CytoSorbents Corporation, a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, provided a regulatory update on its marketing applications for DrugSorb-ATR with the U.S. Food and Drug Administration and Health Canada. DrugSorb-ATR is an FDA-designated Breakthrough Device 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.
Health Technology Insights: Mammogen Appoints Denise DeMan as Chairwoman of the Board
U.S. FDA Update:
On June 27, 2025, the FDA confirmed the scheduling of an appeal hearing date for the Company’s requested supervisory review (administrative appeal) under 21 CFR 10.75. The Company continues to believe remaining deficiencies in its De Novo Request can be effectively resolved through this supervisory review process that enables direct interaction and engagement with FDA senior leadership and our external experts, which is expected to complete by the end of August 2025.
Health Canada Update:
On June 26, 2025, Health Canada issued a Notice of Refusal of the Company’s Medical Device License application, citing non-compliance with certain Medical Devices Regulations. As part of Health Canada’s prescribed reconsideration process, the Company intends to file a Level 1 “Request for Reconsideration” with the Medical Devices Directorate Bureau Director by July 25, 2025. The prescribed reconsideration process allows for supervisory review and provides the opportunity to directly address issues raised in the Notice of Refusal with staff not involved in the original review and may include input from qualified external subject matter experts. If marketing authorization is not received as part of the reconsideration process, the Company can then file a formal Appeal with the Director General of the Medical Devices Directorate.
Health Technology Insights: IHI Appoints Sylvia Trent-Adams President and CEO
“We believe DrugSorb-ATR addresses a critical and growing need in cardiac surgery by helping to reduce the severity of perioperative bleeding in patients undergoing CABG surgery on Brilinta,” said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “With no other approved therapies currently available to patients and cardiac surgeons in the U.S. and Canada, we believe DrugSorb-ATR offers a highly differentiated solution to this large and underserved market. We remain confident in the strength of our regulatory submissions and are committed to working through the appeals processes in a timely manner with both FDA and Health Canada to bring this FDA Breakthrough Designated therapy to the tens of thousands of patients at risk and the surgical teams that operate on them each year in these countries. We continue to expect final regulatory decisions by the end of this year.”
Health Technology Insights: Health Technology Insights: Latest News And Innovations – Roundup
To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com
Source – PR Newswire
