Bluejay Diagnostics and SanyoSeiko Expand Strategic Partnership to Advance Commercialization of Symphony Platform (Form 8-K)

Bluejay Diagnostics and SanyoSeiko Expand Strategic Partnership to Advance Commercialization of Symphony Platform

Acton, MA, USA and Yamanashi, Japan - October 9, 2025 - Bluejay Diagnostics, Inc. (NASDAQ: BJDX) ("Bluejay"), a medical diagnostics company focused on developing rapid near-patient testing solutions for critical care, today announced that it has entered into an Agreement to Amend the Master Service Agreement and the Master Supply Agreement with SanyoSeiko Co., Ltd. ("SanyoSeiko"), a Japan-based contract manufacturer specializing in medical devices and precision engineering.

The amended agreement was entered into in connection with Bluejay expanding SanyoSeiko's role in helping to commercialize Bluejay's Symphony platform, a near-patient testing system designed to provide rapid and reliable results for key biomarkers such as IL-6 in sepsis management.

Pursuant to statements of work that Bluejay has begun providing to Sanyoseiko under this agreement, Sanyoseiko will provide end-to-end support for the Symphony platform, including supporting the manufacturing redevelopment process for analyzers and cartridges (with hardware, software, and design updates), managing raw material sourcing and vendor compliance, and serving as Bluejay's contract manufacturing organization for analyzers, cartridges, and related components. In this capacity, Sanyoseiko will oversee fulfillment, kit assembly, labeling, packaging, shipping, and quality control of manufactured products, while also providing regulatory and quality management support, and equipment storage and maintenance.

"This expanded partnership marks a key milestone in Bluejay's commercialization strategy for the Symphony platform," said Neil Dey, CEO of Bluejay. "By formalizing SanyoSeiko's role as manufacturing partner, we strengthen our supply chain resilience, secures high-quality production capacity, and advances readiness for broader clinical validation and market introduction."

"We are excited to extend our partnership with Bluejay Diagnostics," added Futoshi Shirakawa, CEO of SanyoSeiko Co., Ltd. "Our technical capabilities and manufacturing experience will support the successful commercialization of Symphony, a platform with the potential to make a meaningful impact in critical care diagnostics worldwide."

Hogan Lovells

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.

About SanyoSeiko Co., Ltd.

SanyoSeiko Co., Ltd., headquartered in Yamanashi, Japan, is a precision engineering and contract manufacturing company with expertise in medical device design, development, and production. The company provides high-quality solutions in hardware, software, packaging, and fulfillment for global healthcare partners. More information is available at https://sanyoseiko.co.jp/en/