Cytosorbents' Drug in the FDA Approval Process
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. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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
Cytosorbents FDA Events - Frequently Asked Questions
As of now, Cytosorbents (CTSO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Cytosorbents (CTSO) has reported FDA regulatory activity for DrugSorb-ATR.
The most recent FDA-related event for Cytosorbents occurred on September 29, 2025, involving DrugSorb-ATR. The update was categorized as "Provided Update," with the company reporting: "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."
Currently, Cytosorbents has one therapy (DrugSorb-ATR) targeting the following condition: Antithrombotic Removal System.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:CTSO last updated on 9/29/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
