CytoSorbents Receives Recommendation from Independent Data and Safety Monitoring Board to Continue Pivotal STAR-T Trial As Planned Without Modifications
PRINCETON, N.J., Dec. 21, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has received the recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial as planned without any modifications.
Independent DSMB reviews unblinded data and recommends STAR-T study continue unchanged after first enrollment milestone
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, “The independent DSMB has completed the review of the full unblinded dataset from the first 40 patients enrolled in the STAR-T trial and we are very pleased to receive the recommendation to continue the study as planned without any modifications. All our clinical resources continue to focus on enrollment with the goal of achieving the next milestone of 80 patients enrolled by Spring 2023, triggering another safety review and the execution of the trial’s prespecified interim analysis by the independent DSMB.”
The STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study designed to evaluate the ability of DrugSorb-ATR® to reduce perioperative bleeding by removing the antithrombotic agent, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery. Brilinta is one of the leading “blood thinners” used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. But if the patient is one of the up to 10% that need to undergo coronary artery bypass graft (CABG) or other open heart surgery, the risk of major fatal or life-threatening CABG-related bleeding can be as high as 50-65%, particularly if the surgery is performed within several days of the last Brilinta dose. Waiting in the hospital to wash out the drug is the only acceptable alternative, but this comes at high cost and potential clinical risk. The goal of DrugSorb-ATR is to allow patients to get the critical surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug during the surgery. DrugSorb-ATR has received FDA Breakthrough Device Designation for this indication. The STAR-T pivotal study is being conducted by many of the leading cardiothoracic surgery centers in North America and is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of September 30, 2022, more than 186,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support FDA marketing approval in the United States and Health Canada marketing approval for DrugSorb-ATR in this application.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
PRINCETON, N.J., Nov. 14, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that 40 of the targeted 120 patients have been enrolled in the Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial, achieving the first enrollment milestone and triggering a pre-specified Data and Safety Monitoring Board (DSMB) review. This pivotal study intends to support both U.S. FDA and Health Canada marketing approval of DrugSorb-ATR in the United States and Canada, respectively, to remove the anti-thrombotic agent, ticagrelor (Brilinta®, AstraZeneca), during cardiothoracic surgery.
CytoSorbents’ pivotal STAR-T trial using DrugSorb-ATR to remove ticagrelor during cardiac surgery now a third complete
Dr. Michael J. Mack, Director of the Cardiovascular Service line at Baylor Scott & White Health System, Chairman of the Baylor Plano Research Center in Texas and co-Principal Investigator of the STAR-T trial commented: “Reaching our first trial enrollment milestone of 40 patients is a critical first step in the execution of the landmark STAR-T trial. Currently, cardiac surgeons are either forced to delay life-saving heart surgery in patients who are on antithrombotic drugs or proceed to operation when they are at very high risk for bleeding. The DrugSorb-ATR device is a novel approach that could potentially allow these high-risk surgeries to proceed in a safe and timely manner. We have designed two rigorous, pivotal trials to test the efficacy and safety of this novel device that if successful could make it available to all U.S. cardiac surgeons, so they can join their international colleagues who have it available and use it routinely in their everyday practice. We are currently focused on bringing the STAR-T trial across the finish line, so we can then turn our attention to STAR-D. I’d like to thank all of the participating centers and investigators for helping us reach this first crucial enrollment milestone and we remain very excited to welcome our Canadian colleagues who should begin contributing to enrollment very soon.”
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are pleased to have enrolled a third of our STAR-T pivotal study, which now triggers the first safety review by the independent DSMB of the study. We are now working diligently to complete the necessary operational steps including data collection and validation to support the upcoming DSMB safety review which is estimated in approximately 2 months. With our full attention and resources now dedicated to STAR-T and the upcoming addition of Canadian sites, we anticipate the momentum to continue and project that we can achieve the next study milestone of 80 patients enrolled in Spring 2023 that will trigger the next DSMB safety review and the pre-specified interim analysis.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of September 30, 2022, more than 186,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study intends to support both U.S. FDA and Health Canada marketing approval of DrugSorb-ATR in the United States and Canada, respectively, for this application. The STAR-T trial will be followed by the STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) pivotal trial evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
CytoSorbents expects to achieve first milestone of the U.S. pivotal STAR-T Trial this month
PRINCETON, N.J., Nov. 3, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today reported unaudited financial and operating results for the quarter ended September 30, 2022.
Third Quarter 2022 Financial Results
Total revenue, including product sales and grant income, for Q3 2022 was $8.1 million, a decrease of 17% compared to $9.8 million in Q3 2021
Q3 2022 product sales were $6.5 million (negligible COVID-related sales) versus $8.9 million (includes $1.1 million in COVID-related sales) in Q3 2021. The decrease in the average Euro to U.S. dollar exchange rate lowered Q3 2022 product sales by approximately $771,000. On a constant currency basis, Q3 2022 core non-COVID sales would have been approximately $7.2 million, which represents a 7% decrease from approximately $7.8 million in core non-COVID sales a year ago
As expected, COVID-19 related sales during the quarter were negligible, reflecting the low severity of current COVID-19 illness resulting from high rates of vaccination and natural immunity
Product gross margins were approximately 55% in Q3 2022, versus 82% in Q3 2021. The decrease in the gross margin percentage was due primarily to an inventory write-off related to an equipment failure and to inefficiencies associated with lower production due to a decrease in sales and the process of relocating our production activities to the new facility. Excluding the inventory write-off, product gross margin in Q3 2022 would have been 64%
The Company maintains a healthy balance sheet with cash and cash equivalents of $24.2 million (which includes $1.7 million in restricted cash) as of September 30, 2022, and no debt
Recent Operating Highlights:
More than 186,000 cumulative CytoSorb devices have been utilized worldwide as of September 30, 2022, compared to more than 152,000 devices utilized cumulatively a year ago
The U.S. STAR-T Trial is enrolling well with the expectation of achieving the first milestone with 40 patients enrolled this month
Achieved ISO 13485 certification of our new Princeton, New Jersey manufacturing facility
The Israeli Ministry of Health assigned national reimbursement coverage to CytoSorb for key intraoperative cardiac surgery indications such as antithrombotic drug removal, infective endocarditis, and aortic dissection
The Turkish Ministry of Health granted national reimbursement to CytoSorb, which is now a reimbursed catalog product in the State Supply of Turkey (DMO) portal and can be purchased directly by hospitals and physicians without restrictions
CytoSorbents received funding for HemoDefend-BGA™, a development stage product designed to enable life-saving universal plasma, under two separate Department of Defense contracts. This includes a two year contract valued at $1,977,024 to develop a fully-finished, commercial device that will be evaluated in a pre-clinical porcine study and a three-year Phase III contract valued at $4,292,641 to customize the design of the HemoDefend-BGA™ filter to enable freeze-dried universal plasma
Released new cardiac surgery data at the European Association for Cardio-Thoracic Surgery (EACTS) highlighting the benefits of CytoSorb when used intraoperatively during cardiothoracic surgery in Staphylococcus aureus infective endocarditis, heart transplantation, and to remove antithrombotic agents
The National Institute of General Medical Sciences (NIGMS), a division of the U.S. National Institutes of Health, granted a Phase I SBIR award, valued at $281,835, to CytoSorbents to test novel polymers for cytokine and endotoxin removal from septic porcine plasma, with the goal of advancing new blood purification technologies to treat Gram negative sepsis, a deadly global killer
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “Based upon the increased pace of enrollment, we are excited to be very close to achieving the first of three milestones of the U.S. STAR-T pivotal randomized, controlled study, where we expect to have 40 patients enrolled this month. Should the pace of the study continue, we expect to achieve the second milestone of 80 patients enrolled this Spring 2023, which would trigger a formal interim analysis, and if needed, expected potential completion of enrollment of all 120 patients by Summer 2023. We expect that if the STAR-T study is successful, we would be in a position to submit for U.S. FDA marketing approval for DrugSorb-ATR® in the second half of 2023.
Based upon these projections, and based upon the current macroenvironment, market conditions, and cash conservation imperative, we are taking a number of proactive steps as we work towards the expected achievement of this key objective.
1. Prioritize completion of the U.S. STAR-T Trial
The STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study designed to evaluate the ability of DrugSorb-ATR to reduce perioperative bleeding by removing the antithrombotic agent, Brilinta® (ticagrelor, Astra Zeneca) in patients undergoing cardiothoracic surgery. Today, Brilinta usage is being fueled by the fact that, according to the U.S. Centers of Disease Control and Prevention (CDC), heart disease is the leading cause of mortality in the U.S., accounting for 1 in every 5 deaths. Coronary artery disease is the most common form of heart disease, killing nearly 400,000 people from heart attacks each year. The CDC states that someone in the U.S. has a heart attack every 40 seconds, or more than 800,000 people annually. This is relevant for Brilinta because when patients have signs and symptoms of having a heart attack and cannot get a stent placed or coronary artery bypass graft (CABG) surgery right away, they are often placed on dual antiplatelet therapy (DAPT) in the hospital consisting of aspirin and a “super-asprin” like Brilinta, to thin the blood and reduce the risk of a worsening heart attack and death. If they are not candidates for a stent, they may require surgery but now face the risk of severe or uncontrolled bleeding because of DAPT intervention. The risk of bleeding depends on when the surgery takes place, but the risk of major fatal or life-threatening CABG-related bleeding can be higher than 50% if the surgery happens that day.
The goal of DrugSorb-ATR® is to allow patients to get the critical surgery that they need without delay, while reducing or preventing this bleeding risk by actively removing the drug during the surgery.
This indication has received FDA Breakthrough Device Designation, and is already approved in the European Union, with very positive published data on a reduction in bleeding risk, which is the primary endpoint of the STAR-T trial. In addition to this, there are a number of other reasons why we are excited about this study and believe it is the right time to primarily focus our resources on this trial.
a. STAR-T has overcome the typical inertia of new studies and is enrolling well with many centers participating
b. FDA has given approval to expand the study to Canadian hospitals, who are high users of ticagrelor and have been historically top enrollers in cardiac surgery trials. Expansion to Canada has the potential to accelerate enrollment and completion of the trial. We also believe inclusion of Canadian centers in the STAR-T study may support Health Canada marketing approval for DrugSorb-ATR, potentially helping to expand our commercial sales opportunities in North America
c. Ticagrelor will become generic globally in 2024, likely eliminating cost as the current barrier to usage, and should we stay on schedule, may be ideal timing for the expected commercial availability of DrugSorb-ATR in the U.S. and Canada
d. Ticagrelor monotherapy is now increasingly considered by the cardiology community as a more effective approach than aspirin to reduce cardio-thrombotic events, strokes, and ischemia in patients at high risk. As this treatment paradigm shift evolves, it may potentially change the recommendations on ticagrelor usage from 1 year, to lifelong therapy
e. Based on recent events and certain competitive dynamics, we believe we have the potential to have first-mover advantage in the U.S. market
f. And finally, we have received strong cardiothoracic surgeon feedback for this application internationally, highlighted by the rapidly enrolling STAR registry, which is ahead of schedule and has now enrolled 125 patients
2. Pause the U.S. STAR-D Trial
The U.S. STAR-D randomized, controlled trial is a 120-patient, 30 center pivotal study designed to evaluate the ability of DrugSorb-ATR to reduce perioperative bleeding by removing the direct oral anticoagulants (DOACs), Xarelto® (rivaroxaban, Janssen/Bayer) and Eliquis® (apixaban, Bristol-Myers Squibb/Pfizer), in patients undergoing cardiothoracic surgery. DOACs are used as chronic therapy to thin the blood to reduce the risk of stroke and heart attack in patients with atrial fibrillation, or a history of stroke, heart attack, or vascular disease, but uses a different mechanism of action than ticagrelor and are not directly interchangeable. However, like ticagrelor, patients on DOACs who require urgent cardiothoracic surgery have a particularly high risk of perioperative bleeding. The goal of DrugSorb-ATR in this population is identical to that for ticagrelor – remove the drug and reduce or prevent perioperative bleeding. In fact, we believe DrugSorb-ATR will eventually become the “one-stop-shop” for the removal of all classes of antithrombotic agents during cardiothoracic surgery, and potentially other surgeries such as orthopedic and neurosurgery, in the future.
We view STAR-D as the sister trial to STAR-T, that leverages many of the same study centers, trial design and user training, but trails STAR-T by at least 6 months. Rather than run this study in parallel, we have decided to pause STAR-D to focus our internal resources on our lead program, STAR-T, including opening new Canadian trial sites to potentially accelerate enrollment and drive STAR-T to completion. This will save an estimated $4 million in expenses in 2023. We fully intend to return to STAR-D when either STAR-T nears, or is at, completion or when we have the financial resources to do so.
3. Restore sales growth and product gross margins
We strongly believe that our commercial markets will recover, but it will take some time. To this point, 2022 continues to be a work-in-progress as hospitals in our core markets continue to struggle to recover from the worst of the COVID pandemic, while grappling with macroeconomic issues such as inflation and high energy costs. Internationally, many hospitals are operating in the red, with rising costs and decreased revenue from issues such as healthcare workforce shortages that negatively impact bed capacity, scheduled operations and procedures, and patient volume. Given our focus on critical care, cardiac surgery, and the hospital market, we are witnessing these issues firsthand. That said, we recorded approximately $6.5 million in core non-COVID product sales in a historically weak seasonal quarter, which on a constant currency basis, was approximately $7.2 million. Adjusting for currency effects, core sales were down 7% year over year, which we view as a modest decline.
As we wait for these global headwinds to clear, we are actively pursuing new exciting growth initiatives and sales optimization strategies to drive sales, despite the challenging environment. We have previously detailed a number of important programs that we are executing upon, such as our standalone blood pump initiative with Nikkiso, our global marketing agreement with Fresenius Medical Care, our therapy area focus in critical care, cardiac surgery, and liver & kidney, and our preferred supplier agreements with the top two largest private hospital networks in Germany, Asklepios and Helios. We believe each of these initiatives has the potential for a tangible return on investment and the ability to add significantly to our growth prospects. We also believe there are some exciting areas of growth in the treatment of acute respiratory distress syndrome (ECMO and CytoSorb), liver dysfunction and failure (CytoSorb), blood thinner removal (DrugSorb-ATR and CytoSorb), and ex vivo organ perfusion for transplant (e.g., ECOS-300CY® and PerSorb®), some of which we will discuss in more detail in the earnings call. In the meantime, we currently expect to return our product gross margins to historic levels (≥ 80%) in 2023, once we consolidate manufacturing completely to the new Princeton, New Jersey facility and close the old facility, and upon an expected resumption in CytoSorb sales growth, pending an improvement in market conditions.
4. Strengthen our cash balance with debt
We currently expect to bolster our balance sheet and current cash position by drawing down a portion of the $15 million in debt under our existing term loan facility before year-end. We believe this amount of debt is very manageable and will provide a suitable financial cushion for us as we drive our clinical and commercial initiatives.
5. Control expenses
Cash conservation is a priority and we continue to focus on controlling expenses. During 2022, we have already reduced our headcount by approximately 10% across our company, including full and part-time employees, and consultants, and shifted our R&D headcount to funded grant programs, where we have an extensive $13.2 million backlog as of the end of Q3 2022. Some of the cost savings of our headcount reduction are not yet visible in our results due to notice periods and labor laws in Europe, but will be reflected in our 2023 operating budget. Meanwhile, we are working diligently to prioritize activities that we believe have a near-term return on investment and advance our strategic priorities, while cutting non-core or non-essential activities and spend. Our goal is, through a combination of driving an increase in sales and gross margin, and cutting costs, to significantly reduce our cash burn and to extend our operating runway with the resources we have.
Dr. Chan concluded, “We are excited to rally around the progress of our U.S. STAR-T program and if successful, strongly believe this has the potential to unlock significant value in our Company and open up a very important commercial growth opportunity for years to come.”
Results of Operations
Comparison for the three months ended September 30, 2022 and 2021:
Revenues:
Total revenues were approximately $8.1 million for the three months ended September 30, 2022, as compared to total revenues of approximately $9.8 million for the three months ended September 30, 2021, a decrease of approximately $1.6 million, or 17%. Revenue from product sales was approximately $6.5 million in the three months ended September 30, 2022, as compared to approximately $8.9 million in the three months ended September 30, 2021, a decrease of approximately $2.4 million or 27%. The decrease in the average exchange rate of the Euro to the U.S. dollar negatively impacted 2022 product sales by approximately $.7 million. For the three months ended September 30, 2022, the average exchange rate of the Euro to the U.S. dollar was $1.01 as compared to an average exchange rate of $1.18 for the three months ended September 30, 2021. We estimate that demand for CytoSorb to treat COVID-19 patients was de minimis in the third quarter of 2022 as compared to approximately $1.1 million in the third quarter of 2021. Overall direct sales declined by approximately $1,407,000 resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market conditions, and unfavorable currency conversions. Although improved, continued staffing shortages, reduction in ICU bed capacity, decreased elective surgical procedures, hospital budgets, and hospital restrictions which at some hospitals continue to limit our access to hospital personnel, continue to impact the hospital market.
Grant income was approximately $1.6 million for the three months ended September 30, 2022, as compared to approximately $859,000 for the three months ended September 30, 2021, an increase of approximately $790,000, or 92%. During the three months ended September 30, 2021, our research and development employees were either deployed to work-from-home status or reassigned to assist in activities related to increasing the production of CytoSorb. In 2022, research and development employees were assigned exclusively to grant and other research and development activities.
Cost of Revenues:
For the three months ended September 30, 2022 and 2021, cost of revenue was approximately $4.5 million and $2.5 million, respectively. Product gross margins were approximately 55% for the three months ended September 30, 2022 as compared to approximately 82% for the three months ended September 30, 2021. The decrease in the gross margin percentage was due to an equipment failure of a refrigeration unit at our new manufacturing facility that caused a write-off of approximately $0.6 million of work-in-process inventory and to inefficiencies associated with lower production due to a decrease in sales and the process of relocating our production activities to the new facility. Excluding the write-off of inventory related to the equipment failure, product gross margin would have been 64% in Q3 2022.
Operating Expenses:
For the three months ended September 30, 2022, operating expenses were approximately $12.6 million, as compared to approximately $12.7 million for the three months ended September 30, 2021, a decrease of approximately $0.1 million. Selling, general and administrative (SG&A) expenses increased approximately $0.9 million to $8.7 million in the quarter from $7.8 million in the prior year. This increase was due to an increase in sales and marketing costs, which include advertising and conference attendance of approximately $0.4 million, an increase in occupancy costs of approximately $0.4 million related to the rent expense on our new manufacturing facility, increases in salaries, severance, commissions, and related costs of approximately $0.1 million and an increase in other general and administrative expenses of approximately $0.2 million. This was offset by a decrease in royalty expenses of approximately $0.2 million due to the decrease in product sales. Research and development expenses decreased approximately $1.0 million due to a decrease of approximately $0.7 million in clinical trial expenditures and a decrease in non-grant R&D activities of approximately $0.3 million.
Loss on Foreign Currency Transactions:
For the three months ended September 30, 2022, the loss on foreign currency transactions was approximately $3.2 million as compared to a loss of approximately $1.0 million for the three months ended September 30, 2021. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar, which was $0.98 as of September 30, 2022 as compared to $1.05 at June 30, 2022.
Comparison for the nine months ended September 30, 2022 and 2021:
Revenues:
Total revenues were approximately $25.3 million for the nine months ended September 30, 2022, as compared to total revenues of approximately $32.4 million for the nine months ended September 30, 2021, a decrease of approximately $7.1 million, or 22%. Revenue from product sales was approximately $21.1 million in the nine months ended September 30, 2022, as compared to approximately $30.4 million in the nine months ended September 30, 2021, a decrease of approximately $8.7 million, or 29%. The decrease in the average exchange rate of the Euro to the U.S. dollar negatively impacted 2022 product sales by approximately $2.3 million. For the nine months ended September 30, 2022, the average exchange rate of the Euro to the U.S. dollar was $1.06 as compared to an average exchange rate of $1.20 for the nine months ended September 30, 2021. Though difficult to quantify, we estimate that approximately $0.3 million of total product sales in the nine months ended September 30, 2022 was due to the demand for CytoSorb to treat COVID-19 patients as compared to $4.6 million in the nine months ended September 30, 2021. Overall direct sales declined by of approximately $6.8 million resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market conditions and unfavorable currency exchange conversions. Although improved, continued staffing shortages, reduction in ICU bed capacity, decreased elective surgical procedures, hospital budgets, and hospital restrictions which at some hospitals continue to limit our access to hospital personnel, continue to impact the hospital market.
Grant income was approximately $3.6 million for the nine months ended September 30, 2022 as compared to approximately $2.0 million for the nine months ended September 30, 2021, an increase of approximately $1.6 million or 81%. During the nine months ended September 30, 2021, our research and development employees were either deployed to work-from-home status or reassigned to assist in activities related to increasing the production of CytoSorb. In 2022, research and development employees were assigned exclusively to grant and other research and development activities.
Cost of Revenues:
For the nine months ended September 30, 2022 and 2021, cost of revenue was approximately $10.3 million and $7.9 million, respectively, an increase of approximately $2.4 million. Product gross margins were approximately 68% for the nine months ended September 30, 2022 and approximately 80% for the nine months ended September 30, 2021. The decrease in the gross margin percentage in 2022 was primarily due to an equipment failure of a refrigeration unit at our new manufacturing facility that caused a write-off of approximately $0.6 million of work-in-process inventory and to inefficiencies associated with lower production due to a decrease in sales and the process of relocating our production activities to the new facility, including a scheduled four-week production hiatus in Q2 2022.
Operating Expenses:
For the nine months ended September 30, 2022, operating expenses were approximately $40.1 million as compared to approximately $37.6 million for the nine months ended September 30, 2021, an increase of approximately $2.5 million, or 7%, for the nine months ended September 30, 2022. Research and development expenses were approximately $11.7 million as compared to approximately $10.2 million for nine months ended September 30, 2021, an increase of approximately $1.5 million or 14%. This increase was primarily due to an increase in costs associated with our STAR-T and STAR-D trials in the United States. Selling, general and administrative expenses were approximately $26.3 million for the nine months ended September 30, 2022, as compared to $25.3 million for the nine months ended September 30, 2021, an increase of $1.0 million. This increase is related to an increase in sales and marketing costs, which include advertising and conference attendance of approximately $1.1 million, an increase in salaries, severance, commissions, and related costs of approximately $1.3 million, an increase in travel and entertainment costs of approximately $0.5 million and an increase in occupancy costs of approximately $1.1 million related to the rent expense on our new manufacturing facility. These increases were offset by a decrease in royalty expenses of approximately $0.7 million, a decrease in non-cash restricted stock expense of approximately $1.7 million related to restricted stock units granted to the Company’s executive officers, a decrease in non-cash stock compensation expense of approximately $0.7 million.
Loss on Foreign Currency Transactions:
For the nine months ended September 30, 2022, the loss on foreign currency transactions was approximately $7.0 million as compared to a loss of approximately $2.1 million for the nine months ended September 30, 2021. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar which was $0.98 as of September 30, 2022 as compared to $1.14 as of December 31, 2021.
Liquidity and Capital Resources
Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of September 30, 2022, we had current assets of approximately $32.4 million including unrestricted cash on hand of approximately $22.6 million and current liabilities of approximately $10.1 million. As of September 30, 2022, $25 million of our total shelf amount was allocated to our ATM facility, all of which remains available. In addition, we have $15 million of debt availability, providing financial flexibility, if needed. In April of 2022, we received approximately $0.7 million in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey.
We are also managing our resources proactively, continuing to invest in key areas such as our U.S. clinical program. while driving cost-cutting throughout our Company. At the beginning of Q2 2022, we began instituting tighter cost controls and have reduced our headcount internationally by 10%, with the goal of reducing our cash burn. A reduction in product sales and product gross margins, as well as a delay in realizing headcount reduction cost savings in Europe, have offset these cost cutting efforts. We are currently actively engaged in making further reductions to our operating costs to reduce our future cash burn.
Including cash related to the use of a portion of our available debt facility, we believe that we have sufficient cash to fund the Company’s operations beyond twelve months from the issuance of these consolidated financial statements.
Outlook Guidance
The macro environment in which we operate remains difficult to predict given the complex drivers of our business, the global nature of our operations, and external factors such as the COVID-19 pandemic, the Russia-Ukraine war, inflation, foreign currency exchange rate volatility, and other factors that are not under our direct control.
We expect that our business, and in particular product sales, will continue to be challenging for the remainder of 2022 and into 2023. However, we expect a gradual recovery of normalized hospital activity and sales access in Germany and other key countries in the coming quarters. With improved access, we expect a resumption of growth in our core non-COVID-19 product sales.
Meanwhile, we remain focused on completing enrollment of our U.S. STAR-T randomized, controlled trial for ticagrelor removal during cardiothoracic surgery, estimated for Summer 2023, and if successful, being in a position to apply for U.S. FDA marketing approval in the second half of 2023.
For additional information, please see the Company’s Form 10-Q for the period ended September 30, 2022, filed on November 3, 2022, on http://www.sec.gov.
Conference Call
The Company will conduct its third quarter 2022 results call today at 4:30 p.m. Eastern time.
It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: : https://viavid.webcasts.com/starthere.jsp?ei=1576192&tp_key=7e23c8c13c
About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in more than 70 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of September 30, 2022, more than 186,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other body fluids through pore entrapment and surface adsorption. The company’s technologies have received more than $41.5 million in non-dilutive grants, contracts and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC) and others. The company has numerous marketed and in-development products based on this unique blood purification technology protected by numerous issued U.S. and international patents and registered trademarks, as well as several pending patent applications, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb and others. For more information, please visit the company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (amounts in thousands, except per share data)
Three months ended September 30,
Nine months ended September 30,
2022
2021
2022
2021
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Revenue:
CytoSorb sales
$
6,271
$
8,901
$
21,176
$
30,405
Other sales
191
1
542
6
Total product sales
6,462
8,902
21,718
30,411
Grant income
1,649
858
3,580
1,972
Total revenue
8,111
9,760
25,298
32,383
Cost of revenue
4,494
2,463
10,322
7,924
Gross profit
3,617
7,297
14,976
24,459
Other Expenses:
Research and development
3,290
4,262
11,717
10,244
Legal, financial and other consulting
609
665
2,089
2,090
Selling, general and administrative
8,735
7,776
26,335
25,308
Total expenses
12,634
12,703
40,141
37,642
Loss from operations
(9,017)
(5,406)
(25,165)
(13,183)
Other income/(expense):
Interest income (expense), net
47
13
79
16
Loss on foreign currency transactions
(3,231)
(1,013)
(6,967)
(2,085)
Miscellaneous Income
—–
—–
7
—–
Total other expense), net
(3,184)
(1,000)
(6,881)
(2,069)
Loss before benefit from income taxes
(12,201)
(6,406)
(32,046)
(15,252)
Benefit from income taxes
—–
—–
—–
—–
Net loss
$
(12,201)
$
(6,406)
$
(32,046)
$
(15,252)
Basic and diluted net loss per common share
$
(0.28)
$
(0.15)
$
(0.74)
$
(0.35)
Weighted average number of shares of common stock outstanding
43,606,980
43,396,464
43,552,238
43,319,507
Net loss
$
(12,201)
$
(6,406)
$
(32,046)
$
(15,252)
Other comprehensive income (loss):
Currency translation adjustment
2,659
808
5,675
1,701
Total Comprehensive loss
$
(9,542)
$
(5,598)
$
(26,371)
$
(13,551)
CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (amounts in thousands)
90-day survival was 74% overall, with early intervention with ECMO and CytoSorb associated with improved survival, and shorter duration on ECMO, mechanical ventilation, and ICU stay compared to late intervention
PRINCETON, N.J., Nov. 2, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using its CytoSorb® blood purification technology, announced the presentation of the final key results from the U.S. multicenter CytoSorb Therapy in COVID-19 (CTC) Registry at the 35th Annual Congress of the European Society of Intensive Care Medicine (ESICM) in Paris last week. CytoSorb was granted U.S. FDA Emergency Use Authorization (EUA) in April 2020 for use in adult, critically ill COVID-19 patients with imminent or confirmed respiratory failure to reduce cytokines and other inflammatory toxins that can cause hyperinflammation. Severe hyperinflammation is strongly correlated with more severe COVID-19 illness, need for mechanical ventilation, and risk of death.
Enhanced lung rest with CytoSorb+ECMO yields high survival among sickest COVID-19 patients with refractory lung failure
The CTC registry captured outcomes data on 100 critically ill hyper-inflamed COVID-19 patients with severe acute respiratory distress syndrome (ARDS) and refractory respiratory failure who were treated with an “Enhanced Lung Rest” strategy using CytoSorb and extracorporeal membrane oxygenation (ECMO) at five major U.S. ECMO centers. ECMO helps to rest the lungs and avoid ventilator-induced lung injury (VILI) by pumping blood and conducting gas exchange outside of the body, and reducing or eliminating the need for mechanical ventilation. CytoSorb® is easily installed into the ECMO circuit and actively removes a broad range of cytokines and other inflammatory toxins from the bloodstream that can cause blood vessel injury and capillary leak syndrome – a key pathology in ARDS that results in pulmonary edema, severely compromised gas exchange, and unrelenting damage to the lungs. The goal of this “Enhanced Lung Rest” strategy is to allow the lungs to rest and heal, which we believe is the key to reversing ARDS, getting patients off of ECMO and mechanical ventilation, and ultimately to survive.
Primary Outcome: Survival
In 100 patients treated with CytoSorb and ECMO at 5 U.S. centers, survival was 86% at 30 days and 74% at 90 days. For context, the International Extracorporeal Life Support Organization (ELSO) COVID-19 registry, reported survival of 52% at 90 days in the North American cohort (11/2/22, n=9,509)
Secondary analyses:
CytoSorb was initiated significantly earlier following ICU admission in survivors compared with non-survivors: 64 (34-151) vs. 151(44-260) hours, p=0.007*
Compared to non-survivors, survivors had significantly lower levels of inflammatory mediators after 3 days of CytoSorb treatment, such as CRP: 6.9 (2.1-11.0) vs 9.5 (6.0-17.1) mg/dL, p=0.04, and ferritin: 743.0 (339.5-1237.0) vs 1,622.0 (986.0-3411.0) ng/mL, p=0.0002, and required less time on ECMO: 302 (161-932) vs. 630 (268-1187) hours, p=0.04*
Among survivors, those where CytoSorb was initiated early before the median start time of ≤ 86.7 hours after ICU admission, had a trend to improved survival (78% early vs 62% late, p=0.08) and significantly shorter average duration on ECMO (532.76 ± 533.05 vs. 800.74 ± 701.67 hours; p=0.021). Time on mechanical ventilation [167 (43-597) vs. 321 (67-909) hours, p=0.045] and time to ICU discharge [17 (10 – 40) vs. 36 (19 – 55) days, p=0.002] were also significantly reduced in patients treated earlier*
Combined ECMO and CytoSorb treatment was performed with no device related adverse events reported by any of the centers
* Values represented as median (interquartile range)
Dr. J.W. Awori Hayanga, MD, MPH, FACS, FRCS, FCCP, Professor in Cardiovascular & Thoracic Surgery and Director of the ECMO program at West Virginia University School of Medicine, led a team of investigators from 5 U.S. academic institutions to implement the strategy of “enhanced lung rest” in this population. Dr. Hayanga commented, “We are pleased with the very favorable survival rates that we observed in the CTC Registry among the sickest possible COVID-19 patients that are on life support with ECMO. These results suggest that hyperinflammation plays a critical role in the severity of respiratory failure in patients with ARDS and support the strategy of integrating CytoSorb with ECMO to simultaneously rest and heal the lungs. This multicenter dataset is very exciting and sets the stage for further investigation into this novel approach to treat severe ARDS.”
Dr. Joerg Scheier, Vice President, Medical Affairs – Critical Care at CytoSorbents commented, “These compelling results support the concept of improved lung protection and recovery with CytoSorb in combination with veno-venous ECMO treatment. We see from the data that, very similar to other CytoSorb application fields, early initiation of CytoSorb therapy seems to be a key to positive treatment outcomes. Overall, these very positive results on ECMO-integrated CytoSorb therapy support the further evaluation of the promising and safe approach of “enhanced lung rest” by the combination of ECMO and CytoSorb in the treatment of ARDS.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “This is the largest multicenter case series using CytoSorb with ECMO in critically ill COVID-19 patients in the world to date. It highlights that when CytoSorb is used in the right patients, at the right time, with the right dose, the outcomes are excellent and reproducible among different centers. Specifically, we targeted early intervention with CytoSorb and ECMO in COVID-19 patients with hyperinflammation who developed refractory respiratory failure and severe ARDS and rapidly failed mechanical ventilation, and who did not yet have fulminant thromboembolic disease as measured by D-dimers. These criteria were based upon knowledge gained from the CytoSorb-ECMO user community around the world during the rapidly evolving pandemic, most of whom have had years of experience integrating the two therapies together to treat non-COVID ARDS, our own insights, and those from our former Chief Medical Officer and pioneer of ECMO, Dr. Robert Bartlett. We are grateful to have had the opportunity to positively impact the lives of critically ill COVID patients here in the U.S. under FDA EUA and those around the world and look forward to advancing this concept of “enhanced lung rest” for the primary treatment of moderate to severe ARDS in the future.”
About CytoSorb FDA Emergency Use Authorization
In April 2020, the United States Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to CytoSorb® for use in patients with COVID-19 infection. The EUA allows CytoSorb to be commercially sold to, and used in, all hospitals in the United States for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure who have either severe disease, early acute lung injury or acute respiratory distress syndrome (ARDS), or life-threatening illness resulting in respiratory failure, septic shock, and/or multiple organ dysfunction or failure. As with all EUA therapies, the CytoSorb device has neither been cleared nor approved for the indication to treat patients with COVID-19 Infection. The EUA will be effective until the declaration, that circumstances exist justifying the authorization of the emergency use of the CytoSorb device during the COVID-19 pandemic, is terminated under section 564(B)(2) of the Act, or the EUA is revoked under section 564(g) of the Act.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Goal is to advance new combined blood purification technologies to treat Gram negative sepsis – a deadly global killer
PRINCETON, N.J., Oct. 31, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the National Institute of General Medical Sciences (NIGMS), a division of the U.S. National Institutes of Health, has granted CytoSorbents a Phase I Small Business Innovation Research (SBIR) award valued at $281,835. The eight-month award (Award #1R43GM144973-01) will allow CytoSorbents to test the ability of its novel and existing polymers to remove cytokines and lipopolysaccharide (LPS) endotoxin from septic porcine plasma. LPS endotoxin, released by Gram-negative bacteria such as E. coli, Salmonella, Pseudomonas, Klebsiella, and Legionella, is a well-known potent and deadly trigger of sepsis and septic shock by activating the immune system and generating a cytokine storm that can lead to massive, uncontrolled systemic inflammation, organ failure, and potentially death.
Goal is to advance new combined blood purification technologies to treat Gram negative sepsis – a deadly global killer
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, “Gram-negative infections play an important and feared role in sepsis, accounting for approximately 40% of cases of septic shock, and more than 30% of hospital-acquired infections. These patients tend to be very sick and have a high risk of death. We are the pioneer in the treatment of sepsis and septic shock by targeting cytokine storm and deadly inflammation with our European Union approved extracorporeal cytokine adsorber, CytoSorb®. But we believe the combination of extracorporeal cytokine and endotoxin removal from blood, in conjunction with antibiotics, may be an even more effective therapy for Gram-negative infections, and will help us to save more lives. We are grateful for the support from NIGMS to conduct the preliminary in vitro work needed before we evaluate our new polymers in a pig model of Gram-negative sepsis in the future.”
Sepsis is the overzealous immune response to an infection and is responsible for approximately one in every five deaths worldwide each year. This has led the World Health Organization (WHO) to declare it a “global health priority.” Sepsis accounts for approximately 10-20% of all intensive care unit (ICU) admissions, where patients either have sepsis when admitted to the ICU, or develop sepsis as a result of a nosocomial or hospital-acquired infection while in the ICU. Gram-negative infections commonly trigger septic shock, a serious complication of sepsis where the blood pressure drops to dangerously low levels and organ failure and death can ensue. Despite antibiotics and the best standard of care, septic shock still has a mortality of 35-50%.
The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
PRINCETON, N.J., Oct. 27, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will report third quarter 2022 operating and financial results after the market close on Thursday, November 3, 2022. CytoSorbents’ management will host a live conference call and presentation webcast at 4:30 p.m. Eastern the same day.
It is recommended that participants dial approximately 10 minutes prior to the start of the call. An archived recording of the conference call will be available under the Investor Relations portion of the company’s website at https://cytosorbents.com/investor-relations/financial-results/
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-looking statements
This press release contains forward-looking statements that fall within the safe harbor of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding our plans, objectives, future goals and prospects for our business, expectations regarding the future impact of COVID-19 or the ongoing conflict between Russia and Ukraine, representations and assertions, and are not historical facts and are generally identified by the use of words such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar terms, although some forward-looking statements are worded differently. You should be aware that the forward-looking statements in this press release reflect management’s current beliefs and expectations, but that our actual results, events and performance may differ materially from those in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the risks disclosed in our Annual Report on Form 10-K filed with the SEC on March 10, 2022, our Quarterly Reports on Form 10-Q and the press releases and other communications to stockholders that we issue from time to time seeking to inform interested parties of the risks and factors that may affect our business. We caution you not to place undue reliance on such forward-looking statements. We are under no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by federal securities laws.
PRINCETON, N.J., Oct. 12, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced the presentation of exciting new data on the use of CytoSorb® in various cardiac surgery indications at the 36th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting last week in Milan, Italy.
The incidence of infective endocarditis, or infection of a heart valve, is increasing globally. Staphylococcal aureus endocarditis (SAE) accounts for roughly a quarter to a third of all cases and is a dreaded complication associated with intravenous drug abuse and use of dirty needles, hospital-acquired infections, prosthetic heart valves, and community acquired endocarditis. Importantly, SAE is the most aggressive form of valvular infection and can lead to a myriad of complications including rapid destruction of the valve, heart failure, cytokine storm, florid septic shock, septic embolization, and the highest mortality risk among all types of infective endocarditis, even with surgical replacement of the heart valve. CytoSorb is used in this patient population during open heart surgery to control cytokine storm, reduce inflammation and Staphylococcal toxins, and reverse shock.
Study population: 130 consecutive patients with confirmed SAE who underwent heart valve surgery at 2 leading German Heart Centers between 01/2015 – 03/2022. Mean age (60.8 vs. 60.7, p=ns) and baseline risk according to EuroScore II (12.0 vs. 11.9, p=ns) were nearly identical in the two groups. Approximately 25% of patients had a repeat cardiac operation while almost 20% were IV drug users.
Study objectives: To compare clinical outcomes between patients who underwent standard of care valve replacement surgery (Control group; n=55) and patients who underwent standard of care valve replacement surgery plus intraoperative hemoadsorption (HA) with CytoSorb (n=75).
Primary outcome: Postoperative vasopressor requirements assessed by the Vasoactive-Inotropic Score (a well-established and accepted measure of vasopressor support required to manage hemodynamic instability) was significantly reduced in the CytoSorb group at 6, 12, 24, 48 and 72 hours (p<0.02 for all), consistent with improved hemodynamic stability after surgery
Secondary outcomes: Sepsis-related mortality was significantly reduced in the CytoSorb group (8.0% vs. 21.8%, p=0.02), as was overall 30-day (17.3% vs. 32.7%, p=0.03) and 90-day mortality (21.3% vs. 40%, p=0.03). This marked effect on mortality translated into a Number Needed to Treat (NNT) of just 5 patients to save a life.
The authors summarized the results as: “1) Mortality following cardiac surgery in infective endocarditis, particularly caused by S. aureus, is still high; 2) Intraoperative cytokine adsorption leads to improved postoperative hemodynamics, 3) Improved survival in patients treated by intraoperative adjunctive hemoadsorption” and concluded that: “Hemoadsorption with CytoSorb seems to be a safe and effective adjunctive therapy in Staphylococcus aureus infective endocarditis during cardiac surgery.“
Dr. Daniel Wendt, Vice President – Medical Affairs Cardiovascular at CytoSorbents, stated, “The selection of this study for presentation in the main scientific program highlights the importance of these findings. As these results clearly demonstrate, CytoSorb can address some of the biggest management challenges in these very high risk endocarditis patients.”
CytoSorbents also hosted a lunch symposium entitled, “Hemoadsorption with CytoSorb in high-risk cardiac surgery indications – new data” that drew approximately 150 attendees and was chaired by Professors Christophe Baufreton (Angers, France) and Piotr Suwalski (Warsaw, Poland). Key presentations included:
“Clinical benefits in patients undergoing heart transplantation – results of a single center RCT.” Dr. Endre Németh (Budapest, Hungary) presented the results of the first ever randomized, controlled trial (RCT) using CytoSorb intraoperatively during cardiac transplantation.
Study population: 55 patients were randomized 1:1 to either standard of care (SOC) or SOC plus CytoSorb. Baseline characteristics were well-balanced between the two groups, including mean recipient age of 56 years in both arms and donor heart age of approximately 10 years less. Approximately half of the patients suffered from idiopathic cardiomyopathy and approximately one third from ischemic cardiomyopathy. Both cardiopulmonary bypass duration (SOC 129 [104-169] vs. SOC + CytoSorb 133 [116-165] minutes, p=ns) and total ischemic time (SOC 173±41 vs. SOC + CytoSorb 152±45 minutes, p=ns) were similar.
Primary outcome: Need for vasopressors to support blood pressure as measured by the Vasoactive Inotropic Score (VIS) was significantly reduced by CytoSorb (p=0.046), driven by reductions in both noradrenaline and vasopressin requirements. Importantly, this resulted in significantly lower rates of vasoplegia or vasodilatory shock (SOC 48% vs. SOC + CytoSorb 20%; 58% relative risk reduction (RRR), p=0.028) and shorter overall duration of vasopressor support (p=0.046).
Secondary outcomes: All clinical secondary endpoints evaluated in the trial were either similar between the two groups or statistically superior with SOC + CytoSorb including less time on mechanical ventilation (SOC 65 [23-287] vs. 25 [19-68.8] hours, p=0.025), lower rates of postoperative acute kidney injury (SOC 76% vs. SOC + CytoSorb 36.7%; RRR 52%, p=0.004) and fewer days in the ICU (SOC 12 [8.5-18] vs. 8.5 [8-10.3] days, p=0.022). Importantly, there were no differences in all rejection markers evaluated at 30 days, while there were 2 deaths in the SOC group and no deaths in the CytoSorb group.
Based on these RCT data, the authors concluded that proactive intraoperative CytoSorb use in patients undergoing heart transplantation resulted in important improvements in clinical and economic outcomes, including: 1) Significantly improved postoperative hemodynamic stability with reduced severity and duration of vasoplegia, 2) Significantly lower rates of postoperative acute kidney injury, 3) Significantly shorter time on postop mechanical ventilation, and 4) Significant reduction in ICU stay.
Key Outcomes: Among CABG patients, the use of CytoSorb was associated with significant reductions in 24-hour chest tube drainage (relative risk reduction [RRR] 60%; p=0.004), platelet (RRR 67%; p=0.048) and red blood cell transfusions (RRR 67; p=0.012) and need for re-operation (RRR 100%; p=0.0003). Total operative time was also significantly reduced (RRR 15%; p=0.004) and patients who underwent antithrombotic removal with CytoSorb spent 2 fewer days in the ICU (RRR: 50%; p=0.014) and 5 fewer days overall in the hospital (RRR 31%; p=0.024). Similar types and magnitude of benefits were also observed in patients undergoing antithrombotic removal during aortic dissection surgery, but due to the smaller sample size, statistical significance was only achieved for reduction in 24-hour chest tube drainage (RRR 47%, p<0.001) and platelet transfusions (RRR 31%, p=0.049).
Cost Benefit: A boot strap analysis on the 55 CABG patients, investigating the budget impact of CytoSorb use for antithrombotic removal, demonstrated CytoSorb to be a dominant therapy resulting in both clinical benefit and also substantial cost-savings. Specifically, each use of CytoSorb was associated with median budget savings of approximately € 4,200 (including the cost of the device), driven primarily by less operative time and shorter ICU stays.
“CytoSorb in infective endocarditis patients – what can we learn from recent data?” Professor Matthias Thielmann (Essen, Germany) followed his presentation in the main scientific session of the conference by providing a summary of recently published data from different studies at the West German Heart & Vascular Center, highlighting the use of CytoSorb in cardiac surgery applications to mitigate the harmful effects of surgery.
Publication on “Intraoperative hemoadsorption in patients with native mitral valve infective endocarditis” in 58 consecutive patients (CytoSorb, n=30; Control, n=28) showed that CytoSorb led to a significant reduction in the need for vasopressors, a reduced incidence of postoperative sepsis (Control 39.2% vs CytoSorb 16.7%, p=0.05), and a significant reduction in sepsis-related mortality (Control 18% vs CytoSorb 0%, p=0.02) in this well-defined population.
Publication on “Extracorporeal cytokine adsorption: Significant reduction of catecholamine requirement in patients with AKI and septic shock after cardiac surgery” detailed a case series of 98 high-risk cardiac surgery patients who developed postoperative acute kidney injury and sepsis, and were treated by postoperative continuous renal replacement therapy (CRRT) plus 15 hours of adjunctive hemoadsorption with CytoSorb. In this trial, that involved the Department of Nephrology at the University of Essen in a team-based, patient-centric approach, patients demonstrated a rapid and significant decrease of lactate levels and vasopressor support.
Publication on “Intraoperative hemoadsorption in high-risk patients with infective endocarditis” evaluated a series of 70 high-risk patients undergoing cardiac surgery for infective endocarditis. In a propensity-score matched comparison (35 vs. 35 patients), the SOFA-score normalized significantly faster over a 7-day period in the CytoSorb treated group, among other benefits.
Professor Thielmann then commented on the results of the REMOVE endocarditis trial and compared them to the latest data from the University of Nuremberg and Essen and concluded that patient selection in infective endocarditis is crucial, especially since high-risk patients, such as those with SAE, are likely to benefit most from adjunctive hemoadsorption techniques. Professor Thielmann concluded by stating that CytoSorb is the only new concept in the surgical treatment of infective endocarditis in many years, and has been used routinely for this indication at his institution.
Dr. Wendt added, “I was delighted to attend the annual EACTS meeting in person this year and was impressed by my discussions with so many highly-motivated and experienced cardiac surgeons and intensivists from all over the world who are using CytoSorb during and after cardiothoracic surgery. From Hamburg to Madrid, Budapest to Rome, and Warsaw to Paris, clinical adoption of CytoSorb is rapidly increasing as cardiac surgeons recognize the significant benefits of using hemoadsorption in their most challenging cases. With more data coming from multiple investigator-initiated trials, as well as our own company-sponsored studies, we anticipate that this momentum will only grow stronger in the future. As a busy academic cardiac surgeon, I had the opportunity to use CytoSorb in my most challenging cases for many years and witnessed first-hand its value in my practice. In my current role, my top priority is to make our key enabling technology the new standard in cardiac surgery around the world.”
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents concluded, “The new data presented at this year’s EACTS conference validate our conviction that our proprietary hemoadsorption therapy is a “game-changing” intervention in cardiac surgery. The clinical benefits ranging from reversing shock and stabilizing patients postoperatively, to shorter ICU stays for heart transplant patients, to significantly less bleeding in patients on antithrombotic drugs undergoing high risk surgery, to reductions in mortality in the sickest endocarditis patients, speak to the power of our technology. These data support a robust clinical and economic value proposition that directly translates to significantly better outcomes and cost savings to heart centers around the world. We remain laser-focused on our clinical efforts to continue generating high quality evidence in cardiac surgery and are committed to making our technology available to U.S. centers with the execution of our currently ongoing pivotal STAR-T and STAR-D trials under FDA Breakthrough Device Designation.”
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
PRINCETON, N.J., Oct. 7, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that its Chief Financial Officer, Kathleen P. Bloch, MBA, CPA, plans to retire on March 31, 2023 at age 68, following a distinguished decade-long career at the Company. A search has been initiated for Ms. Bloch’s replacement. Meanwhile, following her retirement next year, Ms. Bloch will continue as a consultant of the Company to provide, among other services, continuity during the transition of her successor.
Ms. Bloch stated, “It has been a privilege and a pleasure to be a part of the incredible team at CytoSorbents over the past 9 plus years, during which time we have achieved rapid growth in both our company and our business, while helping to save the lives of patients around the world. It has been an exciting and personally fulfilling journey, made more enjoyable by the positive chemistry and culture of our management team and employee base, which is a major reason why I have postponed my retirement for so long. But I am pleased to have been a major contributor, and look back on the accomplishments of my talented and highly capable finance and accounting teams in both the U.S. and Europe with pride. I believe the Company has an exciting future ahead, and look forward to an anticipated return to sales growth and the achievement of our first U.S. FDA marketing approval. Although I will retire formally at the end of March next year, I intend to continue supporting the Company from the sidelines as both a long-term shareholder and as a consultant as needed.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “Kathy is an outstanding CFO and member of our leadership team, and we are extremely fortunate to have her. Among Kathy’s many accomplishments, she was instrumental in our successful up-listing to Nasdaq. As CFO of a public company, Kathy has also been responsible for timely and consistent accounting, SEC reporting, and Sarbanes Oxley compliance, and has worked diligently to design and strengthen our system of internal controls. Kathy was also key in the capitalization of our company by supporting numerous successful fund raisings in cumulative excess of $140 million and establishing a favorable debt facility, enabling us to finance the global expansion of our business to 75 countries and to build a state-of-the-art manufacturing facility. Through maintenance of a strong network of investors, bankers, and analysts, and presentations and investor meetings at numerous conferences, Kathy supports analyst coverage from six investment banks, and has been a welcomed partner in our investor relations outreach. Meanwhile, she has developed, mentored, and led an outstanding group of finance and accounting professionals who expertly manage a broad and complex range of international trade and accounting issues, from consolidation of subsidiary results based in different currencies, to international tax policies. Lastly, Kathy has overseen the modernization of our finance and accounting information technology systems to support our growing needs.”
“We are also very proud of Kathy’s well-deserved accomplishments outside of the Company. Kathy was the 2016 NJ BIZ Magazine’s Public Company CFO of the Year, currently serves as Chapter President and Member of the Board of Directors of the Mercer Chapter of the New Jersey Society of Certified Public Accountants (NJCPA), and was the recipient of the 2021 NJCPA Ovation Award recognizing CPAs who have had an impact on their jobs, communities, and the accounting profession.”
Dr. Chan concluded, “Above all, Kathy has been a tremendous pleasure to work with as a trusted colleague who embodies the values of our Company as a positive, kind, committed, and generous leader who puts our people and our mission ahead of herself. We feel honored to cap her outstanding financial executive career in successful private and public companies, and will miss her greatly. On behalf of the entire Company and our Board of Directors, we thank Kathy for her many years of dedication and service to the Company and wish her all the best in retirement and in this next phase in her life.”
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR–D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
PRINCETON, N.J., Oct. 6, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader specializing in blood purification, announced today that the U.S. Army Medical Research Acquisition Activity (USAMRAA) has awarded the Company a three-year Phase III contract valued at $4,292,641 to customize the design of the HemoDefend-BGA™ filter for sterile integration into collections systems for freeze-dried plasma processing to generate freeze-dried universal plasma. Without the need for blood typing, widespread availability of universal plasma could help save lives via faster emergency treatment in both civilian and military settings.
CytoSorbents awarded $4.3M from U.S. DOD to enable freeze-dried universal plasma using its HemoDefend-BGA technology
Dr. Maryann Gruda, PhD, Principal Investigator and Senior Director of Biology at CytoSorbents stated, “We are excited to begin this phase of our development program. The continued support and funding of our anti-A and anti-B blood group antibody (BGA) reduction technology by the Defense Health Agency and U.S. Army will be instrumental in bringing this technology to market. This award will fund the development and scale-up of a specialized HemoDefend-BGA filter that can be integrated with freeze-dried plasma technologies to generate a logistically superior, low titer plasma product that can be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity.”
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, “Freeze-dried plasma is dry and lightweight, stable for up to 2 years at room temperature, and can be quickly reconstituted with sterile water when needed. However, it currently remains a blood-type specific product, complicating its use. HemoDefend-BGA can remove blood-type specific antibodies from single donor or pooled plasma prior to freeze-drying, with the goal of ultimately producing a ‘one-size-fits-all’ freeze-dried universal plasma – a major advance. Such a product would also eliminate the need for cold-chain storage – greatly simplifying battlefield logistics and enabling first responders to provide mobile/remote emergency resuscitation in civilian trauma.”
The HemoDefend-BGA filter is not yet approved in the U.S. or elsewhere. This award was supported by the Defense Health Agency (DHA) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Programs/Joint Warfighter Medical Research Program (JWMRP) under U.S. Army Medical Research Acquisition Activity (USAMRAA) Contract No. W81XWH-22-C-0046. The award is entitled “Integrating Isoagglutinin Reduction for a Universal Dried Plasma Product for Battlefield and First Responder Use.” The outcome of this award is expected to be the large-scale manufacturing of the active polymer for subsequent integration of the device into the plasma freeze-drying process.
The content of this press release is solely the responsibility of the authors and any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Department of Defense, DHA, SBIR/STTR Programs, JWMRP, or USAMRAA.
About HemoDefend-BGA™
CytoSorbents is developing HemoDefend-BGA to enable both universal plasma and fresh whole blood transfusions through the reduction of anti-A and anti-B blood group antibodies via our advanced blood purification technology. Today, plasma and whole blood products must be carefully blood-type matched to prevent potentially fatal hemolytic transfusion reactions in the recipient, caused by the accidental administration of mismatched blood products. The reduction of anti-A and anti-B antibodies could potentially reduce or eliminate this risk, allowing for a broader range of available donors and simplifying the transfusion process. According to the American Red Cross, nearly 10,000 units of plasma are needed daily in the United States, or more than 3.5 million units a year. The World Health Organization (WHO) reports that plasma is transfused at a rate of 2.2 – 18.9 units per 1,000 population (median 7.7 units) globally. In westernized countries alone, with a population of 1.5 billion, there are approximately 12 million units of plasma administered each year. The total addressable market for HemoDefend-BGA in transfusion medicine in westernized countries alone is an estimated $400 million to $600 million and represents a fraction of the global market.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR–D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
PRINCETON, N.J., Oct. 4, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces that Dr. Phillip Chan, Chief Executive Officer, will present at the Dawson James Securities 2022 Small Cap Growth Conference on Wednesday, October 12th, 2022. Company management will also meet with investors in 1×1 meetings throughout the conference. To schedule a meeting with management, please contact your Dawson James representative.
A live webcast of the presentation will be available at the above webcast link. An archived recording of CytoSorbents’ presentation at the conference will be available under the Investor Relations portion of the Company’s website at Events & Presentations – CytoSorbents, and will be available for 90 days.
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in more than 70 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other body fluids through pore entrapment and surface adsorption. The company’s technologies have received more than $41.5 million in non-dilutive grants, contracts and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC) and others. The company has numerous marketed and in-development products based on this unique blood purification technology protected by numerous issued U.S. and international patents and registered trademarks, as well as several pending patent applications, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb and others. For more information, please visit the company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-looking statements
This press release contains forward-looking statements that fall within the safe harbor of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding our plans, objectives, future goals and prospects for our business, expectations regarding the future impact of COVID-19 or the ongoing conflict between Russia and Ukraine, representations and assertions, and are not historical facts and are generally identified by the use of words such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar terms, although some forward-looking statements are worded differently. You should be aware that the forward-looking statements in this press release reflect management’s current beliefs and expectations, but that our actual results, events and performance may differ materially from those in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the risks disclosed in our Annual Report on Form 10-K filed with the SEC on March 10, 2022, our Quarterly Reports on Form 10-Q and the press releases and other communications to stockholders that we issue from time to time seeking to inform interested parties of the risks and factors that may affect our business. We caution you not to place undue reliance on such forward-looking statements. We are under no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by federal securities laws.
Public Relations Contact: Eric Kim Rubenstein Public Relations 212-805-3052 [email protected]
SOURCE CytoSorbents Corporation
CytoSorbents is a leader in critical care immunotherapy. The company is committed to serving the best interests of our patients and their families, our customers, our employees, and our shareholders.
CytoSorb® is a unique blood purification therapy.The product is currently approved in the European Union and distributed in 58 countries around the world
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U.S. FDA Grants CytoSorb® Emergency Use Authorization for Use in Patients with COVID-19 Infection. Call 848-667-8990 to Order.
