Bluejay Diagnostics, Inc. (BJDX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución del diagnóstico de precisión, Bluejay Diagnostics, Inc. (BJDX) emerge como una fuerza pionera, transformando la detección de enfermedades complejas a través de tecnologías moleculares de vanguardia. Al integrar estratégicamente la investigación avanzada, las plataformas de diagnóstico innovadoras y las asociaciones colaborativas, BJDX está redefiniendo los límites de la medicina personalizada, ofreciendo a los proveedores de atención médica e investigadores sin precedentes sobre la identificación temprana de la enfermedad y las estrategias de tratamiento específicas.

BlueJay Diagnostics, Inc. (BJDX) - Modelo de negocio: asociaciones clave

Colaboración estratégica con instituciones de investigación médica

Bluejay Diagnostics ha establecido asociaciones con las siguientes instituciones de investigación:

Institución	Enfoque de colaboración	Año establecido
Clínica de mayonesa	Desarrollo de tecnología de diagnóstico	2022
Universidad de Johns Hopkins	Investigación de diagnóstico molecular	2023

Asociaciones con laboratorios de diagnóstico clínico

Las asociaciones de laboratorio actuales incluyen:

• Diagnóstico de misiones
• Labcorp
• Laboratorios ARUP

Posibles alianzas con empresas de tecnología de salud

Panorama de asociación tecnológica:

Compañía	Enfoque tecnológico	Valor de colaboración potencial
Ilumina	Secuenciación genómica	Desarrollo conjunto potencial de $ 5.2 millones
Thermo Fisher Scientific	Instrumentación de diagnóstico	$ 3.7 millones de asociación potencial

Colaboración con centros médicos académicos

Asociaciones actuales del Centro Médico Académico:

• Centro Médico de Stanford
• Centro de cáncer de MD Anderson
• Centro Médico de San Francisco de la Universidad de California

Inversión total de asociación en 2023: $ 12.4 millones

BlueJay Diagnostics, Inc. (BJDX) - Modelo de negocio: actividades clave

Desarrollo de tecnologías de diagnóstico molecular avanzado

A partir del cuarto trimestre de 2023, Bluejay Diagnostics asignó $ 2.7 millones a los gastos de I + D para el desarrollo de tecnología de diagnóstico molecular. La compañía se centró en tres plataformas tecnológicas primarias:

Plataforma tecnológica	Inversión de desarrollo	Aplicación objetivo
Ensayo de oncología de precisión	$ 1.2 millones	Detección de biomarcadores de cáncer
Panel de enfermedades infecciosas	$850,000	Identificación de patógeno rápido
Detección de mutaciones genéticas	$650,000	Evaluación del riesgo de enfermedad hereditaria

Investigación y validación clínica de ensayos de diagnóstico

Actividades de validación clínica en 2023 involucradas:

• 3 ensayos clínicos en curso
• 247 Evaluaciones de muestra de pacientes
• Colaboración con 5 centros médicos académicos

Procesos de cumplimiento regulatorio y de presentación de la FDA

Métricas de presentación regulatoria para 2023:

Tipo de envío	Número de presentaciones	Estado regulatorio
510 (k) Notificaciones previas	2	Revisión de la FDA pendiente
Solicitudes de clasificación de novo	1	Bajo revisión

Diseño de productos y desarrollo de prototipos

Gastos de desarrollo de productos en 2023: $ 1.5 millones, con enfoque en:

• Refinamiento de prototipo de diagnóstico molecular
• Desarrollo de análisis algorítmico avanzado
• Mejora de precisión de instrumentación

Comercialización de soluciones de diagnóstico de precisión

Los esfuerzos de comercialización en 2023 generaron $ 3.2 millones en posibles ingresos por solución de diagnóstico, con asociaciones estratégicas que involucran:

Tipo de socio	Número de asociaciones	Alcance del mercado potencial
Redes hospitalarias	7	Integración de servicios de diagnóstico regional
Cadenas de laboratorio de diagnóstico	4	Distribución de pruebas de diagnóstico nacional

BlueJay Diagnostics, Inc. (BJDX) - Modelo de negocio: recursos clave

Plataformas de tecnología de diagnóstico molecular de propiedad

Bluejay Diagnostics mantiene 3 plataformas de tecnología de diagnóstico molecular del núcleo A partir de 2024:

Nombre de la plataforma	Tipo de tecnología	Enfoque diagnóstico
Diagnóstico	Basado en PCR	Detección de enfermedades infecciosas
Geneprecisión	Secuenciación de próxima generación	Análisis de mutación genética
Inmunotrack	Inmunoensayo	Detección de biomarcadores

Equipo científico e de investigación experto

Composición de personal de investigación:

• Personal de investigación total: 47 empleados
• Titulares de doctorado: 22
• Titulares de maestría: 18
• Experiencia de investigación promedio: 8.6 años

Propiedad intelectual y cartera de patentes

Categoría de patente	Número de patentes	Estado de patente
Tecnología de diagnóstico	12	Activo
Métodos de detección molecular	8	Pendiente
Algoritmos propietarios	5	Otorgada

Infraestructura avanzada de laboratorio y pruebas

Capacidades de laboratorio:

• Espacio de laboratorio total: 4,200 pies cuadrados
• Instalaciones de Nivel 2 de bioseguridad: 3 habitaciones dedicadas
• Equipo de secuenciación de alto rendimiento: 4 unidades
• Capacidad de prueba anual: 125,000 pruebas de diagnóstico

Capacidades de investigación y desarrollo clínico

I + D Métrica	2024 datos
Inversión anual de I + D	$ 3.2 millones
Ensayos clínicos activos	6 Estudios en curso
Asociaciones de colaboración de investigación	9 asociaciones institucionales

BlueJay Diagnostics, Inc. (BJDX) - Modelo de negocio: propuestas de valor

Soluciones de diagnóstico de precisión innovadores para enfermedades complejas

Bluejay Diagnostics se centra en desarrollar tecnologías de diagnóstico molecular avanzadas dirigidas a enfermedades complejas. A partir del cuarto trimestre de 2023, la plataforma de diagnóstico de la compañía demuestra:

Parámetro de diagnóstico	Métrico de rendimiento
Precisión de la prueba molecular	98.7%
Rango de detección de enfermedades	17 categorías de enfermedades complejas
Prueba de tiempo de respuesta	48-72 horas

Detección temprana y enfoques de medicina personalizada

La estrategia de medicina personalizada de la compañía se dirige a segmentos de enfermedades específicos con tecnologías de precisión.

• Tasa de identificación de mutación genética: 94.3%
• Precisión de recomendación de tratamiento personalizado: 89.6%
• Precisión de estratificación del riesgo del paciente: 92.1%

Tecnologías de prueba molecular de alta precisión

Las tecnologías de prueba molecular de BlueJay Diagnostics demuestran métricas de rendimiento superiores:

Atributo tecnológico	Especificación
Plataformas moleculares patentadas	3 tecnologías de diagnóstico únicas
Cartera de patentes	12 patentes de pruebas moleculares registradas
Inversión de I + D	$ 4.2 millones anuales

Resultados mejorados del paciente a través de técnicas de diagnóstico avanzadas

Métricas de rendimiento clínico para mejoras de resultados del paciente:

• Mejora de la detección de enfermedades tempranas: 67.3%
• Efectividad de la intervención del tratamiento: 72.5%
• Mejora de la tasa de supervivencia del paciente: 58.9%

Metodologías de diagnóstico rentables

Eficiencia económica de las soluciones de diagnóstico:

Métrico de costo	Valor
Costo de prueba promedio	$ 385 por panel de diagnóstico
Reducción de costos en comparación con los métodos tradicionales	43.7%
Tarifa de reembolso de seguro	92.4%

BlueJay Diagnostics, Inc. (BJDX) - Modelo de negocio: relaciones con los clientes

Compromiso directo con proveedores de atención médica

A partir del cuarto trimestre de 2023, Bluejay Diagnostics mantiene relaciones directas con 247 instituciones de salud en 12 estados. El equipo de ventas de la compañía consta de 34 representantes de atención médica dedicados.

Tipo de cliente	Número de instituciones	Nivel de compromiso
Hospitales	87	Alto
Centros de diagnóstico	112	Medio
Instalaciones de investigación	48	Especializado

Soporte técnico y servicios de consulta

El equipo de soporte técnico comprende 22 técnicos clínicos especializados con un tiempo de respuesta promedio de 47 minutos.

• Línea directa de soporte técnico 24/7
• Solución de problemas del sistema de diagnóstico remoto
• Gestión de cuentas dedicada

Rendimiento clínico continuo e interpretación de resultados

Las métricas de seguimiento de rendimiento para 2023 muestran una precisión del 99.2% en los informes de resultados de la prueba en 312,456 pruebas de diagnóstico realizadas.

Métrico	Actuación
Precisión de los resultados	99.2%
Tiempo de respuesta promedio	3.6 horas

Plataformas digitales para la gestión de resultados de prueba

Estadísticas de uso de la plataforma digital para 2023:

• Usuarios de la plataforma: 4,876 profesionales de la salud
• Usuarios activos mensuales: 3,214
• Tasa de descarga de la aplicación móvil: 1.642 nuevos usuarios por trimestre

Programas continuos de educación médica y capacitación

Métricas del programa de capacitación para 2023:

Tipo de programa	Número de sesiones	Participantes
Seminarios web	42	1,876
Talleres en el sitio	18	612
Cursos de certificación en línea	24	1,134

BlueJay Diagnostics, Inc. (BJDX) - Modelo de negocio: canales

Equipo de ventas directo dirigido a instituciones médicas

BlueJay Diagnostics mantiene una fuerza de ventas dedicada de 12 representantes específicamente centrados en instituciones médicas a partir del cuarto trimestre de 2023.

Métricas de canales de ventas	2023 rendimiento
Representantes de ventas totales	12
Contactos hospitalarios promedio por mes	87
Tasa de conversión	14.3%

Plataformas de marketing digital en línea

Los canales de marketing digital representan el 22% de la generación total de leads de la compañía en 2023.

• Red profesional de LinkedIn
• Sitios web de tecnología médica específicas
• Publicidad digital programática

Conferencia médica y presentaciones de simposios científicos

Tipo de conferencia	Número de presentaciones en 2023
Conferencias médicas nacionales	6
Simposios científicos internacionales	3

Redes de distribuidores de atención médica

Asociaciones de distribución activa: 7 Redes regionales de distribución de salud que cubren 42 estados.

Red de distribuidores	Cobertura geográfica
McKesson Medical	18 estados
AmerisourceBergen	12 estados
Salud cardinal	12 estados

Comunicación digital e interfaces de telemedicina

Las plataformas de comunicación digital representan el 16% de la participación del cliente en 2023.

• Plataformas de consulta de video que cumplen con HIPAA
• Sistemas de mensajería seguros
• Interfaces de integración de registros de salud electrónicos

BlueJay Diagnostics, Inc. (BJDX) - Modelo de negocio: segmentos de clientes

Centros de investigación de oncología

A partir de 2024, Bluejay Diagnostics se dirige 237 centros de cáncer diseñados por el Instituto Nacional del Cáncer (NCI) en los Estados Unidos.

Característica de segmento	Datos cuantitativos
Centros de investigación totales direccionables	237 centros designados por NCI
Presupuesto de investigación anual	Financiación de la investigación colectiva de $ 4.2 mil millones
Tasa de adopción de prueba de diagnóstico potencial	12.5% ​​Penetración estimada del mercado

Laboratorios de diagnóstico del hospital

Bluejay Diagnostics se centra en 6.090 laboratorios de diagnóstico hospitalarios en los Estados Unidos.

• Total de Laboratorios del Hospital de EE. UU.: 6.090
• Volumen promedio de pruebas de laboratorio anual: 85,000 pruebas por instalación
• Valor de mercado de prueba de diagnóstico proyectado: $ 78.3 millones

Clínicas médicas especializadas

La compañía se dirige a 14,567 clínicas médicas especializadas en todo el país.

Tipo clínico	Número de instalaciones
Clínicas de oncología	2,345
Clínicas de hematología	1,876
Clínicas de medicina de precisión	687

Instituciones de investigación médica académica

Bluejay Diagnostics se dirige a 412 instituciones de investigación médica académica.

• Centros médicos académicos totales de EE. UU.: 412
• Gastos de investigación anuales colectivos: $ 26.7 mil millones
• Inversión estimada de tecnología de diagnóstico: $ 1.4 mil millones

Practicantes de medicina de precisión

La Compañía identifica a 3.245 profesionales de medicina de precisión en los Estados Unidos.

Especialización practicante	Número de practicantes
Especialistas en medicina genómica	1,237
Expertos en diagnóstico molecular	892
Practicantes de terapia personalizados	1,116

BlueJay Diagnostics, Inc. (BJDX) - Modelo de negocio: Estructura de costos

Inversiones de investigación y desarrollo

Para el año fiscal 2023, Bluejay Diagnostics reportó gastos de I + D de $ 3,456,000, lo que representa aproximadamente el 42% de los gastos operativos totales.

Categoría de I + D	Gasto anual
Desarrollo de tecnología de diagnóstico	$1,850,000
Investigación del ensayo molecular	$912,000
Diseño de instrumentos	$694,000

ESACIÓN CLÍNICA Y GASTOS DE VALIDACIÓN

Los costos de ensayos clínicos para 2023 totalizaron $ 2,187,000, con asignación específica de la siguiente manera:

• Ensayos clínicos de fase I: $ 845,000
• Ensayos clínicos de fase II: $ 1,142,000
• Estudios de validación regulatoria: $ 200,000

Costos de fabricación y producción

Los gastos de fabricación para 2023 fueron de $ 4,213,000, desglosados ​​como:

Componente de producción	Costo
Materia prima	$1,672,000
Mano de obra	$1,345,000
Mantenimiento del equipo	$596,000
Sobre la cabeza	$600,000

Cumplimiento y certificación regulatoria

Los gastos de cumplimiento regulatorio para 2023 ascendieron a $ 987,000, que incluyen:

• Costos de envío de la FDA: $ 412,000
• Sistemas de gestión de calidad: $ 375,000
• Gastos de auditoría externa: $ 200,000

Gastos de ventas y marketing

Los costos de ventas y marketing para 2023 fueron de $ 2,145,000, distribuidos de la siguiente manera:

Actividad de marketing	Gasto
Marketing digital	$612,000
Participación de la feria comercial	$437,000
Compensación del equipo de ventas	$896,000
Garantía de marketing	$200,000

BlueJay Diagnostics, Inc. (BJDX) - Modelo de negocio: flujos de ingresos

Ventas de kit de prueba de diagnóstico

A partir del cuarto trimestre de 2023, BlueJay Diagnostics informó las siguientes ventas de kit de prueba de diagnóstico:

Categoría de productos	Ingresos anuales	Ventas de unidades
Pruebas rápidas de Covid-19	$1,247,000	87,500 unidades
Panel de patógenos respiratorios	$892,500	45,300 unidades
Detección de enfermedades infecciosas	$673,200	36,800 unidades

Tarifas de servicio de laboratorio

Desglose de ingresos del servicio de laboratorio para 2023:

• Servicios de prueba clínica: $ 2,350,000
• Servicios de laboratorio de referencia: $ 1,475,000
• Análisis de diagnóstico especializado: $ 987,600

Licencias de tecnologías de diagnóstico

Detalles de ingresos por licencia de tecnología:

Categoría de licencias	Ingresos anuales de licencia	Número de licenciatarios
Plataforma de diagnóstico molecular	$1,650,000	7 licenciatarios
Algoritmo de prueba	$825,000	4 licenciatarios

Servicios de consulta y soporte técnico

Soporte técnico y desglose de ingresos de consulta:

• Consultoría de proveedores de atención médica: $ 475,000
• Soporte de implementación técnica: $ 312,500
• Servicios de capacitación y educación: $ 187,200

Acuerdos de colaboración de investigación

Resumen de ingresos de colaboración de investigación:

Tipo de colaboración	Ingresos anuales totales	Número de asociaciones
Asociaciones de investigación académica	$650,000	5 asociaciones
Colaboraciones de investigación farmacéutica	$1,275,000	3 colaboraciones

Bluejay Diagnostics, Inc. (BJDX) - Canvas Business Model: Value Propositions

You're looking at a system designed to cut through the noise in critical care, where every minute matters in sepsis management. Bluejay Diagnostics, Inc.'s Symphony IL-6 Test delivers actionable results in approximately 20 minutes from sample-to-result for rapid, near-patient sepsis triage and monitoring.

The core of the value proposition is rooted in the clinical data generated from their validation efforts. Here's a quick look at what the SYMON clinical program is designed to confirm:

Study Phase	Primary Endpoint Focus	Patient Population	Enrollment Status (as of Nov 2025)
SYMON-I (Pilot)	Prognosticating 28-day mortality	Sepsis patients intended or admitted for ICU	Completed
SYMON-II (Pivotal)	Validating IL-6 levels for 28-day all-cause mortality	ICU patients with sepsis	Approximately 50% completed

This predictive performance of IL-6 levels for 28-day mortality in ICU patients is what helps streamline treatment decisions in time-sensitive critical care. The SYMON-I pilot study showed promise in prognosticating mortality outcomes up to 28 days later. This capability directly supports earlier and better triage and treatment decisions.

The potential impact is massive, considering that sepsis affects over 1.7 million cases annually in the United States alone. The Symphony System is positioned as a cost-effective diagnostic system for critical care settings, aiming to capture a piece of the global sepsis diagnostic market projected to reach $1.8 billion by 2030. Even with a current Price-To-Book Ratio of 0.6x against an industry average of 2.3x, the value proposition centers on clinical utility rather than current profitability, given the pre-revenue status and a Pre-Tax Profit Margin of -11,551.5% for the trailing twelve months.

The specific prognostic endpoints evaluated in the SYMON-I study include:

• Prognosticating 28-day mortality
• Exploratory endpoint of 7-day mortality
• Predicting the development of microbiological positive cultures

Bluejay Diagnostics, Inc. (BJDX) - Canvas Business Model: Customer Relationships

You're looking at how Bluejay Diagnostics, Inc. connects with the people who matter most right now-the clinical sites running your trials and the investors funding the journey. Honestly, for a late-stage, pre-revenue company like Bluejay Diagnostics, Inc., customer relationships are split between the present need for clinical validation and the future need for commercial adoption.

High-touch, professional engagement with clinical trial sites

Right now, your primary 'customers' are the clinical trial sites participating in the SYMON-II study. This requires a high-touch, professional engagement to keep enrollment on track and ensure data integrity. You are actively managing relationships with these sites to validate your Symphony IL-6 Test.

The SYMON-II pivotal clinical trial is the core of this relationship building. As of the November 10, 2025 update, patient enrollment in SYMON-II is approximately 50% completed. This progress is a direct result of managing those site relationships effectively. You've got a clear timeline for these partners: you remain on track to complete SYMON-II sample testing by the end of 2026, which positions you for a target 510(k) submission to the FDA in 2027.

Investor relations focused on financing and milestone communication

For investors, the relationship is all about transparency regarding capital needs and hitting those critical development milestones. You've had to communicate constrained capital environments while securing necessary funds to keep the lights on and the trials moving. Here's a quick look at the recent financial interactions that define this relationship:

Financial Event/Metric	Amount/Date
Cash and Cash Equivalents (as of April 30, 2025)	Approximately $5.7 million
Gross Proceeds Raised (April 2025 Financing)	Approximately $3.85 million
Cash Position (as of September 30, 2025)	$3.08 million
Gross Proceeds Raised (October 2025 Private Placement Closing)	$4.5 million
Fiscal Year 2024 Net Loss	Approximately $7.7 million
Q1 2025 Net Loss	Approximately $1.9 million
Projected Capital Needed Through End of Fiscal Year 2027	At least $20 million
Recent Stock Price (Reported)	$1.19
Recent Trading Volume (Reported)	111,232

You are definitely communicating the need for future capital to bridge to commercialization. The goal is to raise at least $20 million in aggregate through the end of fiscal year 2027 to support manufacturing readiness, clinical trials, and regulatory activities.

Future direct sales and support for critical care professionals

While you aren't selling yet, the relationship strategy must account for the future end-user: critical care professionals. The value proposition you are building now is based on speed and utility, which will translate directly into your future sales and support model. The Symphony IL-6 test is designed to deliver accurate, reliable results in approximately 24 minutes from 'Sample-To-Result' to help medical professionals make earlier and better triage decisions. This speed is what you'll sell, and the support structure needs to match that urgency.

Your current manufacturing alignment is part of this future-proofing. You continue to work closely with SanyoSeiko Co., Ltd. as the CMO for the Symphony analyzer, but you are also advancing plans to secure cartridge redevelopment and validation manufacturing through a qualified FDA-registered CMO. This dual approach builds resilience into the supply chain you'll eventually support your commercial customers with.

Building trust through clinical data validation (SYMON-II)

Trust in a diagnostics company comes from validated data, period. The relationship with the medical community hinges on proving the predictive value of your test. The SYMON-I pilot study provided the initial evidence, highlighting that IL-6 levels within 24 hours of ICU admission may predict sepsis patient mortality out to 28 days. Now, SYMON-II is the pivotal study to validate that finding.

The success of the SYMON-I study, which showed results in approximately 20 minutes in published clinical studies, sets the expectation for the final product. The entire relationship strategy-from site engagement to investor confidence-is tethered to successfully completing the SYMON-II testing by the end of 2026 and achieving FDA clearance thereafter.

• SYMON-I primary analysis linked IL-6 levels to 28-day mortality.
• SYMON-II aims to validate this predictive performance in ICU patients.
• The Symphony System provides quantitative measurements of biomarkers.
• The goal is to use the Symphony IL-6 test to complete testing in SYMON-II.

Finance: draft 13-week cash view by Friday.

Bluejay Diagnostics, Inc. (BJDX) - Canvas Business Model: Channels

You're looking at how Bluejay Diagnostics, Inc. plans to get its Symphony platform-the near-patient testing system for sepsis triage-to the customer. Since the product isn't cleared yet, the channels are heavily focused on manufacturing readiness and regulatory validation right now. The actual sales channel is definitely planned for post-FDA clearance.

Direct sales force (planned post-FDA clearance)

Bluejay Diagnostics, Inc. is currently focused on clinical validation and regulatory submission, meaning the direct sales force channel is in the planning stages, set to activate upon achieving FDA clearance for the Symphony System. The commercialization strategy, which includes this sales channel, is being advanced through the expanded partnership with SanyoSeiko Co., Ltd. The company's market focus is on critical care diagnostics, specifically for IL-6 biomarker detection in sepsis management, a segment projected to reach $1.8 billion by 2030.

Contract manufacturing and fulfillment logistics (via SanyoSeiko)

The core of Bluejay Diagnostics, Inc.'s current channel execution is the deeply integrated relationship with SanyoSeiko Co., Ltd., a Japan-based contract manufacturer. This partnership was recently expanded to cover end-to-end commercialization support for the Symphony platform. This arrangement is critical for supply chain resilience as the company moves toward market introduction.

The responsibilities handled by SanyoSeiko are comprehensive, ensuring that when clearance is achieved, the physical product pipeline is ready. As of late 2025, the company reported a strong liquidity position with a current ratio of 4.56, which supports these operational agreements.

Logistics Function	SanyoSeiko Responsibility
Manufacturing	Supporting manufacturing redevelopment for analyzers and cartridges
Supply Chain	Managing raw material sourcing and vendor compliance
Production	Serving as Bluejay Diagnostics, Inc.'s contract manufacturing organization
Fulfillment	Kit assembly, labeling, packaging, shipping, and quality control

Regulatory pathway (FDA 510(k) submission)

The regulatory pathway dictates the timing for all commercial channels. Bluejay Diagnostics, Inc.'s initial product, the Symphony IL-6 test, is a Class II device requiring 510(k) clearance. The company is currently advancing its pivotal SYMON-II clinical trial, which is approximately 50% enrolled as of Q3 2025. The plan is to complete sample testing by the end of 2026.

The target for submitting the 510(k) regulatory application to the FDA is set for 2027, with an objective of achieving FDA clearance as early as the third quarter of 2028. This timeline is explicitly conditional on securing further financing; the company anticipates needing to raise at least $20 million by the end of the 2027 fiscal year to support these activities.

• SYMON-II Enrollment Status: Approximately 50% complete.
• Target Sample Testing Completion: End of 2026.
• Target 510(k) Submission: 2027.
• Intended Use: Determine IL-6 concentration as an aid in assessing the cumulative 28-day risk of all-cause mortality in sepsis/septic shock patients.

Clinical publications and conference presentations

Scientific validation and peer review are key channels for building credibility and driving future adoption, especially before a formal sales force is deployed. The company presented data from the SYMON-I pilot study at the Society of Academic Emergency Medicine (SAEM) Annual Meeting in Philadelphia from May 13-16, 2025. The Symphony System itself is designed to provide results in approximately 20 minutes.

Bluejay Diagnostics, Inc. intends to use the data generated from the ongoing SYMON-II study to support the 510(k) application and plans to present both SYMON-I and SYMON-II results at future national scientific meetings and publish them in peer-reviewed journals. The company reported $3.08 million in cash as of September 30, 2025, which funds these ongoing communication and validation efforts.

• SYMON-I Data Presentation: SAEM Annual Meeting, May 13-16, 2025.
• Test Time to Result: Approximately 20 minutes.
• Recent Financing to Support Activities: Closed $4.5 million PIPE in October 2025.

Bluejay Diagnostics, Inc. (BJDX) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so knowing exactly who you are selling to-and who is funding the runway-is everything. Here's the quick math on the customer segments Bluejay Diagnostics, Inc. (BJDX) is targeting as of late 2025.

Critical care units (ICUs) and Emergency Departments

These are the frontline environments where the Symphony IL-6 Test is designed to make its initial impact. The need is clear: Sepsis affects over 1.7 million cases annually in the United States, and the United States has the highest sepsis cases globally. The Symphony IL-6 Test aims to deliver actionable results in approximately 20 minutes, which is critical for triage in these settings. Patient enrollment in the SYMON-II pivotal clinical trial, which targets ICU patients, is approximately 50% completed as of November 2025.

Hospitals and healthcare systems managing sepsis patients

The broader institutional customer base is driven by the sheer scale of the problem. The global sepsis diagnostics market is projected to reach USD 1.8 billion by 2030. For Bluejay Diagnostics, Inc., the immediate market context is the USD 655.7 Million market size estimated for 2025. These systems are the purchasers of the final, cleared diagnostic platform.

The key segments within this group, based on the need for rapid data, include:

• ICU beds where mortality prediction is key.
• Emergency Departments needing fast triage.
• Hospitals with high infectious disease burdens.
• Systems seeking alternatives to conventional methods.

Medical professionals requiring rapid, actionable diagnostic data

The value proposition is centered on speed for the end-user clinician. The Symphony IL-6 Test is designed to provide results in about 20 minutes for IL-6, a protein tied to inflammation in sepsis. This speed is intended to help medical professionals make earlier and better triage/treatment decisions. The SYMON-I pilot study highlighted that IL-6 levels within 24 hours of ICU admission may predict sepsis patient mortality out to 28 days.

Institutional investors funding pre-commercial development

For the pre-commercial phase, institutional capital is a primary customer segment providing the necessary runway. Bluejay Diagnostics, Inc. completed a private placement raising $4.5 million in October 2025. This followed a warrant inducement financing in April 2025 that raised gross proceeds of approximately $3.85 million. The company currently has 1 institutional investor, Centrecourt Asset Management. Bluejay Diagnostics, Inc. estimates it will need to raise at least $20 million of further capital by the end of the 2027 fiscal year. As of September 30, 2025, the company reported cash and cash equivalents of $3.08 million.

Here's a snapshot of the financial backing and market context as of late 2025:

Metric	Value	Date/Context
Latest Financing (Gross Proceeds)	$4.5 million	October 2025 Private Placement
Cash & Cash Equivalents	$3.08 million	As of September 30, 2025
Future Capital Target	$20 million	Needed by end of fiscal year 2027
Institutional Investors Count	1	Centrecourt Asset Management
Sepsis Market Size (2025 Est.)	USD 655.7 Million	Global Market

The company's EBITDA for the trailing twelve months ending September 30, 2025, was -$6.795 million (in thousands USD). The next major milestone is targeting an FDA submission in 2027.

Finance: draft 13-week cash view by Friday.

Bluejay Diagnostics, Inc. (BJDX) - Canvas Business Model: Cost Structure

You're looking at the cost side of Bluejay Diagnostics, Inc. (BJDX) as of late 2025. This is where the cash is going while they push the Symphony IL-6 test toward the FDA. It's a classic pre-revenue biotech structure: heavy on development and operations, light on sales and marketing right now.

The core operating expenses are clearly driven by the clinical program and getting the manufacturing locked down. For the third quarter of 2025, the reported operating expenses look like this:

Expense Category	Amount for Q3 2025
Research and Development (R&D) expenses	$785,608
General and Administrative (G&A) expenses	$831,339

Honestly, these figures represent the burn rate necessary to keep the lights on and, more importantly, to fund the critical path activities. The G&A is relatively high compared to R&D for the quarter, which sometimes suggests overhead related to financing activities or executive functions supporting the capital-raising efforts.

The major cost drivers, though not always itemized in the same line items, revolve around the clinical and operational milestones:

• Clinical trial costs for the SYMON-II pivotal study.
• Manufacturing transfer and supply chain readiness costs.

The SYMON-II pivotal study is a huge cost center. Patient enrollment is continuing, aiming to validate IL-6 levels for predicting 28-day all-cause mortality in ICU patients. Bluejay Diagnostics, Inc. has a timeline that suggests they expect to complete sample testing by the end of 2026, which means significant costs for sample processing and analysis are baked into the 2026 budget, following the $3.85 million raised in April 2025 and the $4.5 million PIPE financing in October 2025.

Supply chain readiness is another area where cash is being deployed. Bluejay Diagnostics, Inc. is actively working on cartridge redevelopment and validation manufacturing with a qualified FDA-registered Contract Manufacturing Organization (CMO). They also have an amended agreement with SanyoSeiko Co., Ltd. to support the Symphony analyzer manufacturing, and an extension with Toray Industries for cartridge know-how transfer until October 2026. These activities require upfront payments and milestone fees.

The financial reality is that Bluejay Diagnostics, Inc. is operating at a significant negative cash flow. As of September 30, 2025, the cash position stood at $3.08 million. This follows a cash balance of $4,443,076 as of June 30, 2025. The accumulated deficit reached $38,489,823 by June 30, 2025. This negative cash flow is the reason for the ongoing concern about the continuation of the business as a going concern, which management explicitly notes in their filings. The company estimates it will need to raise at least $20 million in additional capital through the end of fiscal year 2027 just to fund manufacturing readiness, clinical trials, and regulatory activities.

Here's a quick look at the cash runway situation based on recent financing and cash balances:

• Cash as of September 30, 2025: $3.08 million.
• Financing in April 2025: $3.85 million gross proceeds.
• Financing in October 2025: $4.5 million gross proceeds.
• Capital needed through 2027: At least $20 million.

The cost structure is entirely dependent on successful fundraising to cover these operational needs.

Bluejay Diagnostics, Inc. (BJDX) - Canvas Business Model: Revenue Streams

You're looking at the current state of Bluejay Diagnostics, Inc. (BJDX) revenue, and honestly, as of late 2025, the picture is entirely focused on financing the path to revenue. The company has explicitly stated that it has no current revenue-generating operations as of its March 31, 2025, 10-K filing, and it did not expect sources of revenue in the near future.

The immediate financial reality is that Bluejay Diagnostics, Inc. is sustained by capital raises to fund its clinical and regulatory path. The primary mechanism for this has been equity financing. You saw a significant capital event in October 2025, which is key to understanding their current liquidity.

Here's a breakdown of the most recent financing activities that are currently fueling operations, since product sales aren't yet a factor:

Financing Event	Date	Gross Proceeds	Price Per Share/Unit
Private Placement (PIPE)	October 2025	$4.5 million	$2.00 per share/pre-funded warrant
Warrant Inducement Financing	April 2025	$3.85 million	N/A (Warrant-related)

The October 2025 PIPE involved selling an aggregate of 2,250,000 shares of common stock (or pre-funded warrants) along with Series F warrants to purchase up to 4,500,000 additional shares. This capital, along with the $3.85 million raised in April 2025, is being used to fund FDA approval efforts, including clinical studies, and general working capital needs. As of September 30, 2025, the cash on hand was reported at $3.08 million.

The true, long-term revenue model hinges entirely on the successful commercialization of the Symphony platform. This model is structured around two distinct revenue components:

• Future sales of the Symphony System analyzers, which are the capital equipment component.
• Future recurring revenue derived from the disposable Symphony IL-6 Test cartridges used in the analyzers.

While there are no sales yet, Wall Street analysts, as of November 2025, were forecasting an average revenue of $5.16M for the full fiscal year 2025, with an average EPS forecast of -$0.33. This forecast is entirely speculative, based on the expectation of future product launch, but it gives you a sense of the potential scale analysts are modeling. The target market is substantial; the global sepsis diagnostic market is projected to reach $1.8 billion by 2030.

Beyond equity, Bluejay Diagnostics, Inc. is keeping its options open for non-dilutive funding sources. The company continues to explore other avenues to bridge the gap to commercial revenue. This includes:

• Exploring future grants.
• Seeking strategic partnership payments.

To execute its plan, which includes a targeted 510(k) submission to the FDA in 2027, the company anticipates needing to raise at least $20 million of further capital by the end of the 2027 fiscal year. That need for future capital is a critical, non-revenue stream that dictates near-term operational spending.

Finance: draft 13-week cash view by Friday.