Press Releases

ACTON, Mass., April 15, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX), today announced acceptance of an abstract related to the Symphony IL-6 Test, the company’s lead product candidate, for presentation at the Society of Academic Emergency Medicine (SAEM) Annual Meeting, taking place in Philadelphia May 13-16, 2025. Results from SYMON-I, a pilot clinical study of interleukin-6 (IL-6) in sepsis patients intended or admitted for the intensive care unit (ICU), will be presented. SYMON-I evaluated IL-6 as a prognosticator for 28-day mortality and exploratory endpoints including 7-day mortality and microbiological positivity.

“Early use of IL-6 in sepsis and septic shock patients shows promise in prognosticating short-term and mid-term mortality, and in predicting the development of microbiological positive cultures,” said Nathan Shapiro, M.D., Vice Chairman of Emergency Medicine Research at Beth Israel Deaconess Medical Center and Professor of Emergency Medicine at Harvard Medical School. “The findings from SYMON-I raise the potential to use IL-6 measured in the emergency department for early prognosis and to guide management in sepsis.”

“The 2025 SAEM Annual Meeting provides a timely opportunity to engage with emergency medicine professionals and share important information related to the role of IL-6 as an early biomarker for the inflammatory response and in the management of sepsis patients,” said Mark Feinberg, M.D., Chief Medical Advisor at Bluejay Diagnostics and Professor of Medicine at Harvard Medical School. “Enrollment in our SYMON-II validation clinical study is underway, which will help define IL-6 as a prognostic biomarker for mortality and other impactful critical care endpoints.”

Details of the presentation:

Title: Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I)

Presenters: John H. Lee, M.D., Ph.D. and Nathan Shapiro, M.D.

Presentation Date: May 14, 2025

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.

About the SYMON Clinical Study Program:

The SYMON Clinical Study Program includes SYMON-I I (clinicaltrials.gov ID NCT06181604) and SYMON-II (NCT06654895). 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.

About Bluejay Diagnostics: Bluejay Diagnostics, Inc. is committed to advancing healthcare by developing accessible, affordable, rapid and direct biomarker testing, in whole blood, near patient. Bluejay’s first product candidate, an IL-6 test for sepsis triage, is designed to provide accurate, reliable results in approximately 20 minutes from ‘Sample-To-Result’ to help medical professionals make earlier and better triage/treatment decisions. Based in Acton, Massachusetts, Bluejay aims to improve clinical outcomes through timely and precise diagnostic tests.

Symphony is a registered trademark of Bluejay Diagnostics, Inc.

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. These statements include, but are not limited to, statements relating to the expected nature and timing of the Company’s planned FDA submissions and related plans for clinical study completion, whether the Company’s cash position will be sufficient to fund operations needed to achieve regulatory approval and initial commercialization of the Symphony IL-6 Test, whether such regulatory approval will actually occur, and the continuation of the Company as a going concern. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest”, “will,” and variations of such words or similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). 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 those discussed in the Company’s filings with the Securities and Exchange Commission, including as set forth in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024. You should not rely on these statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. The Company expressly disclaims any obligation to update or revise any forward looking statements found herein to reflect any changes in the Company’s expectations of results or any change in events.

Investor Contact:
Investor Relations
Bluejay Diagnostics, Inc.
ir@bluejaydx.com
Website: www.bluejaydx.com

Source: Bluejay Diagnostics, Inc.