Bluejay Diagnostics Successfully Enrolls 545 Patients in SYMON II Study and Advances Manufacturing Readiness into 2026

ACTON, Mass., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics (NASDAQ: BJDX) today announced that it has successfully enrolled 545 patients in its SYMON™ II multicenter clinical study and has made substantial progress in advancing manufacturing readiness and technology transfer initiatives into 2026, representing a key execution milestone as the Company transitions from clinical enrollment toward data analysis, regulatory engagement, and commercialization readiness.

SYMON-II Clinical trials
Bluejay is successfully enrolling across all participating sites in its SYMON™ II multicenter IL-6 monitoring study, with a total of 545 patients enrolled with a target of 750 patients, exceeding initial expectations. All enrollments are under approved IRB protocols.

Management believes the scale and diversity of the dataset will meaningfully strengthen the Company’s regulatory positioning and support future partner and stakeholder discussions. Current progress materially reduces enrollment execution risk and marks a transition point for the SYMON™ II program.

Manufacturing Readiness
Manufacturing readiness activities continue to advance across multiple parallel workstreams, including antibodies, tooling, analytical validation, and commercial manufacturing infrastructure.

Key developments include:

• Completion of cartridge characterization supporting U.S. commercial production
• Completion of monoclonal and polyclonal antibody production, providing supply capacity sufficient for more than 10 million test cartridges
• Ongoing fabrication and validation of cartridge and reservoir for FDA submission and commercialization
• The Company is also evaluating select material substitutions intended to improve quality consistency and cost efficiency. These efforts are being conducted under defined validation protocols and are actively managed as part of the broader manufacturing readiness plan.
  
  

Management noted that technology transfer activities are progressing without a single point of failure, supported by parallel execution strategies designed to mitigate timing and scale-up risk.

As Bluejay enters 2026, management believes the Company is operating from a materially stronger execution position, with reduced clinical risk and increased focus on value realization through data analysis, regulatory engagement, and commercialization preparedness.

About Bluejay Diagnostics:

Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay does not yet have regulatory clearance for the Symphony System, and we will need to receive regulatory authorization from the U.S. Food and Drug Administration before Symphony can be marketed as a diagnostic product in the United States. Bluejay’s first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results in approximately 20 minutes from ’sample-to-result’ to help medical professionals make earlier and better triage/treatment decisions. More information is available at www.bluejaydx.com.