Bluejay Diagnostics announces results from preliminary analysis of SYMON-I

Bluejay Diagnostics announced results from the primary analysis of SYMON-I, a multicenter pilot clinical study investigating the role of interleukin-6 in patients diagnosed with sepsis and septic shock. This prospective study assessed the utility of IL-6 upon initial presentation to the intensive care unit, ICU. The primary analysis of the SYMON-I study highlighted that IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to the ICU may predict patient mortality out to 28 days. These findings will be validated in the SYMON-II pivotal study. Furthermore, a secondary outcome of the SYMON-I study showed that IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to the ICU is a predictor of patient mortality during their hospitalization. Bluejay Diagnostics is planning to initiate the SYMON-II pivotal clinical study in Q3 2024. If the results are positive, the Company intends to use SYMON-II as support in a 510(k) application to the FDA in 2025 for the following intended use: Symphony IL-6 is intended for use to determine the IL-6 concentration as an aid in assessing the cumulative 28-day risk of all-cause mortality in conjunction with other laboratory findings and clinical assessments for patients diagnosed with sepsis or septic shock in the ICU.