CytoSorbents Corp. engages in critical care immunotherapy, investigation, and commercialization of blood purification technology. Its product portfolio includes CytoSorb, ContrastSorb XL, HemoDefend, VetResQ, and DrugSorb. The company was founded by Joseph Rubin in August 1997 and is headquartered in Princeton, NJ.
相关临床试验
10
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
4
40.0%
招募中
2
20.0%
终止
3
30.0%
撤回
1
10.0%
暂无批准数据
- The FDA has issued a denial letter for CytoSorbents' DrugSorb-ATR device, designed to reduce bleeding in CABG surgery patients who recently took ticagrelor, citing unresolved deficiencies. - CytoSorbents has met with the FDA and will continue discussions to address the issues, with plans to file a formal appeal within 60 days if resolution cannot be reached through dialogue. - Despite the setback, CEO Dr. Phillip Chan remains confident that the company can resolve the remaining issues and still anticipates a final regulatory decision in 2025 for the FDA-designated Breakthrough Device.
- CytoSorbents has submitted a Medical Device License application to Health Canada for DrugSorb-ATR, targeting reduced bleeding during CABG surgery in patients on ticagrelor. - The application follows successful MDSAP certification, ensuring compliance with quality management system requirements in Canada and the U.S. - Regulatory decisions from Health Canada and the U.S. FDA are anticipated in 2025, potentially improving the standard of care for heart attack patients. - The STAR-T trial data supports the application, demonstrating DrugSorb-ATR's safety and efficacy in reducing perioperative bleeding complications.
