Bluejay Diagnostics, Inc. (NASDAQ:BJDX), a medical diagnostics company developing rapid, near-patient diagnostic technologies for critical care, today announced the successful completion of patient enrollment in its SYMON-II multicenter clinical validation study. The study achieved its targeted enrollment of 750 patients earlier than the Company had originally anticipated, representing an important operational milestone in the development of the Company's Symphony™ rapid diagnostic platform.

SYMON-II is a prospective, multicenter clinical validation study designed to evaluate the ability of Bluejay's Symphony™ IL-6 test to assist clinicians in the early assessment of 28-day all-cause mortality risk in patients with sepsis who were admitted or intended for admission to the intensive care unit (ICU). The study enrolled patients across leading U.S. healthcare institutions, and the Company expects that it will provide the clinical dataset needed to analyze whether clinical evidence supports future regulatory submissions and commercialization efforts.

Preliminary observations from the enrolled population indicate an approximately 17% 28-day mortality rate, providing a robust clinical dataset for evaluating the prognostic utility of IL-6 in patients presenting with sepsis. Bluejay believes this event rate represents a clinically meaningful population and underscores the importance of early identification of patients at elevated risk of deterioration.