Bluejay Diagnostics provides corporate update, reduces headcount to five

Bluejay Diagnostics (BJDX) provided a 2025 mid-year business and corporate update. The company has initiated its SYMON-II clinical study, following the successful completion of the SYMON-I pilot study, for which a primary analysis highlighted that IL-6 levels within 24 hours of ICU admission may predict sepsis patient mortality out to 28 days. Currently, the company is collecting, freezing and biobanking samples, with plans to subsequently measure IL-6 concentrations in the bio banked samples near the end of patient enrollment or after the patient enrollment has completed, and later analyze the IL-6 data with the patient outcomes to see if the established IL-6 cutoff value has been validated for 28-day all-cause mortality. Patient enrollment started during the fourth quarter of 2024 and is continuing. The company’s goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial, following completion of the Company’s redevelopment of the cartridges used in the Symphony system. Based on previous interactions with the FDA, the Company continues to plan for a 510(k) submission for its Symphony IL-6 test, with a goal of submitting a 510(k) regulatory application to the FDA in the fourth quarter of 2027 and an objective of achieving FDA approval as early as the third quarter of 2028. Bluejay continues its collaboration with SanyoSeiko for manufacturing of the Symphony analyzer. The company is also beginning the process of redeveloping aspects of the Symphony cartridges to address several technical challenges to bring Symphony to a level consistent with necessary performance and quality requirements. While the company continues to explore the potential for conducting cartridge redevelopment at an in-house facility, it is now actively exploring other alternative pathways for how to pursue such redevelopment, including by outsourcing this work to a third-party contract manufacturing organization that would oversee this process and provide cartridge supply to the company. To preserve cash resources and seek to extend its cash runway, the company has recently implemented a series of recent cost savings measures in its product development operations and has reduced its overall company-wide full-time employee headcount to five persons following the recent departure of its CTO.