Bluejay Diagnostics Q2 Update: Advancements in Sepsis Testing

Bluejay Diagnostics Announces Significant Progress in Q2

Bluejay Diagnostics, Inc. (NASDAQ: BJDX), a dedicated player in the medical diagnostics field, has made substantial strides as it continues developing near-patient solutions tailored for critical care. With a recently published report on its performance and the progress of the Symphony IL-6 diagnostic program, the company is focused on improving patient outcomes.

Recent Corporate Highlights

In the second quarter of 2025, Bluejay presented several noteworthy advancements that demonstrate its commitment to enhancing healthcare capabilities.

Launch of the SYMON-II Clinical Trial

Bluejay Diagnostics has officially begun patient enrollment in the SYMON-II pivotal clinical trial. This trial aims to confirm the findings from the previous SYMON-I pilot study. Early indicators from the study are promising, aiming to evaluate IL-6 levels in ICU patients and their correlation with a 28-day all-cause mortality rate.

Development Pathway for the Symphony IL-6 Test

The company remains firmly on target to complete testing for the SYMON-II trial by the close of 2026, with hopes of submitting its 510(k) application to the FDA in 2027. This timeline is crucial for bringing the Symphony IL-6 test to market and ensuring accessibility for medical professionals.

Manufacturing Partnership with SanyoSeiko

Bluejay has forged a productive relationship with SanyoSeiko Co., Ltd., serving as its contract manufacturing organization (CMO) for the Symphony analyzer. Efforts are underway to secure a qualified FDA-registered CMO for cartridge redevelopment and validation, enhancing the regulatory-grade supply chain readiness for future clinical use.

Strategic Agreement with Toray Industries

On July 23, an amendment to the licensing and supply agreement with Toray Industries was finalized. This extension outlines the timeline for establishing alternative cartridge manufacturing processes by October 2026, bolstering Bluejay's autonomy in manufacturing capabilities going forward.

Financial Insights and Future Outlook

Bluejay Diagnostics raised $3.85 million in gross proceeds during April 2025 through a warrant inducement financing. However, to support ongoing clinical trials and manufacturing readiness through 2027, the company anticipates needing additional capital. Strategic discussions and institutional financing avenues are currently being explored to meet these future requirements.

Anticipated Developments

As Bluejay moves forward, several key catalysts are anticipated, which include:

• Selection and onboarding of a manufacturing site for cartridge redevelopment.
• Finalization of cartridge redevelopment specifications and readiness for validation.
• Acceleration of patient enrollment in SYMON-II and forthcoming interim data presentations.
• Initiation of analytical validation studies to confirm test efficacy.
• Continued dialogue with potential financing partners to facilitate regulatory strategies.

Neil Dey, the Chief Executive Officer of Bluejay Diagnostics, stated, "Our commitment remains unwavering as we progress through various channels—clinical, operational, and financial. The SYMON-II trial represents a pivotal step towards validating the predictive capabilities of our Symphony IL-6 test in treating sepsis. With the solidified agreements with Toray and SanyoSeiko, we are on course for scalable development and effective partnerships to support our mission."

Understanding the Symphony IL-6 Test

The Symphony platform is designed to evaluate a patient's acuity quickly, helping healthcare providers make informed decision-making in critical situations. The Symphony IL-6 test is positioned as the standout candidate among Bluejay's innovations, promising rapid results to enhance patient monitoring and treatment decisions.

The SYMON Clinical Study Program

The SYMON Clinical Study Program is comprised of two pivotal studies: SYMON-I and SYMON-II. The former serves as a pilot study focused on determining IL-6 levels and their relation to various health outcomes, including 28-day all-cause mortality. The forthcoming SYMON-II study is critical for validating SYMON-I results and is foundational for the anticipated 510(k) application to the FDA.

About Bluejay Diagnostics

Bluejay Diagnostics, Inc. is committed to improving patient care through its Symphony System, a rapid and cost-effective testing solution for the assessment and progression monitoring of sepsis and other critical conditions. The company's IL-6 test is designed to deliver reliable results in about 20 minutes, empowering healthcare providers to make timely and effective decisions concerning patient care. For further details, visit the corporate website.

Frequently Asked Questions

What is the primary goal of the SYMON-II clinical trial?

The SYMON-II clinical trial aims to validate the findings from the SYMON-I pilot study by assessing IL-6 levels and their predictive performance regarding ICU patient mortality.

When does Bluejay Diagnostics plan to submit its 510(k) application?

Bluejay is targeting a 510(k) submission to the FDA in 2027 as part of its regulatory pathway for the Symphony IL-6 test.

Who is the contract manufacturing partner for the Symphony analyzer?

Bluejay Diagnostics is working with SanyoSeiko Co., Ltd. as its contract manufacturing organization for the Symphony analyzer.

What recent agreements has Bluejay entered into?

Recently, Bluejay amended its agreement with Toray Industries, extending the timeline for establishing alternate cartridge manufacturing to October 2026.

How does the Symphony IL-6 test benefit medical professionals?

The Symphony IL-6 test offers quick, accurate results that help healthcare providers make better triage and treatment decisions in critical care scenarios.

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