Danbury, Conn. – September 11, 2026 -- Perosphere Technologies Inc. announced that a clinical study evaluating its ClotChek point-of-care coagulometer has been published in the peer-reviewed journal Thrombosis and Haemostasis, confirming the device's ability to detect anticoagulation levels in patients on Factor Xa inhibitors apixaban and rivaroxaban.
Study confirms ClotChek detects DOAC anticoagulation at two clinical thresholds
The research measured ClotChek Clotting Time (CKCT) against anti-FXa drug levels in patients on direct oral anticoagulants, finding strong correlations when categorized by Medical Decision Limits. The device demonstrated the ability to identify clinically meaningful anticoagulation at both the >75 ng/mL and >30 ng/mL thresholds, including sensitivity at lower drug concentrations.
Device delivers reagent-free whole blood results without lab processing
ClotChek provides a pharmacodynamic measurement of a patient's coagulation status directly from whole blood, without reagents, in 3 to 8 minutes. The point-of-care format targets time-sensitive clinical scenarios including major bleeding, acute ischemic stroke, trauma, and emergent surgery, where clinicians currently lack rapid, objective tools to assess DOAC effect.
"These findings support the potential for ClotChek to address a longstanding unmet clinical need for rapid, bedside assessment of DOAC anticoagulant effect," said Sasha Bakhru, PhD, co-author of the study and CEO of Perosphere. Dr. Jack Ansell, MD, former Chairman of the Department of Medicine at Lenox Hill Hospital and study co-author, noted that without such rapid assessment, clinicians may be forced into empiric treatment decisions or delayed interventions.
ClotChek carries CE mark in EU but remains unapproved for U.S. use
Perosphere ClotChek is CE marked in the European Union but is not cleared by the FDA for use in the United States. Co-authors on the published study included Drs. Bakhru, Connors, Ansell, and Giugliano of the TIMI Study Group.