Bluejay Diagnostics reports progress on sepsis test clinical trial

ACTON, Mass. - Bluejay Diagnostics, Inc. (NASDAQ:BJDX) announced Monday that patient enrollment in its SYMON-II pivotal clinical trial has reached approximately 50% completion, as the company continues development of its Symphony IL-6 test for sepsis detection.

The medical diagnostics company, focused on near-patient testing solutions for critical care, is conducting the trial to validate findings from its earlier SYMON-I pilot study. The current study aims to assess the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality.

Bluejay reported $3.08 million in cash and cash equivalents as of September 30, 2025, with $3.69 million in stockholders’ equity. The company recently completed a $4.5 million private placement transaction in October, following a $3.85 million warrant-inducement financing in April.

According to the company’s timeline, subject to securing additional financing, Bluejay plans to complete sample testing by late 2026 and potentially submit an application to the U.S. Food and Drug Administration in 2027. The company estimates it will need to raise at least $20 million in additional capital by the end of fiscal year 2027.

The Symphony IL-6 test is designed to deliver results in approximately 20 minutes, potentially enabling faster triage in ICU and emergency settings. Bluejay does not yet have regulatory clearance for the Symphony System.

The company also reported an amended agreement with Japan-based contract manufacturer SanyoSeiko Co., Ltd. to support manufacturing processes for the Symphony platform.

Sepsis affects over 1.7 million cases annually in the United States, according to information provided in the company’s press release statement.

In other recent news, Bluejay Diagnostics, Inc. announced the closing of a $4.5 million private placement. The company sold 2,250,000 shares of common stock and Series F warrants to purchase up to 4,500,000 shares. The offering was priced at $2.00 per share, with accompanying warrants priced at-the-market under Nasdaq rules. Additionally, Bluejay Diagnostics has expanded its manufacturing partnership with Japan’s SanyoSeiko Co., Ltd. The amended agreements will enhance SanyoSeiko’s role in commercializing Bluejay’s Symphony platform. This platform is designed for rapid biomarker detection, including IL-6 for sepsis management. These developments reflect significant steps in Bluejay Diagnostics’ strategic initiatives.

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