The presentation will report findings from SYMON-I, a multicenter pilot clinical study evaluating interleukin-6 (IL-6) levels in patients with sepsis who were admitted or intended for admission to the intensive care unit (ICU). The analysis evaluates the relationship between IL-6 levels measured in the emergency department and organ dysfunction as assessed by Sequential Organ Failure Assessment (SOFA) scores during the first three days of hospitalization.
“The findings from the SYMON-I study suggest that IL-6 measured in the emergency department may be associated with subsequent organ dysfunction in patients with sepsis and septic shock. These data contribute to the growing body of evidence evaluating IL-6 as a potential biomarker in the early assessment of critically ill patients.”
“The SAEM Annual Meeting provides an opportunity to present emerging clinical data evaluating IL-6 as a biomarker associated with the inflammatory response and organ dysfunction in sepsis. Bluejay’s ongoing SYMON-II validation study is intended to further evaluate IL-6 as a prognostic biomarker associated with mortality and other clinically meaningful outcomes in critically ill patients.”
Presentation Details
Title: Emergency Department Interleukin-6 Levels and Organ Dysfunction in Sepsis Across Multiple Centers
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Conference:
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About the Symphony IL-6 Test:
The Symphony™ Test platform is designed to determine patient acuity for triage and monitoring based on the measurement of a specific biomarker. The Symphony™ IL-6 Test to determine patient acuity for sepsis triage and monitoring (“Symphony™ IL-6 Test”) is currently Bluejay’s lead product candidate.
Note: Investigational device. Limited by
About the SYMON Clinical Study Program:
The SYMON Clinical Study Program includes SYMON-I (clinicaltrials.gov ID NCT06181604), SYMON-II (NCT06654895), and SYMON-III (NCT07425587). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA. The SYMON-III study is a pilot study to determine IL-6 levels associated with patients presenting with increasing severity of infection in the emergency department and risk of developing sepsis.
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Forward-Looking Statements:
This press release contains statements that the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest,” “will,” and similar expressions. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended
Investor Contact:
neil.dey@bluejaydx.com
978-631-0310
Website: www.bluejaydx.com
Source: Bluejay Diagnostics, Inc.