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SEC filingBluejay Diagnostics announced completion of 624 patient enrollments in its pivotal SYMON-II clinical trial for the Symphony™ IL-6 test, with enrollment expected to conclude within 2–3 months as it advances toward FDA 510(k) submission and clinical validation in sepsis triage.
This enrollment update signals meaningful progress in Bluejay’s clinical development pathway, directly supporting its near-term regulatory strategy. With 624 of 750 targeted patients enrolled and no material enrollment barriers reported, the trial remains on track for completion in 2–3 months — a critical prerequisite before initiating data analysis and preparing the 510(k) submission. The absence of significant exclusions due to protocol criteria strengthens confidence in the study’s ability to generate clinically representative data for sepsis triage in critical care. As SYMON-II validates findings from the earlier SYMON-I pilot study, successful completion positions Bluejay to advance toward clinical validation milestones and potential commercialization planning. However, the test remains investigational with no FDA clearance, and no financial, operational, or regulatory timelines beyond enrollment are disclosed — limiting immediate commercial or revenue implications. Investors should monitor subsequent disclosures regarding database lock, statistical analysis plan, and regulatory engagement.