BJDX

ACTON, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (“Bluejay” or the “Company”), a medical diagnostics company focused on improving patient outcomes in critical care settings, today provided a corporate update highlighting progress achieved during the first quarter of 2026 and recent operational developments related to its Symphony™ near-patient diagnostic platform. During the first quarter of 2026, Bluejay continued advancing the clinical, manufacturing, and regulatory activities supporting the development of its Symphony IL-6 test for sepsis patient monitoring and risk assessment in critical care settings. Q1 2026 and Recent Highlights • Continued enrollment progress in the ongoing SYMON-II pivotal clinical study evaluating the role of IL-6 in sepsis and septic shock patients. As of May 5, 2026, approximately 680 patients have been enrolled toward the target enrollment of 750 patients across participating clinical sites. • Advanced manufacturing readiness activities for Symphony cartridges in collaboration with Sanyoseiko Co. Ltd., Bluejay’s contract manufacturing organization. The Company successfully resolved technical issues related to the Symphony cartridge manufacturing process and is progressing toward analytical and clinical validation activities intended to support future regulatory submission. • Continued execution of Bluejay’s FDA-focused regulatory strategy for Symphony IL-6, with the Company maintaining its objective of preparing for a future 510(k) submission following completion of required analytical and clinical validation activities. • Continued development activities related to Bluejay’s broader Symphony platform strategy, which includes future potential applications in additional critical care biomarkers and cardiovascular disease monitoring. Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics, commented, “We believe the first quarter of 2026 represented meaningful operational progress across several key areas of our Symphony program. Most importantly, we continued strong enrollment momentum in our SYMON-II pivotal study while also advancing manufacturing readiness activities intended to support future analytical and clinical validation. We are encouraged by the progress our team and partners have made in positioning Symphony toward the next phase of development.” Mr. Dey continued, “We believe Sy...

ACTON, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical diagnostics company developing near-patient solutions for critical care, today announced financial results for the quarter ended June 30, 2025, and provided an update on its Symphony IL-6 test program and key operational milestones. Second Quarter 2025 and Recent Corporate Highlights SYMON-II Pivotal Clinical Study Underway: Bluejay has initiated patient enrollment in the SYMON-II pivotal clinical trial, designed to validate findings from the successful SYMON-I pilot study. Early indicators show continued clinical momentum. The trial aims to assess the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality. Symphony IL-6 Development and Regulatory Pathway: Bluejay remains on track to complete SYMON-II sample testing by the end of 2026, with a target 510(k) submission to the FDA in 2027. Strategic Manufacturing Alignment with SanyoSeiko: Bluejay continues to work closely with SanyoSeiko Co., Ltd. as its contract manufacturing organization (CMO) for the Symphony analyzer. In parallel, the Company is advancing plans to secure cartridge redevelopment and validation manufacturing through a qualified FDA-registered CMO. These steps aim to ensure regulatory-grade supply chain readiness for clinical validation and commercialization. Amended License & Supply Agreement with Toray Industries: On July 23, 2025, Bluejay entered into an amendment with Toray Industries, extending the timeline to establish alternate cartridge manufacturing to October 2026. The amendment also confirms completion of Toray’s know-how transfer and final supply obligations—strengthening Bluejay’s independence in future manufacturing. Financing Progress and Outlook: In April 2025, Bluejay raised gross proceeds of $3.85 million through a warrant inducement financing. The Company anticipates requiring additional capital through 2027 to support manufacturing readiness, clinical trials, and regulatory activities. The Company is actively exploring strategic and institutional financing avenues to meet these milestones. Upcoming Catalysts Manufacturing Site Selection and Onboarding for Cartridge Redevelopment Completion of Cartridge Redevelopment Specifications and Validation Readiness Patient Enrollment Acceleration and Interim Data Review from S...