This section highlights FDA-related milestones and regulatory updates for drugs developed by Cytosorbents (CTSO).
Over the past two years, Cytosorbents has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DrugSorb-ATR, CytoSorb, and PuriFi™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
DrugSorb-ATR FDA Regulatory Timeline and Events
DrugSorb-ATR is a drug developed by Cytosorbents for the following indication: Antithrombotic Removal System.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DrugSorb-ATR
- Announced Date:
- September 29, 2025
- Indication:
- Antithrombotic Removal System
Announcement
CytoSorbents Corporation announced its strong scientific presence at the upcoming European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting, the world's largest gathering for the global cardiothoracic community, taking place October 8–11, 2025 in Copenhagen, Denmark.
AI Summary
CytoSorbents Corporation will showcase its work at the European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, October 8–11, 2025. This event brings together more than 5,000 heart surgeons and researchers. CytoSorbents leads in blood purification for critical care and cardiac surgery.
On October 9, Professor Richard Whitlock will present the first randomized trial of DrugSorb™-ATR, which significantly reduces direct oral anticoagulants during urgent surgery. Professor Matthias Thielmann will share real-world data showing that CytoSorb® with dual antiplatelet therapy cuts severe bleeding in acute coronary syndrome patients undergoing emergency bypass surgery.
On October 10, CytoSorbents will host a lunch symposium on hemoadsorption as a safety net in cardiac surgery. Topics include improving outcomes for endocarditis patients, combining ECMO (heart-lung support) with blood filtration, and removing antithrombotic drugs. The company aims to engage cardiac surgeons and highlight its expanding role in heart surgery safety.
Read Announcement- Drug:
- DrugSorb-ATR
- Announced Date:
- September 16, 2025
- Indication:
- Antithrombotic Removal System
Announcement
CytoSorbents Corporation today provided a regulatory update on DrugSorb™-ATR.
AI Summary
On August 20, 2025, CytoSorbents reported an FDA appeal decision on its Breakthrough Device, DrugSorb™-ATR, designed to remove antithrombotic drugs during cardiothoracic surgery. The agency confirmed there were no safety concerns but said more data are needed to support the full label indication.
The FDA also proposed an expedited review path. After a constructive meeting, CytoSorbents decided not to pursue a higher-level appeal. Instead, it will submit a new De Novo application that includes real-world data from ticagrelor patients undergoing urgent coronary artery bypass graft surgery.
CytoSorbents believes these additional analyses, combined with its prior clinical results, will strengthen the device’s benefit-risk profile. The FDA indicated it will focus on the remaining open items and conduct a priority, interactive review under the Breakthrough Device program.
Next steps include filing a pre-submission meeting request next month, holding a formal meeting in Q4 2025, and expecting a mid-2026 regulatory decision after a standard 150-day review.
Read Announcement- Drug:
- DrugSorb-ATR
- Announced Date:
- August 20, 2025
- Indication:
- Antithrombotic Removal System
Announcement
CytoSorbents Corporation updates the regulatory status of its appeal with the U.S. Food and Drug Administration (FDA) for De Novo market authorization of DrugSorb™-ATR.
AI Summary
On August 14, 2025, CytoSorbents Corporation received an FDA appeal decision on its De Novo market authorization request for DrugSorb-ATR. The FDA found no safety concerns with the device but upheld its earlier denial because more data are needed to support the proposed label indication. The agency also offered a potential path forward toward market authorization.
CytoSorbents is in ongoing discussions with the FDA to clarify this proposal and address the remaining questions. The company is also evaluating an additional appeal to the Director of the FDA’s Center for Devices and Radiologic Health, which must be filed within 30 days of the decision. CytoSorbents remains committed to working collaboratively with the agency to bring DrugSorb-ATR to heart surgery patients who need urgent treatment.
DrugSorb-ATR is a Breakthrough Device that helps remove blood thinners during heart surgery, aiming to lower bleeding risks in urgent bypass patients.
Read Announcement- Drug:
- DrugSorb-ATR
- Announced Date:
- July 2, 2025
- Indication:
- Antithrombotic Removal System
Announcement
CytoSorbents Corporation today provided a regulatory update on its marketing applications for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada.
AI Summary
CytoSorbents Corporation recently provided a regulatory update on its marketing applications for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada. The FDA confirmed on June 27, 2025, that an appeal hearing is scheduled for the company’s request for a supervisory review under 21 CFR 10.75. CytoSorbents believes that this formal review, which allows direct interactions with FDA senior leadership and external experts, will resolve the remaining deficiencies in its De Novo Request by the end of August 2025.
Meanwhile, Health Canada issued a Notice of Refusal for the Medical Device License application on June 26, 2025, due to non-compliance with certain regulations. The company plans to file a Level 1 "Request for Reconsideration" by July 25, 2025, as part of the prescribed process to address these issues and work toward marketing authorization.
Read Announcement- Drug:
- DrugSorb-ATR
- Announced Date:
- June 24, 2025
- Indication:
- Antithrombotic Removal System
Announcement
CytoSorbents Corporation announced that on June 18, 2025, it filed a request for supervisory review (administrative appeal) with the U.S. Food and Drug Administration (FDA) under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25, 2025 for CytoSorbents' DrugSorb-ATR Device, (the denial letter). DrugSorb-ATR, which previously received Breakthrough Device Designation from the FDA, is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within two days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner.
AI Summary
CytoSorbents Corporation announced on June 18, 2025, that it filed an administrative appeal under 21 CFR 10.75 with the U.S. Food and Drug Administration (FDA). The appeal challenges the De Novo Denial Letter issued on April 25, 2025, for its DrugSorb-ATR Device. This device is designed to help reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within two days of stopping the antiplatelet drug Brilinta®. The company believes that the administrative appeals process will allow it to work directly with senior FDA leadership and external cardiac surgery experts to address the deficiencies noted in the denial. CytoSorbents is confident that this formal judicial review will effectively resolve the FDA’s concerns and help move the approval process forward for a treatment that meets a critical need in CABG patients.
Read Announcement- Drug:
- DrugSorb-ATR
- Announced Date:
- May 1, 2025
- Indication:
- Antithrombotic Removal System
Announcement
CytoSorbents Corporation today provided a regulatory update for DrugSorb™-ATR, its FDA-designated Breakthrough Device. DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner.
AI Summary
CytoSorbents Corporation recently provided a regulatory update for its FDA-designated Breakthrough Device, DrugSorb™-ATR. The device is developed to help reduce severe bleeding during coronary artery bypass grafting (CABG) surgery in patients who have stopped taking the blood thinner Brilinta® (ticagrelor) within two days before their procedure. This innovative technology aims to offer a new solution for patients who face an increased risk of bleeding due to antiplatelet therapy. By targeting the removal of ticagrelor during surgery, DrugSorb-ATR may improve patient outcomes and fill an important gap in current treatment options. The company continues to work closely with the FDA, demonstrating its commitment to bringing this much-needed therapy to market to enhance the safety of high-risk surgical procedures.
Read Announcement
CytoSorb FDA Regulatory Events
CytoSorb is a drug developed by Cytosorbents for the following indication: Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation (ECMO).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CytoSorb
- Announced Date:
- June 24, 2024
- Indication:
- Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation (ECMO)
Announcement
CytoSorbents Corporation announces the regulatory approval of CytoSorb® in Taiwan by the Taiwan Food and Drug Administration (TFDA).
AI Summary
CytoSorbents Corporation has received regulatory approval from the Taiwan Food and Drug Administration (TFDA) for its CytoSorb® device. The new approval allows CytoSorb® to be used in Taiwan for the extracorporeal removal of cytokines, bilirubin, and myoglobin from the blood. This innovative treatment can help manage conditions such as cytokine storms, sepsis, liver disease, and trauma by removing harmful substances that can lead to organ failure. Additionally, CytoSorb® is approved for use during cardiothoracic surgery to help remove antithrombotic drugs like Brilinta® and Xarelto®, reducing the risk of severe bleeding in patients. Hemoscien Corporation will distribute the device in Taiwan, where an advanced healthcare system and high standards make it possible to provide cutting-edge treatments for critically ill patients.
Read Announcement- Drug:
- CytoSorb
- Announced Date:
- June 4, 2024
- Indication:
- Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation (ECMO)
Announcement
CytoSorbents Corporation announces the recent data presentation entitled "Early CABG with Intraoperative Haemoadsorption in Patients on Ticagrelor: The Safe and Timely Antithrombotic Removal (STAR) Registry," at the international EuroPCR 2024 conference in Paris, France - the world-leading course in interventional cardiovascular medicine with over 12,000 attendees - where it was also selected as a top 5 finalist in the best scientific abstract competition.
AI Summary
CytoSorbents Corporation recently presented promising data at EuroPCR 2024 in Paris, one of the world’s leading cardiovascular events attended by more than 12,000 specialists. The company showcased its study titled “Early CABG with Intraoperative Haemoadsorption in Patients on Ticagrelor: The Safe and Timely Antithrombotic Removal (STAR) Registry.” This real-world study involved patients requiring urgent coronary artery bypass graft (CABG) surgery while on ticagrelor. The data demonstrated that using intraoperative CytoSorb blood purification helped remove ticagrelor quickly, enabling surgeons to perform surgery before the typical three-day waiting period, potentially lowering the risk of severe bleeding compared to historical reports. Moreover, the abstract was honored as a top 5 finalist in the best scientific abstract competition, underlining its significant impact and the potential to improve outcomes for high-risk cardiac patients.
Read Announcement
PuriFi™ FDA Regulatory Events
PuriFi™ is a drug developed by Cytosorbents for the following indication: hemoperfusion machine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PuriFi™
- Announced Date:
- June 13, 2024
- Indication:
- hemoperfusion machine
Announcement
CytoSorbents Corporation announces the launch and immediate availability of its PuriFi™ hemoperfusion machine in the E.U., following approval and certification under the E.U. Medical Device Regulation (MDR).
AI Summary
CytoSorbents Corporation has launched its innovative PuriFi™ hemoperfusion machine in the European Union. The device is now available immediately after receiving approval and certification under the E.U. Medical Device Regulation (MDR).
The new PuriFi pump is designed to simplify and speed up blood purification for critically ill and cardiac surgery patients. It features a peristaltic blood pump with several user-friendly and advanced features, including auto-priming, a pre-assembled adult and pediatric blood line kit, an auto-leveling bubble catcher, a touchscreen interface with a guided set-up, optional blood warming, and a rapid 10-minute set-up time. These innovations help deliver the company’s leading CytoSorb® blood purification cartridge in a more efficient manner, marking an important step in expanding its market presence across the E.U.
Read Announcement
