CytoSorbents (NSDQ: CTSO) today announced that it has enrolled the first patient in its STAR-T trial for the DrugSorb-ATR System.
CytoSorbents, based in Monmouth Junction, NJ, has designed its DrugSorb-ATR antithrombotic elimination system for the intraoperative elimination of ticagrelor during cardiothoracic surgery.
According to a press release, the Safe and Timely Antithrombotic Removal-Ticagrelor (STAR-T) study, a controlled, randomized, double-blind clinical trial received full investigational device exemption approval from the FDA in July on the back of the FDA’s revolutionary device designation. was granted in April 2020.
Dr Bradley S. Taylor, Division Chief of Cardiac Surgery and Director of Coronary Revascularization and Site Principal Investigator at University of Maryland Medical Center, registered the first patient. The company plans to enroll up to 120 patients at 20 sites and plans to complete the trial by 2022.
“Ticagrelor is an antiplatelet agent commonly used in the management of patients with acute coronary syndrome to reduce the risk of death, myocardial infarction and stroke,” Taylor said in the statement. “However, when urgent surgery is required, patients on ticagrelor are at very high risk of serious and potentially fatal bleeding. We are very pleased to enroll the first patient in the landmark STAR-T study which investigates the ability of DrugSorb-ATR to clear ticagrelor during surgery and reduce the risk of bleeding in these patients.
“If positive, STAR-T could make DrugSorb-ATR an easy-to-implement solution that addresses a long-standing, frequent and critical medical need facing cardiac surgery centers around the world. “
CytoSorbents based the DrugSorb-ATR system on the same polymer technology used in its CytoSorb therapy to remove ticagrelor during cardiopulmonary bypass.
“The intraoperative elimination of antithrombotic agents with the DrugSorb-ATR system in patients requiring urgent cardiac surgery has the potential to save lives, reduce morbidity and achieve substantial cost savings for heart centers around the world,” said said Dr Efthymios N. Deliagyris, CMO of CytoSorbents. “The FDA-approved STAR-T trial has now left the station and we will work diligently to meet our stated goal of completing the trial in 2022.… We anticipate an early start of the study and estimate that the first patient is will be recruited early in 2022.
“The goal of both studies is to gain FDA market approval for the most widely prescribed new generation antiplatelet and anticoagulant agents and to unlock an estimate. $ 1 billion Opportunity of the American market.