Bluejay Diagnostics Enrolls 680 of 750 Patients, Bolsters Symphony Manufacturing Readiness
Bluejay Diagnostics enrolled 680 of 750 patients in its SYMON-II pivotal sepsis IL-6 study and advanced manufacturing readiness with Sanyoseiko, resolving cartridge issues and progressing toward validation. As of March 31, 2026, cash stood at $3.7M with a Q1 net loss of $1.9M as it readies for a 510(k) submission.
1. SYMON-II Enrollment Progress
Bluejay reached 680 enrolled patients toward its 750-patient goal in the pivotal SYMON-II study evaluating IL-6 levels in sepsis and septic shock, with multiple clinical sites contributing to ongoing data collection.
2. Manufacturing and Cartridge Validation
In partnership with Sanyoseiko Co. Ltd., the company resolved technical challenges in Symphony cartridge production, completed key manufacturing readiness steps, and is advancing toward analytical and clinical validation.
3. Regulatory Strategy and Platform Expansion
Bluejay continues executing its FDA-focused strategy, targeting a future 510(k) submission for the Symphony IL-6 test and exploring additional critical care biomarkers and cardiovascular monitoring applications on the platform.
4. Financial Position and Operational Funding
As of March 31, 2026, Bluejay held $3.7 million in cash and cash equivalents and reported a first-quarter net loss of $1.9 million, maintaining financial discipline to support critical clinical, manufacturing and regulatory activities.