8-K: Bluejay Diagnostics Expands Sanyoseiko Partnership for Symphony

Bluejay Diagnostics, Inc. has expanded its strategic partnership with Sanyoseiko Co., Ltd. to accelerate the commercialization of its Symphony near-patient testing platform.

Summary

• Bluejay Diagnostics, Inc. (Bluejay) entered into an agreement on October 3, 2025, to amend its Master Service Agreement and Master Supply Agreement with Sanyoseiko Co., Ltd. (Sanyoseiko).
• The amendment expands Sanyoseiko's role to provide end-to-end support for Bluejay's Symphony platform, a near-patient testing system for biomarkers like IL-6 in sepsis management.
• Sanyoseiko will now support manufacturing redevelopment for analyzers and cartridges (including hardware, software, and design updates), manage raw material sourcing, and serve as Bluejay's contract manufacturing organization.
• Sanyoseiko's responsibilities include overseeing fulfillment, kit assembly, labeling, packaging, shipping, quality control, regulatory and quality management support, and equipment storage and maintenance.
• The amended Master Service Agreement outlines that Sanyoseiko will provide services based on Statements of Work (SOWs) agreed upon by both parties.
• If Bluejay does not issue a draft SOW and Sanyoseiko performs no services for three consecutive months, Sanyoseiko may invoice Bluejay for reasonable personnel and facility costs related to equipment storage and maintenance.
• The amended Master Supply Agreement now covers products such as the Symphony Fluorescence Immunoanalyzer, Power Cable, Balance Cartridge, Labeling and Packaging, and Symphony IL-6 Cartridge, with prices for these products currently 'To Be Determined'.
• A press release was issued on October 9, 2025, announcing the expanded partnership.

Sentiment

Score: 7

Explanation: The expanded partnership is a positive strategic development for Bluejay's commercialization efforts, strengthening its manufacturing and supply chain. However, the lack of immediate financial metrics and the pending FDA clearance for the Symphony system temper the overall sentiment, indicating a positive but cautious outlook.

Positives

• Strengthens Bluejay's supply chain resilience by formalizing Sanyoseiko's role as a manufacturing partner.
• Secures high-quality production capacity for the Symphony platform.
• Advances readiness for broader clinical validation and market introduction of the Symphony system.
• Provides end-to-end support for the Symphony platform, covering manufacturing, supply chain, quality control, and regulatory aspects.
• Leverages Sanyoseiko's technical capabilities and manufacturing experience for successful commercialization.

Negatives

• Prices for key Symphony platform products under the amended Master Supply Agreement are currently 'To Be Determined', introducing some financial uncertainty.
• Sanyoseiko may invoice Bluejay for personnel and facility costs if no services are performed for three consecutive months, and can terminate the agreement if an agreed amount is not reached.

Risks

• Bluejay does not yet have regulatory clearance for the Symphony System and requires U.S. Food and Drug Administration (FDA) authorization before it can be marketed as a diagnostic product in the United States.
• The company's forward-looking statements are subject to known and unknown risks, uncertainties, and other factors, including market conditions, as detailed in previous SEC filings (Form 10-K for fiscal year ended December 31, 2024, and Quarterly Reports on Form 10-Q for fiscal quarters ended March 31, 2025, and June 30, 2025).
• Sanyoseiko has the right to terminate the Master Service Agreement and Master Supply Agreement if Bluejay fails to issue Statements of Work for three consecutive months and the parties cannot agree on reasonable personnel and facility costs for equipment storage and maintenance.

Future Outlook

The company anticipates that the expanded partnership will strengthen its supply chain, secure high-quality production capacity, and advance readiness for broader clinical validation and market introduction of the Symphony platform. The Symphony platform has the potential to make a meaningful impact in critical care diagnostics worldwide, pending U.S. FDA regulatory authorization.

Management Comments

• Neil Dey, CEO of Bluejay, stated: 'This expanded partnership marks a key milestone in Bluejay's commercialization strategy for the Symphony platform. 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.'
• Futoshi Shirakawa, CEO of SanyoSeiko Co., Ltd., added: 'We are excited to extend our partnership with Bluejay Diagnostics. 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.'

Industry Context

The expansion of this partnership aligns with the growing demand for rapid, near-patient testing solutions in critical care, particularly for conditions like sepsis where timely diagnosis and monitoring are crucial. The Symphony platform's focus on key biomarkers such as IL-6 positions Bluejay to address a significant need in the medical diagnostics market, contributing to the broader trend of decentralized and efficient healthcare diagnostics.

Stakeholder Impact

• Shareholders: Potential for increased long-term value through accelerated commercialization and market penetration of the Symphony platform.
• Customers (healthcare providers and patients): Improved access to rapid and reliable near-patient testing for sepsis management, potentially leading to better triage and treatment decisions.
• Employees: Potential for company growth and stability, supporting job security and expansion.
• Sanyoseiko: Expanded business relationship and increased revenue opportunities as a key manufacturing and service partner for Bluejay.

Next Steps

• Bluejay needs to receive regulatory authorization from the U.S. Food and Drug Administration (FDA) for the Symphony System before it can be marketed as a diagnostic product.
• Bluejay will continue providing draft Statements of Work (SOWs) to Sanyoseiko for services related to the Symphony platform.
• The parties will consult to determine the supply capacity and necessary stock of the products to be supplied by Sanyoseiko.
• Bluejay and Sanyoseiko will further discuss and determine detailed terms relating to the purchase and supply of the products, including pricing.

Key Dates

Recommendation

The expanded partnership with Sanyoseiko is a crucial strategic step towards commercializing the Symphony platform, strengthening the supply chain and manufacturing capabilities. However, the Symphony system still requires FDA regulatory clearance before it can be marketed, and product pricing is yet to be determined. While positive for long-term prospects, immediate financial impact is not detailed, warranting a 'hold' until further progress on regulatory approval and market penetration is evident.

Keywords

Bluejay Diagnostics, Sanyoseiko, Symphony platform, near-patient testing, sepsis management, IL-6 biomarker, contract manufacturing, medical devices, diagnostics, supply chain, commercialization, regulatory affairs, quality control