---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-106999"
form_type: "8-K"
ticker: "BJDX"
cik: "0001704287"
company_name: "Bluejay Diagnostics, Inc."
filed_at: "2026-10-06T13:04:23+00:00"
generated_at: "2026-10-12T16:30:32.710674+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Bluejay Diagnostics SYMON-II study has 777 patients, 18% 28-day mortality; supports IL-6 510(k) path

## Summary
- Preliminary SYMON-II analysis includes 777 evaluable patients: 637 28-day survivors and 140 non-survivors, an overall 28-day mortality rate of about 18%.
- 39.5% of the study population met Sepsis-3 criteria for septic shock; septic shock present in 56.4% of non-survivors vs 35.8% of survivors.
- 84.0% of patients had bacterial infection, 32.4% had a positive blood culture, and infection was highly likely or likely in 86.5%.
- SYMON-II is the pivotal study intended to support a 510(k) application to FDA for the Symphony IL-6 Test; the test is not cleared or approved and not commercially available in the U.S.
- Bluejay continues analyzing IL-6 measurements versus 28-day mortality; baseline characteristics alone do not establish prognostic performance, clinical utility, sensitivity or specificity.

## SEC filing metadata
- accession: 0001213900-26-106999
- form_type: 8-K
- ticker: BJDX
- cik: 0001704287
- company_name: Bluejay Diagnostics, Inc.
- filed_at: 2026-10-06T13:04:23+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1704287/000121390026106999/0001213900-26-106999-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1704287/000121390026106999/ea0307769-8k_bluejay.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-106999
- JSON: https://secwatch.observer/filing/0001213900-26-106999.json
- Plain text: https://secwatch.observer/filing/0001213900-26-106999.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.
