CytoSorbents (NSDQ:CTSO) announced today that it enrolled the first patient in a trial of its STAR-T trial for the DrugSorb-ATR system.
Monmouth Junction, New Jersey-based CytoSorbents designed its DrugSorb-ATR antithrombotic removal system for the intraoperative removal of ticagrelor during cardiothoracic surgery.
According to a CytoSorbents news release, the STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) double-blind, randomized, controlled clinical trial received full FDA investigational device exemption approval in July on the back of the FDA breakthrough device designation it was granted in April 2020.
Dr. Bradley S. Taylor — director of coronary revascularization at the University of Maryland Medical Center and the site’s principal investigator — enrolled the first patient. The company expects to enroll up to 120 patients across 20 sites and plans to complete the trial by 2022.
“Ticagrelor is an antiplatelet agent routinely used in the management of patients with acute coronary syndrome to reduce the risk of death, myocardial infarction, and stroke,” Taylor said in the news release. “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 that is investigating the ability of DrugSorb-ATR to remove ticagrelor during surgery and reduce the risk of bleeding in these patients.
“If positive, STAR-T could establish DrugSorb-ATR as an easily implemented solution that addresses a long-standing, frequent, and critical unmet medical need faced by cardiac surgery centers around the world,” said Taylor, who is also cardiac surgery division chief at the University of Maryland School of Medicine.
CytoSorbents based the DrugSorb-ATR system on the same polymer technology used in its CytoSorb therapy for removing ticagrelor during cardiopulmonary bypass.
“Removing antithrombotic agents intraoperatively with the DrugSorb-ATR system in patients requiring urgent cardiac surgery has the potential to save lives, reduce morbidity and provide substantial cost savings to heart centers around the world,” said CytoSorbents Chief Medical Officer Dr. Efthymios Deliagyris. “The FDA approved STAR-T trial has now left the station and we will work diligently to deliver on our stated goal to finish the trial in 2022. … We anticipate fast study start-up and estimate that the first patient will be enrolled early in 2022.
“The goal of both studies is to gain FDA marketing approval for the most widely prescribed next-generation antiplatelet and anticoagulant agents and unlock an estimated $1 billion U.S. market opportunity.”