Perosphere Technologies Inc. (Perosphere), a medical technology company developing next-generation coagulation diagnostics, announced that a new clinical study evaluating the Perosphere ClotChek rapid, point-of-care coagulometer has been published in the international journal Thrombosis and Haemostasis.

The study evaluated ClotChek Clotting Time (CKCT) in patients receiving Factor Xa (FXa) inhibitors apixaban and rivaroxaban, demonstrating DOAC-sensitivity and strong correlations between the CKCT and the DOAC-related anti-FXa drug levels when patients were categorized based on meaningful Medical Decision Limits (MDL), as well as the ability to detect clinically meaningful anticoagulation at both >75 ng/mL and >30 ng/mL MDL thresholds.

"These findings support the potential for ClotChek to address a longstanding unmet clinical need for rapid, bedside assessment of DOAC anticoagulant effect. Results can help inform decision-making in time-sensitive patient scenarios such as major bleeding, acute ischemic stroke, trauma, and emergent surgery," said Sasha Bakhru, PhD, co-author and CEO of Perosphere.

Importantly, ClotChek provides a pharmacodynamic measurement of a patient's coagulation status in whole blood, without reagents, and demonstrated sensitivity at lower drug concentrations, where knowing how anticoagulated a patient is can be particularly important when making critical decisions.

"Without rapid, objective assessment of anticoagulation status for DOAC patients, clinicians may be forced to make empiric treatment decisions - or even delay or defer potentially time-sensitive interventions," said Dr. Jack Ansell, MD, co-author and former Chairman, Department of Medicine at Lenox Hill Hospital.