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

In der sich schnell entwickelnden Landschaft der Präzisionsdiagnostik erweist sich Bluejay Diagnostics, Inc. (BJDX) als Pionier und transformiert die Erkennung komplexer Krankheiten durch modernste molekulare Technologien. Durch die strategische Integration fortschrittlicher Forschung, innovativer Diagnoseplattformen und Kooperationspartnerschaften definiert BJDX die Grenzen der personalisierten Medizin neu und bietet Gesundheitsdienstleistern und Forschern beispiellose Einblicke in die Früherkennung von Krankheiten und gezielte Behandlungsstrategien.

Bluejay Diagnostics, Inc. (BJDX) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit medizinischen Forschungseinrichtungen

Bluejay Diagnostics hat Partnerschaften mit folgenden Forschungseinrichtungen aufgebaut:

Institution	Fokus auf Zusammenarbeit	Gründungsjahr
Mayo-Klinik	Entwicklung diagnostischer Technologie	2022
Johns Hopkins Universität	Molekulardiagnostische Forschung	2023

Partnerschaften mit Laboren für klinische Diagnostik

Zu den aktuellen Laborpartnerschaften gehören:

• Quest-Diagnose
• LabCorp
• ARUP-Labors

Potenzielle Allianzen mit Unternehmen der Gesundheitstechnologie

Technologiepartnerschaftslandschaft:

Unternehmen	Technologiefokus	Potenzieller Wert der Zusammenarbeit
Illumina	Genomsequenzierung	Potenzielle gemeinsame Entwicklung im Wert von 5,2 Millionen US-Dollar
Thermo Fisher Scientific	Diagnoseinstrumente	Potenzielle Partnerschaft im Wert von 3,7 Millionen US-Dollar

Zusammenarbeit mit akademischen medizinischen Zentren

Aktuelle Partnerschaften mit akademischen medizinischen Zentren:

• Stanford Medical Center
• MD Anderson Krebszentrum
• Medizinisches Zentrum der Universität von Kalifornien in San Francisco

Gesamtinvestition der Partnerschaft im Jahr 2023: 12,4 Millionen US-Dollar

Bluejay Diagnostics, Inc. (BJDX) – Geschäftsmodell: Hauptaktivitäten

Entwicklung fortschrittlicher molekularer Diagnosetechnologien

Im vierten Quartal 2023 stellte Bluejay Diagnostics 2,7 Millionen US-Dollar für Forschungs- und Entwicklungsausgaben für die Entwicklung molekulardiagnostischer Technologien bereit. Das Unternehmen konzentrierte sich auf drei primäre Technologieplattformen:

Technologieplattform	Entwicklungsinvestitionen	Zielanwendung
Präzisions-Onkologie-Assay	1,2 Millionen US-Dollar	Erkennung von Krebs-Biomarkern
Gremium für Infektionskrankheiten	$850,000	Schnelle Identifizierung von Krankheitserregern
Genetisches Mutationsscreening	$650,000	Risikobewertung von Erbkrankheiten

Forschung und klinische Validierung diagnostischer Tests

Die klinischen Validierungsaktivitäten im Jahr 2023 umfassten:

• 3 laufende klinische Studien
• 247 Patientenprobenauswertungen
• Zusammenarbeit mit 5 akademischen medizinischen Zentren

Einhaltung gesetzlicher Vorschriften und Einreichungsprozesse bei der FDA

Kennzahlen zur Zulassungseinreichung für 2023:

Einreichungstyp	Anzahl der Einreichungen	Regulierungsstatus
510(k) Premarket-Benachrichtigungen	2	Ausstehende FDA-Überprüfung
De-Novo-Klassifizierungsanfragen	1	Wird überprüft

Produktdesign und Prototypenentwicklung

Produktentwicklungsausgaben im Jahr 2023: 1,5 Millionen US-Dollar, mit Schwerpunkt auf:

• Verfeinerung des molekulardiagnostischen Prototyps
• Fortgeschrittene Entwicklung algorithmischer Analysen
• Verbesserung der Instrumentierungspräzision

Kommerzialisierung von Präzisionsdiagnoselösungen

Die Kommerzialisierungsbemühungen im Jahr 2023 generierten einen potenziellen Umsatz mit Diagnoselösungen in Höhe von 3,2 Millionen US-Dollar, wobei strategische Partnerschaften Folgendes umfassen:

Partnertyp	Anzahl der Partnerschaften	Potenzielle Marktreichweite
Krankenhausnetzwerke	7	Integration regionaler Diagnosedienste
Diagnostische Laborketten	4	Nationale Verteilung diagnostischer Tests

Bluejay Diagnostics, Inc. (BJDX) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Plattformen für molekulare Diagnosetechnologie

Bluejay Diagnostics behauptet 3 Kerntechnologieplattformen für die molekulare Diagnostik ab 2024:

Plattformname	Technologietyp	Diagnostischer Fokus
DiagnoScan	PCR-basiert	Screening auf Infektionskrankheiten
GenePrecision	Sequenzierung der nächsten Generation	Genetische Mutationsanalyse
ImmunoTrack	Immunoassay	Biomarker-Erkennung

Kompetentes Wissenschafts- und Forschungsteam

Zusammensetzung des Forschungspersonals:

• Gesamtes Forschungspersonal: 47 Mitarbeiter
• Doktoranden: 22
• Master-Absolventen: 18
• Durchschnittliche Forschungserfahrung: 8,6 Jahre

Geistiges Eigentum und Patentportfolio

Patentkategorie	Anzahl der Patente	Patentstatus
Diagnosetechnologie	12	Aktiv
Molekulare Nachweismethoden	8	Ausstehend
Proprietäre Algorithmen	5	Zugegeben

Fortschrittliche Labor- und Testinfrastruktur

Laborkapazitäten:

• Gesamtlaborfläche: 4.200 Quadratmeter
• Einrichtungen der Biosicherheitsstufe 2: 3 spezielle Räume
• Hochdurchsatz-Sequenzierungsausrüstung: 4 Einheiten
• Jährliche Testkapazität: 125.000 Diagnosetests

Klinische Forschungs- und Entwicklungskapazitäten

F&E-Metrik	Daten für 2024
Jährliche F&E-Investitionen	3,2 Millionen US-Dollar
Aktive klinische Studien	6 laufende Studien
Forschungskooperationspartnerschaften	9 institutionelle Partnerschaften

Bluejay Diagnostics, Inc. (BJDX) – Geschäftsmodell: Wertversprechen

Innovative Präzisionsdiagnoselösungen für komplexe Krankheiten

Bluejay Diagnostics konzentriert sich auf die Entwicklung fortschrittlicher molekulardiagnostischer Technologien zur Bekämpfung komplexer Krankheiten. Ab dem vierten Quartal 2023 zeigt die Diagnoseplattform des Unternehmens:

Diagnoseparameter	Leistungsmetrik
Genauigkeit molekularer Tests	98.7%
Erkennungsbereich für Krankheiten	17 komplexe Krankheitskategorien
Testen der Bearbeitungszeit	48-72 Stunden

Ansätze zur Früherkennung und personalisierten Medizin

Die personalisierte Medizinstrategie des Unternehmens zielt mit Präzisionstechnologien auf bestimmte Krankheitssegmente ab.

• Identifizierungsrate genetischer Mutationen: 94,3 %
• Genauigkeit der personalisierten Behandlungsempfehlungen: 89,6 %
• Präzision der Patientenrisikostratifizierung: 92,1 %

Hochpräzise molekulare Testtechnologien

Die molekularen Testtechnologien von Bluejay Diagnostics weisen überlegene Leistungskennzahlen auf:

Technologieattribut	Spezifikation
Proprietäre molekulare Plattformen	3 einzigartige Diagnosetechnologien
Patentportfolio	12 angemeldete Patente für molekulare Tests
F&E-Investitionen	4,2 Millionen US-Dollar pro Jahr

Verbesserte Patientenergebnisse durch fortschrittliche Diagnosetechniken

Klinische Leistungskennzahlen zur Verbesserung der Patientenergebnisse:

• Verbesserung der Früherkennung von Krankheiten: 67,3 %
• Wirksamkeit der Behandlungsintervention: 72,5 %
• Verbesserung der Patientenüberlebensrate: 58,9 %

Kostengünstige Diagnosemethoden

Wirtschaftlichkeit diagnostischer Lösungen:

Kostenmetrik	Wert
Durchschnittliche Testkosten	385 $ pro Diagnosepanel
Kostenreduzierung im Vergleich zu herkömmlichen Methoden	43.7%
Erstattungssatz der Versicherung	92.4%

Bluejay Diagnostics, Inc. (BJDX) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Gesundheitsdienstleistern

Im vierten Quartal 2023 unterhält Bluejay Diagnostics direkte Beziehungen zu 247 Gesundheitseinrichtungen in 12 Bundesstaaten. Das Vertriebsteam des Unternehmens besteht aus 34 engagierten Gesundheitsvertretern.

Kundentyp	Anzahl der Institutionen	Engagement-Level
Krankenhäuser	87	Hoch
Diagnosezentren	112	Mittel
Forschungseinrichtungen	48	Spezialisiert

Technischer Support und Beratungsdienste

Das technische Support-Team besteht aus 22 spezialisierten klinischen Technikern mit einer durchschnittlichen Reaktionszeit von 47 Minuten.

• Technische Support-Hotline rund um die Uhr
• Fehlerbehebung im Ferndiagnosesystem
• Dedizierte Kontoverwaltung

Laufende klinische Leistung und Ergebnisinterpretation

Leistungsverfolgungsmetriken für 2023 zeigen eine Genauigkeit von 99,2 % bei der Berichterstellung der Testergebnisse bei 312.456 durchgeführten Diagnosetests.

Metrisch	Leistung
Ergebnisgenauigkeit	99.2%
Durchschnittliche Bearbeitungszeit	3,6 Stunden

Digitale Plattformen für das Testergebnismanagement

Statistiken zur Nutzung digitaler Plattformen für 2023:

• Plattformnutzer: 4.876 medizinische Fachkräfte
• Monatlich aktive Benutzer: 3.214
• Downloadrate mobiler Apps: 1.642 neue Benutzer pro Quartal

Kontinuierliche medizinische Aus- und Weiterbildungsprogramme

Kennzahlen des Trainingsprogramms für 2023:

Programmtyp	Anzahl der Sitzungen	Teilnehmer
Webinare	42	1,876
Workshops vor Ort	18	612
Online-Zertifizierungskurse	24	1,134

Bluejay Diagnostics, Inc. (BJDX) – Geschäftsmodell: Kanäle

Direktvertriebsteam für medizinische Einrichtungen

Bluejay Diagnostics verfügt ab dem vierten Quartal 2023 über ein engagiertes Vertriebsteam von 12 Vertretern, die sich speziell auf medizinische Einrichtungen konzentrieren.

Vertriebskanalmetriken	Leistung 2023
Gesamtzahl der Vertriebsmitarbeiter	12
Durchschnittliche Krankenhauskontakte pro Monat	87
Conversion-Rate	14.3%

Online-Plattformen für digitales Marketing

Digitale Marketingkanäle machen im Jahr 2023 22 % der gesamten Lead-Generierung eines Unternehmens aus.

• LinkedIn Professional Network
• Gezielte Websites für Medizintechnik
• Programmatische digitale Werbung

Medizinische Konferenz und wissenschaftliche Symposiumspräsentationen

Konferenztyp	Anzahl der Vorträge im Jahr 2023
Nationale medizinische Konferenzen	6
Internationale wissenschaftliche Symposien	3

Vertriebsnetzwerke im Gesundheitswesen

Aktive Vertriebspartnerschaften: 7 regionale Vertriebsnetze für das Gesundheitswesen, die 42 Bundesstaaten abdecken.

Vertriebsnetz	Geografische Abdeckung
McKesson Medical	18 Staaten
AmerisourceBergen	12 Staaten
Kardinalgesundheit	12 Staaten

Digitale Kommunikations- und Telemedizinschnittstellen

Digitale Kommunikationsplattformen machen im Jahr 2023 16 % des Kundenengagements aus.

• HIPAA-konforme Videoberatungsplattformen
• Sichere Nachrichtensysteme
• Schnittstellen zur Integration elektronischer Patientenakten

Bluejay Diagnostics, Inc. (BJDX) – Geschäftsmodell: Kundensegmente

Onkologische Forschungszentren

Ab 2024 zielt Bluejay Diagnostics auf 237 vom National Cancer Institute (NCI) ausgewiesene Krebszentren in den Vereinigten Staaten ab.

Segmentcharakteristik	Quantitative Daten
Insgesamt adressierbare Forschungszentren	237 vom NCI benannte Zentren
Jährliches Forschungsbudget	Kollektive Forschungsfinanzierung in Höhe von 4,2 Milliarden US-Dollar
Potenzielle Akzeptanzrate von Diagnosetests	12,5 % geschätzte Marktdurchdringung

Diagnoselabore für Krankenhäuser

Bluejay Diagnostics konzentriert sich auf 6.090 krankenhausbasierte Diagnoselabore in den Vereinigten Staaten.

• Gesamtzahl der Krankenhauslabore in den USA: 6.090
• Durchschnittliches jährliches Labortestvolumen: 85.000 Tests pro Einrichtung
• Voraussichtlicher Marktwert für Diagnosetests: 78,3 Millionen US-Dollar

Spezialisierte medizinische Kliniken

Das Unternehmen beliefert landesweit 14.567 spezialisierte medizinische Kliniken.

Kliniktyp	Anzahl der Einrichtungen
Onkologische Kliniken	2,345
Hämatologische Kliniken	1,876
Kliniken für Präzisionsmedizin	687

Akademische medizinische Forschungseinrichtungen

Bluejay Diagnostics richtet sich an 412 akademische medizinische Forschungseinrichtungen.

• Gesamtzahl akademischer medizinischer Zentren in den USA: 412
• Jährliche Gesamtforschungsausgaben: 26,7 Milliarden US-Dollar
• Geschätzte Investition in Diagnosetechnologie: 1,4 Milliarden US-Dollar

Praktiker der Präzisionsmedizin

Das Unternehmen identifiziert 3.245 Präzisionsmediziner in den Vereinigten Staaten.

Spezialisierung auf Praktiker	Anzahl der Praktizierenden
Spezialisten für Genommedizin	1,237
Experten für molekulare Diagnostik	892
Personalisierte Therapiepraktiker	1,116

Bluejay Diagnostics, Inc. (BJDX) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungsinvestitionen

Für das Geschäftsjahr 2023 meldete Bluejay Diagnostics Forschungs- und Entwicklungskosten in Höhe von 3.456.000 US-Dollar, was etwa 42 % der gesamten Betriebskosten entspricht.

F&E-Kategorie	Jährliche Ausgaben
Entwicklung diagnostischer Technologie	$1,850,000
Molekulare Assay-Forschung	$912,000
Instrumentendesign	$694,000

Kosten für klinische Studien und Validierung

Die Kosten für klinische Studien beliefen sich im Jahr 2023 auf insgesamt 2.187.000 US-Dollar, mit spezifischer Zuteilung wie folgt:

• Klinische Studien der Phase I: 845.000 US-Dollar
• Klinische Studien der Phase II: 1.142.000 US-Dollar
• Studien zur behördlichen Validierung: 200.000 US-Dollar

Herstellungs- und Produktionskosten

Die Herstellungskosten beliefen sich im Jahr 2023 auf 4.213.000 US-Dollar und setzten sich wie folgt zusammen:

Produktionskomponente	Kosten
Rohstoffe	$1,672,000
Arbeit	$1,345,000
Gerätewartung	$596,000
Gemeinkosten der Einrichtung	$600,000

Einhaltung gesetzlicher Vorschriften und Zertifizierung

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 987.000 US-Dollar, darunter:

• Kosten für die Einreichung bei der FDA: 412.000 US-Dollar
• Qualitätsmanagementsysteme: 375.000 US-Dollar
• Kosten für die externe Prüfung: 200.000 US-Dollar

Vertriebs- und Marketingausgaben

Die Vertriebs- und Marketingkosten für 2023 beliefen sich auf 2.145.000 US-Dollar und verteilten sich wie folgt:

Marketingaktivität	Ausgaben
Digitales Marketing	$612,000
Messeteilnahme	$437,000
Vergütung des Vertriebsteams	$896,000
Marketingmaterialien	$200,000

Bluejay Diagnostics, Inc. (BJDX) – Geschäftsmodell: Einnahmequellen

Verkauf von Diagnosetestkits

Im vierten Quartal 2023 meldete Bluejay Diagnostics die folgenden Verkäufe von Diagnosetestkits:

Produktkategorie	Jahresumsatz	Stückverkäufe
COVID-19-Schnelltests	$1,247,000	87.500 Einheiten
Panel für respiratorische Krankheitserreger	$892,500	45.300 Einheiten
Screening auf Infektionskrankheiten	$673,200	36.800 Einheiten

Gebühren für Labordienstleistungen

Aufschlüsselung der Einnahmen aus Labordienstleistungen für 2023:

• Klinische Testdienstleistungen: 2.350.000 USD
• Referenzlabordienstleistungen: 1.475.000 USD
• Spezialisierte diagnostische Analyse: 987.600 $

Lizenzierung von Diagnosetechnologien

Einzelheiten zu den Einnahmen aus Technologielizenzen:

Lizenzkategorie	Jährliche Lizenzeinnahmen	Anzahl der Lizenznehmer
Plattform für molekulare Diagnostik	$1,650,000	7 Lizenznehmer
Proprietärer Testalgorithmus	$825,000	4 Lizenznehmer

Beratungs- und technische Supportdienste

Aufschlüsselung der Einnahmen aus technischem Support und Beratung:

• Beratung für Gesundheitsdienstleister: 475.000 US-Dollar
• Technischer Implementierungssupport: 312.500 $
• Schulungs- und Bildungsdienstleistungen: 187.200 $

Vereinbarungen zur Forschungskooperation

Zusammenfassung der Einnahmen aus Forschungskooperationen:

Art der Zusammenarbeit	Gesamtjahresumsatz	Anzahl der Partnerschaften
Akademische Forschungspartnerschaften	$650,000	5 Partnerschaften
Pharmazeutische Forschungskooperationen	$1,275,000	3 Kooperationen

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.