Bluejay Diagnostics Provides Second Quarter Business and Corporate Update
Bluejay Diagnostics (NASDAQ: BJDX) has reported its Q2 2025 business update, highlighting progress in its Symphony IL-6 test program. The company has initiated the SYMON-II pivotal clinical trial to validate findings from the successful SYMON-I pilot study, with completion expected by end of 2026 and FDA 510(k) submission targeted for 2027.
Key developments include a manufacturing partnership with SanyoSeiko Co. for the Symphony analyzer and an amended agreement with Toray Industries extending cartridge manufacturing timeline to October 2026. The company raised $3.85 million through warrant inducement financing in April 2025 but anticipates requiring additional capital through 2027 for manufacturing, clinical trials, and regulatory activities.
Bluejay Diagnostics (NASDAQ: BJDX) ha comunicato l'aggiornamento aziendale relativo al secondo trimestre 2025, evidenziando i progressi nel programma di test Symphony IL-6. L'azienda ha avviato il trial clinico pivotale SYMON-II per convalidare i risultati ottenuti dallo studio pilota SYMON-I, con completamento previsto entro la fine del 2026 e la presentazione della richiesta FDA 510(k) programmata per il 2027.
Tra gli sviluppi principali vi è una partnership produttiva con SanyoSeiko Co. per l'analizzatore Symphony e un accordo modificato con Toray Industries che estende la tempistica di produzione delle cartucce fino a ottobre 2026. Nel aprile 2025, la società ha raccolto 3,85 milioni di dollari tramite finanziamento con warrant inducement, ma prevede di necessitare ulteriori capitali fino al 2027 per la produzione, le sperimentazioni cliniche e le attività regolatorie.
Bluejay Diagnostics (NASDAQ: BJDX) ha informado su su actualización comercial del segundo trimestre de 2025, destacando los avances en su programa de pruebas Symphony IL-6. La compañía ha iniciado el ensayo clínico pivotal SYMON-II para validar los hallazgos del exitoso estudio piloto SYMON-I, con finalización prevista para finales de 2026 y la presentación de la solicitud FDA 510(k) programada para 2027.
Los desarrollos clave incluyen una asociación de fabricación con SanyoSeiko Co. para el analizador Symphony y un acuerdo enmendado con Toray Industries que extiende el plazo de fabricación de cartuchos hasta octubre de 2026. En abril de 2025, la empresa recaudó 3,85 millones de dólares mediante financiamiento con incentivos de warrants, pero anticipa necesitar capital adicional hasta 2027 para fabricación, ensayos clínicos y actividades regulatorias.
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Bluejay Diagnostics (NASDAQ : BJDX) a publié sa mise à jour commerciale du deuxième trimestre 2025, mettant en avant les progrès de son programme de test Symphony IL-6. La société a lancé l'essai clinique pivot SYMON-II pour valider les résultats de l'étude pilote SYMON-I réussie, avec une finalisation prévue d'ici fin 2026 et un dépôt FDA 510(k) prévu pour 2027.
Les développements clés incluent un partenariat de fabrication avec SanyoSeiko Co. pour l'analyseur Symphony et un accord modifié avec Toray Industries prolongeant le calendrier de fabrication des cartouches jusqu'en octobre 2026. En avril 2025, la société a levé 3,85 millions de dollars via un financement par incitation aux bons de souscription, mais prévoit de nécessiter des capitaux supplémentaires jusqu'en 2027 pour la fabrication, les essais cliniques et les activités réglementaires.
Bluejay Diagnostics (NASDAQ: BJDX) hat sein Geschäftsupdate für das zweite Quartal 2025 veröffentlicht und dabei Fortschritte im Symphony IL-6 Testprogramm hervorgehoben. Das Unternehmen hat die SYMON-II entscheidende klinische Studie gestartet, um die Ergebnisse der erfolgreichen SYMON-I Pilotstudie zu validieren, mit Abschluss bis Ende 2026 und geplanter FDA 510(k) Einreichung im Jahr 2027.
Zu den wichtigsten Entwicklungen gehört eine Fertigungspartnerschaft mit SanyoSeiko Co. für den Symphony-Analysator sowie eine geänderte Vereinbarung mit Toray Industries, die den Zeitplan für die Herstellung der Kartuschen bis Oktober 2026 verlängert. Im April 2025 hat das Unternehmen 3,85 Millionen US-Dollar durch eine Finanzierung mittels Warrant-Induzierung aufgebracht, erwartet jedoch zusätzlichen Kapitalbedarf bis 2027 für Produktion, klinische Studien und regulatorische Aktivitäten.
- None.
- Additional capital requirements through 2027 indicate future dilution risk
- Extended timeline for alternate cartridge manufacturing to October 2026
- 510(k) submission timeline pushed to 2027
Insights
Bluejay advances Symphony IL-6 test with ongoing trial enrollment while securing manufacturing partners and $3.85M funding, but faces extended timeline to commercialization.
Bluejay Diagnostics is making steady progress with its Symphony IL-6 test for critical care applications, though investors should note the extended timeline to market. The company has initiated patient enrollment in its pivotal SYMON-II clinical trial, which aims to validate the test's ability to predict 28-day mortality in ICU patients. However, the regulatory pathway extends well into the future, with sample testing completion targeted for late 2026 and FDA submission not planned until 2027.
On the manufacturing front, Bluejay has made strategic moves to secure its supply chain. The company continues working with SanyoSeiko as the contract manufacturer for its Symphony analyzer while simultaneously seeking a qualified FDA-registered CMO for cartridge production. An important development is the amended agreement with Toray Industries, which extends the timeline for establishing alternate cartridge manufacturing to October 2026 while confirming completion of Toray's know-how transfer obligations.
Financially, the company raised
ACTON, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay� or the “Company�), a medical diagnostics company developing near-patient solutions for critical care, today announced financial results for the quarter ended June 30, 2025, and provided an update on its Symphony IL-6 test program and key operational milestones.
Second Quarter 2025 and Recent Corporate Highlights
- SYMON-II Pivotal Clinical Study Underway: Bluejay has initiated patient enrollment in the SYMON-II pivotal clinical trial, designed to validate findings from the successful SYMON-I pilot study. Early indicators show continued clinical momentum. The trial aims to assess the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality.
- Symphony IL-6 Development and Regulatory Pathway: Bluejay remains on track to complete SYMON-II sample testing by the end of 2026, with a target 510(k) submission to the FDA in 2027.
- Strategic Manufacturing Alignment with SanyoSeiko: Bluejay continues to work closely with SanyoSeiko Co., Ltd. as its contract manufacturing organization (CMO) for the Symphony analyzer. In parallel, the Company is advancing plans to secure cartridge redevelopment and validation manufacturing through a qualified FDA-registered CMO. These steps aim to ensure regulatory-grade supply chain readiness for clinical validation and commercialization.
- Amended License & Supply Agreement with Toray Industries: On July 23, 2025, Bluejay entered into an amendment with Toray Industries, extending the timeline to establish alternate cartridge manufacturing to October 2026. The amendment also confirms completion of Toray’s know-how transfer and final supply obligations—strengthening Bluejay’s independence in future manufacturing.
- Financing Progress and Outlook: In April 2025, Bluejay raised gross proceeds of
$3.85 million through a warrant inducement financing. The Company anticipates requiring additional capital through 2027 to support manufacturing readiness, clinical trials, and regulatory activities. The Company is actively exploring strategic and institutional financing avenues to meet these milestones.
Upcoming Catalysts
- Manufacturing Site Selection and Onboarding for Cartridge Redevelopment
- Completion of Cartridge Redevelopment Specifications and Validation Readiness
- Patient Enrollment Acceleration and Interim Data Review from SYMON-II
- Initiation of Analytical Validation Studies
- Ongoing Partnership and Financing Discussions to Support Regulatory Strategy
“We continue to make focused progress on multiple fronts—clinically, operationally, and financially. Our continued and timely progress of SYMON-II clinical studies marks a major step toward demonstrating Symphony IL-6’s predictive value in sepsis care,� said Neil Dey, Chief Executive Officer of Bluejay Diagnostics. “With updated licensing terms from Toray and manufacturing alignment through SanyoSeiko, we are positioning the Symphony platform for scalable development. We are actively engaging with strategic partners and capital providers to support this mission.�
About the Symphony IL-6 Test:
The Symphony Test platform is designed to determine patient acuity for triage and monitoring based on the measurement of a specific biomarker. The Symphony IL-6 Test to determine patient acuity for sepsis triage and monitoring (“Symphony IL-6 Test�) is currently Bluejay’s lead product candidate.
About the SYMON Clinical Study Program:
The SYMON Clinical Study Program includes SYMON-I I (clinicaltrials.gov ID NCT06181604) and SYMON-II (NCT06654895). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA.
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’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.
Symphony is a registered trademark of Bluejay Diagnostics, Inc.
Forward Looking Statements:
This press release contains statements that the Company believes are “forward-looking statements� within the meaning of the Private Litigation Reform Act. Forward-looking statements in this press release include, without limitation, statements about the ongoing SYMON-II clinical trial, plans to redevelop the cartridges used in the Company’s Symphony system, including the potential for working with a third-party contract manufacturing organization in connection with such redevelopment, the expected nature and timing of the Company’s planned FDA submission and related plans for clinical study completion, whether the Company’s cash position will be sufficient to fund operations needed to achieve regulatory approval and initial commercialization of the Symphony IL-6 Test, whether such regulatory approval will actually occur, the Company’s plans for future fundraising, and the continuation of the Company as a going concern. Forward-looking statements may be identified by words such as “anticipates,� “believes,� “estimates,� “expects,� “intends,� “may,� “plans,� “projects,� “seeks,� “should,� “suggest,� “will,� and similar expressions. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025, filed with the SEC on May 13, 2025, and in its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025, filed with the SEC on August7th , 2025. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company’s expectations of results or any future change in events, except as required by law.
Investor Contact:
Investor Relations
Bluejay Diagnostics, Inc.
Website: www.bluejaydx.com
