Bluejay Diagnostics (NASDAQ: BJDX) completes 750-patient SYMON-II enrollment
Rhea-AI Filing Summary
Bluejay Diagnostics, Inc. reports successful completion of patient enrollment in its SYMON-II multicenter clinical validation study, reaching its target of 750 sepsis patients ahead of plan. SYMON-II is a pivotal study evaluating the Symphony IL-6 test for early assessment of 28-day all-cause mortality risk in ICU sepsis patients.
Preliminary observations show an approximately 17% 28-day mortality rate in the enrolled population, providing a large dataset to assess the prognostic utility of IL-6. The company states that SYMON-II is intended to validate earlier findings and is part of a clinical program it plans to use to support a future FDA 510(k) application and potential commercialization of its investigational Symphony rapid, near-patient diagnostic platform.
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Filing Explained
Enrollment is complete, but Bluejay still needs to analyze the study and obtain FDA authorization before marketing Symphony in the United States.
Form 8-K Item 7.01 furnishes Bluejay’s July 21 announcement rather than filing it as an Exchange Act disclosure or incorporating it into another filing. The company reports that SYMON-II enrollment is complete at
The release says the Symphony platform remains an investigational device, and Bluejay does not yet have FDA clearance to market it as a diagnostic product in the United States.
The next specified resolution path is completion of the study analysis and reporting, followed by use of the results in the company’s planned regulatory strategy; the release does not state that a 510(k) application has been submitted or authorized.
8-K Event Classification
Key Figures
Key Terms
pivotal study medical
510(k) application regulatory
investigational device medical
near-patient testing medical
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FAQ
What did Bluejay Diagnostics (BJDX) announce regarding the SYMON-II study?
How many patients were enrolled in Bluejay Diagnostics (BJDX) SYMON-II, and why is that notable?
What preliminary mortality rate was observed in the SYMON-II population for BJDX?
How does Bluejay Diagnostics (BJDX) plan to use SYMON-II data for regulatory purposes?
Is the Symphony IL-6 platform from Bluejay Diagnostics (BJDX) already FDA-cleared?
What does the Symphony IL-6 test from Bluejay Diagnostics (BJDX) aim to provide clinicians?
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Item 7.01 Regulation FD Disclosure.
On July 21, 2026, Bluejay Diagnostics, Inc. issued a press release regarding the completion of patient enrollment in its ongoing SYMON-II clinical trial.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be “filed” for the purpose of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| 99.1 | Press Release, dated July 21, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| Bluejay Diagnostics, Inc. | ||
| By: | /s/ Neil Dey | |
| Neil Dey | ||
| President and Chief Executive Officer | ||
Date: July 22, 2026
2
Exhibit 99.1
Bluejay Diagnostics Announces Successful Completion of Enrollment in the SYMON-II Multicenter Clinical Validation Study
750 Patients Enrolled Ahead of Plan in Pivotal Study Evaluating Symphony™ IL-6 for Early Assessment of 28-Day Sepsis Mortality Risk
ACTON, Mass., July 21, 2026 – Bluejay Diagnostics, Inc. (NASDAQ: BJDX), a medical diagnostics company developing rapid, near-patient diagnostic technologies for critical care, today announced the successful completion of patient enrollment in its SYMON-II multicenter clinical validation study. The study achieved its targeted enrollment of 750 patients earlier than the Company had originally anticipated, representing an important operational milestone in the development of the Company’s Symphony™ rapid diagnostic platform.
SYMON-II is a prospective, multicenter clinical validation study designed to evaluate the ability of Bluejay’s Symphony™ IL-6 test to assist clinicians in the early assessment of 28-day all-cause mortality risk in patients with sepsis who were admitted or intended for admission to the intensive care unit (ICU). The study enrolled patients across leading U.S. healthcare institutions, and the Company expects that it will provide the clinical dataset needed to analyze whether clinical evidence supports future regulatory submissions and commercialization efforts.
Preliminary observations from the enrolled population indicate an approximately 17% 28-day mortality rate, providing a robust clinical dataset for evaluating the prognostic utility of IL-6 in patients presenting with sepsis. Bluejay believes this event rate represents a clinically meaningful population and underscores the importance of early identification of patients at elevated risk of deterioration.
Dr. Mark Feinberg, Chief Medical Advisor of Bluejay Diagnostics, commented:
“Sepsis remains one of the leading causes of hospital mortality worldwide, and timely identification of patients at greatest risk continues to be one of the most significant challenges in emergency and critical care medicine. The successful completion of SYMON-II’s enrollment represents an important advancement in evaluating the clinical utility of IL-6 as an early prognostic biomarker. The study’s large, well-characterized patient population and meaningful number of mortality events are expected to provide a robust foundation for assessing the prognostic performance of IL-6. If supported by the study results, rapid IL-6 testing could help clinicians identify high-risk patients earlier, improve risk stratification and triage decisions, and potentially enable more timely therapeutic interventions.”
“Successfully completing enrollment ahead of schedule is an important operational achievement and reflects the dedication of our clinical investigators, study coordinators, and Bluejay’s clinical and technical teams,” said Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics. “The enrollment of 750 patients provides one of the largest prospective datasets focused on the role of IL-6 in early sepsis mortality risk assessment. We believe this study represents an important step toward bringing clinicians a rapid, near-patient tool capable of supporting earlier and more informed clinical decision-making in one of medicine’s most time-critical conditions.”
The Company expects to complete data cleaning, statistical analysis, and clinical reporting over the coming months. Results from the study are anticipated to be a critical component of Bluejay’s planned regulatory strategy for the Symphony™ IL-6 platform.
The Symphony™ platform is designed to provide rapid, quantitative biomarker results directly at or near the patient’s bedside, supporting clinical decision-making in emergency departments, intensive care units, and other critical care settings. The platform is intended to integrate seamlessly into existing clinical workflows while enabling future expansion to additional biomarkers and AI-enabled clinical decision support capabilities.
Completion of SYMON-II enrollment represents another important milestone in Bluejay’s broader strategy to advance Symphony™ toward regulatory submission and commercialization.
Note: The Company’s Symphony™ rapid diagnostic platform is an investigational device and is limited by United States law to investigational use.
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.
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.
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 December 31, 2025, and in Part II, Item 1A, “Risk Factors” in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026. 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 Dey
Bluejay Diagnostics, Inc.
neil.dey@bluejaydx.com
Website: www.bluejaydx.com