quarter is a traditionally seasonal quarter affected by COVID. European vacation schedules where many people leave for vacation in July and August, including healthcare workers. And so it's typically a slower quarter, whereas the fourth quarter is typically our strongest quarter. You know, I think that the dynamic of low-severity COVID cases and high restrictions in Q3 is in a seasonal quarter makes Q3 comparisons a little bit more difficult. I think what we've said is that ICU beds are starting to fill from increased rates of COVID, markedly increased rates of COVID just within the past month, and that we are starting to generate sales related to COVID-19. which is, again, different from what was seen in the third quarter. So that being said, I think the overall guidance that we've provided is that Q4 will be flat with Q3. So we're assuming no benefit and no real changes in the situation necessarily in Germany, but we do expect that that will improve over time. We just can't predict when. Christian, I don't know if you had anything else you wanted to add.
spk06: Yeah, thank you, Phil. Maybe a few more points just to give you more color on the situation. So the fear, obviously, in all the markets is that another wave of COVID patients is stressing the healthcare system too much so that the available number of ICU beds is too low and that the patient cannot be treated appropriately. So that's why when the wave of COVID infection started in Q3, a lot of ICU beds, available ICU beds, were reserved for COVID patients. But as you know, there is always a lag also between infection and hospitalization. And then another one, towards ICU dependency. So as I said already before, there are more ICU patients, COVID patients now. And so also we have to see that the pattern of where these patients are has changed over the last year. So there are now dedicated COVID centers or sites where COVID patients are kind of concentrated and they are treating all the COVID patients and other hospitals are kind of on standby. So that is one thing. And another thing is that over the last 12 months, the German health system has lost more than 4,500 ICU beds because the similar effect what Mike was saying from the US that personnel has left. So there are not enough trained ICU nurses to keep those beds open. So that makes the whole situation difficult in general, but also difficult to judge on how the situation is going forward with one, COVID patients, and number two, with normal non-COVID patients. Because again, elective surgical programs are down, to keep stress for the health care system low or lower, let's say. And the other thing is that other patients are sometimes not even coming to the hospitals because they are fearing to get infected with COVID. So it's a very difficult situation. It's not easy to judge on. And so I would not give more guidance than what Phil has already done. but maybe the caller's helping you.
spk05: Yeah, you know, one other point to note. Thank you, Christian. You know, last year, because of increased restrictions related to COVID-19, hospitals lost approximately 9.5 billion euros in revenue related to deferred elective procedures. So, in fact, they were under a lot of financial stress, had to be really rescued with financial aid from the German government earlier this year, and they're very motivated to try to lift these restrictions, right? But given the current surge in COVID right now, we cannot predict when those restrictions will end. But we do know that I think they're equally motivated, as we are, to have those restrictions end and to get back to business as usual.
spk01: Okay, thank you. And on the U.S. clinical program for antithrombotic removal, I realize STAR-T is a few months ahead of STAR-D, but given the similarities in the trial designs and the overlap in the participating sites and investigators, is it your plan to make a single FDA submission for both indications? And if not, should we expect the roughly four-month difference in the trial's progress now to persist into the studies completion and the subsequent filing?
spk05: Yes, that's a good question. Mike, do you want to take that?
spk08: Yes, thank you. Thanks, Brian. So, as you correctly stated, there was a few months difference in the initiation from STAR-T to the expected initiation of STAR-D. However, as I mentioned earlier, you know, it's not clear yet the exact enrollment trajectory for each of the studies. So we're going to have to wait for a few months for these studies to be, you know, ongoing to really see if the speed is exactly the same of enrollment and whether this four-month difference will persist all the way to the end of the study. So I think as of now, you know, main focus to get the sites up and running, to get patients in the study, and then down the road once we have better visibility of how they're enrolling, then we'll be able to answer your question. As of now, we view them as independent programs. As you know, we haven't gotten two independent breakthrough device designations for both. So we'll have to see how the trials perform in regards to, you know, the sequence of applications with the FDA.
spk09: Understood. Thank you.
spk07: Thanks, Frank. There are no further questions. At this time, I would like to turn it back to management for any additional or closing remarks.
spk05: Well, thank you, everyone, for joining today on today's earnings conference call. We appreciate your participation. If you have any other questions, please feel free to reach out to Terri-Ann Powers at tpowers.siteservants.com, and we'll try to reply to your questions as soon as we can. Thank you.
spk07: That concludes our conference for today. I'd like to thank everyone for their participation. Have a great evening.
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