Good afternoon and welcome to the Cytosorbents Corp.'s First Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call for 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 Terri Anne Powers, Vice President of Investor Relations and Corporate Communications. Please go ahead Ms. Powers.

Thank you, Stacy. Good afternoon. Welcome to the Cytosorbents' first quarter 2022 financial and operating results conference call. Joining me today from the company are Dr. Phillip Chan, our Chief Executive Officer; Vincent Capponi, President and Chief Operating Officer; Kathleen Bloch, Chief Financial Officer; Dr. Efthymios Deliargyris, our Chief Medical Officer; Dr. Christian Steiner, Executive Vice President of Sales and Marketing and Managing Director of Cytosorbents Europe; and Christopher Cramer, our 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 to 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 May 3rd, 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 and financial highlights for the first quarter of 2022 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. Phillip Chan. Phil?

Thank you very much, Terri Anne. By the end of the first quarter, over 170,000 CytoSorb devices had been used, reflecting a 30% increase from the previous year. The clinical trials in the United States for antithrombotic removal are advancing, with the first patient enrolled in the STAR-D trial in April this year. The START-T trial is also moving forward toward its first enrollment milestone, and we expect the first meeting of the Data Safety Monitoring Board when 40 patients have been enrolled this summer. We previously mentioned the US CTC registry, and new data involving 56 critically ill patients treated with ECMO and CytoSorb at five leading ECMO centers under FDA emergency authorization confirms a high survival rate of over 70%. Moreover, early intervention seems to improve lung function and help patients wean off ECMO. We are also excited to welcome Ms. Jiny Kim to our Board of Directors. As Vice President of Smart Implants Technology and Data Solutions at Zimmer Biomet, where she is working on commercializing the world's first smart knee, Jiny brings extensive expertise in US commercialization, marketing, and business development to our team. Additionally, we've established our operations in the UK and hired Shaun Whittemore, the former Country Manager for LivaNova in the UK and Ireland, to lead that effort for us. Our strategy involves selling CytoSorb directly in the UK and Ireland to expand our direct sales territories over time. Furthermore, we successfully completed our audit by the European Union Notified Body of our new manufacturing facility in Princeton, New Jersey in April with no significant findings. The facility is 95% complete, and we expect full certification in the coming months, allowing us to start manufacturing and shipping CytoSorb globally. In terms of sales, total revenue, which encompasses product sales and grant income, was $8.7 million for Q1 this year compared to $10.6 million in the same quarter last year. Product sales reached $7.9 million in the first quarter of 2022, with $7.6 million from core non-COVID product sales and $0.3 million from COVID-related sales, down from $10.1 million last year, where $8.3 million was core and $1.8 million was COVID-related. Our product gross margins remained strong at 80%, a 300 basis point increase from last year. Core sales for Q1 2022 were steady, which is significant as they were consistent with the third and fourth quarters of the prior year. On a constant currency basis, this reveals a 7% to 8% reduction in the euro-to-dollar exchange rate. Adjusted core sales for this quarter would have been $8.2 million compared to $8.3 million the previous year. Revenue from COVID-19 dropped to $0.3 million in Q1 2022 from $1.8 million the previous year, mainly accounting for the change in product sales. The lower COVID-related sales reflect the reduced demand for CytoSorb due to the less severe nature of COVID-19 illness as a result of vaccinations and natural immunity. During the first quarter, Germany dealt with the highest COVID rates since the pandemic began, exacerbated by a surge from the new BA.2 variant, which has slowed our recovery and sales in the country. First quarter sales in Germany were $3.8 million compared to $5.9 million last year, largely due to COVID-related challenges at hospitals. In the early part of the second quarter, we are seeing similar sales patterns as in Q1. Thankfully, cases are diminishing rapidly, now falling below 100,000 new cases per day. While Germany remains a hotspot, the situation is improving. Vaccination rates stand at 77% of the population, and one in three people have been infected with COVID-19, contributing to high natural immunity, while mortality rates remain low. This leads us to believe the pandemic may come to an end this year, shifting COVID into a milder, seasonal virus akin to influenza. Globally, we observe a similar trend with declining COVID cases, although certain areas like Europe continue to have hotspots. There are reasons for optimism regarding the pandemic's conclusion this year, with 67% of the global population having received at least one vaccine dose and 61% fully vaccinated. Major European countries report vaccination rates exceeding 70%, and natural immunity from infections is substantial. Mortality rates have notably fallen in developed nations, nearing those associated with seasonal influenza. Treatment approaches for COVID-19 are now well understood, with the introduction of new drugs, strategies, and vaccines making a significant difference. In fact, in many hospitals, COVID is now often an incidental finding in patients admitted for other reasons. Given the trends observed since our last earnings call, particularly the BA.2 COVID case surge in Germany late in Q1, which we believe affected the recovery in German hospitals and our business there, we are adjusting our guidance as follows: We anticipate a continued decline in COVID-19 cases and hospitalizations worldwide, leading to a more normalized operating environment as the year goes on. Accordingly, we expect ongoing improvement in underlying core non-COVID-19 business and growth in core product sales on a constant currency basis for 2022. However, due to limited visibility, we will not provide specific growth targets at this time, with plans to reassess later in the year when we have more clarity. This outlook relies on three key assumptions: a gradual return to normal hospital activity and sales access in Germany and other critical markets; no significant economic downturns or surges in COVID-19 infections due to new variants; and negligible sales contribution from Russia and neighboring countries due to the ongoing war scenarios. In 2021, sales from these areas represented less than 4% of our total product sales. We hope for no escalation of the Russia-Ukraine conflict into other regions and anticipate limited COVID-19-related product sales in 2022, driven by high vaccination rates and natural immunity, which have lessened the severity of COVID-19 illness and subsequently, the necessity for hospitalization and ICU care, thus reducing the usage of CytoSorb in those patients. Nevertheless, we are actively working to not simply wait for conditions to improve. We are financially well-positioned with $44.7 million in cash to navigate through this challenging period. We will continue investing purposefully in priority programs while taking proactive steps to significantly lower our cash burn, expecting to end 2022 with over $30 million in cash and the option to take on debt if necessary. Our focus remains on four key objectives: First, securing FDA marketing approval for DrugSorb-ATR to remove blood-thinning drugs during cardiothoracic surgery through the START-T and STAR-D trials. Second, reviving growth in core CytoSorb sales. Third, transitioning production of CytoSorb to our new facility in Princeton, New Jersey this year. Fourth, establishing and expanding new and existing strategic partnerships to enhance the synergy between our technology and that of our partners, driving new global growth opportunities. Throughout this presentation, I have asked each member of the management team to provide insights on these four goals. We are committed to restoring sales growth and advancing multiple key initiatives to achieve improved results as the pandemic wanes, while also laying the groundwork for long-term growth. We believe we have a solid customer base from which to revive sales growth. Christian will share insights on this. We've organized three specific therapy divisions within our commercial operations – critical care, cardiovascular, and liver and kidney – to further develop these markets internationally, supported by dedicated medical and commercial experts who will collaborate closely with our sales teams to meet customers' needs effectively. Christian will highlight some early successes of this initiative in his remarks. Additionally, we have established a growing strategy of exclusive partnerships with hospital chains, positioning us as the preferred provider of hemoperfusion technology to three major private hospital groups in Germany, including Asklepios Kliniken GmbH, as announced yesterday. We also envision exciting new applications that we believe will broaden the use of CytoSorb across various settings, including shock reversal in about 10% of ICU patients and additional applications in liver disease and lung injury, where we anticipate increased adoption will lead to significant growth. Now, I'll turn it over to Vince to give a brief update on the manufacturing facility expansion.

Thank you, Phil. I'm pleased to share that we are progressing well with the construction of our new facility. We have outgrown our current location, and this transition will give us the essential space and flexibility we need. Historically, we started with just 2,000 square feet and have expanded to over 22,000 square feet by acquiring additional space in our business park as it has become available. This rapid growth has created limits on material processing and our staffing capabilities as we prepare for future commercialization in the U.S. Our new facility will allow us to incorporate new product lines, enhance our process flow, improve logistics, and provide the much-needed office space. We plan to start moving into the new site in May, as our current lease will expire, which will help us eliminate unnecessary rent. The start-up of the new facility is going smoothly, despite challenges with delivery disruptions for construction materials and the limited availability of skilled trades due to COVID. The manufacturing facility is nearly complete, at about 95%. All the equipment has been installed, qualified, and audited by our notified body with positive outcomes. We are very satisfied with the audit results and the efforts of our manufacturing, quality, product development, and regulatory teams which have achieved this milestone. We expect to begin production in the second quarter, launching the product for sale once we receive the final updated site certificate. With the site certified, we can start consolidating our administrative, R&D, and production teams into one location. This will help us achieve our goal of increasing capacity, establishing infrastructure to reduce costs as our business grows, enhancing operational efficiencies, and providing a new base for our future U.S. sales team as we commercialize DrugSorb-ATR. I have a few slides to show you regarding the new facility. The first slide shows the exterior of our new site in Princeton, New Jersey. We started moving into this facility last April, beginning with our biology team. The second slide presents our new manufacturing suite. The next slide features a new break room we constructed at the facility. Lastly, the final slide displays our new R&D labs, where we have started relocating. We are excited about this next phase of our development. Now, I will hand it over to Kathy Bloch for the financial highlights.

Thank you so much, Vince, and greetings to everyone on the call. Today, I will briefly review Cytosorbents' first quarter financial results and provide an update around our working capital and financial focus for 2022. Total revenue, which includes both product sales and grant revenue, decreased by 18% to $8.7 million in the first quarter of 2022, as compared to $10.6 million for the first quarter of 2021. Product sales for the first quarter were approximately $7.9 million, a decrease of 22% compared to product sales of $10.1 million in the first quarter of 2021. This was driven primarily by the expected drop in COVID-19 sales, which were approximately $300,000 in the first quarter of 2022, compared to $1.8 million in the first quarter of 2021. In addition, the stronger dollar relative to the euro negatively impacted sales by approximately $552,000. At constant currency, product sales in the first quarter were down 16% year-over-year. Direct sales in Germany fell by approximately $2 million due to COVID-19 pandemic-driven market conditions, which has already been discussed by Phil. Grant revenue was $767,000, compared to $455,000 a year ago and product gross margins were 80% compared to 77% a year ago. I think this slide puts into perspective the trends that we have observed in our product sales. Clearly, COVID-19 fueled sales growth surges in 2020 and 2021. We experienced lower sales in the first quarter of 2022 due to a decline in severely ill COVID-19 patients and COVID-19-related hospital restrictions, especially in Germany, our largest market. Even with these pandemic-driven market conditions in place, we think it is important to note that compared to pre-pandemic levels, first quarter 2022 sales levels are still 73% higher than 2019 levels. That's a compound annual growth rate of more than 20%. Looking at our quarterly sales trends over time broken down by core and COVID-19 sales, we can see that COVID-19 sales have declined with only $300,000 in COVID-19 sales in the first quarter of 2022. Core non-COVID-19 product sales were $7.6 million in the first quarter, compared to $8.3 million in the prior year. At constant currency, core COVID-19 product sales were $8.2 million, which is roughly comparable to those in the first quarter of 2021. Regarding our working capital, we ended the quarter with a healthy balance sheet with over $43 million in unrestricted cash. I'll provide additional color on our expectations with regard to cash for the remainder of 2022 in a moment. Our cap table indicates that we now have approximately 49.6 million shares outstanding on a fully diluted basis. Finally, I want to provide a few words on the actions that the company is taking to conserve cash until market conditions improve. We have already started to implement cost-cutting measures, which are designed to reduce planned quarterly cash spend by approximately $2 million per quarter for the remainder of 2022. These actions include a company-wide hiring freeze, excluding essential hires that will be needed, postponement of the planned build-out of office space, and reductions in non-grant R&D spending, among others. Our spend is laser-focused and fully aligned with our strategic priorities, those being key clinical trials in particular our STAR-T and STAR-D trials to support US FDA marketing approval, sales and marketing, and the build-out of our new manufacturing facility. We expect to fund our operating needs and CapEx with cash on hand and we expect to end the year with approximately $30 million in cash. We also have financial flexibility if needed with $15 million available in debt financing from Bridge Bank. That concludes my remarks for today. It's my pleasure to turn the call over to our Executive Vice President of Sales and Marketing, Dr. Christian Steiner, to provide a summary of the sales and marketing update.

Thank you, Kathy. Good afternoon to everyone from the Americas and good evening to Europe. As Phil has spoken about, there continues to be a material impact of the pandemic situation on our business. Importantly, as seen in the chart presented by Kathy, the business has significantly grown compared to the pre-pandemic period. I'd like to build on that and provide some additional information regarding the current status of the business, which gives us confidence in the future growth opportunity once the pandemic fades. In this chart, you can see the development of the number of active customers in our direct territories. The number of active customers has increased by 20% to 25% within the first quarter of the pandemic and has stabilized at that level since then. Although the number of purchased adsorbers per customer has fluctuated because of the pandemic, we have observed that customer loyalty has significantly improved. As we are shifting to more frequent and personal events and meetings, we are seeing increased customer excitement. We believe that post-pandemic growth will start from that higher baseline. Higher customer satisfaction and loyalty are supported by the fact that we have been able to consistently increase the number of customer hospitals that are collaborating with us under exclusive or preferred supply contracts. This number has more than tripled over the last year. These contracts are improving our collaboration with single hospitals and securing an opportunity for further development and growth. More importantly, exclusive or preferred supply contracts with hospital chains or purchasing groups open up access to sell to additional accounts within these groups. As announced recently, we signed a preferred supply agreement with Asklepios Group, one of the biggest hospital chains in Germany. Asklepios operates more than 170 hospitals in 14 out of the 16 federal states of Germany, and out of those 170 hospitals, 70 are acute care clinics. With this agreement, we have now exclusive or preferred supply agreements with the three biggest hospital networks in Germany. These three groups alone include almost 300 acute care hospitals that are actual or potential customers for CytoSorb. We already collaborate with the St. Georg Asklepios Hospital in Hamburg, where they have pioneered the clinical application of our technology for the removal of antithrombotic agents in cardiac surgery. Phil has explained that we have established three distinct therapy divisions within our commercial operations: critical care, cardiovascular, and liver, kidney. We have successfully built the team supporting the cardiovascular therapeutic area which is now led on the commercial side by an experienced marketing professional who joined us from a leading cardiovascular medical device company. The medical side is led by a renowned cardiac surgeon from the University of Athens, Germany. While the medical team is enhancing the KOL network and coordinating scientific development, the commercial team is translating this into improved tactics. In Germany, 98% of the 83 cardiac surgery centers are our customers, nearly 70% use CytoSorb for patients with infective endocarditis, and over 60% use our technology to remove antithrombotic agents during open heart surgery. Despite pandemic restrictions, we've seen significant growth in this area, which reflects acceptance of our technology. The pandemic has hindered our ability to effectively work with customers, but this has motivated us even more to focus on key growth initiatives. We are confident that our enhanced active customer base will enable us to significantly increase CytoSorb usage once patient volumes return to normal. Our new supplier partnerships have opened access to numerous potential new customers, and we will continue to pursue additional partnerships. The new therapeutic area teams with experts in select fields are already accelerating approaches to targets and will continue to do so. I would like to turn it over to Chris Cramer, our VP of Business Development, who will provide more details on this initiative and how we plan to increase access to CytoSorb.

Thank you, Christian. I'd like to take a moment to talk about an exciting new growth opportunity with a stand-alone blood pump business model. We constantly listen to feedback from our customers. Recently, they told us that access to an extracorporeal platform can impact their ability to provide CytoSorb therapy to their patients. In particular, we heard about a couple of key challenges that if addressed could lead to greater usage of CytoSorb. Many physicians have indicated that they want to start CytoSorb treatment prior to kidney failure and prior to the initiation of CRT. This is consistent with our guidance to start early with CytoSorb treatment. Access to CytoSorb therapy can be challenging in regions where CRT is limited due to high costs, lack of skilled nursing, or where market clearance for CRT devices has not yet been obtained. In the future, we could also benefit from a low-cost easy-to-use platform to accelerate our hospital-wide strategy outside of the ICU. In response, we launched a pilot program to bring a low-cost easy-to-use hemoperfusion platform directly to our customers. The company has executed an agreement with a large multinational extracorporeal machine provider to supply hemoperfusion machines and accessories. We have the ability to provide hemoperfusion machines, tubing sets, and field support to our customers, along with various business models that can be tailored to the market situation, whether it's buying, leasing, or other options. The initial results from the hemoperfusion pilot have been promising. Machines are being placed in accounts, CytoSorb is being used successfully across multiple indications, and we're receiving consistent positive feedback from customers. The next steps are to continue to evaluate and refine the program and to scale the business model more broadly both within and beyond the current set of countries in the pilot. We are very excited about the new business model we've created and the opportunities it represents to unlock and accelerate growth of CytoSorb therapy. Now I'll turn it over to our Chief Medical Officer, Makis Deliargyris, to provide the clinical update.

I'm happy to provide an update on the progress made in our clinical studies. We have tried to maintain the same format in the slides so you can follow along the progress made since our last presentation. The theme that we outlined in the shareholder letter earlier this year is the theme of execution and focus. That is how we are approaching our global clinical plan, and I’m happy to report that all seven programs, including three randomized clinical trials, three registries, and one pilot study are now all active. Three of these programs are in the US, including our pivotal STAR-T and STAR-D programs designed to support FDA marketing approval and the COVID-19 CTC registry under the Emergency Use Authorization granted to us by the FDA in 2020. We have four programs that we're executing in Europe, including PROCYSS, our flagship study in critical care targeting patients with refractory septic shock, HepOnFire, a pilot study in acute liver failure, and two international registries, STAR and COSMOS. The STAR and STAR-D trials remain our top priority. We continue to see high levels of enthusiasm from US centers wanting to participate in these trials. We recently approached the FDA and expanded the studies to include 30 sites. A majority of those sites are activated and enrolling in the trial. We project STAR-T to hit the first milestone of 40 patients enrolled this summer. There is a high unmet need with patients requiring antithrombolytics that extend beyond one agent to include the more frequently prescribed DOAC class. We are dedicating maximum resources to ensure momentum in the studies. Additionally, we will be hosting a STAR investigator event at the upcoming American Association of Thoracic Surgery in Boston in approximately two weeks. Institutions are slowly recovering from COVID, and although they are still facing staffing shortages, they are enthusiastic about participating in our studies. We remain optimistic about the upcoming readouts and potential impacts from these programs.

Thank you, Makis. As shareholders ourselves, we understand that the macro environment and stock price have created great uncertainty among investors. However, we firmly believe we are in an innovative and robustly financed company that can weather the current turbulence with a strategic and tactical plan that positions us well for both near-term and long-term success once the pandemic abates. We believe the world has never needed our world-class technology more, and that we are on the cusp of significant value creation with a planned return to sales growth of CytoSorb and the goal of opening the US market with DrugSorb-ATR. Though we know it's been challenging for you, we thank you for your support. Operator, that ends our formal remarks. Please open the call for the question-and-answer session.

Thank you. We will now be conducting a question-and-answer session. Your first question comes from Frank Pinal with Jefferies. Please go ahead.

Hi, everyone. Thank you for your question. I hope you are all well. To start, could you discuss the trends in hospital access, particularly in Germany and more generally in the EU, towards the end of the quarter and into early Q2? How do you anticipate these trends will develop for the remainder of the year? I have two more follow-up questions after this.

Sure. Thanks Frank. Let me turn it over to Christian to address that question. Christian?

Yes, sure, and thank you for the question. It appears to be still a very challenging environment for the sales forces. Hospitals in general are more accessible, but because of the staff shortages and decreased number of doctors, it's still very difficult to speak with the right people and to promote the therapy. The pandemic has resulted in many ICU beds being locked for patients. Just imagine when there are rooms with two or three beds, if there's one COVID patient, the other two have to be locked because of isolation. This leads to a significant shortage of ICU beds, and elective surgeries are postponed because ICU beds have to be available for surgical procedures. There is improvement visible, but the pace is slow. Our sales forces have more face-to-face meetings, as I have mentioned. Regional and national events are starting to pick up.

Thank you for that. Congratulations on the preferred supply agreement with Asklepios. Can you discuss the significance of that agreement for the company? Additionally, could you provide some quantitative or qualitative insights on the impact of that agreement? Are there any relevant pricing and volume details that investors should be aware of?

Christian, do you want to take that?

Yes, I can continue here. We are very pleased that we have made such progress with the exclusive or preferred supplier agreements. These agreements with single hospitals protect accounts and increase collaboration on an official level, allowing us to offer training and support. With higher volumes or increased usage, there are benefits to customers in terms of price, although we are trying to maintain competitive pricing. More importantly, agreements with hospital chains or purchasing networks open up access to sell to additional accounts within these networks, allowing us to develop standardized usage of CytoSorb.

Great. Thank you so much. Just one last question if you will here, and I'll jump back in queue. If you could just remind us on the expected final readout dates for the STAR-T and STAR-D trials at this point? I guess given a few items, I guess you posted an interim analysis. I'm wondering if that data is going to be presented and if you're expecting it toward the end of the year or early next year. With the 30 trials, is expanding to the 30 sites, is that sort of net neutral on timing?

Thanks Frank. Makis, would you like to take that?

Sure. Thank you. Those are great questions. Expanding the number of sites was driven by multiple sites that wanted to participate. We felt that limiting the initial number could hinder engagement with top institutions. In general, more sites provide positive factors for enrollment, but ultimately we're focused on hitting our first milestone. As for timing, we project STAR-T to reach its first milestone of 40 patients enrolled this summer. It’s too early to project the timing for STAR-D since it just began enrolling, but we expect it to continue to progress along similar timelines.

That covers my question. Thank you again.

Your next question comes from Justin Walsh with B. Riley Securities. Please go ahead.

Hi, thanks for taking the question. Just one for me today. Can you expand on the rationale behind establishing the new therapeutic area divisions? How you anticipate that this could help improve or streamline operations?

Yes, as Christian mentioned, when we first started commercializing CytoSorb, we focused primarily on critical care. We learned there was a market push for cardiac surgery and other applications, and our sales force, initially aimed at critical care, needed to adapt to meet that demand. By revamping into a multi-vertical approach, we can have dedicated experts in specialized fields, thereby improving efficiency and effectiveness in market development, which we believe will enhance our operations and drive growth.

Hey, thanks for taking the follow-up from us. Just a few on the model here. I understand kind of a tough environment with FX headwinds and various other factors. Can you give us some color on where we should expect product gross margins going forward? You've seen they've hovered around that 80% mark. Is that where it will stay, or should we see some margin expansion?

Kathy?

In the near term, we will not be experiencing margin expansion, as we bring up the new facility. However, as the facility comes up to scale, we expect to see improvements in our operating margin in 2023 due to increased batch sizes that will allow us to spread overhead more effectively.

That's helpful. I understand the commentary that you're controlling spending in the current environment. Can you give a little bit of color on how we should be thinking about the middle of the P&L over the next several quarters? Is 1Q 2021 the right way to think about OpEx going forward or some other approach?

We are still working through the final details, but I would guide you that the decreases we are implementing, which will take full effect by the end of this quarter, will primarily fall into SG&A and capital expenditures.

Thank you. We will now take a question from Priya Sachdeva with SVB Securities. Please go ahead.

Hi, thanks for squeezing me in here. As you have noted the tightening of spending as it relates to sales force development, what are your expectations over the near to medium term? Given that you do anticipate increased in-person selling and you're also on the cusp of US approval?

There are key hires that still need to be made, but in general, our sales forces are well-structured at this point. We want to manage risk and ensure sales develop as anticipated before incurring additional costs. We'll have some incremental spending there, but overall, we expect modest growth in this area.

Next question comes from Brian with Cowen and Company. Please go ahead.

Thanks for taking my questions. Can I circle back to the interim analysis for STAR-T? Can you clarify whether you intend to publicly announce those results, or will only the DSMB see them?

The interim analysis is built with the intent of looking at the un-blinded data by the DSMB based on pre-specified boundaries for efficacy. The DSMB will have the ability to recommend potentially stopping the trial early, depending on results. If stopped for efficacy, we will disclose the decision.

Can you remind us whether the endpoints are non-inferiority or superiority?

No, this is a superiority trial.

On the FDA submission, have you received clarity on whether it will be a de novo 510(k) or PMA? Will you file the two data sets together?

The FDA will not opine on the regulatory pathway until we provide the complete data set, primarily driven by safety. The data sets will be provided to the FDA based on the timing of trial completion, with submission occurring once the first trial is finished.

Thank you. There are no further questions. I would like to turn the floor over to Dr. Chan for closing remarks.

Thank you very much for participating in today's earnings conference call. If you have any further questions, feel free to reach out to Terri Anne Powers at [email protected]. Thank you all.

This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.