Core Insights - Bluejay Diagnostics, Inc. announced that an abstract related to its Symphony™ IL-6 Test has been accepted for presentation at the 2026 Society of Academic Emergency Medicine Annual Meeting [1] - The SYMON-I study evaluates the relationship between IL-6 levels in sepsis patients and organ dysfunction, measured by SOFA scores during the first three days of hospitalization [2][3] Study Details - SYMON-I is a multicenter pilot clinical study focusing on IL-6 levels in sepsis patients admitted to the ICU [2] - The study aims to determine if IL-6 levels can serve as a biomarker for early assessment of organ dysfunction in critically ill patients [3] Presentation Information - The presentation titled "Emergency Department Interleukin-6 Levels and Organ Dysfunction in Sepsis Across Multiple Centers" will be delivered by Dr. John H. Lee and Dr. Nathan Shapiro at the SAEM Annual Meeting in Atlanta, Georgia [4] Product Information - The Symphony™ IL-6 Test is designed for rapid assessment of patient acuity for sepsis triage and monitoring, providing results in approximately 20 minutes [8] - Bluejay's ongoing SYMON-II study aims to validate the findings of SYMON-I and support a 510(k) application to the FDA [6] Company Overview - Bluejay Diagnostics focuses on improving patient outcomes through its Symphony System, which is a cost-effective, rapid testing system for sepsis [8]

Company Overview - Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes through its Symphony System, which is a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression [3] Recent Developments - As of February 19, 2026, all prefunded warrants issued in the October 2025 private placement have been fully exercised, resulting in approximately 972,000 shares of common stock outstanding [1] - The company has cash exercisable warrants outstanding for approximately 1.5 million shares, with a cash exercise price of $7.00 or greater per share [1] Stock Information - Recent Schedule 13G filings by investors do not reflect the 1-for-4 reverse stock split that occurred on January 29, 2026, which may lead to discrepancies in reported beneficial ownership share amounts [2]

Core Insights - Bluejay Diagnostics has successfully enrolled 545 patients in its SYMON™ II multicenter clinical study, exceeding initial expectations with a target of 750 patients [1][2] - The company is making significant progress in manufacturing readiness and technology transfer initiatives, marking a key transition from clinical enrollment to data analysis and commercialization [1][5] Clinical Study Progress - The SYMON™ II study focuses on IL-6 monitoring, with all patient enrollments conducted under approved IRB protocols [2] - The scale and diversity of the dataset are expected to enhance the company's regulatory positioning and facilitate discussions with future partners and stakeholders [3] Manufacturing Readiness - Manufacturing readiness activities are advancing across multiple workstreams, including antibodies, tooling, analytical validation, and commercial manufacturing infrastructure [4] - Key developments include the completion of monoclonal and polyclonal antibody production, which provides supply capacity for over 10 million test cartridges [8] - Technology transfer activities are progressing effectively, supported by strategies to mitigate timing and scale-up risks [4] Future Outlook - As Bluejay enters 2026, the company believes it is in a stronger execution position with reduced clinical risk and a heightened focus on value realization through data analysis and regulatory engagement [5]

ACTON, Mass., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical technology company developing rapid diagnostics on its Symphony platform to improve patient outcomes in critical care settings, today announced that the Company’s Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-4 (the “Reverse Stock Split”). The Reverse Stock Split will become effective at 12:01 a.m. Eastern Time on January 2 ...

Core Insights - Bluejay Diagnostics, Inc. reported financial results for Q3 2025, highlighting progress in clinical, operational, and financial initiatives [1][2] Financial Performance - As of September 30, 2025, the company had $3.08 million in cash and cash equivalents and $3.69 million in stockholders' equity [3] - The company completed a $3.85 million warrant-inducement financing in April and a $4.5 million PIPE financing in October [3] Market Opportunity - Sepsis is a leading cause of mortality, with over 1.7 million cases annually in the U.S. [3] - The global sepsis diagnostic market is projected to reach $1.8 billion by 2030, presenting a significant opportunity for near-patient testing of sepsis biomarkers [3] Clinical Development - The SYMON-II clinical trial is approximately 50% completed, aiming to validate findings from the SYMON-I pilot study [5][6] - The trial assesses the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality [6] - The company plans to begin testing samples collected in the SYMON-II trial by late 2026, with a goal to submit a 510(k) regulatory application to the FDA in 2027 [3][6] Strategic Partnerships - Bluejay has amended agreements with SanyoSeiko Co., Ltd. to enhance its manufacturing process and support the commercialization of the Symphony platform [6]

Core Points - Bluejay Diagnostics, Inc. has completed a private placement of 2,250,000 shares of common stock and Series F warrants to purchase up to 4,500,000 shares at a price of $2.00 per share, with Series F warrants having an exercise price of $1.75 and expiring in five and a half years [1][2] - The gross proceeds from this offering amounted to $4.5 million, which will be used for FDA approval processes, clinical studies, research and development, and general working capital needs [2] - The securities were offered under Section 4(a)(2) of the Securities Act and have not been registered, meaning they cannot be sold in the U.S. without an effective registration statement or applicable exemption [3] Company Overview - Bluejay Diagnostics focuses on improving patient outcomes through its Symphony System, a rapid near-patient testing system for sepsis triage and disease monitoring [5] - The company's first product candidate is an IL-6 Test for sepsis, designed to deliver accurate results in approximately 20 minutes, aiding medical professionals in making timely treatment decisions [5]

Core Viewpoint - Bluejay Diagnostics, Inc. has announced a private placement of common stock and Series F warrants to raise approximately $4.5 million to fund FDA approval processes and other R&D activities [1][2]. Group 1: Offering Details - The company will sell 2,250,000 shares of common stock at a price of $2.00 per share, along with Series F warrants to purchase up to 4,500,000 additional shares at an exercise price of $1.75 [1]. - The Series F warrants will be exercisable immediately and will expire 5.5 years from the issuance date [1]. - The private placement is expected to close on or about October 10, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for obtaining FDA approval, including related clinical studies, as well as for general working capital and other research and development activities [2]. Group 3: Company Overview - Bluejay Diagnostics focuses on improving patient outcomes with its Symphony System, a rapid near-patient testing system for sepsis triage and disease monitoring [5]. - The company's first product candidate is an IL-6 Test for sepsis, designed to deliver results in approximately 20 minutes, aiding medical professionals in making timely treatment decisions [5].

Core Insights - Bluejay Diagnostics, Inc. provided a mid-year business update for 2025, highlighting progress in its clinical programs and financial status [1][2] Business Highlights and Developments - The 2025 Annual Meeting of Stockholders is scheduled for June 18, 2025, with a proposal to reduce the Board of Directors from six to five members and to consider two reverse stock split proposals to meet Nasdaq listing requirements [3] - The SYMON-II clinical study has been initiated, following the successful SYMON-I pilot study, which indicated that IL-6 levels could predict sepsis patient mortality [4] - The company aims to submit a 510(k) application for its Symphony IL-6 test to the FDA in Q4 2027, with potential approval as early as Q3 2028 [4] - Bluejay is collaborating with SanyoSeiko for manufacturing the Symphony analyzer and is redeveloping Symphony cartridges to address technical challenges [4] Financial Results - As of April 30, 2025, Bluejay had cash and cash equivalents of approximately $5.7 million and current liabilities of about $1.0 million [4] - The company reported losses of approximately $7.7 million for the fiscal year ended December 31, 2024, and $1.9 million for the fiscal quarter ended March 31, 2025 [4] - In April 2025, Bluejay raised approximately $3.8 million through Class C warrant exercises and new Class E warrants, with a goal to raise at least $30 million by the end of the 2027 fiscal year [4] Product and Clinical Study Information - The Symphony IL-6 Test is designed for sepsis triage and monitoring, providing results in about 20 minutes [5][7] - The SYMON Clinical Study Program includes SYMON-I and SYMON-II, with SYMON-I focusing on IL-6 levels related to mortality outcomes [6]

Core Viewpoint - Bluejay Diagnostics, Inc. has entered into an agreement with existing institutional investors to exercise warrants for common stock, raising approximately $3.7 million in gross proceeds at a reduced exercise price of $3.42 per share [1][2]. Company Overview - Bluejay Diagnostics, Inc. is a medical technology company focused on developing rapid diagnostics through its Symphony platform to enhance patient outcomes in critical care settings [1][5]. - The company's first product candidate is an IL-6 Test for sepsis, designed to deliver accurate results in about 20 minutes, aiding medical professionals in making timely treatment decisions [5]. Financial Transaction Details - Investors will receive new warrants to purchase an equal number of shares (1,085,106) at the same exercise price of $3.42, which are exercisable immediately and will expire in five years [2]. - The transaction was facilitated by Aegis Capital Corp. as the exclusive financial advisor, with legal counsel provided by Hogan Lovells US LLP for the company and Kaufman & Canoles, P.C. for Aegis Capital Corp. [4].