Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes in critical care settings with a primary emphasis on sepsis. The company is developing the Symphony technology platform which consists of an analyzer, and single use protein detection cartridges designed to deliver laboratory quality results from whole blood in approximately 20 minutes. The first product candidate is an interleukin 6 test intended to monitor disease progression in critically ill patients. Bluejay has completed preclinical work, and is conducting the SYMON II pivotal clinical trial to validate the test’s predictive value for 28 day all cause mortality in sepsis patients. The goal is to obtain FDA clearance through a 510(k) submission in 2027, and subsequently commercialize the platform.

Bluejay Diagnostics, Inc. currently has no revenue generating operations as its Symphony platform has not yet received regulatory clearance. Upon obtaining FDA approval the company intends to generate revenue through the sale of Symphony analyzers, and the recurring sale of single use cartridges that run on the platform. The business model includes offering financing options for the analyzer to reduce upfront capital costs for hospitals, and creating a growing recurring revenue stream as cartridge utilization increases. Additionally Bluejay plans to expand the menu of diagnostic tests available on Symphony to increase annual revenue per customer through higher product usage.

Bluejay Diagnostics, Inc. occupies an early stage position in the in vitro diagnostics market where there are currently no FDA cleared or approved interleukin 6 tests for general use. Existing interleukin 6 assays are available only under emergency use authorization for COVID 19 patients, and are performed on central laboratory instruments that require blood preprocessing. The Symphony platform offers a competitive advantage by providing rapid whole blood testing at the point of care with a compact analyzer, and integrated cartridge design. Competitors include large life science companies, and numerous innovative start ups that are developing alternative sepsis biomarkers and rapid testing solutions. Bluejay’s reliance on licensed intellectual property from Toray, with patents expiring between 2027 and 2030, creates a narrow window of exclusivity that will require timely commercialization to maintain market advantage.

The company intends to sell its Symphony system to hospital emergency rooms, intensive care units, and long term acute care facilities in the United States. In addition Bluejay is evaluating opportunities to place analyzers for research use only purposes in laboratories, and academic institutions. Specific customer names have not been disclosed in the filing.