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Bluejay Diagnostics Corporate Update: Advancing Clinical Milestones and Strategic Partnerships

Key Takeaway: Bluejay Diagnostics, Inc. has reported its financial results for Q3 2025, emphasizing progress in its clinical and operational initiatives. The company aims to redefine sepsis management through its Symphony platform, which is designed for rapid near-patient testing. However, the Symphony System is still awaiting FDA regulatory clearance before it can be marketed in the U.S.

Market Sentiment Analysis

POSITIVE FACTORS

  • Bluejay is advancing its Symphony platform for sepsis management.
  • The company is focused on operational excellence and scientific innovation.
  • Progress in clinical and operational initiatives is being highlighted.

CONCERNS & RISKS

  • The Symphony System lacks regulatory clearance from the FDA.
  • There are inherent risks and uncertainties in the company's forward-looking statements.

Full Press Release Details

ACTON, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) --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

“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 atwww.bluejaydx.com.

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 in this press release include, without limitation, statements pertaining to Bluejay’s relationship with SanyoSeiko and the work SanyoSeiko has been requested to undertake for Bluejay supporting the manufacturing process redevelopment, supply chain management, and manufacturing of Bluejay’s Symphony platform. 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 our Form 10-K for the fiscal year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, and inPart II, Item 1A, “Risk Factors”in its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2025, June 30, 2025 and September 30, 2025, filed with the SEC on May 13, 2025, August 7, 2025 and November 7, 2025, respectively. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or 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, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company’s expectations of results or any future change in events, except as required by law.

Investor Contact:Neil DeyBluejay Diagnostics, Inc.neil.dey@bluejaydx.com978-631-0310

Frequently Asked Questions

What is the Symphony platform by Bluejay Diagnostics?

The Symphony platform is a rapid, near-patient testing system designed for sepsis triage and monitoring.

Is the Symphony System approved by the FDA?

No, the Symphony System does not yet have regulatory clearance from the FDA.

What are the recent highlights from Bluejay Diagnostics?

Bluejay highlighted progress in clinical, operational, and financial initiatives in Q3 2025.

What is the purpose of the IL-6 Test?

The IL-6 Test aims to provide accurate results in about 20 minutes for better triage decisions.

Last updated: Nov 10, 2025