Bluejay's sepsis test nears FDA filing with only $7.38M in the bank

Bluejay Diagnostics reported on 12 November 2026, alongside third-quarter results, that it has finished recruiting patients for SYMON-II, the pivotal study of its Symphony IL-6 test, which is intended for prognosis in sepsis. The company plans to file a 510(k) application with the US Food and Drug Administration in the first half of 2027.

The balance sheet is the main constraint. Bluejay held $7.38M in cash at the reporting date and says that will fund operations only through the second quarter of 2027. It states that further financing will be required, and that need falls close to the period in which it hopes to submit to the FDA. The company did not say in the material reviewed how or when it intends to raise capital.

Preliminary figures covering 777 evaluable patients showed 28-day mortality of about 18%. Bluejay has not described any further analyses from the study in the material available, and final results have yet to be reported.

Bluejay also said it has lined up an additional site to make its test cartridges, and that it did so before a contractual deadline set by Toray, its current manufacturing partner. For context, a 510(k) is the FDA route in which a device maker shows its product is substantially equivalent to one already legally marketed. Whether Bluejay's submission is cleared remains to be seen.