CytoSorbents Corp. (NASDAQ: CTSO) has announced that the U.S. Food and Drug Administration (FDA) has accepted its De Novo marketing application for DrugSorb™-ATR, an investigational medical device intended to reduce the severity of perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft (CABG) surgery. The FDA’s acceptance includes priority review status, as DrugSorb-ATR previously received Breakthrough Device Designation. Final regulatory decisions are expected in 2025.
Addressing Perioperative Bleeding in CABG Surgery
Ticagrelor, a blood-thinning drug, is commonly administered to patients post-heart attack. However, patients ineligible for coronary stents often require CABG surgery. Current guidelines suggest delaying surgery by three to five days to allow the drug to naturally eliminate from the system, mitigating the risk of serious bleeding. DrugSorb-ATR aims to circumvent this delay by removing ticagrelor during surgery, reducing bleeding complications.
STAR-T Trial and Regulatory Pathway
The application is supported by data from the 140-patient North American pivotal STAR-T trial, a randomized, double-blind, sham-controlled study. This trial evaluated the safety and efficacy of DrugSorb-ATR in urgent CABG surgeries on patients taking ticagrelor. The FDA's De Novo pathway is designed for novel medical devices with low to moderate risk where no legally marketed predicate exists. The Breakthrough Device designation facilitates an interactive priority review, potentially accelerating the approval timeline.
Management Perspective
"The DrugSorb-ATR De Novo submission to FDA is the culmination of multiple years of significant clinical, regulatory, and manufacturing accomplishments company-wide, centered on the execution and data analysis from the U.S. and Canadian pivotal STAR-T randomized controlled trial and the product development of DrugSorb-ATR," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents.
Anticipated Regulatory Decisions
CytoSorbents anticipates decisions from both the FDA and Health Canada in 2025. The Health Canada Medical Device License (MDL) application is prepared for submission, contingent on the expected receipt of Medical Device Single Audit Program (MDSAP) certification.
