CSP #2037T - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-T) Trial

* The trial will compare two anticoagulants ("blood thinners") that are currently used in the VA and are considered standard care to prevent strokes in patients with atrial fibrillation. The two most commonly-used anticoagulants will be compared: apixaban (Eliquis) and rivaroxaban (Xarelto). They are considered by many doctors to have similar benefits and risks, but no one knows for sure.
* The trial only enrolls patients with a diagnosis of atrial fibrillation ("A Fib").
* We will measure, in about 10,000 VA patients nationally, whether the rates of stroke, major bleeding, or death differ between these two drugs.
* The trial will last about 7 years, but after the first prescription, all information will be collected from electronic medical records.

Start Date02 Jun 2025

Sponsor / Collaborator

VA Office of Research and Development

[+1]

NCT06474182

/ Not yet recruitingNot ApplicableIIT

Comparison of the Effects of Prophylactic Administration of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma and Patients Undergoing a Surgery for Total Knee Replacement

Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.

Start Date01 May 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Saint-Etienne

NCT06933056

/ Not yet recruitingEarly Phase 1IIT

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

Start Date01 May 2025

Sponsor / Collaborator

University of Michigan

[+1]

100 Clinical Results associated with Apixaban

100 Translational Medicine associated with Apixaban

100 Patents (Medical) associated with Apixaban

7,008

Literatures (Medical) associated with Apixaban

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Decision model to evaluate the cost of clinical events associated with switching from apixaban to rivaroxaban among patients with non-valvular atrial fibrillation in the United States and Germany

Article

Author: Dworatzek, Elke ; Kongnakorn, Thitima ; Duan, Cecilia ; Shah, Anshul ; Kisser, Agnes ; Hines, Dionne M. ; Subash, Rupesh ; Hagan, Melissa ; Zhang, Michelle

AIMS:

Direct-acting oral anticoagulants (DOACs) have emerged as the preferred treatment for nonvalvular atrial fibrillation (NVAF). However, evidence concerning the economic outcomes of DOAC switching remains limited. This study aimed to assess the economic outcomes of DOAC switching in the US and Germany, two countries with a high AF prevalence and DOAC utilization.

METHODS:

A decision model was developed to assess the incidence and cost of stroke/systemic embolism (SE) and major bleeding (MB) associated with switching from apixaban to rivaroxaban in patients with NVAF. The model compared two scenarios: continuers (patients continuing apixaban) and switchers (patients switching from apixaban to rivaroxaban). Model inputs on clinical event rates were sourced from a published real-world study, cost inputs were from a standard costing database and published literature. The analysis was conducted over a 1-year time horizon from US Medicare fee-for-service and German public healthcare payer perspectives.

RESULTS:

Over one year, 47,036 patients among a hypothetical plan size of 1,000,000 US Medicare fee-for-service members and 1,019,079 patients among the German adult population size of 70,107,122 were estimated to be treated for NVAF with apixaban. Switching all patients from apixaban to rivaroxaban resulted in 1,498 and 32,447 additional clinical events (stroke/SE and MB) and deaths in the US and Germany, respectively, compared to continuing with apixaban. This led to a total incremental cost of $17.3 million and €153 million from Medicare fee-for-service and German public healthcare perspectives, respectively.

LIMITATIONS:

The incidence and hazard ratios of clinical events informing this analysis were based on a US commercial and Medicare Advantage population and may not be generalizable to other populations.

CONCLUSIONS:

Switching from apixaban to rivaroxaban was associated with increased clinical events, deaths, and higher medical care costs, potentially representing a less favorable strategy economically compared to continuing apixaban among patients with NVAF.

01 Jun 2025·JOURNAL OF PHARMACY PRACTICE

Apixaban as a Secondary Prophylaxis Agent for Patent Foramen Ovale-Associated Stroke

Article

Author: Donatien, Claudette ; Khaimova, Rebecca M. ; Ramnarain, Justin ; Toderika, Yuliana

Background: The purpose of this case report is to describe a case of switching warfarin to apixaban in a patient on anticoagulant prophylaxis for a patent foramen ovale (PFO)-associated stroke. Case Summary: An 86-year-old Afro-Latina female with a past medical history of cerebrovascular accident (CVA) in 2012 secondary to PFO and diagnosed Atrial Fibrillation (AF). Patient was switched from warfarin to apixaban after 3 months of labile international normalized ratio (INR) levels. The patient’s INR was monitored at a pharmacist-led anticoagulation clinic. As the patient’s INR remained subtherapeutic while on warfarin, a shared decision was made to switch the patient to apixaban 2.5 mg twice daily due to consistently painful enoxaparin injections, inconsistent vitamin K intake, frequent clinic visits and unstable renal function. Patient tolerated the anticoagulant switch well and reported satisfaction with decreased clinic visits and variable vitamin K diet. At 12 months post-switch, the patient’s complete blood count remains stable, no reported signs and symptoms of bleeding, and no new CVA or venous thromboembolism (VTE) events identified. Based on an improvement in renal function, the dose was increased to 5 mg twice daily.

01 Jun 2025·ESC Heart Failure

Long‐term outcomes of apixaban as main anticoagulant in patients with HeartMate 3 left ventricular assist devices

Article

Author: Rojas‐Marte, Geurys R. ; Jdaidani, Jennifer ; Shadi, Mahmoud ; Asogwa, Nnedi ; Winik, Jennifer ; Rossi, Dora ; Avila, Maria D. ; Saikus, Christina

Abstract:

Aims:

HeartMate 3 (HM3) left ventricular assist devices (LVADs) offer improved haemocompatibility‐related outcomes for end‐stage heart failure patients, facilitating the exploration of alternative anticoagulation therapies beyond warfarin. This study presents a long‐term evaluation of thrombotic and bleeding outcomes in HM3 LVAD patients transitioned from warfarin to apixaban.

Methods:

We retrospectively identified HM3 LVAD patients at our single centre who transitioned from warfarin to apixaban. Baseline characteristics were described at discharge from implant hospitalization and at the last follow‐up on each anticoagulation regimen. We reported survival, thrombo‐embolic events (including LVAD pump thrombosis, stroke, arterial thrombo‐embolic events and pump exchange) and bleeding events on both warfarin and apixaban.

Results:

Eight patients were identified between May 2018 and June 2022 who transitioned from warfarin to apixaban 5 mg twice daily. Patients were followed for a mean of 1233 days after LVAD implantation and 789 days after transition to apixaban. All patients were transitioned due to difficulty maintaining a therapeutic international normalized ratio (INR), including five patients who experienced bleeding complications on warfarin. No patients encountered LVAD pump thrombosis, stroke events, arterial thrombo‐embolic event, pump exchange or death. While on warfarin, five patients had eight bleeding events: one major [requiring 2 units of packed red blood cells (pRBCs)] and seven minors (five gastrointestinal bleeds, one episode of haematuria and one episode of haemoptysis). After switching to apixaban, one patient with angioectasia had a major gastrointestinal bleed requiring two pRBCs and endoscopic clipping.

Conclusions:

Apixaban demonstrated safe and favourable long‐term outcomes in a cohort of HM3 LVAD patients over a mean follow‐up of more than 2 years. To our knowledge, our report provides the longest follow‐up duration for this patient population to date. Larger prospective studies are needed before this can be adopted as the standard of care.

282

News (Medical) associated with Apixaban

27 May 2025

·www.fiercepharma.com

7 top pharmas posted revenue declines in Q1. The common thread? All are US firms

Seven of the biopharma industry's top 25 companies saw their revenue decrease in the first quarter of 2025, all from the U.S. The declines came after revenues boomed in the fourth quarter of 2024. After a fourth quarter in which revenue boomed throughout the biopharma industry, there were reversals for several drugmakers in the first three months of 2025. The companies that took the biggest hits were in the U.S., where there is already considerable angst in the industry over the tariff threats and drug price-slashing aspirations of President Donald Trump, along with the unsettling prospects of having a pharma adversary, Robert F. Kennedy Jr., heading up the Department of Health and Human Services.Among the top 25 revenue companies in the industry in the first quarter, there were seven that saw year-over-year sales declines, all from the U.S. Viatris took the biggest hit at 11%, followed by Pfizer (-8%), Organon (-7%), Bristol Myers Squibb (-6%), Regeneron (-4%), Merck (-2%) and Gilead (-0.3%).Additionally, only two of the top 25 companies in the industry—Daiichi Sankyo (6%) and Novartis (0.6%)—had sequential revenue increases in the first quarter, though analysts warn that fourth quarter sales can skew positively, with drugmakers often expecting a sequential slide.While many factors are at play with the political landscape that could have depressed sales in the first quarter, most companies that saw first-quarter declines cited non-macroeconomic reasons for their results.The decline for Viatris, for example, was not a surprise. Its annual revenue has decreased each year since 2021 as the Pittsburgh-based company has executed a series of selloffs. But it still was Viatris’ largest quarterly sales decrease—on a percentage basis—since the company was formed in 2020 with the merger of generics specialists Mylan and Upjohn.The drop-off for Pfizer can be chalked up (PDF) to a decline in sales for COVID-19 antiviral Paxlovid, which plummeted from $2 billion in the first quarter of 2024 to $491 million in the first quarter of 2025. In recent years, revenue for the company has varied dramatically based on the demand for its COVID products. For example, last year in the first quarter, Pfizer delivered a 19% year-over-year decrease. Two quarters later, sales were up 32%.Another factor in the sales slide for Pfizer—as well as that for BMS—was a premature decline in the sales for Eliquis. The megablockbuster blood thinner, which is shared by the New York City drugmakers, is set for a Medicare price reduction next year under the Inflation Reduction Act (IRA). But it is already facing market headwinds, as its sales fell by 4% in the first quarter.In its earnings release, Pfizer explained that the decline was driven primarily by a “lower net price in the U.S., including the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign.”The 6% decrease in the first quarter for BMS came after the company reported increases of between 5% and 9% in each of the four quarters in 2024. Also tied to the decline for BMS were plummeting sales of aging blood cancer drugs Revlimid, Pomalyst and Imnovid.The sales shortfall for Regeneron, which came after the company posted double-digit increases in each of the previous three quarters, highlighted the continuing struggles of eye disease treatment Eylea and Eylea HD, which saw a combined 16% year-over-year sales free fall from $2.25 billion to $1.90 billion.Regeneron cited a host of issues, including “competitive pressures,” which is a reference to Roche’ surging Vabysmo. Launched in 2022, the drug has robbed Eylea of its dominance of the market—especially in the U.S.Regeneron also said sales were affected in the period by an 11% sequential decrease in “physician unit demand,” in addition to lower net selling prices and lower wholesaler inventory levels. Additionally, the company warned of continuing headwinds affecting Eylea sales this year.The sales drop for Merck came after increases in the previous seven quarters, thanks largely to juggernaut cancer treatment Keytruda. But in Q1, a YOY increase in Keytruda sales from $6.9 billion to $7.2 billion could not compensate for a free fall in Gardasil sales, from $2.2 billion to $1.3 billion, as the company continues to navigate demand declines in China.“We see significant risk to the Gardasil franchise, as China woes continue,” Leerink Partners analyst Daina Graybosch, Ph.D., said in a note to investors.There are even signs of a slowdown for Keytruda, which had its first sequential sales decline since the first quarter of 2020—and the drop was significant, from $7.8 billion in the fourth quarter of 2024 to $7.2 billion in the most recent earnings period.No shortfall for surging Lilly While many other American companies navigated various hurdles in the first quarter, there was nothing to slow the roll of Eli Lilly. Fueled by still-growing demand for its diabetes and obesity drugs, Lilly saw sales increase by 45%, which was more than twice that of any other company among the 25 that generated the most revenue in the industry in the period.It was the second straight quarter in which Lilly achieved a 45% YOY increase in sales and the eighth quarter in a row that Lilly pulled off a quarterly increase of at least 20%. Much of the run can be attributed to booming sales of diabetes drug Mounjaro and its obesity follow-on Zepbound. In the first quarter, the duo rolled up combined sales of $6.1 billion.Lilly has seized the momentum in the market from Novo Nordisk, which recently decided to start a CEO search and move on from its longtime leader Lars Fruergaard Jørgensen. In contrast, in the first quarter, Novo had a 19% sales increase. It was the first time since the fourth quarter of 2021 that Novo’s quarterly sales boost came up short of 20%. Combined sales of Novo’s diabetes drug Ozempic and obesity follow-on Wegovy still exceeded those of Lilly’s corresponding drugs, coming in at $7.5 billion in the quarter. But the gap is quickly shrinking. Expect Novo’s headwinds to continue throughout this year. In its first quarter report, the Danish company slashed its annual revenue projection from a window of 16% to 24% to one of 13% to 21%. At the midpoint of its 2025 revenue projection, Lilly expects a sales increase of 41%.Other gainers in Q1 In addition to Lilly and Novo, there were four other companies that accomplished double-digit revenue gains in the first quarter, including Japanese companies Daiichi Sankyo (+21%) and Astellas (11%). Both drugmakers are enjoying sales growth as a result of successful Big Pharma-partnered cancer medicines.The other two double-digit gainers—Novartis (+12%) and Sanofi (+11%)—are growing after executing sell-offs to become pure-play innovators. Among its divestments, Novartis spun off its generics and biosimilars unit Sandoz, while Sanofi recently sold a controlling stake in the consumer health business Opella. Also of note among the other companies that saw revenue increases in the period was Amgen’s 9% figure, which was its first true quarterly growth measure since completing the $27.8 billion acquisition of Horizon Therapeutics in October 2023. AbbVie’s 8% boost was its largest quarterly increase since the third quarter of 2021, indicating that the company has compensated for the loss of patent protection for powerhouse Humira with its pair of next-gen immunology treatments Skyrizi and Rinvoq. The quarterly increases for AstraZeneca (+7%) and Vertex (+3%) came after both companies had double-digit annual growth in 2024. On the flip side, the gains for Biogen (+6%) and Bayer (+4%) come after both companies saw saw their revenues slide in 2024.

AcquisitionBiosimilar

22 May 2025

·www.prnewswire.com

CytoSorbents Therapy Significantly Reduces Bleeding in Urgent CABG Patients on Ticagrelor in New Data Presented at EuroPCR 2025

Real-World Analysis Shows Statistically Significant Reduction in Severe Bleeding and Transfusion Needs in CABG Patients on the Blood Thinner, Ticagrelor, with CytoSorbents Therapy PRINCETON, N.J., May 22, 2025 /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, announced today's presentation at EuroPCR 2025 of a new contemporary real-world data analysis highlighting the intraoperative use of its technology to significantly reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta®, AstraZeneca) who had not completed the recommended drug washout period. Presented by Professor Robert F. Storey, Academic Director and Honorary Consultant Interventional Cardiologist for the Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust (U.K.) and co-Principal Investigator of the international STAR (Safe and Timely Antithrombotic Removal) Registry, the findings were shared during the session titled, "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data." Key Study Insights The analysis compared two patient populations undergoing urgent CABG surgery on ticagrelor before completing the guideline-recommended 3-day washout period. The device group consisted of an updated cohort of 150 patients from the STAR Registry who were all operated on with the use of CytoSorbents' device, while the control group comprised 644 similar patients from a recent publication who were all operated on without the use of the device. The results showed statistically significant and clinically meaningful reductions in severe bleeding complications with device use, including: Reductions in the rate of BARC-4 (validated measure of severe bleeding after CABG) severe bleeding: 10.7% vs. 33% control, p<0.001) Reduction in large transfusion events (≥5 units of blood): 6% vs. 27% control, p<0.001) Reduction in the need for re-operations to control bleeding (4% vs. 9.6% control, p=0.02) Importantly, no device-related adverse events or device deficiencies were reported by participating centers, underscoring the device's ease-of-use and safety in real-world clinical practice. Professor Storey concluded his presentation, stating, "A device that removes free ticagrelor from blood and is easily integrated into the CPB circuit appears safe and effective in mitigating excess bleeding in ticagrelor-treated patients undergoing CABG surgery before completing the 3-day washout," Dr. Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, "Today's presentation in Paris is a vital addition to the growing evidence base of blood thinner removal with our technology. The data show that device use is simple and safe but more importantly establish that patients on ticagrelor undergoing urgent CABG at heart centers using our device as part of their standard care, experience significantly lower bleeding complications compared to patients operated without the device. We are thrilled with these new data that support routine use of our device as an effective solution to address the major unmet medical need of patients on blood thinners like ticagrelor requiring urgent cardiac surgery." Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, noted, "We are proud to see the updated STAR Registry data presented alongside one of the largest and most recent meta-analyses of non-device treated CABG patients on Brilinta®. With growing adoption of our technology by cardiac surgery centers worldwide, this important real-world evidence from our registry reinforces the clinical value of our therapy that we hope to bring to all countries and patients around the world." Additional Presentation and Study Details In today's oral presentation titled "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data" at the 2025 EuroPCR conference in Paris, France, the world-leading course in interventional cardiovascular medicine with over 12,000 attendees, Professor Robert Storey presented the results of a comparative analysis in patients on ticagrelor undergoing CABG surgery before completing the recommended three-day washout period with or without the intraoperative use of the CytoSorb® device. Device group: 150 patients from the STAR Registry that is actively enrolling at 28 sites in 6 European countries (Germany, United Kingdom, Austria, Belgium, Sweden and Switzerland) who were all operated with the use of the device Control group: 644 similar patients from the recently published individual patient data meta-analysis in the peer-reviewed journal, European Journal of Cardiothoracic Surgery, who were all operated without the use of the device Key Data Highlights: There were no significant differences in baseline characteristics between the two groups (device vs. control), including age (65 vs. 67 years), acute coronary syndrome presentation (90.5% vs. 89.1%) and overall perioperative risk according to Euroscore II (2.5 vs. 2.8%). Most importantly, the two groups had near identical distribution of the time of CABG relative to the last dose of ticagrelor, a very strong factor determining bleeding risk (within 1 day of last dose 41.4% vs. 41.9%, more than 1 but less than 3 days 58.6% vs. 58.1%). The primary outcome of the analysis was incidence of the composite of severe bleeding according to the Bleeding Academic Research Consortium (BARC)-4 definition that includes: intracranial bleeding; re-operation for bleeding; transfusion ≥ 5 units of packed red blood cells (pRBC) and 24-hour chest tube drainage of ≥ 2 liters. Additional individual outcomes included the rate of large transfusion events (≥ 5 units of pRBC) and the rate of re-operation for bleeding. BARC-4 bleeding was significantly reduced with the use of the device (10.7% vs. 33% control, p<0.001) as were large transfusion events (6% vs. 27% control, p<0.001) and re-operations for bleeding (4% vs. 9.6% control, p=0.02). Mortality at 30 days was not different between the 2 groups (4.4% vs. 6.5%, p=ns). Importantly, there were no device deficiencies or device-related adverse events reported by participating centers, underscoring the ease and safety of the use of the device in the real world. About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood 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. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than a quarter million devices used cumulatively to date. 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. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has 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. In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. On April 25, 2025, the FDA issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process, which facilitates engagement with FDA senior leadership and our external surgical experts. Given the expedited timelines associated with the appeal process, the Company believes that a final regulatory decision can be achieved in 2025. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. CytoSorbents' DrugSorb-ATR application with Health Canada remains under advanced review. While Health Canada has indicated that application reviews are currently delayed beyond their target Market Authorization Times (MAT) due to a backlog, they have reaffirmed their commitment to issuing a decision at the earliest opportunity. The Company remains confident in receiving a final regulatory decision in 2025. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. 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™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. 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, representations and contentions, and the outcome of our regulatory submissions, 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, our restructuring of our direct sales team and strategy in Germany, our ability to resolve deficiencies in the FDA denial letter through a successfully appeal the FDA's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, 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. Please Click to Follow Us on Facebook and X U.S. Company Contact: Peter J. Mariani, Chief Financial Officer 305 College Road East Princeton, NJ 08540 [email protected] Investor Relations Contact: Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected] SOURCE Cytosorbents Corp WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalBreakthrough Therapy

14 May 2025

·www.prnewswire.com

CytoSorbents Reports First Quarter 2025 Financial Results and Provides Business Update

PRINCETON, N.J., May 14, 2025 /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, today reported financial results for the first quarter ended March 31, 2025, and recent business highlights. First Quarter 2025 Financial Results Product revenue was $8.7 million, a decrease of 3%, and flat on a constant currency basis, compared to $9.0 million in Q1 2024. Gross margin was 71% compared to 77% in Q1 2024. Operating loss improved by 17% to $3.9 million compared to $4.7 million in Q1 2024, reflecting a 12% reduction in operating expenses. Net loss was $1.5 million or $0.02 per share, compared to net loss of $6.1 million or $0.11 per share in Q1 2024. Adjusted net loss(1) was $3.7 million or $0.06 per share, compared to an adjusted net loss of $3.7 million or $0.07 per share in Q1 2024. Adjusted EBITDA(2) loss improved by 17% to $2.7 million compared to a loss of $3.3 million in Q1 2024. Total cash, cash equivalents, and restricted cash of $13.1 million at March 31, 2025, compared to $9.8 million as of December 31, 2024, reflecting proceeds from the Rights Offering of $6.8 million, net of fees, and net cash used in the quarter of approximately $3.7 million which includes disbursements unique to Q1 of approximately $0.9 million. On April 21, the Company received $1.7 million in cash proceeds from the sale of its 2023 and amended 2022 Net Operating Loss and R&D tax credits from the Technology Business Tax Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority (NJEDA). "Strong revenue growth in our distributor and other direct sales territories across the E.U. helped to substantially offset a temporary disruption in direct sales in Germany during the quarter. This was primarily due to our proactive reorganization and strategic realignment of our German commercial team and sales approach that is intended to renew sales growth in the country through deeper customer engagement, more effective market development, and improved sales representative productivity," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "We are making steady progress with this important initiative and are confident it will lead to stronger execution and improved performance in Germany and our financial results overall this year, as we continue to advance our core business toward near breakeven." Dr. Chan continued, "Meanwhile, our message - Treating the right patient , at the right time , with the right dose of CytoSorb ® - continues to resonate strongly with clinicians. The approach is much like using antibiotics: start early, treat aggressively, and complete the full course. When used this way, CytoSorb has been shown to disrupt the deadly cycle of inflammation, stabilize patients in shock, protect organ function, and ultimately improve clinical outcomes. Recent data confirm that early and aggressive use of CytoSorb leads to statistically significant improvements in survival and other key clinical indicators. We are now using this evidence to train our users and are confident our guidance will continue to drive broader adoption and more effective usage of this critical therapy." Additional Business Highlights Completed Shareholder Rights Offering and raised total proceeds of $6.8 million, net of fees, from the offering, and the exercise of the Series A Right Warrant. The raise also allowed for the release of $5.0 million of restricted cash on the Company's balance sheet, and combined, provided increased liquidity of $11.8 million. Expanded our global footprint with the opening of our new regional sales subsidiary in Dubai, United Arab Emirates, providing a gateway into the Middle East and Africa. Appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy and execution for DrugSorb™-ATR in the U.S. and Canada. Appointed Melanie Grossman, CPA as Vice President and Corporate Controller. The Company remains deeply committed to bringing DrugSorb™-ATR, an Investigational FDA Breakthrough Designated Device, to the large and important North American market, as a critical solution to address the serious, unmet need of reducing life-threatening bleeding in patients on Brilinta® undergoing coronary artery bypass grafting (CABG) surgery. Awareness of DrugSorb-ATR's potential to lessen bleeding severity in this high-risk population continues to grow. Compelling new real-world data from Europe on our technology, being presented and published throughout 2025, further reinforces the device's potential clinical impact to meaningfully reduce perioperative bleeding severity and provide surgeons with an important therapy to address this ongoing challenge in cardiac surgery. On April 25, 2025, the U.S. Food and Drug Administration (FDA) issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, citing outstanding items that must be addressed before the device can be authorized for U.S. commercialization. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process that enables direct interaction and engagement with FDA senior leadership and our external experts. Given the expedited timelines associated with the appeal process, we believe that a final regulatory decision can be achieved in 2025. Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, "We remain confident in the strength of our DrugSorb-ATR De Novo Request and believe the remaining issues can be successfully addressed. We are committed to working collaboratively with the FDA to secure marketing authorization for this FDA Breakthrough Designated Device, which has the potential to address a significant and routine challenge faced by cardiac surgery centers. We believe the formal appeals process offers the most efficient path forward to resolve the remaining issues and bring this important technology to patients in the U.S. Meanwhile real-world adoption continues to grow with an increasing number of heart centers around the world incorporating our technology as part of their standard care to reduce bleeding complications in patients on blood thinners undergoing cardiac surgery based on the growing evidence from our international STAR Registry showing that our device is a safe and effective strategy to address this major clinical need." Finally, CytoSorbents' DrugSorb-ATR application with Health Canada remains under advanced review. While Health Canada has indicated that application reviews are currently delayed beyond their target Market Authorization Times (MAT) due to a backlog, Health Canada has confirmed its commitment to issuing a decision at the earliest opportunity. We remain confident in receiving a final regulatory decision in 2025. First Quarter 2025 Earnings Conference Call CytoSorbents' management will host a live conference call, presentation webcast, and a question-and-answer session with the following information: Date: Wednesday, May 14, 2025 Time: 4:30 PM ET North American toll-free: 1-800-836-8184 International toll: 1-646-357-8785 Live webcast link: It is recommended that participants dial in approximately 10 minutes prior to the start of the call. An archived recording of the conference call will be available under the Investor Relations section of the Company's website at About Non-GAAP Financial Measures To supplement our condensed consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense, and gain or loss of foreign exchange translation. We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share which excludes non-cash stock compensation expense and gain or loss of foreign exchange translation from Net Loss and Net Loss Per Common Share, respectively. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP should be carefully evaluated. We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they are used by investors and the analyst community to help them analyze the performance of our business, the Company's cash available for operations, and the Company's ability to meet future capital expenditure and working capital requirements. About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood 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. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than a quarter million devices used cumulatively to date. 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. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has 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. In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. On April 25, 2025, the FDA issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process, which facilitates engagement with FDA senior leadership and our external surgical experts. Given the expedited timelines associated with the appeal process, the Company believes that a final regulatory decision can be achieved in 2025. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. CytoSorbents' DrugSorb-ATR application with Health Canada remains under advanced review. While Health Canada has indicated that application reviews are currently delayed beyond their target Market Authorization Times (MAT) due to a backlog, they have reaffirmed their commitment to issuing a decision at the earliest opportunity. The Company remains confident in receiving a final regulatory decision in 2025. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. 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™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. 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, representations and contentions, and the outcome of our regulatory submissions, 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, our restructuring of our direct sales team and strategy in Germany, our ability to resolve deficiencies in the FDA denial letter through a successfully appeal the FDA's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, 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. Please Click to Follow Us on Facebook and X U.S. Company Contact: Peter J. Mariani, Chief Financial Officer 305 College Road East Princeton, NJ 08540 [email protected] Investor Relations Contact: Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected] SOURCE Cytosorbents Corp WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementDrug ApprovalExecutive ChangeBreakthrough Therapy

100 Deals associated with Apixaban

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KEGG	Wiki	ATC	Drug Bank
D03213	Apixaban	B01AF02	DB06605

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent deep vein thrombosis	European Union	Accord Healthcare SLU	23 Jul 2020
Recurrent deep vein thrombosis	Iceland	Accord Healthcare SLU	23 Jul 2020
Recurrent deep vein thrombosis	Liechtenstein	Accord Healthcare SLU	23 Jul 2020
Recurrent deep vein thrombosis	Norway	Accord Healthcare SLU	23 Jul 2020
Thrombosis	China	Bristol-Myers Squibb/Pfizer EEIG	22 Jan 2013
Ischemic stroke	Japan	Bristol-Myers Squibb KK	25 Dec 2012
Systemic embolism	Australia	Bristol Myers Squibb Co.	21 Jul 2011
Atrial Fibrillation	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Atrial Fibrillation	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Atrial Fibrillation	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Atrial Fibrillation	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Stroke	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Limb-Threatening Ischemia	Phase 3	Brazil	Wyeth AB	09 Jan 2020
Cognitive Dysfunction	Phase 3	United States	Bristol Myers Squibb Co.	19 Dec 2018
Cognitive Dysfunction	Phase 3	United States	Pfizer Inc.	19 Dec 2018
Basal Cell Carcinoma	Phase 3	Austria	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Belgium	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Canada	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	France	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Greece	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Italy	Bristol Myers Squibb Co.	11 Oct 2018
Basal Cell Carcinoma	Phase 3	Netherlands	Bristol Myers Squibb Co.	11 Oct 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03192215 (ARCADIA, CTgov)	Phase 3	Foramen Ovale, Patent \| Atrial Myxoma, Familial \| Myocardial Infarction ... View more	1,015	Apixaban (Active Agent: Apixaban)	sdidkdtfwa = zwyhxkpibx oqhtlgxdsn (gtqnikrjsp, aktbwthmer - pdcjyjxcmd) View more	-	09 Apr 2025
				Aspirin (Active Control: Aspirin)	sdidkdtfwa = igetfbqlha oqhtlgxdsn (gtqnikrjsp, vzfdsmxhov - zkgjuqqoxn) View more
P9-13.008 (AAN2025)	Not Applicable	Atrial Fibrillation systolic blood pressure \| type 2 diabetes \| LDL ... View more	-	Apixaban (Favorable PRFP)	ouazbaqjkh(jzqekqcfqf) = qrewsrmqpn enyukgsuvd (fsrulsvnwz, 1.00 - 2.20)	Positive	07 Apr 2025
				Apixaban (Adverse PRFP)	-
NCT02415400 (AUGUSTUS, Pubmed \| JACC Adv)	Phase 4	Acute Coronary Syndrome	-	Apixaban 2.5 mg	bhxzimigvu(kdzsfddutk) = bqmlmfudga rxergpqmgv (rinivxkvhf )	Positive	01 Apr 2025
				Apixaban 5.0 mg	bhxzimigvu(kdzsfddutk) = cxxaxnmeop rxergpqmgv (rinivxkvhf )
NCT04650087 (CTgov)	Phase 3	Post Acute COVID 19 Syndrome	1,291	Placebo (Placebo)	kgdqoxftuw = ayirnbvnhc ifcoqlhjdw (swjohzjdym, jmaheywget - quilwgrzjg) View more	-	25 Feb 2025
				Apixaban 2.5 MG (Apixaban)	kgdqoxftuw = ysrgygvatr ifcoqlhjdw (swjohzjdym, vwemnkyfbh - kujfipmraz) View more
NCT06689436 (NEWS) Manual	Phase 2	Thromboembolism	48	TAH3311	mucswdsuix(ouatmqmpvv) = 在监管机构认可的范围(80-125%)内 mddfrsfizt (lpwjmmgtue ) View more	Positive	18 Feb 2025
				艾乐妥
NCT02415400 (AUGUSTUS, Pubmed \| Am Heart J)	Phase 4	Thrombosis \| Acute Coronary Syndrome \| Heart Valve Diseases ... View more	4,614	Apixaban + Placebo	ziuqfqbuzd(lwrdflgfne) = oibqxooylh wgqxqhghof (lpvhszjvfd, 28)	Negative	01 Feb 2025
				Apixaban + Aspirin	ziuqfqbuzd(lwrdflgfne) = mstnthkzdm wgqxqhghof (lpvhszjvfd, 29)
All of Us (ISC2025)	Not Applicable	Atrial Fibrillation systolic blood pressure \| type 2 diabetes \| high-density lipoproteins ... View more	-	Apixaban (Favorable Polygenic Profile)	eivlhhldya(cocdkyryyd) = cumulative incidence:1.5%[95%CI:1.00–2.20] dcugfziyrc (noszpsnddn )	Positive	30 Jan 2025
				Apixaban (Adverse Polygenic Profile)
ARTESIA (ISC2025)	Not Applicable	Atrial Fibrillation	-	Apixaban	nvnzqmqkvm(kcscsnfzyu) = mrpfrjtptp ygpepxwmfy (kkxthhqoqd, 0.29 - 0.81) View more	Positive	30 Jan 2025
ISC2025	Not Applicable	Atrial Fibrillation	-	Apixaban	trawnlcmjl(loyossrvby): HR = 0.92 (95% CI, 0.83 - 1.03), P-Value = 0.13 View more	Positive	30 Jan 2025
				Standard of Care (SOC)
ASH2024	Not Applicable	Obesity, Morbid	-	Apixaban 2.5mg bid	zrkphfusfg(ondoeqdzyl) = mcvqrvymip sidjcpgtxf (ehpklusyuk, ±5.4) View more	-	08 Dec 2024

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