Welcome. I am Dr. Phillip P. Chan, Chief Executive Officer of CytoSorbents Corporation. Will the meeting please come to order? Let me take this opportunity to welcome all those present to this annual meeting of stockholders of CytoSorbents Corporation. We are excited to be hosting our virtual meeting, which allows us to be more inclusive and reach a greater number of stockholders. Before proceeding to the business of this meeting, there are certain technical legal matters which we must dispose of in order to make certain that we are conducting a duly authorized meeting. As soon as these are completed, I would like to introduce you to the officers and directors of the company, and also to describe to you matters proposed for your consideration and action at this meeting. The company has designated Christopher J. Woods from American Election Services, LLC to serve as the Inspector of Elections. Will the Inspector of Election please present to the secretary his signed oath as Inspector of Election? If there are no objections, I will direct that such oath be filed with the minutes of the meeting. Any stockholder who has not yet voted or wishes to change their vote may do so by clicking on the voting button on the web portal and following the instructions. Stockholders who have sent in proxies or have previously voted via telephone or internet and do not want to change their vote do not need to take any further action at this time. We will pause for a moment while the Inspector of Election makes his final tabulation of stockholders present in person or by proxy. Will the Inspector of Election kindly submit his report of the number of shares of common stock of the company represented at the meeting, either virtually or by proxy? There are represented at the meeting, either virtually or by proxy, 42,487,327 shares of common stock, $0.001 par value per share, out of a total number of 62,842,748 shares of common stock issued and outstanding and entitled to vote at the meeting. Each share of common stock is entitled to one vote, and accordingly, there are an aggregate of 62,842,748 votes entitled to be cast at this meeting, of which an aggregate of 42,487,327 are present virtually or represented by proxy. The report of the Inspector of Election indicates that there are present at the meeting, virtually or represented by proxy, the holders of a majority of the total number of shares of stock of the company outstanding and entitled to vote at the meeting. There is, therefore, a quorum present, and the meeting is competent to transact business. Will the Inspector of Election kindly execute his certificate as to stockholders present at the meeting, and if there are no objections, I will direct that the certificate be filed with the minutes of the meeting. Will the Secretary of the meeting please report on the mailing of the proxy materials and the availability of a list of stockholders. Dr. Chan, a copy of the notice of the annual meeting of stockholders dated June 25th, 2026, concerning the matters to be considered and acted upon at the meeting, and a copy of the proxy statement, proxy card, and annual report to stockholders for the fiscal year ended December 31st, 2025, were made available electronically or by mail to each stockholder of record at the close of business on June 15th, 2026, the date affixed by the board of directors as the record date for this meeting, on or about June 25th, 2026. An affidavit of distribution to that effect, executed by an officer of Broadridge Corporate Issuer Solutions, Inc., will be filed with the minutes of the meeting. The Inspector of Elections also has at the meeting a list of holders of record of the outstanding shares of common stock of the company, which list is certified by an officer of Equiniti Trust Company, LLC, arranged in alphabetical order, listing each stockholder of record at the close of business on June 15th, 2026, the date fixed by the board of directors as the record date for the meeting. The affidavit of distribution will be filed with the minutes of this meeting, and the list of stockholders is available for inspection via the web portal. Now that the technical organizational phase of the meeting has been completed, and before proceeding to the business to be transacted at this meeting, I'd like to take this opportunity to introduce you to the current directors of the company other than myself. Dr. Edward R. Jones, Michael Bator, Alan D. Sobel, and Jiny Kim. I would also like to introduce the officers and management of the company other than those officers who are current directors of the company or nominees for directors of the company. These include Pete Mariani, Chief Financial Officer, Vincent Capponi, President and Chief Operating Officer, Dr. Efthymios Deliargyris, Chief Medical Officer, Dr. Christian Steiner, Executive Vice President of Sales and Marketing, and Chris Cramer, Senior Vice President of Business Development. Finally, I would like to introduce Taryn Bostjancic of WithumSmith+Brown, the company's independent registered public accounting firm. The chair now deems the following matters to be properly before this meeting: A, the nominees for directors who will serve until the 2027 annual meeting of stockholders and until their respective successors are elected, except in the case of the death, resignation, or removal of any director are Dr. Phillip P. Chan, Dr. Edward R. Jones, Michael Bator, Alan D. Sobel, and Jiny Kim. B, the proposal to approve on a non-binding advisory basis the compensation of the company's named executive officers disclosed pursuant to Item 402 of Regulation S-K. C, the proposal to ratify the appointment of WithumSmith+Brown PC as the company's independent registered public accounting firm for the fiscal year ending December 31st, 2026. D, the proposal to approve an amendment of the company's certificate of incorporation to effect a reverse stock split of the company's common stock at a ratio of not less than one for five and not greater than one for 20, with the exact ratio to be determined by the board at any time prior to the one-year anniversary of this meeting. E, the proposal to approve an adjournment of the annual meeting to a later date or time, if necessary, to permit further solicitation and vote of proxies if there are insufficient votes at the time of this annual meeting to approve any of the proposals presented for vote. The polls are now open and will remain open for a reasonable time so that those of you who desire to cast your vote upon nominations and proposals may now do so. Any stockholder who has not yet voted or wishes to change their vote may do so by clicking on the voting button on the web portal and following the instructions there. Stockholders who have sent in proxies or voted via telephone or internet and do not want to change their vote do not need to take any further action. We will pause for a moment. Mr. Woods, are we ready? Yes, we can proceed. The polls are now closed. Will the Inspector of Election please give his report concerning the votes upon the election of directors and the aforesaid proposal. Based on the preliminary voting results, each of Dr. Phillip Chan, Dr. Edward R. Jones, Michael Bator, Alan D. Sobel, and Jiny Kim have received a majority of the votes cast by stockholders present at the annual meeting in person or represented by proxy. The proposal to approve the compensation of the company's named executive officers, as disclosed pursuant to Item 402 of Regulation S-K, has received a majority in voting power of the shares present in person or represented by proxy and entitled to vote on such proposal. The proposal to appoint WithumSmith+Brown, PC as the company's independent registered public accounting firm for the fiscal year ending December 31, 2026, has received a majority in voting power of the shares present in person or represented by proxy and entitled to vote on such proposal. The proposal to approve an amendment to the company's certificate of incorporation to effect a reverse stock split of the company's common stock at a ratio of not less than 1:5 and not greater than one for 20, with the exact ratio to be determined by the board at any time prior to the one-year anniversary of this annual meeting, has received a majority in voting power of the shares present in person or represented by proxy and entitled to vote on such proposal. The proposal to approve the adjournment of the annual meeting to a later date or time, if necessary, to permit further solicitation and vote of proxies if there are insufficient votes at the time of this annual meeting to approve any of the proposals presented for a vote, has received a majority of the shares of stock present or represented at the annual meeting and entitled to vote on such proposal. The report of the Inspector of Election therefore indicates on a preliminary basis that, one, Dr. Phillip P. Chan, Dr. Edward R. Jones, Michael Bator, Alan D. Sobel, and Jiny Kim have been duly elected as directors of the company to serve for a term expiring at the 2027 annual meeting of stockholders and until their respective successors have been duly elected and qualified or until such director's earlier resignation, removal, or death. Two, the proposal to approve on a non-binding advisory basis the compensation of the company's named executive officers disclosed pursuant to Item 402 of Regulation S-K has been approved. Three, the proposal to ratify the appointment of WithumSmith+Brown, PC as the company's independent registered public accounting firm for the fiscal year ending December 31, 2026, has been ratified. Four, the proposal to approve an amendment of the company's certificate of incorporation to effect a reverse stock split of the company's common stock at a ratio of not less than one for five and not greater than one for 20, with the exact ratio to be determined by the board at any time prior to the one-year anniversary of this meeting, has been approved. Five, the proposal to approve an adjournment of the annual meeting to a later date or time, if necessary, to permit further solicitation and vote of proxies if there are insufficient votes at the time of this annual meeting to approve any of the proposals presented for vote, has been approved. However, such adjournment was not necessary. Will the Inspector of Election please execute his certificate as to the total number of votes cast on each of the matters considered at this meeting? If there are no objections, I will direct that the certificate be filed with the minutes of the meeting. The company will file its Form 8-K reporting the final voting results within four business days of the conclusion of this meeting. If there's any further business to come before the meeting, please submit your questions or comments via the web portal. Are there any other products for business? There are no questions, Dr. Chan. Thank you. Since there's no further business, the meeting is now adjourned. At this time, the company's management team will provide a corporate update. Following this update, we'll answer any questions from shareholders. Questions may be posed by typing them on the website portal. I will serve as the moderator for the question and answer period. Let's go ahead with the presentation. We will now transition to the company's presentation part of the meeting. On behalf of the board of directors, our management team, and all of our employees around the world, thank you for joining us today. Importantly, thank you for your continued support of CytoSorbents. Today, we want to give you a clear picture of where CytoSorbents stands and why we believe the next 12 - 18 months have the potential to be a very important period for the company. Before we begin, I would remind everyone that today's presentation contains forward-looking statements and references to certain non-GAAP financial measures. I encourage you to review the safe harbor language on this slide, as well as the risk factors contained in our SEC filings. With that, let's begin. I'm Dr. Phil Chan, Chief Executive Officer of CytoSorbents, and it's my pleasure to welcome all of you to today's meeting. Before we get into the business of the presentation, it is my pleasure to introduce Michael Bator, Chairman of the Board of CytoSorbents, for his opening remarks. Michael has served on our board since 2015 and as chairman since 2023. He brings extensive experience across healthcare, finance, investment banking, and strategic consulting. Michael is founder and partner of Quartz Advisory Group, a capital markets investment bank, and previously served as Managing Director of Healthcare Research at Jennison Associates, a global investment management company, as well as in senior roles in the pharmaceutical industry and management consulting. Michael earned his MBA in finance from The Wharton School at the University of Pennsylvania and his undergraduate degree from Princeton University. Michael? Thank you, Dr. Chan. Good morning. Thank you all for attending this annual shareholders meeting. It's been a busy year, and while we have made progress on a number of fronts to address financial and operating challenges and progressed with two approaches to the FDA to bring DrugSorb-ATR towards U.S. approval. Nevertheless, we recognize that our share price continues to reflect skepticism regarding our ability to execute and grow. In fact, we believe the company today is stronger and better positioned than it was just one year ago. Over the past year, we have fundamentally reshaped our organization. We significantly reduced our costs, improved manufacturing efficiencies, strengthened our commercial organization, and advanced our regulatory programs while substantially reducing our cash burn. These actions, we believe, are critical to positioning the company for the future. The efforts come from a group of employees whom I would like to recognize here. We're working with a smaller staff and organization. We're working with limited resources in a competitive environment. Our people have repeatedly shown their competence and ability and hard work. In manufacturing, operations, finance, sales, and management, we have asked a great deal of our people, and I want to thank them for their efforts. I also want to thank our shareholders. Our returns have been poor, and it's our job to build the value of this company. However, I believe that as we approach cash flow breakeven, reestablish growth in our core business, and continue progress towards U.S. approval of DrugSorb-ATR, the true value of our life-saving technologies will be better recognized. It is our job to succeed in these efforts, and I believe they are the critical efforts for the future. I thank you for your continued support, and I'll turn it back now to you, Dr. Chan. Thank you, Michael. I'd also like to take a moment to recognize our board of directors and our executive leadership team. On the board of directors, we're fortunate to have an experienced and engaged group that brings expertise across medicine, finance, corporate governance, healthcare, and business strategy. I'd like to first ask Dr. Edward Jones to briefly introduce himself. Ed? Thank you, Phil, and welcome, everyone. Thank you for participating. I've been on the board now for over 15 years, and it's been an exciting time, watching things develop, and Michael has gone through many of the achievements that have occurred. I have a great deal of experience dealing with patients with chronic kidney disease as well as critical care medicine and many of the diseases that our products could help. I've taken care of patients with end-stage renal disease on various modalities of dialysis as well as ultrafiltration and active involvement in patients in the intensive care unit who are septic, in dire need of additional help that we could offer them. I've been involved with many clinical trials, which are exciting, sometimes complicated. I've been managing partner of a practice of nephrology in the Philadelphia area now for a number of years, watching the scene of medicine change dramatically. I've been heavily involved with public policy, both at a local and national level, representing physicians as well as patients as we go through the murk that we see in Washington, D.C., as well as our state level. Finally, I've been actively involved with the education of students, residents, and others. It's been a pleasure to work with my colleagues and the leadership that they've shown for the patients that we take care of, which is the ultimate importance of the whole business. Thank you for the opportunity to participate. Alan? Yes. Thanks, Phil. Good morning, everybody. My name is Alan D. Sobel, and I am privileged and honored to be on the CytoSorbents board. I joined the board in late 2014 and have seen tremendous progress of the company over that period of time. Obviously, as Michael spoke, we certainly have our challenges, and we have dealt with them, but we continue to be committed towards the goals of getting U.S. approval and breakeven and so on and so forth. My primary role outside of just a general board member is I am the chair of the audit committee and the nominating committee. My experience is I have been in public accounting, the public accounting profession since 1983. I have served both public and private companies throughout that period of time, helping them with their assurance roles, their tax responsibilities, as well as strategic and other types of matters. I currently am a principal in the national accounting firm of CLA, and I appreciate all your support as shareholders and look forward to seeing progress in the coming year. Thank you, Alan. Jiny? Good morning, everyone. My name is Jiny Kim, and it has been my privilege to serve as a board member of CytoSorbents for the past four years. I currently serve on the governance and compensation committee. In my professional career, I am a senior vice president at Solta Medical, part of Bausch Health Companies, where I lead the global medical aesthetics business, overseeing both commercial and R&D activities. I have spent more than 20 years in the medical technology industry, with experience across a range of businesses and functions. Prior to joining Solta Medical, I held leadership roles at Zimmer Biomet, LivaNova, Johnson & Johnson, and Endotronix, Inc. Throughout my career, I have had the opportunity to lead across general management, sales, marketing, R&D, and business development, giving me a broad perspective on building and growing medical technology businesses. I would like to take a moment and this opportunity to thank our management team and all of our employees for their tremendous hard work, dedication, and commitment to the company and its mission. I look forward to continuing to support CytoSorbents in helping the company achieve its long-term goal. Thank you, and back to you, Phil. Thank you, Jiny. I want to thank the board for their counsel and support, particularly during what has been a very demanding period for the company. I am also extremely fortunate to work alongside an excellent management team. Many of these individuals have been with CytoSorbents for a very long time and have helped build this company from the ground up. You will hear today from all of them. Vince Capponi, our President and Chief Operating Officer, and Pete Mariani, our Chief Financial Officer, will discuss our progress towards financial sustainability. Dr. Christian Steiner, Executive VP of Sales and Marketing and Managing Director of our CytoSorbents Europe GmbH subsidiary, will discuss how we plan to return our core CytoSorb franchise to stronger growth. Dr. Makis Deliargyris, our Chief Medical Officer, will summarize our U.S. regulatory status and strategy for DrugSorb-ATR to reduce the risk of serious postoperative bleeding in patients undergoing unscheduled open heart bypass surgery on blood thinners. Chris Cramer, our Senior VP of Business Development, will provide more detail on unlocking value from our HemoDefend-BGA program for universal blood products. These are four areas that we believe will represent largely independent paths to significant value creation for CytoSorbents. But before we get there, I want to remind everyone what this company is fundamentally about. CytoSorbents has always been about more than a medical device. For more than a decade, we have worked side by side with physicians, nurses, perfusionists, researchers, distributors, and healthcare systems around the world to try to help some of the sickest patients in medicine. Today, CytoSorb has been used in more than 300,000 human treatments across more than 70 countries, supported by hundreds of peer-reviewed publications. That experience has taught us an enormous amount about how to use blood purification effectively, what we describe as treating the right patient at the right time with the right dose. Although much of today's presentation will focus on financial performance, regulatory milestones, and shareholder value, our mission remains unchanged. We are here to help save lives. That is what motivates all of us, our employees, our management, our board every day, and it remains the foundation of everything that we do. When we look back at 2025, I think the fairest characterization is the title of this slide, A Good Year, Building for Better. It was not the year that we wanted in every respect, but beneath the surface, we made important progress. Revenue grew 4% to $37.1 million, particularly driven by direct sales outside Germany, which grew 13%, and distributor sales, which grew 11%, while we reorganized and implemented broad improvements in Germany. We also continued to build the clinical evidence for CytoSorb across sepsis, liver failure, cardiogenic shock, cardiac surgery, transplantation, and many other applications. On DrugSorb-ATR, although the regulatory process has taken significantly longer than we anticipated, FDA confirmed that it has no major safety concerns with our therapy for this indication, a key to demonstrating the standard for De Novo market approvals where the probable benefit must outweigh the probable risk. They also provided a potential path towards a new De Novo submission incorporating additional mechanistic data and real-world evidence. We further expanded our treatment ecosystem with more than 100 PuriFi hemoperfusion systems placed internationally and prepared HotSwap for its 2026 launch. Perhaps most importantly for where we are today, we began fundamentally reshaping the company's cost structure. Gross margins improved to 71% for the year of 2025, operating loss declined, and we began implementing the restructuring and cost reduction initiatives that are now having a meaningful impact on our financial performance. That brings us to 2026. In our annual report shareholder letter, I described 2026 as a year where we expect to see certain parts of our business begin to turn the corner. Although more work needs to be done, here are some positive signs. We have an established commercial foundation with nearly $40 million in annual revenue, healthy 73% product gross margins in the last quarter that mixed higher margin direct sales with lower margin distributor sales, and now easily more than 300,000 treatments across a global footprint of more than 70 countries. We have done a lot of hard work to position the company for renewed growth. Our German commercial restructuring has improved sales productivity, and we are actively hiring to get our team back to full strength, while HotSwap and PuriFi are being received extremely well in the marketplace and are helping us to communicate our message of treating the right patient at the right time with the right dose of CytoSorb. We have meaningfully improved our manufacturing model as well. As you will hear today, we have worked hard to optimize our manufacturing, drive supply chain efficiencies, and enact disciplined expense management that are strengthening margins and lowering the cost structure. We are now at a point where every $10 million in sales yields $7.3 million in gross margin to offset our operating expenses and potentially help drive the company to profitability. We are nearing a critical financial milestone, targeting operating cash flow breakeven in the second half of 2026, which could reduce financing risks and provide greater strategic flexibility. DrugSorb-ATR remains a major potential driver of value. Our scheduled pre-submission meetings with FDA this month are intended to clarify requirements and the path towards future De Novo submissions. We see multiple additional opportunities beyond the core business. HemoDefend-BGA for universal blood products, organ perfusion with ECOS-300CY, and VetResQ for animal health that could provide potential sources of future value that extend beyond CytoSorb and DrugSorb-ATR. Thanks to your vote today, we have another option to regain our Nasdaq compliance, and we will be in a position to look forward from there. Over the next 12-18 months, we will be focused on a handful of important strategic priorities. At the center of our strategy are four major value drivers. First, achieve sustainable operating cash flow breakeven. This is fundamental. Financial sustainability gives us greater control over our future and reduces our dependence on the capital markets. Second, return the core CytoSorb franchise to stronger profitable growth. We have a global business with significant infrastructure already in place. The opportunity is to generate more growth and more utilization from that existing platform. Third, obtain FDA marketing approval for DrugSorb-ATR and open the U.S. market. As Makis will discuss, we now potentially have two shots on goal. Ticagrelor, BRILINTA, and the direct oral anticoagulants, including ELIQUIS and XARELTO. Fourth, unlock the value of HemoDefend-BGA and our other strategic assets. Around those four priorities, we also need to strengthen our financials, resolve our credit facility, maintain Nasdaq compliance, broaden our investor base, and then pursue strategic partnerships that can accelerate our business. Although we certainly have our work cut out for us, what I want shareholders to appreciate is that we do not need everything to go right for CytoSorbents to create meaningful value. We have multiple independent opportunities to change the trajectory of this company. With that, let us look at the first one, achieving financial sustainability. Let me now turn over the presentation to our CFO, Pete Mariani, and our President and Chief Operating Officer, Vince Capponi. Gentlemen. Thank you, Phil. As you can see on this slide, we are available in more than 70 countries worldwide and have more than 300,000 treatments to date. We sell in Germany, where we direct sell in Germany with about 32% of our revenue and nine other countries with about 24% of our revenue, with the balance being through distributors and other partners worldwide. You can see that about half of our business is in sepsis and septic shock. A third of our business is focused in the cardiac surgery applications, with the balance of the business being in other important critical care applications. Next slide. You can see here we have a history of strong revenue growth, and as Phil mentioned earlier, we have about $37 million trailing 12 months revenue here as we get through the second quarter of 2026. Next slide. Achieving operating cash flow breakeven has been a key objective for us, and we are pleased with the continued progress toward this goal through the second quarter of this year, including an increase in gross margins to 73%, a 27% reduction in operating loss, and a 38% improvement in adjusted EBITDA loss. Importantly, a reduction in our operating cash burn to $200,000, excluding restructuring payments. These gains reflect disciplined execution across our organization, including manufacturing optimization, improved working capital management, commercial execution, and tighter cost controls. As a result, we remain on track toward our objective of achieving operating cash flow breakeven in the second half of this year. Next slide. This slide shows the + 12-quarter trend line, noting the improvement in negative free cash flow, which we define as total cash used in operating activities, plus cash used in investing activities. It demonstrates the meaningful progress towards this important objective. We believe that achieving cash flow profitability is important because it fundamentally changes the company's financial profile. Every dollar of operating cash burn eliminated reduces future financing needs, strengthens our balance sheet, increases strategic flexibility, and allows a greater proportion of future growth to accrue to shareholders. Although important work remains, we believe the progress achieved over the past year demonstrates that this strategy is working and that we remain on path to achieving our goal of becoming operating cash flow breakeven in the second half of this year. Phil? Thanks, Pete. Now to turn it over to Vince, our President and Chief Operating Officer. Vince? Thank you, Phil. Operationally, we have made significant progress over the past six months. Through production restructuring, tighter inventory management, and engineering optimization projects, we reduced global device inventory from approximately 2.7 million at year-end 2025 to 1.5 million at end of June. That is a 43% reduction. Importantly, these initiatives are doing more than just reducing inventory. They are also lowering our product costs and contributing to improved gross margins. So we are seeing benefits across three important areas: lower inventory, improved cash efficiency, and stronger gross margins. Next slide, please. Turning to cost reduction specifically, we have made meaningful progress improving our manufacturing cost structure through product production efficiencies, packaging improvements, supplier optimization, and workforce cross-training. Together, these initiatives are expected to generate approximately $1.2 million in annualized savings, with several of these initiatives already completed or well underway. These actions have contributed to gross margins exceeding 73% for Q2, as we reported in our 10-Q. Importantly, we believe that there is additional upside. As production volumes increase, we expect to further leverage our manufacturing infrastructure, reduce unit costs, and expand gross margins, all in support of our objective to reach cash flow breakeven in the second half of 2026. In summary, we have accomplished much, but there is more to do as we march towards the company goal of cash flow breakeven in the second half. With that, Phil, I turn it back to you. Thanks, Vince. Thanks, Pete. I want to emphasize one point before we move on. What you just saw represents more than just cost-cutting. It represents the outcome of a holistic approach to improving our operating outcomes and achieving our financial objectives. To get to this point, we have also had to make very difficult decisions to get here, including reducing our workforce by 23% since September 2025. Those decisions have affected good people who helped build this company, where we have greatly appreciated their contributions, and we don't take that lightly. But these actions were necessary to put CytoSorbents on a more sustainable foundation. Our goal remains operating cash flow breakeven in the second half of 2026. Once we have reached that point, the next question becomes: how do we begin growing again? That brings us to our second value driver. With that, I would like to turn it over to Dr. Christian Steiner, our EVP of Sales and Marketing and Managing Director of CytoSorbents Europe. Christian? Yes, thank you, Phil. Good morning, everyone, and good afternoon from Berlin, Germany. Let me briefly show you how we are working to drive deeper market penetration with CytoSorb outside the U.S. The basic idea is simple. Better treatment drives better adoption. We are standardizing how CytoSorb is used through continuous education, best treatment practice, and hospital-level SOPs. We have started also to support better treatment conduction through new offerings. For example, our HotSwap accessory, which allows easier and safer exchange of adsorbers during the therapy. All this moves us from an individual experience towards a more systematic model. Our teams work with physicians and centers to identify patients most likely to benefit, start treatment at the right point, and using appropriate treatment intensity. We then reinforce that approach through training and repeatable workflows. Our focus is the right patient, the right timing, and the right dose. We are applying this across our major growth areas in cardiac surgery, with especially ATR and other interoperative uses, as well as septic shock, rhabdomyolysis, and liver failure in critical care. The commercial logic is equally clear. More consistent results can create stronger physician confidence, broader use within existing centers, and a better foundation for opening new accounts. When successful treatment becomes more reproducible, physician confidence grows, and utilization can grow with it. Next slide, please. In septic shock, we continue to see evidence of both clinical and economic benefit. A recent Swiss real-world study in 246 patients associated CytoSorb treatment with shorter ventilation time and ICU and hospital stays. Importantly, there was a significantly higher net case profitability for the hospital despite slightly higher treatment costs. That matters because hospitals increasingly need therapies that make sense both clinically and economically. It gives our teams a stronger value discussion with clinicians and hospital decision makers. Better evidence strengthens the case for adoption and supports future utilization growth in critical care. Next slide, please. Rhabdomyolysis is another promising development area. In critically ill rhabdomyolysis patients, early combined renal replacement therapy and CytoSorb treatment was associated with better kidney recovery and survival compared to RRT alone. Commercially, the important point is that this is a clearly defined patient population that allows us to build standardized protocols, targeted education, and focus account development. Defined patients plus standardized treatment creates a practical path for evidence to adoption and from adoption to revenue. Next slide, please. We see a similar opportunity in liver failure treatments. CytoSorb treatment in acute liver failure was associated with improvements in liver biochemistry and hemodynamics, and was reported to be safe. Liver diseases are still an earlier stage commercial application for us, but clinical interest is increasing. We are using that interest to identify the right centers, build experience, and develop another source of future growth. This is how we broaden the growth space of the existing CytoSorb franchise. Next slide, please. How does this translate into the business? The picture outside the United States is differentiated and there are clear areas of momentum. Our international distributor business grew 16% year-over-year in Q2 despite significant disruption in the Middle East and marked a new record in our company history. Our direct business outside Germany grew 9%, supported by cardiovascular applications, new and reactivated customers, and increased activity in liver treatments and rhabdomyolysis. These two channels grow in different ways. In distributor markets, we can leverage an established international footprint and capable local partners. In our direct markets, our own teams can work account by account, building clinical champions, reactivating customers, and expanding use across application fields. These are important growth engines. Our priority is to scale what is working, deepen utilization in existing accounts, activate new centers, and use our clinical programs to broaden adoption. That gives us several practical revenue levers, more active customers, more applications within each center, and more consistent utilization per patient pathway. Growth outside Germany shows that the commercial model works and gives us a strong base for future revenue. Germany remains our key turnaround priority. Q2 was down 24%, primarily reflecting a difficult critical care environment around the septic shock indication and reduced field coverage. We recognize the performance gap and we have a focused plan to close it. The objective is not simply to add resources. It is to rebuild coverage while remaining sharper account prioritization and higher productivity. Next slide. We are addressing this directly, rebuilding territory coverage, increasing sales rep productivity, and driving deeper penetration in cardiac surgery while maintaining focused development in critical care. In practice, that means concentrating on hospitals with the strongest adoption potential, supporting clinicians with clearer treatment practices, and expanding beyond individual users towards broader hospital routines. Cardiac surgery provides an important near-term opportunity while selected critical care programs remain part of the longer-term recovery. We are not waiting for the market to recover. We are rebuilding growth with people, focused programs, and better treatment execution. With this, back to Phillip. Thank you, Christian. The key message here is that the majority of our commercial business is already growing. As Christian has described, we're now executing our plan to bring particularly Germany back to growth by rebuilding our territory coverage, continuing to improve productivity, expand cardiac surgery while maintaining our critical care franchise, scale distributor markets, and increase utilization within existing accounts. It is about more hospitals, more procedures, and higher utilization across a global franchise. Stronger growth from CytoSorbents is something else that is extremely important. It strengthens our path to financial sustainability while allowing us to preserve the longer-term opportunity represented by DrugSorb-ATR, which brings us to our third value driver, opening the U.S. market with DrugSorb-ATR. Let me now turn it over to Dr. Makis Deliargyris, our Chief Medical Officer, for a brief update of our regulatory status. Makis. Thank you, Phil, and good morning to everyone on the call. It's important to remind everyone that the DrugSorb-ATR device has received two breakthrough designations by the FDA. These designations are granted to technologies that can address a major unmet medical need for which there are currently no available solutions. DrugSorb-ATR can live up to the spirit of this breakthrough designation, and we remain very confident in the strength of our clinical data. Next. Earlier this year published in the leading cardiothoracic journal in the United States. In this paper, the investigator of the trials that include some titans in the field of cardiac surgery and interventional cardiology, such as Dr. Michael Mack, Michael Gibson, and Richard Whitlock, summarize the main findings of the trial. This publication is available online, open access, and we urge all of you to read it if you haven't already done so. Within this publication, you will read the methodology employed in the trial and of course, all the results. In order to ensure that the community of cardiac surgeons in the U.S. come to understand the main finding of the trial, I identified the central message to come out of this trial. Highlighted that in the front page of the. Okay, back. Basically, what this graph summarizes is the incidence of severe bleeding that happened in the control population versus the people treated with our device. What we observed in the trial was a highly significant, almost 60% reduction in severe bleeding complications in patients on BRILINTA. Makis, we appear to be having some difficulty with your audio. I do not know if it is possible to get to a better area. In- Why do you go ahead and continue? Thank you. Moving on to the regulatory update. Next slide, please. As all of you are aware, we had submitted a De Novo application in September of 2024 on the back of the STAR-T clinical trial data to FDA, which was eventually denied. The standard, the regulatory standard for approval of De Novo is that the probable benefit outweighs the probable risk. Primarily due to the fact that the addition of a small number of surgeries that were imbalanced between the treatment groups within the STAR-T study, the primary endpoint was missed, even though, as I previously showed you, there is clear evidence of benefit within the homogeneous population of patients undergoing coronary bypass surgery. However, during the discussions with FDA, we concluded that the safety of the device has been established since there were no associated risks with the use of the device in this population. Since the primary endpoint was missed, what the FDA has said that we need to tip the scale further to demonstrate the probable benefit outweighs probable risk. This is exactly our strategy leading into a second De Novo submission. We plan to tip the scale by adding two additional datasets. First, some additional mechanistic data to further demonstrate how the device works, and we are meeting with the FDA in an interactive manner to outline the experimental design to get us that data. Furthermore, additional evidence for device benefit with its use in the real world. In fact, we have a very exciting real-world analysis that will be presented at the upcoming European Society of Cardiology meeting in Munich later this month, which is the largest cardiovascular conference in the world. We believe the addition of these two datasets on top of the strength of the STAR-T data and with the fact that the safety side of the equations has already been aligned with FDA, will allow us to have a strong second submission for De Novo, which we are estimating will take place in the beginning of 2027. Next slide, please. However, what is equally exciting is I noted earlier that DrugSorb has received two breakthrough designations. The second breakthrough designation is for the removal of a class of drugs called direct oral anticoagulants. These drugs are very popular. They are used by tens of millions of patients around the world. In fact, the leaders of that class, ELIQUIS and XARELTO, are blockbuster drugs with multibillion-dollar sales globally. We have previously discussed our intention that once DrugSorb-ATR enters the U.S. market, we were planning to expand the indication by including additional blood thinners such as DOACs during cardiac surgery. However, given the delays in the ticagrelor submissions, we have now scheduled a separate meeting with the FDA that will also take place later this month to review the data we already have on this application and demonstrate the ability of the device to remove these drugs from circulation in patients undergoing cardiac surgery. Following that meeting, to determine what, if any, additional information we will need to collect in order to support a parallel De Novo submission for DOAC removal. Therefore, we have initiated the process for a second shot on goal to open the U.S. market for DrugSorb-ATR. With that, back to you, Phil. Phil? I'm sorry. Thank you, Makis. Now let's turn to our fourth value driver, one that I believe remains significantly underappreciated, but with the progress made by the team, has so much potential. Here to walk you through the opportunity is Chris Cramer, our Senior VP of Business Development. Chris? Thank you, Phil. Good morning, everyone. I want to give you a quick update on HemoDefend and why we believe it represents an important strategic opportunity for CytoSorbents. HemoDefend addresses a fundamental challenge in transfusion medicine, blood type compatibility. What began as a promising technology is now attracting growing interest from regulators, leading blood organizations, government agencies, and potential strategic partners. Next, please. At its core, the concept is simple. HemoDefend removes anti-A and anti-B antibodies from blood products with the goal of creating broadly compatible products that could be used across patients regardless of blood type. The potential market is significant. Approximately 2.2 million platelet units and 1.9 million plasma units are transfused annually in the U.S. alone. Compatibility remains an important constraint for both, particularly platelets because of their short shelf life and frequent ABO mismatched use. Together, platelets and plasma represent more than four million transfusions annually, creating potential substantial U.S. market opportunity. Importantly, HemoDefend is not limited to just platelets or plasma. The same platform could potentially extend into whole blood, freeze-dried plasma, military and emergency medicine, international markets, and plasma processing applications. The opportunity is potentially one platform addressing compatibility across multiple major blood product categories. Next slide, please. A key part of the value proposition is simplicity. HemoDefend is gravity driven, requires no capital equipment, and processing takes approximately 5-10 minutes. It's designed to integrate into existing blood center workflows. Essentially, you collect the platelet or plasma product, filter it through HemoDefend, and create a low-titer, broadly compatible product. For hospitals, that could mean a more flexible product that can be used for more patients. For blood centers, the value may be even more compelling operationally. More broadly compatible products could simplify inventory management, reduce the complexity associated with blood type matching, and potentially improve utilization of available inventory. Because the same core technology could potentially be applied across multiple blood products, we believe HemoDefend has the characteristics of a platform rather than a single product opportunity. Next slide, please. The platform creates potential across several parts of the blood ecosystem. Blood centers create more broadly compatible products and simplify inventory. Hospitals gain greater access to compatible blood products and reduce reliance on off-type transfusions. For the military and emergency medicine, where blood type may be unknown and time is critical, broadly compatible products could be particularly valuable. There are additional opportunities in plasma processing where ABO antibodies can also create constraints. This gives HemoDefend multiple potential customers, applications, and ultimately, multiple potential paths to market. Next slide, please. Perhaps most importantly for shareholders, HemoDefend has increasingly attracted external validation while we have continued to advance the program in a capital-efficient way. Approximately $16 million in non-dilutive funding has supported development, manufacturing, testing, and regulatory planning to date. We are also in discussions regarding additional U.S. government funding that could potentially support clinical trials. On the regulatory side, we have made important progress. Recent written FDA feedback supported several core elements of our plasma development strategy, including the anti-A and anti-B antibody endpoint and elements of our bench testing and clinical approach. That provides greater clarity on the regulatory path for plasma and lays the groundwork for a planned platelet pre-submission with the FDA. We have also had testing, validation, or engagement with leading blood centers, major government agencies, and companies across the blood transfusion industry. We are seeing growing strategic interest around potential development support, investment, commercialization, and other forms of collaboration. One recent development worth highlighting is the FDA's July 29th licensing of Teleflex's EZPLAZ, the first freeze-dried plasma product licensed in the U.S. That opens up a new U.S. commercial category for freeze-dried plasma, and we believe HemoDefend could potentially take that category a step further by helping enable broadly compatible or universal freeze-dried plasma. The HemoDefend story today is increasingly about more than the technology itself. We have a large potential market, a platform with multiple applications, significant non-dilutive investment behind the program, increasing regulatory clarity, external validation, and multiple potential strategic paths forward. I also want to recognize the broader HemoDefend team for their tremendous amount of work that has gone into achieving this progress. There is still meaningful work ahead, but we believe HemoDefend is a valuable CytoSorbents asset with significant strategic and funding possibilities, and our objective is straightforward, continue to de-risk the program while preserving the path that we believe can create the greatest value for shareholders. Thank you, and back to you, Phil. Thanks very much, Chris. Bringing this all back together, we have four largely independent paths to value creation. One, achieve sustainable operating cash flow breakeven. Two, return the core CytoSorb franchise to stronger growth. Three, open the U.S. market with DrugSorb-ATR. Four, unlock the strategic value of HemoDefend-BGA and other assets. I think the important word here is independent. We do not necessarily need all four to succeed simultaneously, but each has the potential to meaningfully change the financial profile and valuation of this company, and we are working to achieve all of these over the next 6-18 months. Which brings me to how we think about CytoSorbents as an investment today and the risk-reward asymmetry that we see. We recognize where our stock trades. We recognize that the market is assigning significant risk to this company. We also recognize that this has been one of the most difficult funding environments for med tech in the past 20 - 30 years. However, we know what we need to get done and are working very hard to make improved visibility for shareholders and mitigate that risk. Risk is only one side of the equation. The other side is what has changed fundamentally beneath the surface. Over the past year, we have done the difficult work to significantly reduce our cost structure and preserve cash. Q2 demonstrated tangible evidence of that progress with 73% product gross margins, substantially improved operating performance, and operating cash burn approaching breakeven. At the same time, we have a global CytoSorb franchise with significant existing infrastructure and the potential to return to stronger growth. We have a U.S. regulatory opportunity with DrugSorb-ATR, supported by a positive randomized controlled trial, a peer-reviewed published paper, a wealth of real-world evidence, and potentially two regulatory shots on goal. We have HemoDefend-BGA, an asset that has already attracted approximately $16 million in non-dilutive government funding with growing strategic interest. Yet today, our valuation continues to reflect primarily the risks and very little in our view of the potential upside. That's what we mean by risk-reward asymmetry. I can't tell you exactly when the market will recognize that difference, but what I can tell you is that our job is to close that gap through execution, reach cash flow breakeven, return CytoSorb to stronger growth, advance DrugSorb-ATR towards U.S. FDA approval, and unlock HemoDefend value. We also resolve our financing issues and Nasdaq issues Again, if we execute against those objectives, we believe that the value proposition of CytoSorbents can look very different from where it does today. I'd like to close with this slide because ultimately, CytoSorbents is about our people. These are the people who have continued to come to work every day through an extraordinarily challenging period and remain committed to our mission. Over the years, this team, together with many colleagues who are no longer with us, built CytoSorbents from a small development stage company into a global medical technology company. We now operate around the world. CytoSorb has been used in more than 300,000 treatments, and our technologies are helping physicians treat some of the most critically ill patients in medicine. None of that happened by accident. It happened because of the commitment, creativity, and perseverance of our employees, the trust of physicians and researchers who use our therapy, our distributors and partners, and their strong support, and the shareholders who supported us along the way. On behalf of our board, our management team, and everyone at CytoSorbents, thank you for your patience, your confidence, and your continued support. We are committed to increasing the value of this company and driving our company to success. Thank you. With that, we'll conclude the formal presentation. We now will open up the Q&A for questions. Phil, we have a couple questions in the Q&A. The first one is, "The share price is down significantly over the past five years. The board of directors are responsible for increasing shareholder value, and you have not been successful. What are each of you doing to rebuild trust in enhancing shareholder value? Pete, I'll take that one. This is Michael Bator, chairman of the board. That is a question, I think, fundamentally about trust. As I think about trust, I think about two things. The first thing is a common alignment in goals. I think it's very clear there that the board does have the same goals as shareholders. I think the second thing that is important in trust is doing what you say you're going to do so that people can rely on you, and then over time, they begin to know that what you say you're going to do, you do. I think that we have done the things that we said we have done. We have run into some issues that we did not expect, and obviously the FDA process has taken much longer than we had planned for. What we are doing to establish or reestablish trust now is to try and make commitments that, as Phil just talked through, four different commitments. It is our job to satisfy those promises, those commitments. Along the way, I think we've made enormous progress, particularly around cash burn. We are progressing with the FDA, but obviously that's a process that we don't completely control. I think that we have established a new base in Germany, which is another key and critical effort for us to reestablish growth in Germany. I think that we have now reorganized in a way, and we are beginning to see the results, albeit short-staffed results. We're beginning to see the results of the success of that reorganization. Fundamentally, I think that our goals are aligned. I think that the onus is on us to succeed in our commitments against financing commitments, against sales commitments, against regulatory commitments, manufacturing commitments. I believe that we will succeed versus those commitments. Pete, I'll send it back to you. Okay. The second question, Michael Bator, again, is, "Why did it take the company so long to cut costs in order to preserve cash? It should have occurred well before the cuts were actually implemented. This is part of the board's responsibility as well. I think that's a fair comment. I think that we are well on our way to cash flow breakeven in the second half of the year, and the efforts we've taken over the last year to get there have been significant. We did start to reduce costs about three years ago after the completion of the STAR-T trial, and we've been balancing costs to support the regulatory approach, but also to anticipate what we hoped would be a U.S. launch and the commercial requirements that are needed to make that successful. When it became clear that those things were not happening this year, we accelerated our cost-cutting dramatically because the impact of a U.S. approval we thought would be significant both to our sales and we hoped to our valuation. When that did not materialize, though we are working diligently so that it will materialize. When that did not materialize, then the planning that we had been doing across the last several years for that contingency was put in place. I believe that the company has executed really very well under difficult circumstances to cut our costs very aggressively and get us close to that critical cash burn breakeven. Okay. Phil Chan, there are no other questions in the Q&A. Okay. Well, on behalf of the board, on behalf of the management team and the employees of CytoSorbents, we thank all of you for your participation today in today's annual shareholder meeting. We look forward to our next update on the third-quarter results in November. Thank you, everyone, and hopefully, we'll have many more updates before then. Thank you, everyone, and have a great day. Bye-bye. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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