Cytosorbents (CTSO) Announces Filing of an Investigational Device Exemption (IDE) for U.S. Trial on Ticagrelor Removal During Cardiothoracic Surgery

CytoSorbents Corporation (NASDAQ: CTSO) announces the filing of an Investigational Device Exemption (IDE) application to conduct the clinical study, "Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)," in the United States to support an initial FDA regulatory approval. This is being done under the previously announced FDA Breakthrough Designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiac surgery.

Dr. Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, "We are very pleased with the investigational plan, set forth in the IDE filing, that we believe accurately reflects the spirit of the Breakthrough Designation and are looking forward to the Agency's feedback. We expect that our discussions with FDA will complete in the second quarter of 2021 with the goal of beginning patient enrollment in the second half of 2021 across multiple leading U.S. institutions that have already expressed their keen interest to participate in this trial. We plan to discuss more detail on the trial upon approval of our IDE application."

You May Also Be Interested In

• Bristol-Myers Squibb (BMY) Granted Positive CHMP Opinion for Onureg (azacitidine tablets; CC-486) as Maintenance Therapy for Adults with AML
• Peeling paint, shoddy cleanups among issues at U.S. plant making J&J COVID-19 vaccine: FDA
• Coherus (CHRS) Announces Toripalimab Achieved Primary Endpoints of PFS and OS in Interim Analysis of Phase 3 Clinical Trial in First-Line Esophageal Squamous Cell Carcinoma