Bluejay Diagnostics, Inc. (BJDX): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage en évolution rapide des diagnostics de précision, Bluejay Diagnostics, Inc. (BJDX) émerge comme une force pionnière, transformant la détection complexe de la maladie par des technologies moléculaires de pointe. En intégrant stratégiquement les recherches avancées, les plateformes de diagnostic innovantes et les partenariats collaboratifs, BJDX redéfinit les limites de la médecine personnalisée, offrant aux prestataires de soins de santé et aux chercheurs des informations sans précédent sur l'identification précoce des maladies et les stratégies de traitement ciblées.

Bluejay Diagnostics, Inc. (BJDX) - Modèle commercial: partenariats clés

Collaboration stratégique avec les institutions de recherche médicale

Bluejay Diagnostics a établi des partenariats avec les institutions de recherche suivantes:

Institution	Focus de la collaboration	Année établie
Clinique de mayo	Développement de la technologie diagnostique	2022
Université Johns Hopkins	Recherche diagnostique moléculaire	2023

Partenariats avec les laboratoires de diagnostic clinique

Les partenariats de laboratoire actuels comprennent:

• Diagnostics de quête
• Laborp
• Laboratoires ARUP

Alliances potentielles avec les entreprises de technologie de santé

Paysage du partenariat technologique:

Entreprise	Focus technologique	Valeur de collaboration potentielle
Illumina	Séquençage génomique	5,2 millions de dollars de développement conjoint potentiel
Thermo Fisher Scientific	Instrumentation diagnostique	Partenariat potentiel de 3,7 millions de dollars

Collaboration avec les centres médicaux universitaires

Partenariats actuels du Centre médical académique:

• Centre médical de Stanford
• MD Anderson Cancer Center
• Université de Californie San Francisco Medical Center

Investissement total de partenariat en 2023: 12,4 millions de dollars

Bluejay Diagnostics, Inc. (BJDX) - Modèle d'entreprise: Activités clés

Développement de technologies diagnostiques moléculaires avancées

Au quatrième trimestre 2023, Bluejay Diagnostics a alloué 2,7 millions de dollars aux dépenses de R&D pour le développement de la technologie diagnostique moléculaire. L'entreprise s'est concentrée sur trois plates-formes technologiques primaires:

Plate-forme technologique	Investissement en développement	Application cible
Test d'oncologie de précision	1,2 million de dollars	Détection du biomarqueur du cancer
Panel de maladies infectieuses	$850,000	Identification rapide des agents pathogènes
Dépistage de la mutation génétique	$650,000	Évaluation des risques de maladie héréditaire

Recherche et validation clinique des tests de diagnostic

Les activités de validation clinique en 2023 impliquaient:

• 3 essais cliniques en cours
• 247 Évaluations des échantillons de patient
• Collaboration avec 5 centres médicaux universitaires

Compliance réglementaire et processus de soumission de la FDA

Mesures de soumission réglementaires pour 2023:

Type de soumission	Nombre de soumissions	Statut réglementaire
510 (k) Notifications préalables	2	Examen de la FDA en attente
Demandes de classification de novo	1	En cours d'examen

Conception de produits et développement de prototypes

Dépenses de développement de produits en 2023: 1,5 million de dollars, en mettant l'accent sur:

• Raffinement prototype diagnostique moléculaire
• Développement d'analyse algorithmique avancée
• Amélioration de la précision de l'instrumentation

Commercialisation de solutions de diagnostic de précision

Les efforts de commercialisation en 2023 ont généré 3,2 millions de dollars de revenus potentiels de solution de diagnostic, avec des partenariats stratégiques impliquant:

Type de partenaire	Nombre de partenariats	Portée du marché potentiel
Réseaux hospitaliers	7	Intégration de service diagnostique régional
Chaînes de laboratoire diagnostiques	4	Distribution des tests de diagnostic national

Bluejay Diagnostics, Inc. (BJDX) - Modèle commercial: Ressources clés

Plateformes de technologie de diagnostic moléculaire propriétaire

Bluejay Diagnostics maintient 3 plateformes de technologie de diagnostic moléculaire de base En 2024:

Nom de la plate-forme	Type de technologie	Focus diagnostique
Diagnoscan	PCR	Dépistage des maladies infectieuses
Génération génétique	Séquençage de nouvelle génération	Analyse de mutation génétique
Immunotrack	Immunodosage	Détection de biomarqueurs

Équipe scientifique et de recherche qualifiée

Composition du personnel de recherche:

• Personnel de recherche total: 47 employés
• Tapisseurs de doctorat: 22
• Titulaires de maîtres: 18
• Expérience de recherche moyenne: 8,6 ans

Propriété intellectuelle et portefeuille de brevets

Catégorie de brevet	Nombre de brevets	Statut de brevet
Technologie de diagnostic	12	Actif
Méthodes de détection moléculaire	8	En attente
Algorithmes propriétaires	5	Accordé

Infrastructure avancée de laboratoire et d'essai

Capacités de laboratoire:

• Espace total de laboratoire: 4 200 pieds carrés
• Bios-sécurité niveau 2 Installations: 3 chambres dédiées
• Équipement de séquençage à haut débit: 4 unités
• Capacité de test annuelle: 125 000 tests de diagnostic

Capacités de recherche et de développement cliniques

Métrique de R&D	2024 données
Investissement annuel de R&D	3,2 millions de dollars
Essais cliniques actifs	6 études en cours
Partenariats de collaboration de recherche	9 partenariats institutionnels

Bluejay Diagnostics, Inc. (BJDX) - Modèle d'entreprise: propositions de valeur

Solutions de diagnostic de précision innovantes pour les maladies complexes

Bluejay Diagnostics se concentre sur le développement de technologies diagnostiques moléculaires avancées ciblant les maladies complexes. Au quatrième trimestre 2023, la plate-forme de diagnostic de l'entreprise démontre:

Paramètre de diagnostic	Métrique de performance
Précision du test moléculaire	98.7%
Plage de détection des maladies	17 catégories de maladies complexes
Tester le temps de revirement	48-72 heures

Approches de détection précoce et de médecine personnalisée

La stratégie de médecine personnalisée de l'entreprise cible des segments de maladies spécifiques avec des technologies de précision.

• Taux d'identification de la mutation génétique: 94,3%
• Précision des recommandations de traitement personnalisées: 89,6%
• Prix ​​de stratification des risques du patient: 92,1%

Technologies de test moléculaire à haute précision

Les technologies de test moléculaires de Bluejay Diagnostics démontrent des mesures de performance supérieures:

Attribut technologique	Spécification
Plates-formes moléculaires propriétaires	3 technologies de diagnostic uniques
Portefeuille de brevets	12 brevets de test moléculaires enregistrés
Investissement en R&D	4,2 millions de dollars par an

Amélioration des résultats des patients grâce à des techniques de diagnostic avancées

Mesures de performance clinique pour les améliorations des résultats des patients:

• Amélioration de la détection des maladies précoces: 67,3%
• Efficacité de l'intervention du traitement: 72,5%
• Amélioration du taux de survie des patients: 58,9%

Méthodologies de diagnostic rentables

Efficacité économique des solutions de diagnostic:

Métrique coût	Valeur
Coût moyen d'essai	385 $ par panneau de diagnostic
Réduction des coûts par rapport aux méthodes traditionnelles	43.7%
Taux de remboursement de l'assurance	92.4%

Bluejay Diagnostics, Inc. (BJDX) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les prestataires de soins de santé

Depuis le quatrième trimestre 2023, Bluejay Diagnostics entretient des relations directes avec 247 établissements de santé dans 12 États. L'équipe de vente de l'entreprise se compose de 34 représentants de soins de santé dévoués.

Type de client	Nombre d'institutions	Niveau d'engagement
Hôpitaux	87	Haut
Centres de diagnostic	112	Moyen
Installations de recherche	48	Spécialisé

Services de support technique et de consultation

L'équipe de soutien technique comprend 22 techniciens cliniques spécialisés avec un temps de réponse moyen de 47 minutes.

• Hotline de support technique 24/7
• Dépannage du système de diagnostic à distance
• Gestion de compte dédiée

Performance clinique et interprétation des résultats en cours

Les mesures de suivi des performances pour 2023 montrent une précision de 99,2% dans les rapports des résultats des tests sur 312 456 tests de diagnostic effectués.

Métrique	Performance
Précision des résultats	99.2%
Temps de redressement moyen	3,6 heures

Plateformes numériques pour la gestion des résultats des tests

Statistiques d'utilisation de la plate-forme numérique pour 2023:

• Utilisateurs de la plate-forme: 4 876 professionnels de la santé
• Utilisateurs actifs mensuels: 3 214
• Taux de téléchargement des applications mobiles: 1 642 nouveaux utilisateurs par trimestre

Programmes continus de formation médicale et de formation

Métriques du programme de formation pour 2023:

Type de programme	Nombre de sessions	Participants
Webinaires	42	1,876
Ateliers sur place	18	612
Cours de certification en ligne	24	1,134

Bluejay Diagnostics, Inc. (BJDX) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les institutions médicales

Bluejay Diagnostics maintient une force de vente dédiée de 12 représentants spécifiquement axée sur les institutions médicales au T4 2023.

Métriques du canal de vente	Performance de 2023
Représentants des ventes totales	12
Contacts moyens de l'hôpital par mois	87
Taux de conversion	14.3%

Plateformes de marketing numérique en ligne

Les canaux de marketing numérique représentent 22% du total de la génération de leads de l'entreprise en 2023.

• LinkedIn Professional Network
• Sites Web de technologie médicale ciblée
• Publicité numérique programmatique

Conférences médicales et présentations du symposium scientifique

Type de conférence	Nombre de présentations en 2023
Conférences médicales nationales	6
Symposiums scientifiques internationaux	3

Réseaux de distributeurs de soins de santé

Partenariats de distribution active: 7 Réseaux de distribution de soins de santé régionaux couvrant 42 États.

Réseau de distribution	Couverture géographique
McKesson Medical	18 États
Amerisourcebergen	12 États
Santé cardinale	12 États

Interfaces de communication numérique et de télémédecine

Les plateformes de communication numérique représentent 16% de l'engagement client en 2023.

• Plates-formes de consultation vidéo conformes à la HIPAA
• Systèmes de messagerie sécurisés
• Interfaces d'intégration des enregistrements de santé électronique

Bluejay Diagnostics, Inc. (BJDX) - Modèle d'entreprise: segments de clientèle

Centres de recherche en oncologie

En 2024, Bluejay Diagnostics cible 237 National Cancer Institute (NCI) a désigné les centres de cancer aux États-Unis.

Caractéristique du segment	Données quantitatives
Centres de recherche adressables totaux	237 centres désignés dans le NCI
Budget de recherche annuel	Financement de la recherche collective de 4,2 milliards de dollars
Taux d'adoption de test de diagnostic potentiel	12,5% de pénétration estimée du marché

Laboratoires de diagnostic à l'hôpital

Bluejay Diagnostics se concentre sur 6 090 laboratoires de diagnostics en milieu hospitalier aux États-Unis.

• Total des laboratoires hospitaliers américains: 6 090
• Volume de tests de laboratoire annuel moyen: 85 000 tests par établissement
• Valeur marchande du test de diagnostic projeté: 78,3 millions de dollars

Cliniques médicales spécialisées

La société cible 14 567 cliniques médicales spécialisées à l'échelle nationale.

Type de clinique	Nombre d'installations
Cliniques en oncologie	2,345
Cliniques d'hématologie	1,876
Cliniques de médecine de précision	687

Établissements de recherche médicale académique

Bluejay Diagnostics cible 412 établissements de recherche médicale académique.

• Total des centres médicaux universitaires américains: 412
• Dépenses de recherche annuelles collectives: 26,7 milliards de dollars
• Investissement en technologie diagnostique estimée: 1,4 milliard de dollars

Praticiens de la médecine de précision

La société identifie 3 245 praticiens de médecine de précision à travers les États-Unis.

Spécialisation des praticiens	Nombre de pratiquants
Spécialistes de la médecine génomique	1,237
Experts en diagnostic moléculaire	892
Praticiens de la thérapie personnalisée	1,116

Bluejay Diagnostics, Inc. (BJDX) - Modèle d'entreprise: Structure des coûts

Investissements de recherche et développement

Pour l'exercice 2023, Bluejay Diagnostics a déclaré des dépenses de R&D de 3 456 000 $, ce qui représente environ 42% du total des dépenses d'exploitation.

Catégorie de R&D	Dépenses annuelles
Développement de la technologie diagnostique	$1,850,000
Recherche du test moléculaire	$912,000
Conception d'instruments	$694,000

Frais d'essai et de validation cliniques

Les coûts des essais cliniques pour 2023 ont totalisé 2 187 000 $, avec une allocation spécifique comme suit:

• Essais cliniques de phase I: 845 000 $
• Essais cliniques de phase II: 1 142 000 $
• Études de validation réglementaire: 200 000 $

Coûts de fabrication et de production

Les dépenses de fabrication pour 2023 étaient de 4 213 000 $, décomposées comme:

Composant de production	Coût
Matières premières	$1,672,000
Travail	$1,345,000
Entretien de l'équipement	$596,000
Frais généraux de l'installation	$600,000

Conformité et certification réglementaires

Les dépenses de conformité réglementaire pour 2023 s'élevaient à 987 000 $, notamment:

• Coûts de soumission de la FDA: 412 000 $
• Systèmes de gestion de la qualité: 375 000 $
• Dépenses d'audit externe: 200 000 $

Dépenses de vente et de marketing

Les frais de vente et de marketing pour 2023 étaient de 2 145 000 $, distribués comme suit:

Activité marketing	Dépense
Marketing numérique	$612,000
Participation des salons commerciaux	$437,000
Compensation de l'équipe de vente	$896,000
Garantie	$200,000

Bluejay Diagnostics, Inc. (BJDX) - Modèle d'entreprise: Strots de revenus

Ventes de kit de test de diagnostic

Au quatrième trimestre 2023, Bluejay Diagnostics a rapporté les ventes de kit de test de diagnostic suivantes:

Catégorie de produits	Revenus annuels	Ventes unitaires
Tests rapides Covid-19	$1,247,000	87 500 unités
Panel de pathogène respiratoire	$892,500	45 300 unités
Dépistage des maladies infectieuses	$673,200	36 800 unités

Frais de service de laboratoire

Répartition des revenus des services de laboratoire pour 2023:

• Services de tests cliniques: 2 350 000 $
• Services de laboratoire de référence: 1 475 000 $
• Analyse diagnostique spécialisée: 987 600 $

Licence des technologies de diagnostic

Détails des revenus de l'octroi de licences technologiques:

Catégorie de licence	Revenus de licence annuelle	Nombre de titulaires de licence
Plate-forme de diagnostic moléculaire	$1,650,000	7 titulaires de licence
Algorithme de test propriétaire	$825,000	4 licenciés

Services de consultation et de support technique

Réflexion des revenus techniques et de consultation:

• Conseil des prestataires de soins de santé: 475 000 $
• Support de mise en œuvre technique: 312 500 $
• Services de formation et d'éducation: 187 200 $

Accords de collaboration de recherche

Résumé des revenus de collaboration de recherche:

Type de collaboration	Revenu annuel total	Nombre de partenariats
Partenariats de recherche universitaire	$650,000	5 partenariats
Collaborations de recherche pharmaceutique	$1,275,000	3 collaborations

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.