Bluejay Diagnostics releases SYMON‑II data showing 777 sepsis patients and ~18% 28‑day mortality
Bluejay Diagnostics announced baseline results from its SYMON‑II clinical validation study, which evaluated interleukin‑6 as a prognostic biomarker for 28‑day mortality in sepsis and septic shock. The preliminary analysis includes 777 evaluable patients, of whom 637 survived and 140 died, yielding an overall 28‑day mortality rate of about 18%. The company plans to use the data to support a 510(k) submission for its Symphony IL‑6 Test, which is not yet FDA‑cleared.
Why it matters
The data provides a clinical foundation for the company’s planned regulatory filing, which could enable commercial launch of the Symphony IL‑6 Test and generate future revenue (the company states this in its press release). The stock rose 3.13% in pre‑market trading following the announcement, indicating market interest.
Key facts
- 1The SYMON‑II study evaluated 777 patients. finanznachrichten.de
- 2There were 637 28‑day survivors and 140 28‑day non‑survivors. finanznachrichten.de
- 3The overall 28‑day mortality rate was approximately 18%. finanznachrichten.de
- 439.5% of patients met Sepsis‑3 criteria for septic shock. finanznachrichten.de
- 584.0% of patients had a bacterial infection reported. finanznachrichten.de
- 6The Symphony IL‑6 Test has not been cleared or approved by the FDA. finanznachrichten.de
Summary written by AlphAI from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.