---
title: "Bluejay completes SYMON-II enrollment of 750 patients ahead of plan"
url: "https://aibio.space/news/bluejay-completes-symon-ii-enrollment-750-patients-ahead-plan/"
publisher: "aibio.space (Biotech Investor Relations News)"
date: "2026-07-21"
section: "Company Updates"
tickers: "NASDAQ:BJDX"
source: "https://www.sec.gov/Archives/edgar/data/1704287/000121390026080474/ea029895501ex99-1.htm"
summary: "Preliminary observations show an approximately 17% 28-day mortality rate in the enrolled population. The company expects to complete data cleaning, statist"
---

By the aibio.space news desk.

Sources

- [Bluejay Diagnostics, Inc. 8-K (2026-07-22)](https://www.sec.gov/Archives/edgar/data/1704287/000121390026080474/ea029895501ex99-1.htm)
- [Bluejay Diagnostics, Inc. financial data (SEC XBRL)](https://www.sec.gov/Archives/edgar/data/1704287/000121390026024616/)

[BJDX](https://aibio.space/companies/bluejay-diagnostics/)

2026-07-21

# Bluejay completes SYMON-II enrollment of 750 patients ahead of plan

Tickers [BJDX](https://aibio.space/companies/bluejay-diagnostics/)

Preliminary observations show an approximately 17% 28-day mortality rate in the enrolled population. The company expects to complete data cleaning, statistical analysis and clinical reporting over the coming months.

## Key facts

- **Company**: Bluejay Diagnostics, Inc. (NASDAQ: BJDX)

- **News type**: Company Updates

- **Primary source**: [Bluejay Diagnostics, Inc. 8-K (2026-07-22)](https://www.sec.gov/Archives/edgar/data/1704287/000121390026080474/ea029895501ex99-1.htm)

*Chemistry glassware in a black and white photograph. CC0, via rawpixel. The picture shows the field, not the companies named.*

In a release dated July 21, 2026, Bluejay Diagnostics, Inc. (NASDAQ: [BJDX](https://aibio.space/companies/bluejay-diagnostics/)) announced that it has completed patient enrollment in SYMON-II, its multicenter clinical validation study. The company also filed the release with the SEC on Form 8-K. The study reached its target of 750 patients earlier than the company had originally expected.

## The study

SYMON-II is a prospective, multicenter clinical validation study. It is designed to test whether the Symphony IL-6 test can help clinicians assess 28-day all-cause mortality risk early in patients with sepsis who were admitted, or were intended for admission, to the intensive care unit. The study enrolled patients across leading U.S. healthcare institutions.

The SYMON clinical program has three studies. SYMON-I is a pilot study of IL-6 levels and endpoints including 28-day all-cause mortality and in-hospital mortality. SYMON-II is the pivotal study that the company plans to use to validate the SYMON-I outcomes and to support a 510(k) application to the FDA. SYMON-III is a pilot study of IL-6 levels in patients presenting to the emergency department with increasing severity of infection and risk of sepsis.

Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics, said: "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." He said that completing enrollment ahead of schedule reflects the work of the clinical investigators, study coordinators and the company's clinical and technical teams.

## Early observations

Preliminary observations from the enrolled population indicate an approximately 17% 28-day mortality rate. The company says that 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, said that the study's large, well-characterized population and meaningful number of mortality events are expected to provide a foundation for assessing the prognostic performance of IL-6. The release says the results will be a critical component of Bluejay's planned regulatory strategy for the Symphony IL-6 platform.

Finishing enrollment is an operational step, not a result. The 17% figure describes how many enrolled patients died within 28 days, and it says nothing about whether the IL-6 test predicts who will die. The release reports no IL-6 data, no sensitivity or specificity and no statistical analysis, calls the observations preliminary, and describes the dataset as robust, which is the company's characterization. Dr. Feinberg's own remarks are conditional on the study results. The release itself says the data cleaning and analysis are still to come, and the company expects the study only to provide the dataset needed to analyze whether the evidence supports future regulatory submissions. The release does not include financial results. Bluejay's XBRL financial data, drawn from its annual report filed March 6, 2026, shows a net income (loss) of negative $6.8 million for the fiscal year ended December 31, 2025, research and development expense of $3.0 million, and cash used in operations of $6.1 million.

## About Bluejay

Bluejay describes itself as a medical diagnostics company developing rapid, near-patient diagnostic technologies for critical care. The Symphony platform is designed to provide rapid, quantitative biomarker results at or near the patient's bedside, supporting decisions in emergency departments, intensive care units and other critical care settings. The company says the platform is intended to fit into existing clinical workflows and to allow later expansion to additional biomarkers and AI-enabled clinical decision support.

The release describes the enrollment as an operational milestone in the development of the Symphony platform, and Dey said the 750-patient enrollment provides one of the largest prospective datasets focused on the role of IL-6 in early sepsis mortality risk assessment.

## What comes next

The company expects to complete data cleaning, statistical analysis and clinical reporting over the coming months. The Symphony platform is designed to provide rapid, quantitative biomarker results at or near the bedside. The Symphony IL-6 Test has not been cleared or approved by the FDA and is not currently available for commercial clinical use in the United States.

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## Companies in this story

BJDX

Bluejay Diagnostics, Inc.

NASDAQ · United States

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Source page: https://aibio.space/news/bluejay-completes-symon-ii-enrollment-750-patients-ahead-plan/. Facts in aibio.space stories are checked against company filings and releases; opinion is labelled. Cite as: aibio.space, "Bluejay completes SYMON-II enrollment of 750 patients ahead of plan", 2026-07-21, https://aibio.space/news/bluejay-completes-symon-ii-enrollment-750-patients-ahead-plan/
