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Bluejay completes 750-patient sepsis study enrollment
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Bluejay completes 750-patient sepsis study enrollment

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  • Bluejay completed enrollment of 750 patients in its pivotal SYMON-II sepsis study ahead of its original schedule.
  • Bluejay shares fell 14.8% to $1.21 in premarket trading following the announcement.
  • The company plans to analyse the data for its regulatory strategy, but the Symphony IL-6 test remains investigational.

Bluejay Diagnostics (NASDAQ:BJDX) completed enrollment of 750 patients in its SYMON-II study evaluating 28-day sepsis mortality risk.

Enrollment increased from approximately 680 patients on May 5 and reached the final target earlier than Bluejay had originally planned.

Bluejay observed an approximately 17% mortality rate, but sensitivity, specificity and other test-performance results remain pending statistical analysis.

Following the announcement, Bluejay Diagnostics' share price was down 14.8% at $1.21 in premarket trading.

SYMON-II is intended to validate earlier SYMON-I findings and support a planned 510(k) application to the U.S. Food and Drug Administration.

Recent moves include an $8.5 million private placement, a manufacturing partnership with Argonaut and continued development of a roughly 20-minute near-patient test.