CytoSorbents at H.C. Wainwright: Strategic Growth and Regulatory Challenges

On Monday, 08 September 2025, CytoSorbents Corporation (NASDAQ:CTSO) presented at the H.C. Wainwright 27th Annual Global Investment Conference. The company highlighted its commercial success with CytoSorb, while also addressing regulatory hurdles faced by DrugSorb-ATR. Despite growth in sales and revenue, challenges remain in gaining approval for its new device.

Key Takeaways

• CytoSorbents reported record sales of $36.1 million for its core product CytoSorb over the past year.
• The company experienced a 9% revenue increase in the second quarter, with notable growth in Germany.
• DrugSorb-ATR faces regulatory challenges, having received denial notices from both the FDA and Health Canada.
• The company holds $11.7 million in cash and aims for near cash flow break-even by the end of 2025.
• CytoSorbents is committed to addressing the unmet medical need for DrugSorb-ATR in the U.S. and Canada.

Financial Results

• Second quarter revenue grew by 9% year-over-year to $9.6 million.
• Germany exhibited a significant 22% sequential growth.
• CytoSorbents maintains a strong gross margin of 71%.
• The company holds $11.7 million in cash, cash equivalents, and restricted stock.
• Debt stands at $15 million, with $5 million available contingent on FDA approval.

Operational Updates

CytoSorb

• Achieved $36.1 million in core product sales over the past 12 months.
• CE-marked and used nearly 300,000 times in over 70 countries.
• Focuses on blood purification for critical care and cardiac surgery.

DrugSorb-ATR

• Designed to reduce perioperative bleeding during CABG surgery related to blood thinners.
• Received two FDA Breakthrough Device designations.
• Despite safety approval, faces regulatory hurdles with denial letters from FDA and Health Canada.
• The company is actively engaging with regulatory bodies to find a path forward.

Future Outlook

• CytoSorbents plans to continue discussions with the FDA and Health Canada for DrugSorb-ATR approval.
• The company aims to drive revenue growth and improve margins, targeting near cash flow break-even by the end of 2025.
• Focus remains on expanding its market presence in Germany and preparing for a potential U.S. and Canada launch of DrugSorb-ATR.

For further details, readers are encouraged to review the full transcript of the conference call.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Operator: Good day.

Sean, Agri Research Analyst, H.C. Wainwright: Can I start?

Okay.

Operator: Let’s go.

Sean, Agri Research Analyst, H.C. Wainwright: All right. Good day, everyone, and welcome to the H.C. Wainwright Global Investment Conference. My name is Sean, and I’m an Agri Research Analyst at the bank. For our next presentation, I’d like to welcome Dr. Phillip Chan, who is the CEO of CytoSorbents Corporation. CytoSorbents Corporation is a maker of blood purifiers and is a commercial company that’s active in many markets.

Operator: Thank you very much, Sean. Thank you, Sean, RK, Jim Cappuccio, and the rest of the H.C. Wainwright team for the kind invitation to present today. My name is Dr. Phillip Chan. I’m the CEO of CytoSorbents Corporation, and I’m joined today by my Chief Medical Officer, Dr. Efthymios Deliargyris, as well as Adanna Alexander from ICR Healthcare. As a publicly traded company, please let me remind you of our safe harbor statement for forward-looking statements. CytoSorbents, at a glance, has a platform blood purification technology for removing toxins and other harmful substances from a patient’s blood. We manufacture in Princeton, New Jersey, out of our manufacturing facility, a high-margin razor blade disposable that is a plug-and-play into existing hospital blood pumps, and we have two main products that leverage the underlying polymer technology.

The main one is CytoSorb, which is for the treatment of life-threatening conditions in the intensive care unit and cardiac surgery that had record core product sales of $36.1 million on a trailing 12-month basis as of the end of the second quarter and 71% product gross margins. This is CE-marked with nearly 300,000 uses cumulatively to date in more than 70 countries around the world. A second product that we’ll be talking about today is DrugSorb-ATR. This is an investigational device to reduce the severity of perioperative bleeding during CABG surgery related to blood thinners. This has been the recipient of two FDA Breakthrough Device designations, and we are currently in interactive discussions with both FDA and Health Canada about a streamlined and suitable path forward to seek marketing approval with an expected update in the near future. This targets a significant unmet medical need in the U.S.

as well as Canada, addressing initially a $300 million market opportunity that could grow to more than a billion dollars over time. The heart of our technology is a hemocompatible, highly porous polymer bead, roughly the size of a grain of salt, that acts like a tiny sponge to remove toxic substances from blood by pore capture, surface adsorption, as well as concentration. It has excellent removal on a broad range of substances from whole blood and plasma, and it has solid state. It’s a solid state porous polymer chemistry that does not use ligands, antibodies, cells, or biologics, and because of that, it is highly stable, gamma sterilizable, three-year shelf life at room temperature. We have 22 issued U.S. patents and multiple patents issued and pending worldwide, and this has been the beneficiary of approximately $50 million in grants from the U.S. government in non-diluted funding.

We are expanding the dimension of blood purification. CytoSorb is a powerful blood purification technology that removes a broad range of harmful substances that dialysis does not. As you know, dialysis works like your kidney, removing small molecules and water-soluble substances like metabolic waste products, electrolytes, and water-soluble drugs. However, we work like your other detoxification organ, your liver, being able to remove large molecules and fat-soluble substances, in particular macromolecules like cytokines, inflammatory mediators, bacterial toxins, liver toxins, and many other things, including lipophilic drugs. Unique to our therapy is that we have massive surface area. A single one of our cartridges has seven football fields’ worth of surface area on which to bind things versus only about three-quarters of a ping-pong table for a standard dialyzer. Turning to our core business of CytoSorb, CytoSorb controls massive inflammation, which is the heart of critical illness.

Acute inflammation is your body’s normal mechanism to fight injury and infection. However, severe inflammation, out of control inflammation that is driven by cytokine storm, can cause a chain reaction of problems that can end in organ failure and death. Shock, capillary leak, immune dysfunction, direct tissue damage, hypercoagulability, cell-mediated injury, and microvascular dysfunction is just the shortlist of things that this massive inflammatory response does. In fact, severe inflammation is the common threat amongst most critical illnesses and impacts up to 60% of patients in the intensive care unit and is directly correlated with the severity of illness, the incidence of organ failure, and mortality. CytoSorb, this is what we do. We control deadly inflammation, and we’ve been able to demonstrate the reversal or prevention of many of these complications. We target deadly conditions that afflict millions of people.

In critical care, we are removing the fuel to the fire of inflammation from the body to treat diseases like sepsis, influenza, COVID, burn injury, trauma, pancreatitis, liver failure, and many other illnesses. In cardiac surgery, we’re also reducing inflammation, but we’re also reducing drugs like blood thinners to prevent complications of cardiac surgery like sepsis, bleeding, shock, and others. As I mentioned before, CytoSorb helps to treat critical illnesses where massive inflammation plays a dangerous role, and this is why we have a play in nearly 40% to 60% of patients in the intensive care unit. Compare this to the only 10% to 15% of patients who require dialysis in the ICU that has created a multi-billion dollar market for companies like Fresenius Medical Care, Bantiv, B. Braun, and others.

We instead are focused on a much larger percentage of patients in the ICU for all the different illnesses that I talked about and more. Given that this week will be commemorating World Sepsis Day on the 13th, as well as this month is Sepsis Awareness Month, let’s talk a little bit about sepsis and septic shock, which is one of the leading indications that we have today worldwide. Sepsis is a life-threatening complex condition where the inflammatory response to serious infection can spiral out of control, fueled by the excessive production of cytokines, often called the cytokine storm, bacterial toxins, and other inflammatory agents. Unchecked, this massive inflammation can lead to septic shock, an often fatal complication marked by circulatory collapse, a lethal drop in blood pressure, and a host of other problems like capillary leak and fluid overload that can lead to multiple organ failure and death.

Sepsis and septic shock afflict a massive number of patients around the world. 49 million people estimated worldwide, killing 11 million, and is the number one cause of death in the world, accounting for one out of every five deaths worldwide each year. Supportive care treatment has improved, but mortality is still unacceptably high despite the use of antibiotics, fluids, mechanical life support, and drugs like vasopressors. We are leading a new era in sepsis treatment. For more than a decade, CytoSorbents has collaborated with clinicians and scientists around the world to advance the treatment of sepsis and septic shock by complementing traditional antibiotics that treat the infection on one hand with the broad spectrum capability of CytoSorb that treats the deadly inflammatory response by, again, removing the fuel to the fire of inflammation that causes this massive system crash in sepsis.

CytoSorb enables a multifaceted attack on septic shock with a wealth of published peer-reviewed studies that support the broad mechanisms of action of CytoSorb from beginning to end. CytoSorb helps to achieve the core treatment goals in septic shock to prevent or treat organ failure and help patients recover. These are: one, break the vicious cycle of massive uncontrolled inflammation; two, stabilize the patient, meaning reverse shock, improve lung function and oxygenation, improve oxygenated blood flow to the rest of the body. An evolving part of our story is the protection of blood vessels. These inflammatory toxins will cause the blood vessels to become leaky, breaking the endothelial barrier that prevents water from leaking out of your blood vessels. This water, unfortunately, in septic patients leaks out into the lungs, into the tissues, into the kidneys, drowning you from the inside out.

We are giving the gift of fluid removal with our therapy by helping repair these leaky blood vessels and allowing the active removal of excessive fluid and reducing fluid overload in these organs. We have found that the key to success is treating the right patient at the right time with the right dosing. Just like antibiotics, CytoSorb works most effectively when you treat early, when you treat intensively, and you complete the full course of treatment. Our COSMOS Registry is a critical care registry that collects real-world data on various applications in the European Union and abroad. Currently, we have 150 patients analyzed from the first analysis, where more than half of the patients had septic shock.

In these patients, you can see that the therapy has been very effective at leading to significant improvements in fundamental problems in critical illness, such as the potentially fatal drop in blood pressure, such as the leaking of the blood vessels, and also in the improvement of lung function and oxygenation of the patient’s blood. In addition, observed mortality rates in registry participants were lower compared to the predicted mortality rates according to standardized and established critical care risk scores. In another study done by Professor Berlot in Italy that was published earlier this year, this was a large retrospective single-center study of 175 patients with septic shock treated by CytoSorb, and they evaluated the impact of early versus late treatment versus low versus high-intensity treatment with CytoSorb on mortality compared to predicted mortality severity scores.

What you can see in the lower left is that when you treat early and you treat with high intensity, there’s a statistically significant reduction in mortality in patients compared to what was expected in these patients. In addition, what they found was that the more blood volumes you treat, the more blood volumes you put through our device, the better it works. You can see here that if you’re doing low-intensity treatment versus high-intensity treatment, there’s a statistically significant dramatic reduction in mortality. One of the very exciting papers that came out was a recent meta-analysis of 744 septic shock patients from multiple studies between 2019 and 2024, of which 449 patients were treated with CytoSorb. What they were able to demonstrate was that CytoSorb reduced in-hospital mortality and, importantly, also have the 28-day to 30-day mortality using the therapy compared to those that did not use the therapy.

This is the endpoint that is used for most major clinical studies and randomized controlled trials in sepsis. In addition, we saw significant hemodynamic improvement with reductions in vasopressor need in patients on CytoSorb. This leads me to a plug for our World Sepsis Day Global Webinar that I’ll be hosting this Wednesday at 11:00 A.M. called Turning the Tide in Sepsis and Septic Shock: Real-World Insights with CytoSorb, where we will be bringing experts that have been using our therapy this way, early intensive therapy over the right duration, and sharing their experiences with users from around the world. Now, turning to DrugSorb-ATR, again, this is focused on reducing blood thinners during cardiac surgery, specifically CABG surgery, coronary artery bypass graft surgery in patients needing unscheduled surgery.

Blood thinners, you may probably know someone, someone that you love or care about, or a colleague or friend that is on a blood thinner to reduce the risk of heart attack and stroke. Names like Eliquis, Xarelto, Brilinta, Plavix, even aspirin. The problem that we are trying to solve initially for this blood thinner issue is patients that are having a heart attack that commonly receive a super aspirin blood thinner like Brilinta to improve clinical outcomes. The problem with Brilinta is that it can cause serious and potentially life-threatening bleeding in patients that fail a cath, a stent placement, and need to go to CABG surgery. The only recommended therapy to try to prevent this bleeding is to have the patient wait while they’re having a heart attack in the hospital to wash out the drug.

If that were someone that you cared about, you would want them to go to surgery right away. That is what our therapy is helping, enabling surgeons to take these patients to surgery quickly. Frequently, surgery cannot wait, but now they face severe bleeding or delaying surgery has its own set of consequences. DrugSorb-ATR is a breakthrough designated device intended to solve this pervasive and serious unmet medical need in the U.S. and Canada that puts tens of thousands of patients at risk each year and, again, addresses a potentially greater than a billion dollar market opportunity over time. Now, again, this is the use case. Someone has a heart attack. Standard conventional wisdom says, "Call 911, take an aspirin," and that’s what they do in the emergency room. They give you an aspirin, and they give you a super aspirin like Brilinta.

Again, all these patients will go to the cath lab. 90% will get a stent, but up to 10% of patients will not be eligible for a stent because of diffuse disease, left main artery disease, maybe they actually perforated the coronary artery, for example. Those patients will need open heart surgery, but if they go to surgery, they will bleed. The only accepted therapy recommended by American Heart Association and American College of Cardiology is to wait in the ICU at $6,000 a day or step down at $4,000 a day or in a hospital monitored ward at $3,000 to $4,000 a day and three to five days to wash out this drug to then go to surgery.

What DrugSorb-ATR allows patients to do is to actually get rid of this waiting and allow patients to get the critical surgery they need without delay while reducing or preventing bleeding complications. We continue to demonstrate and be recognized for the ability of our therapy to address this critical global unmet medical need, particularly in CABG patients on Brilinta. At the Europe PCR Conference this year, Professor Robert Storey presented new comparative data on bleeding risk in 150 CABG patients on Brilinta with CytoSorb coming from our European STAR Registry, where CytoSorb has this indication. Again, we’re seeking DrugSorb-ATR approval for this indication in the U.S. and Canada, but CytoSorb has this indication in Europe versus 644 CABG patients in a meta-analysis control on Brilinta without CytoSorb.

The key findings here were that the use of CytoSorb was associated with significant reductions in the rates of severe CABG-related bleeding, 33% in the control, roughly 11% in the CytoSorb treated group. It significantly reduced the need for large transfusion events, meaning more than five units of blood, going from 27% of patients needing this type of large transfusion to only 6%, and a reduction in the need for reoperations to control bleeding, meaning they’re continuing to bleed. What’s wrong? They take them back to the operating room, they crack them open again to see maybe something was nicked accidentally or was it the blood thinner. That rate was more than halved from about 10% to 4%.

At the 73rd International Congress of the European Society of Cardiovascular and Endovascular Surgery, we were proud to announce that Professor Matthias Tillmann received the Best Oral Presentation Award for his talk, "Early CABG with Intraoperative Hemoadsorption in Patients on Brilinta: Real-World Data from the International STAR Registry" that is collecting real-world data on this for CytoSorb, highlighting the impact this technology is having in the rest of the world, and we look to bring this back to the U.S. Late in 2024, we had submitted a de novo application to FDA and also a health medical device license application to Health Canada, including the results from our START randomized control trial in the U.S. and Canada, as well as our real-world data from our STAR Registry.

Although the interactive review resolved many issues, we received a denial letter in April of this year citing remaining deficiencies that must be addressed to obtain marketing authorization, following an in-person appeal hearing with FDA in July with FDA senior officials and the FDA review team, our company, as well as cardiac surgery experts that we brought to the table. FDA, first of all, importantly, found no issues with device safety. This is extremely important because de novo is predicated on the benefit to risk of the device, but unfortunately, it did uphold its prior denial decision, citing the need for additional information to support our desired label indication.

However, importantly, they did proactively propose a path forward for market authorization of DrugSorb-ATR in the U.S., and we continue to have constructive discussions with the FDA to determine the best path forward and expect to provide an update in the near future. Meanwhile, in June 2025, we received a notice of refusal from Health Canada. I think this was predicated based on the fact that in our primary randomized control trial, we missed the primary endpoint, including all surgeries, but in the pre-specified subpopulation in CABG patients, we met the primary endpoint. That being said, it is what it was, but they cited these certain deficiencies in our application, following which we filed a level one request for reconsideration, and we plan to take up Health Canada pending a more definitive path with FDA.

Importantly, we continue to believe in the favorable benefit risk profile of DrugSorb-ATR and remain committed to driving marketing approval in the U.S. and Canada to help the tens of thousands of CABG patients who face this risk every single year. You may know someone who’s had to have surgery on a blood thinner, and this is just Brilinta alone. From a financial performance standpoint, second quarter, we grew about 9% with $9.6 million in revenue. It was led by 22% growth year over year, sequentially in Germany with continued strength in our other direct territories. Distributor sales were amongst our best ever.

It was down year over year because last year, our second quarter was extremely strong from a distributor standpoint, but we’re pleased with the initial results of a proactive reorganization in Germany that we undertook in Q1, and we hope to have more to show for our efforts come the second half here in 2025. Gross margins remain unchanged at 71%, and this is consistent with the average in 2024 as well as in the first quarter of last year. This is our annualized sales with the green showing trailing 12-month sales. We sell through nine countries direct and 60 other countries through distributors and partners. We have a strong balance sheet with $11.7 million in cash, cash equivalents, and restricted stock as of the end of the second quarter.

This includes $1.7 million received from the sale of New Jersey net operating losses in April, and we have roughly about $15 million in debt and $5 million still available to us on our $20 million debt agreement should we get FDA approval before the end of this year. We continue to prioritize initiatives to drive revenue growth, improve gross margins, and reduce costs to lead our core business towards near cash flow break even as we exit 2025 in preparation for potential market approval of DrugSorb-ATR and a launch in the U.S. and Canada. We believe overall we represent a clear and compelling value proposition. CytoSorb is the basis of our established international core business that generated $36 million in trailing 12-month sales with high product gross margins and expectations for continued growth because we are addressing a major unmet medical need in critical care and cardiac surgery.

We are out there promoting the right patient at the right time with the right dose of CytoSorb. We believe that will drive physician conviction, further physician conviction, and usage of our therapy. We have strong growth from direct sales outside of Germany and distributor partner sales, and we are encouraged by our active measures that we intend to drive Germany back to growth. Secondly, our goal is to drive towards near break even in our core business and achieve financial independence. This is a very important goal of ours.

Though not required for our success, we remain committed to bringing DrugSorb-ATR to the North American market again and continue to believe with no safety issues identified by FDA, we can successfully work through the remaining concerns with FDA and Health Canada and again bring DrugSorb-ATR to the tens of thousands of patients requiring CABG surgery on a blood thinner like Brilinta in these countries. With that, let me thank you very much, and I’m not sure if we have time for questions, but certainly appreciate your attention.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.