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
CytoSorb, DrugSorb-ATR, PuriFi™, and Ticagrelor. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CytoSorb - FDA Regulatory Timeline and 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
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:
- 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
PuriFi™ - FDA Regulatory Timeline and 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
Ticagrelor - FDA Regulatory Timeline and Events
Ticagrelor is a drug developed by Cytosorbents for the following indication: in patients undergoing cardiothoracic surgery.
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:
- Ticagrelor
- Announced Date:
- April 17, 2024
- Indication:
- in patients undergoing cardiothoracic surgery
Announcement
CytoSorbents Corporation announced that topline results from its pivotal U.S. and Canadian Safe and Timely Antithrombotic Removal of Ticagrelor (STAR-T) randomized controlled trial will be featured as a late-breaking clinical trial presentation at the 104th Annual Meeting of the American Association for Thoracic Surgery (AATS), taking place Friday, April 26 through Tuesday, April 30, 2024 in Toronto, ON, Canada.
AI Summary
CytoSorbents Corporation announced that the topline results from its pivotal STAR-T randomized trial in the U.S. and Canada will be featured as a late-breaking clinical trial presentation at the 104th Annual Meeting of the American Association for Thoracic Surgery (AATS). The presentation will take place in Toronto, Canada, from April 26 to April 30, 2024.
During the trial, the company evaluated the safety and effectiveness of its DrugSorb-ATR device in removing ticagrelor—a blood thinner—from patients undergoing urgent cardiac surgery. This study, which included 140 patients across around 30 centers, aims to reduce the risk of surgical complications such as severe bleeding. The clinical session is scheduled for April 28, 2024, from 7:30 to 9:00 AM EDT at the Metro Toronto Convention Center, Room 718B.
Read Announcement
