Bluejay Diagnostics, Inc.

Overview

Bluejay Diagnostics is a medical diagnostics company focused on critical care settings, with a particular emphasis on sepsis. The company is developing rapid, near-patient diagnostic tests that run on the Symphony platform, which consists of an analyzer and single-use protein-detection cartridges that accept whole blood samples.

Product and platform

• The Symphony platform combines Bluejay’s technology with exclusive Toray intellectual property for the Symphony detection cartridges.
• Symphony IL-6 is a candidate immunoassay designed to measure interleukin-6 (IL-6) to monitor disease progression in critical care, with intended use related to sepsis and septic shock in ICU patients.
• Test workflow: a small blood sample is added to a disposable cartridge; the cartridge is inserted into the Symphony analyzer and the test runs automatically, delivering results in about 20 minutes.
• Each Symphony analyzer can run up to six cartridges simultaneously.

Regulatory status and clinical program

• Symphony and the Symphony IL-6 test do not have FDA clearance or marketing authorization as of the filing.
• The regulatory plan centers on a 510(k) submission in 2027, with the goal of FDA clearance thereafter.
• The FDA has classified Symphony as a de novo device.
• Clinical studies include SYMON-I (pilot) and SYMON-II (pivotal), which focus on IL-6 and 28-day mortality in ICU sepsis patients. SYMON-II has an enrollment target of 750 patients; approximately 583 patients were enrolled as of the filing date.

Manufacturing and suppliers

• Bluejay manufactures the Symphony analyzers.
• Cartridges are produced by Sanyoseiko (Japan) under a contract manufacturing agreement; Sanyoseiko is FDA-certified for manufacturing.
• Toray licenses provide exclusive global cartridge technology rights outside Japan and nonexclusive manufacturing rights in Japan. Bluejay holds sublicensing rights to enable cartridge manufacturing by Sanyoseiko under the current agreements.
• A 2025 amendment extended the deadline to establish an alternative cartridge manufacturing site to October 23, 2026. Toray may terminate the license if best-efforts milestones are not met.

Intellectual property

• Core Symphony cartridge IP is licensed from Toray (exclusive outside Japan; nonexclusive manufacturing rights in Japan).
• Royalty structure on cartridge net sales: 7.5% with reductions under certain conditions; 50% reductions after expiry of Toray patents on a country/product basis; royalty terms apply for 10 years and minimum royalties are payable after regulatory clearance.
• The New Toray License Agreement and related Master Supply Agreement were executed in 2023, with amendments in 2025.
• Bluejay does not currently hold granted patents and relies on Toray IP, trade secrets, and other protections.
• A provisional IL-6 use patent application was filed in Q4 2024 but was later deemed unlikely to be material and was not pursued.

Market and commercial model

• The commercial approach targets large U.S. hospitals (ERs and ICUs) and long-term acute care facilities for device sales, with recurring revenue from single-use cartridges.
• The company plans to offer device financing options to reduce upfront capital requirements for customers.
• The company has not generated product revenue to date.

Financial position and operations

• Accumulated deficit since inception: approximately $41.5 million.
• Fiscal year 2025 operating loss: approximately $6.8 million.
• Fiscal year 2024 operating loss: approximately $7.7 million.
• Cash and cash equivalents (as of December 31, 2025): approximately $5.2 million.
• Current liabilities (as of December 31, 2025): approximately $1.1 million.
• Headcount: 6 full-time employees as of March 2, 2026 (the CEO also serves as the principal financial officer). The company uses external consultants for regulatory, manufacturing, and other functions.
• The company plans to raise at least $20 million of additional capital by the end of 2027 to support regulatory submission and commercialization, with funding expected in multiple tranches. There are currently no binding financing commitments.

Corporate and governance

• Bluejay is listed on the Nasdaq Capital Market; the stock has undergone multiple reverse stock splits since 2023 to maintain listing.
• The company maintains governance and compliance frameworks and depends on Toray IP, Sanyoseiko manufacturing, and successful regulatory clearance to commercialize Symphony.

Strategy and outlook

• Primary near-term objective is regulatory clearance for the Symphony IL-6 test for sepsis.
• Longer-term plans include expanding the Symphony test menu (for example, cardiac biomarkers hsTnT and NT-proBNP) and exploring additional IL-6 related applications and biobank opportunities.
• The company is exploring exploratory AI integration for potential future enhancement but has not entered into definitive agreements.

Summary

Bluejay is a pre-revenue, pre-clearance company building a near-patient IL-6 diagnostic platform for sepsis. The path to a 510(k) submission in 2027 depends on securing additional funding and meeting manufacturing and validation milestones. Ongoing priorities include completion of the SYMON-II study, cartridge manufacturing validation, and obtaining regulatory clearance to support commercialization.