secwatch.observer — SEC 8-K summary
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Issuer:     Bluejay Diagnostics, Inc. (BJDX)
CIK:        0001704287
Form:       8-K
Filed at:   2026-10-06T13:04:23+00:00
Accession:  0001213900-26-106999
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1704287/000121390026106999/0001213900-26-106999-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1704287/000121390026106999/ea0307769-8k_bluejay.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-106999

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer