Bluejay Diagnostics, Inc. (BJDX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução do diagnóstico de precisão, o Bluejay Diagnostics, Inc. (BJDX) surge como uma força pioneira, transformando a detecção complexa de doenças através de tecnologias moleculares de ponta. Ao integrar estrategicamente pesquisas avançadas, plataformas inovadoras de diagnóstico e parcerias colaborativas, o BJDX está redefinindo os limites da medicina personalizada, oferecendo a prestadores de cuidados de saúde e pesquisadores insights sem precedentes sobre a identificação precoce de doenças e estratégias de tratamento direcionadas.

Bluejay Diagnostics, Inc. (BJDX) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa médica

A Bluejay Diagnostics estabeleceu parcerias com as seguintes instituições de pesquisa:

Instituição	Foco de colaboração	Ano estabelecido
Clínica Mayo	Desenvolvimento de Tecnologia de Diagnóstico	2022
Universidade Johns Hopkins	Pesquisa de diagnóstico molecular	2023

Parcerias com laboratórios de diagnóstico clínico

As parcerias laboratoriais atuais incluem:

• Diagnostics de missão
• Labcorp
• Laboratórios Arup

Alianças em potencial com empresas de tecnologia de saúde

Cenário de parceria de tecnologia:

Empresa	Foco em tecnologia	Valor potencial de colaboração
Ilumina	Sequenciamento genômico	US $ 5,2 milhões em potencial desenvolvimento conjunto
Thermo Fisher Scientific	Instrumentação de diagnóstico	US $ 3,7 milhões em potencial parceria

Colaboração com centros médicos acadêmicos

As parcerias atuais do Centro Médico Acadêmico:

• Stanford Medical Center
• MD Anderson Cancer Center
• Centro Médico da Universidade da Califórnia em São Francisco

Investimento total de parceria em 2023: US $ 12,4 milhões

Bluejay Diagnostics, Inc. (BJDX) - Modelo de negócios: Atividades -chave

Desenvolvimento de tecnologias avançadas de diagnóstico molecular

A partir do quarto trimestre 2023, o Bluejay Diagnostics alocou US $ 2,7 milhões às despesas de P&D para desenvolvimento de tecnologia de diagnóstico molecular. A empresa se concentrou em três plataformas tecnológicas principais:

Plataforma de tecnologia	Investimento em desenvolvimento	Aplicação de destino
Ensaio de oncologia de precisão	US $ 1,2 milhão	Detecção de biomarcadores de câncer
Painel de doenças infecciosas	$850,000	Identificação rápida de patógenos
Triagem de mutação genética	$650,000	Avaliação de risco de doença hereditária

Pesquisa e validação clínica de ensaios de diagnóstico

Atividades de validação clínica em 2023 envolvidas:

• 3 ensaios clínicos em andamento
• 247 Avaliações de amostra de pacientes
• Colaboração com 5 centros médicos acadêmicos

Processos de conformidade regulatória e submissão da FDA

Métricas de envio regulatório para 2023:

Tipo de envio	Número de envios	Status regulatório
510 (k) Notificações de pré -mercado	2	Revisão da FDA pendente
Solicitações de classificação de novo	1	Em revisão

Design de produto e desenvolvimento de protótipos

Despesas de desenvolvimento de produtos em 2023: US $ 1,5 milhão, com foco em:

• Refinamento de protótipo de diagnóstico molecular
• Desenvolvimento avançado de análise algorítmica
• Melhoramento de precisão da instrumentação

Comercialização de soluções de diagnóstico de precisão

Os esforços de comercialização em 2023 geraram US $ 3,2 milhões em potencial receita de solução de diagnóstico, com parcerias estratégicas envolvendo:

Tipo de parceiro	Número de parcerias	Alcance potencial do mercado
Redes hospitalares	7	Integração regional de serviço de diagnóstico
Cadeias laboratoriais de diagnóstico	4	Distribuição do teste de diagnóstico nacional

Bluejay Diagnostics, Inc. (BJDX) - Modelo de negócios: Recursos -chave

Plataformas de tecnologia de diagnóstico molecular proprietário

O Bluejay Diagnostics mantém 3 plataformas de tecnologia de diagnóstico molecular central a partir de 2024:

Nome da plataforma	Tipo de tecnologia	Foco de diagnóstico
Diagnóstico	Baseado em PCR	Triagem de doenças infecciosas
GenePrecision	Sequenciamento de próxima geração	Análise de mutação genética
Imunotrack	Imunoensaio	Detecção de biomarcadores

Equipe científica e de pesquisa qualificada

Composição do pessoal de pesquisa:

• Equipe total de pesquisa: 47 funcionários
• Titulares de doutorado: 22
• Titulares de mestrado: 18
• Experiência média de pesquisa: 8,6 anos

Propriedade intelectual e portfólio de patentes

Categoria de patentes	Número de patentes	Status de patente
Tecnologia de diagnóstico	12	Ativo
Métodos de detecção molecular	8	Pendente
Algoritmos proprietários	5	Garantido

Infraestrutura de laboratório e teste avançado

Capacidades de laboratório:

• Espaço total de laboratório: 4.200 pés quadrados
• Instalações de Nível 2 da Biossegurança: 3 quartos dedicados
• Equipamento de sequenciamento de alto rendimento: 4 unidades
• Capacidade de teste anual: 125.000 testes de diagnóstico

Capacidades de pesquisa e desenvolvimento clínicos

Métrica de P&D	2024 dados
Investimento anual de P&D	US $ 3,2 milhões
Ensaios clínicos ativos	6 estudos em andamento
Parcerias de colaboração de pesquisa	9 parcerias institucionais

Bluejay Diagnostics, Inc. (BJDX) - Modelo de negócios: proposições de valor

Soluções de diagnóstico de precisão inovadora para doenças complexas

O Bluejay Diagnostics se concentra no desenvolvimento de tecnologias avançadas de diagnóstico molecular direcionadas a doenças complexas. A partir do quarto trimestre 2023, a plataforma de diagnóstico da empresa demonstra:

Parâmetro de diagnóstico	Métrica de desempenho
Precisão do teste molecular	98.7%
Faixa de detecção de doenças	17 categorias de doenças complexas
Testando tempo de resposta	48-72 horas

Abordagens precoces de detecção e medicina personalizada

A estratégia de medicina personalizada da empresa tem como alvo segmentos específicos de doenças com tecnologias de precisão.

• Taxa de identificação de mutação genética: 94,3%
• Precisão de recomendação de tratamento personalizado: 89,6%
• Estratificação de risco do paciente Precisão: 92,1%

Tecnologias de teste moleculares de alta precisão

As tecnologias de teste molecular da Bluejay Diagnostics demonstram métricas de desempenho superior:

Atributo de tecnologia	Especificação
Plataformas moleculares proprietárias	3 tecnologias de diagnóstico exclusivas
Portfólio de patentes	12 Patentes de teste moleculares registradas
Investimento em P&D	US $ 4,2 milhões anualmente

Melhores resultados dos pacientes através de técnicas avançadas de diagnóstico

Métricas de desempenho clínico para melhorias nos resultados do paciente:

• Melhoria da detecção de doenças precoces: 67,3%
• Eficácia da intervenção do tratamento: 72,5%
• Melhoramento da taxa de sobrevivência do paciente: 58,9%

Metodologias de diagnóstico econômicas

Eficiência econômica de soluções de diagnóstico:

Métrica de custo	Valor
Custo médio do teste	US $ 385 por painel de diagnóstico
Redução de custos em comparação aos métodos tradicionais	43.7%
Taxa de reembolso de seguros	92.4%

Bluejay Diagnostics, Inc. (BJDX) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com prestadores de serviços de saúde

A partir do quarto trimestre 2023, o Bluejay Diagnostics mantém relações diretas com 247 instituições de saúde em 12 estados. A equipe de vendas da empresa consiste em 34 representantes de saúde dedicados.

Tipo de cliente	Número de instituições	Nível de engajamento
Hospitais	87	Alto
Centros de diagnóstico	112	Médio
Instalações de pesquisa	48	Especializado

Serviços de suporte técnico e consulta

A equipe de suporte técnico compreende 22 técnicos clínicos especializados com tempo médio de resposta de 47 minutos.

• 24/7 de suporte técnico Linha direta
• Solução de problemas do sistema de diagnóstico remoto
• Gerenciamento de conta dedicado

Desempenho clínico em andamento e interpretação de resultados

As métricas de rastreamento de desempenho para 2023 mostram 99,2% de precisão nos relatórios de resultados de teste em 312.456 testes de diagnóstico realizados.

Métrica	Desempenho
Precisão do resultado	99.2%
Tempo médio de resposta	3,6 horas

Plataformas digitais para gerenciamento de resultados de teste

Estatísticas de uso da plataforma digital para 2023:

• Usuários da plataforma: 4.876 profissionais de saúde
• Usuários ativos mensais: 3.214
• Taxa de download de aplicativos móveis: 1.642 novos usuários por trimestre

Programas contínuos de educação médica e treinamento

Métricas do Programa de Treinamento para 2023:

Tipo de programa	Número de sessões	Participantes
Webinars	42	1,876
Workshops no local	18	612
Cursos de certificação on -line	24	1,134

Bluejay Diagnostics, Inc. (BJDX) - Modelo de negócios: canais

Equipe de vendas direta direcionando instituições médicas

O Bluejay Diagnostics mantém uma força de vendas dedicada de 12 representantes focada especificamente nas instituições médicas no quarto trimestre 2023.

Métricas de canal de vendas	2023 desempenho
Total de representantes de vendas	12
Contatos médios hospitalares por mês	87
Taxa de conversão	14.3%

Plataformas de marketing digital online

Os canais de marketing digital representam 22% da geração total de leads da empresa em 2023.

• Rede Profissional do LinkedIn
• Sites de tecnologia médica direcionados
• Publicidade digital programática

Apresentações de Conferência Médica e Simpósio Científico

Tipo de conferência	Número de apresentações em 2023
Conferências Médicas Nacionais	6
Simpósios científicos internacionais	3

Redes de distribuidores de assistência médica

Parcerias de distribuição ativa: 7 redes regionais de distribuição de saúde, cobrindo 42 estados.

Rede de distribuidores	Cobertura geográfica
McKesson Medical	18 estados
Amerisourcebergen	12 estados
Cardinal Health	12 estados

Comunicação digital e interfaces de telemedicina

As plataformas de comunicação digital representam 16% do envolvimento do cliente em 2023.

• Plataformas de consulta em vídeo compatíveis com HIPAA
• Sistemas de mensagens seguras
• Interfaces de integração de registros eletrônicos de saúde

Bluejay Diagnostics, Inc. (BJDX) - Modelo de negócios: segmentos de clientes

Centros de Pesquisa Oncológica

A partir de 2024, o Bluejay Diagnostics metas 237 Centros de Câncer Assignado pelo Instituto Nacional do Câncer (NCI) nos Estados Unidos.

Característica do segmento	Dados quantitativos
Centros de pesquisa endereçáveis ​​totais	237 centros projetados por NCI
Orçamento de pesquisa anual	Financiamento de pesquisa coletiva de US $ 4,2 bilhões
Taxa potencial de adoção de teste de diagnóstico	12,5% de penetração estimada no mercado

Laboratórios de Diagnóstico Hospitalar

O Bluejay Diagnostics se concentra em 6.090 laboratórios de diagnóstico hospitalares nos Estados Unidos.

• Total de Laboratórios Hospitalados dos EUA: 6.090
• Volume médio de teste de laboratório anual: 85.000 testes por instalação
• Valor de mercado de teste de diagnóstico projetado: US $ 78,3 milhões

Clínicas médicas especializadas

A empresa tem como alvo 14.567 clínicas médicas especializadas em todo o país.

Tipo de clínica	Número de instalações
Clínicas de oncologia	2,345
Clínicas de Hematologia	1,876
Clínicas de Medicina de Precisão	687

Instituições de Pesquisa Médica Acadêmica

Bluejay Diagnostics metas 412 Instituições de Pesquisa Médica Acadêmica.

• Total de centros médicos acadêmicos dos EUA: 412
• Despesas de pesquisa anual coletiva: US $ 26,7 bilhões
• Investimento estimado em tecnologia de diagnóstico: US $ 1,4 bilhão

Profissionais de Medicina de Precisão

A empresa identifica 3.245 profissionais de medicina de precisão nos Estados Unidos.

Especialização do praticante	Número de praticantes
Especialistas em medicina genômica	1,237
Especialistas em diagnóstico molecular	892
Profissionais de terapia personalizados	1,116

Bluejay Diagnostics, Inc. (BJDX) - Modelo de negócios: estrutura de custos

Investimentos de pesquisa e desenvolvimento

Para o ano fiscal de 2023, o Bluejay Diagnostics registrou despesas de P&D de US $ 3.456.000, representando aproximadamente 42% do total de despesas operacionais.

Categoria de P&D	Despesas anuais
Desenvolvimento de Tecnologia de Diagnóstico	$1,850,000
Pesquisa de ensaio molecular	$912,000
Design de instrumentos	$694,000

Ensaio clínico e despesas de validação

Os custos de ensaios clínicos para 2023 totalizaram US $ 2.187.000, com alocação específica da seguinte forma:

• Ensaios clínicos de fase I: $ 845.000
• Ensaios clínicos de fase II: US $ 1.142.000
• Estudos de validação regulatória: US $ 200.000

Custos de fabricação e produção

As despesas de fabricação para 2023 foram de US $ 4.213.000, divididas como:

Componente de produção	Custo
Matérias-primas	$1,672,000
Trabalho	$1,345,000
Manutenção do equipamento	$596,000
Instalação sobrecarga	$600,000

Conformidade e certificação regulatória

As despesas de conformidade regulatória em 2023 totalizaram US $ 987.000, incluindo:

• Custos de envio da FDA: US $ 412.000
• Sistemas de gestão da qualidade: US $ 375.000
• Despesas de auditoria externa: $ 200.000

Despesas de vendas e marketing

Os custos de vendas e marketing para 2023 foram de US $ 2.145.000, distribuídos da seguinte forma:

Atividade de marketing	Gasto
Marketing digital	$612,000
Participação na feira	$437,000
Compensação da equipe de vendas	$896,000
Garantia de marketing	$200,000

Bluejay Diagnostics, Inc. (BJDX) - Modelo de negócios: fluxos de receita

Vendas de kit de teste de diagnóstico

A partir do quarto trimestre 2023, o Bluejay Diagnostics relatou as seguintes vendas de kit de teste de diagnóstico:

Categoria de produto	Receita anual	Vendas de unidades
Covid-19 testes rápidos	$1,247,000	87.500 unidades
Painel de patógenos respiratórios	$892,500	45.300 unidades
Triagem de doenças infecciosas	$673,200	36.800 unidades

Taxas de serviço de laboratório

Repartição da receita do serviço de laboratório para 2023:

• Serviços de teste clínico: US $ 2.350.000
• Serviços de laboratório de referência: US $ 1.475.000
• Análise de Diagnóstico Especializada: US $ 987.600

Licenciamento de tecnologias de diagnóstico

Detalhes da receita de licenciamento de tecnologia:

Categoria de licenciamento	Receita anual de licenciamento	Número de licenciados
Plataforma de diagnóstico molecular	$1,650,000	7 licenciados
Algoritmo de teste proprietário	$825,000	4 licenciados

Serviços de consulta e suporte técnico

Suporte técnico e discurso de receita de consulta:

• Consultoria de prestador de serviços de saúde: US $ 475.000
• Suporte de implementação técnica: US $ 312.500
• Serviços de Treinamento e Educação: US $ 187.200

Acordos de colaboração de pesquisa

Resumo da receita de colaboração de pesquisa:

Tipo de colaboração	Receita anual total	Número de parcerias
Parcerias de pesquisa acadêmica	$650,000	5 parcerias
Colaborações de pesquisa farmacêutica	$1,275,000	3 colaborações

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.