Bluejay Diagnostics Inc.

11/10/2025 | Press release | Distributed by Public on 11/10/2025 15:01

Bluejay Diagnostics Corporate Update: Advancing Clinical Milestones and Strategic Partnerships (Form 8-K)

Bluejay Diagnostics Corporate Update: Advancing Clinical Milestones and Strategic Partnerships

● Company focused on advancing clinical milestones and strategic partnerships, with goal of positioning itself for future FDA clearance and product commercialization.
● Patient enrollment in SYMON-II clinical trial now approximately 50% completed.
● Recent private placement transaction completed in October 2025; Company continues to explore further financing opportunities.

ACTON, MA - November 10, 2025 - Bluejay Diagnostics, Inc. (NASDAQ: BJDX) ("Bluejay" or the "Company"), a medical diagnostics company developing near-patient testing solutions for critical care, announced financial results for the quarter ended September 30, 2025, and highlighted continued progress across its clinical, operational, and financial initiatives.

Third Quarter 2025 and Recent Corporate Highlights

● SYMON-II Pivotal Clinical Study Continues: Bluejay continues patient enrollment in the SYMON-II pivotal clinical trial, designed to validate findings from its SYMON-I pilot study. The trial aims to assess the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality. The Company's goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial. Subject to receipt of further financing, the Company expects to complete sample testing by late 2026, positioning Symphony for a potential submission to the U.S. Food and Drug Administration in 2027.
● Strategic Partnerships and Supply-Chain Independence: Through an amended Master Service Agreement and the Master Supply Agreement with SanyoSeiko Co., Ltd. ("SanyoSeiko"), a Japan-based contract manufacturer specializing in medical devices and precision engineering, Bluejay aims to strengthen its manufacturing process. The amended agreement was entered into in connection with Bluejay expanding SanyoSeiko's role in helping to commercialize Bluejay's Symphony platform.
● Cash Position and Recent Financings:

As of September 30, 2025, the Company reported $3.08 million in cash and cash equivalents and $3.69 million in stockholders' equity, following successful completion of a $3.85 million warrant-inducement financing in April and an additional $4.5 million PIPE financing in October. (For further details on financing please refer to our SEC filings)

● Future Outlook: Sepsis remains one of the leading causes of mortality worldwide, with over 1.7 million cases annually in the United States alone. The Symphony IL-6 test is designed to deliver actionable results in approximately 20 minutes, enabling faster triage in ICU and emergency settings. The global sepsis diagnostic market is projected to reach $1.8 billion by 2030, which the Company believes creates a compelling potential market opportunity for near-patient testing of sepsis biomarkers. To achieve its plan, the Company expects to need to raise at least $20 million of further capital by the end of the 2027 fiscal year, which the Company hopes to do in various tranches. The Company's current plan, subject to achieving necessary financing, is to begin testing of samples it is collecting as part of its ongoing SYMON-II clinical trial by the end of 2026, with a goal of being in position to submit a 510(k) regulatory application to the FDA in 2027, with an objective of achieving FDA clearance thereafter.

"Bluejay is executing against a clear vision-to redefine sepsis management through fast, data-driven, near patient diagnostics," said Neil Dey, President and Chief Executive Officer. "The Symphony platform combines clinical precision with operational efficiency, addressing one of the largest unmet needs in hospital medicine today. Our team remains steadfast in driving operational excellence and scientific innovation. Each milestone brings us closer to transforming critical-care diagnostics and realizing meaningful returns for our investors. Bluejay's trajectory is one of progress, purpose, and potential-and we are committed to unlocking its full value."

About Bluejay Diagnostics:

Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay does not yet have regulatory clearance for the Symphony System, and we will need to receive regulatory authorization from the U.S. Food and Drug Administration before Symphony can be marketed as a diagnostic product in the United States. Bluejay's first product candidate, an IL-6 Test for sepsis, 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. More information is available at www.bluejaydx.com.

Bluejay Diagnostics Inc. published this content on November 10, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 10, 2025 at 21:01 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]