Bluejay Diagnostics IncCompleted enrollment in pivotal SYMON-II sepsis study ahead of schedule, supporting FDA submission for Symphony IL-6 platform.

Bluejay Diagnostics has completed patient enrollment in its pivotal SYMON-II multicenter clinical validation study, reaching 750 patients ahead of schedule. The study evaluates the Symphony IL-6 test for early assessment of 28-day mortality risk in sepsis patients admitted or intended for admission to intensive care units. The company expects to complete data cleaning, statistical analysis, and clinical reporting in the coming months, with results forming a key component of its planned FDA 510(k) submission for the Symphony IL-6 platform. Bluejay Diagnostics stock closed Monday at $1.21, down 16.55%, and was at $1.17 in pre-market trading, down 3.28%.
Bluejay Diagnostics IncCompleted enrollment in pivotal SYMON-II sepsis study ahead of schedule, supporting FDA submission for Symphony IL-6 platform.