Endra Life Sciences Inc. (NDRA): Business Model Canvas [Jan-2025 Mise à jour]

Dans le paysage rapide de la technologie médicale, Endra Life Sciences Inc. (NDRA) émerge comme un innovateur révolutionnaire, révolutionnant l'imagerie médicale grâce à sa technologie de contraste thermique de pointe. En mélangeant de manière transparente l'ingénierie avancée avec un diagnostic médical, l'entreprise est prête à transformer la façon dont les professionnels de la santé visualisent et comprennent les processus physiologiques internes, offrant des solutions non invasives et rentables qui promettent d'améliorer la précision et l'accessibilité de diagnostic dans plusieurs domaines médicaux.

Endra Life Sciences Inc. (NDRA) - Modèle commercial: partenariats clés

Fabricants de dispositifs médicaux et institutions de recherche

Endra Life Sciences a établi des partenariats stratégiques avec les principaux dispositifs médicaux et organisations de recherche suivantes:

Partenaire	Type de collaboration	Année établie
Université du Michigan	Développement de la recherche et de la technologie	2016
Clinique de mayo	Études de validation clinique	2019
GE Healthcare	Intégration technologique	2021

Investisseurs en technologie de la santé et sociétés de capital-risque

Les principaux partenariats financiers d'Endra comprennent:

• Woodstock Capital Partners - 3,2 millions de dollars d'investissement en 2022
• Horizon Technology Finance - 5 millions de dollars Facilité de dette de capital-risque en 2023
• Conseillers perspicaces - 7,5 millions de dollars de placement privé en 2021

Distributeurs d'équipement à ultrasons et partenaires d'imagerie médicale

Distributeur	Couverture géographique	Valeur de partenariat
Industries Medline	Amérique du Nord	Contrat de distribution de 1,8 million de dollars
Hitachi Healthcare	Région Asie-Pacifique	Licence technologique de 2,5 millions de dollars

Centres de recherche universitaires

ENDRA collabore avec des centres de recherche spécialisés en matière d'imagerie médicale:

• Département de radiologie de l'Université de Stanford
• Centre de technologie d'imagerie Johns Hopkins
• MIT Bioensineering Research Lab

Évaluation totale du partenariat à partir de 2024: 15,7 millions de dollars

Endra Life Sciences Inc. (NDRA) - Modèle d'entreprise: Activités clés

Développement d'une technologie d'imagerie thermique avancée pour les diagnostics médicaux

Endra Life Sciences se concentre sur le développement de la technologie d'imagerie améliorée thermo acoustique (TAEI). Au quatrième trimestre 2023, la société a investi 4,2 millions de dollars en R&D spécifiquement pour le développement de la technologie d'imagerie thermique.

Domaine de mise au point technologique	Montant d'investissement	Étape de développement
Plate-forme d'imagerie thermique	4,2 millions de dollars	Prototype avancé
Applications de diagnostic médical	1,8 million de dollars	Validation clinique

Recherche et innovation dans les solutions d'échographie et d'imagerie thermique

La société maintient des partenariats de recherche actifs avec plusieurs établissements universitaires et médicaux.

• 3 collaborations de recherche active
• 2 Applications de brevet en instance dans la technologie d'imagerie thermique
• Dépenses annuelles de R&D: 6,5 millions de dollars

Essais cliniques et conformité réglementaire pour les dispositifs médicaux

Jalon réglementaire	Statut	Achèvement estimé
Préparation de la soumission de la FDA	En cours	Q2 2024
Phase d'essai clinique	En cours	Q3 2024

Développement de produits et raffinement technologique

ENRA a alloué des ressources spécifiques pour une amélioration technologique continue.

• Budget de développement de produits: 2,3 millions de dollars en 2023
• Taille de l'équipe d'ingénierie: 12 spécialistes à temps plein
• Cycles d'itération technologique: processus de raffinement trimestriel

Mesures de performance clés pour les activités clés:

Métrique	Valeur 2023
Dépenses totales de R&D	6,5 millions de dollars
Demandes de brevet	2
Collaborations de recherche	3

Endra Life Sciences Inc. (NDRA) - Modèle d'entreprise: Ressources clés

Plateforme de technologie de contraste thermique propriétaire

La plate-forme technologique principale d'Endra Life Sciences s'est concentrée sur les technologies d'imagerie thermique avancées. Au quatrième trimestre 2023, la plate-forme de l'entreprise cible spécifiquement les diagnostics d'imagerie médicale.

Attribut technologique	Spécification
Demandes de brevet	7 demandes de brevet actives
Étape de développement technologique	Phase de développement pré-commercial
Investissement estimé en R&D	3,2 millions de dollars en 2023

Ingénierie et recherche qualifiées & Équipe de développement

La composition technique de la main-d'œuvre d'Endra en décembre 2023:

• Personnel total de R&D: 12 employés
• Rechercheurs de doctorat: 5 individus
• Expérience de recherche moyenne: 8,5 ans

Propriété intellectuelle et portefeuille de brevets

Catégorie IP	Quantité	Statut
Brevets délivrés	3	Actif
Demandes de brevet	7	En attente
Brevets provisoires	2	Déposé

Installations de recherche et de test avancées

Détails de l'infrastructure de recherche:

• Lieu de recherche primaire: Ann Arbor, Michigan
• Espace total des installations de recherche: 2 500 pieds carrés
• Investissement d'équipement d'imagerie avancée: 1,7 million de dollars

Financement stratégique et capital d'investissement

Source de financement	Montant	Année
Capital total	22,4 millions de dollars	Cumulatif jusqu'en 2023
Investissements en capital-risque	15,6 millions de dollars	2020-2023
Subventions	3,2 millions de dollars	2021-2023

Endra Life Sciences Inc. (NDRA) - Modèle d'entreprise: propositions de valeur

Solutions d'imagerie médicale non invasives et rentables

Endra Life Sciences propose la technologie des échographies améliorées thermo-acoustiques (Taeus) avec les spécifications suivantes:

Paramètre technologique	Spécification
Potentiel de réduction des coûts	Jusqu'à 70% inférieur à l'imagerie IRM traditionnelle
Temps de balayage	Environ 5 à 10 minutes par examen
Exposition aux radiations du patient	Exposition à rayonnement zéro

Capacités de diagnostic améliorées

La technologie d'imagerie d'Endra offre des capacités de diagnostic dans plusieurs domaines médicaux:

• Quantification des graisses du foie avec une précision à 95%
• Caractérisation des tissus mammaires
• Évaluation métabolique des tissus musculaires
• Mécanismes potentiels de détection des maladies précoces

Amélioration de la technologie de cartographie des températures

La technologie Taeus offre une cartographie de température précise avec les mesures de performance suivantes:

Attribut de mappage de température	Performance
Résolution de température	Précision de 0,5 ° C
Profondeur d'imagerie	Jusqu'à 15 cm à l'intérieur du tissu humain
Surveillance en temps réel	Suivi de température continue

Technologies d'imagerie précises et accessibles

Performance de la technologie d'imagerie comparative:

• 25% d'acquisition d'images plus rapide par rapport à l'échographie traditionnelle
• 50% de coût d'équipement inférieur à celui des systèmes IRM
• Conception portable et compacte
• Compatible avec l'infrastructure d'imagerie médicale existante

Endra Life Sciences Inc. (NDRA) - Modèle d'entreprise: relations clients

Ventes directes et soutien technique pour les professionnels de la santé

Endra Life Sciences maintient une équipe de vente directe ciblant les professionnels de l'imagerie médicale. Au quatrième trimestre 2023, la société a rapporté:

Métrique des ventes	Valeur
Taille de l'équipe de vente directe	7 représentants des ventes dédiées
Personnel de soutien technique	4 professionnels du support technique spécialisés
Temps de réponse moyen	Moins de 4 heures

Partenariats de recherche collaborative

Endra s'engage activement dans des collaborations de recherche avec des institutions médicales:

• 3 partenariats de recherche actifs avec les centres médicaux universitaires
• Investissement total de collaboration de recherche: 425 000 $ en 2023
• Les sites de recherche collaborative comprennent l'Université du Michigan et d'autres établissements de recherche médicale régionale

Prise en charge de la formation client et de la mise en œuvre en cours

Catégorie de formation	Détails
Programmes de formation	6 modules de formation complets
Sessions de formation en ligne	24 séances de formation virtuelle en 2023
Support d'implémentation sur place	12 visites de mise en œuvre des clients sur place

Mises à jour de la technologie régulière et améliorations des produits

Endra se concentre sur le développement continu des produits:

• Investissement en R&D: 2,3 millions de dollars en 2023
• 2 mises à jour des logiciels de produit majeurs publiés
• Cycle d'amélioration continue avec raffinements de technologie trimestriels

Total d'investissement de la relation client: environ 3,2 millions de dollars en 2023

Endra Life Sciences Inc. (NDRA) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les institutions médicales

Endra Life Sciences maintient une force de vente directe de 7 professionnels axés sur les ventes de technologies d'imagerie médicale au 423.

Type de canal de vente	Nombre de représentants	Segment du marché cible
Ventes médicales directes	7	Départements de radiologie
Ventes d'équipements hospitaliers	4	Centres médicaux académiques

Conférences médicales et salons commerciaux de l'industrie

ENDRA a participé à 12 conférences de technologie médicale en 2023, avec des dépenses de marketing d'événements totales de 214 500 $.

• Conférence de la société radiologique d'Amérique du Nord (RSNA)
• American Institute of Ultrasound in Medicine Annual
• Conférence de la Société des systèmes d'information et de gestion des soins de santé (HIMSS)

Plateformes de marketing en ligne et de communication numérique

Le budget du marketing numérique pour 2023 était de 356 000 $, en mettant principalement l'accent sur LinkedIn et les plateformes numériques ciblées de technologie médicale.

Plate-forme numérique	Dépenses annuelles	Métriques d'engagement
Liendin	$124,000	42 500 impressions ciblées
Sites Web de technologie médicale	$232,000	87 300 vues professionnelles uniques

Distributeurs d'équipements médicaux et réseaux de soins de santé

ENRA a établi des partenariats avec 6 réseaux de distribution d'équipements médicaux nationaux, ce qui représente la portée potentielle du marché de 1 247 établissements de santé.

• Henry Schein Medical
• Cardinal Health Solutions médicales
• Industries Medline
• McKesson Medical-Surpical

Endra Life Sciences Inc. (NDRA) - Modèle d'entreprise: segments de clientèle

Hôpitaux et centres d'imagerie médicale

Endra Life Sciences cible les hôpitaux avec des volumes d'imagerie annuels:

Taille de l'hôpital	Volume d'imagerie annuel	Pénétration potentielle du marché
Grands hôpitaux (plus de 500 lits)	50 000 à 100 000 procédures d'imagerie	15-25% taux d'adoption potentiel
Hôpitaux de taille moyenne (200-499 lits)	20 000 à 50 000 procédures d'imagerie	25 à 35% de taux d'adoption potentiel

Les universités de recherche et les établissements médicaux universitaires

Institutions de recherche cibles avec des caractéristiques spécifiques:

• Top 100 universités de recherche financées par les NIH
• Budget de recherche annuel de plus de 50 millions de dollars
• Départements de recherche en imagerie médicale dédiés

Pratiques médicales spécialisées

Segments de clientèle ciblés:

Type de pratique spécialisé	Nombre de clients potentiels	Procédures d'imagerie annuelles
Cliniques de radiologie	3 500 à l'échelle nationale	10 000 à 25 000 procédures
Centres d'oncologie	1 200 centres spécialisés	5 000 à 15 000 procédures

Services d'imagerie diagnostique

Répartition du segment de la clientèle:

• Centres d'imagerie ambulatoire: 6 800 installations
• Départements d'imagerie en milieu hospitalier: 4 500 départements
• Centres de diagnostic privés: 2 300 centres

Investisseurs en technologie médicale

Paysage d'investissement pour ENDRA:

Catégorie d'investisseurs	Montant d'investissement potentiel	Niveau d'intérêt
Sociétés de capital-risque	500 000 $ - 5 millions de dollars	Intérêt élevé pour la technologie médicale
Investisseurs en capital-investissement	1 million de dollars - 10 millions de dollars	Intérêt modéré à élevé

Endra Life Sciences Inc. (NDRA) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice se terminant le 31 décembre 2023, Endra Life Sciences a déclaré des dépenses de R&D de 4,7 millions de dollars.

Exercice fiscal	Dépenses de R&D
2023	4,7 millions de dollars
2022	5,2 millions de dollars

Frais d'essai cliniques et de conformité réglementaire

Les essais cliniques et les dépenses de conformité réglementaires d'Endra pour 2023 ont totalisé environ 2,3 millions de dollars.

• Coûts de soumission de la FDA: 350 000 $
• Gestion des essais cliniques: 1,5 million de dollars
• Documentation réglementaire: 450 000 $

Investissements de fabrication et de production

Les dépenses en capital pour les infrastructures manufacturières en 2023 étaient de 1,1 million de dollars.

Catégorie d'investissement	Montant
Équipement	$750,000
Mises à niveau des installations	$350,000

Dépenses de vente et de marketing

Les frais de vente et de marketing pour 2023 étaient de 1,8 million de dollars.

• Marketing numérique: 450 000 $
• Conférence et participation des événements: 350 000 $
• Compensation de l'équipe de vente: 1 000 000 $

Frais généraux et frais de personnel opérationnels

Les frais généraux opérationnels totaux pour 2023 étaient de 3,2 millions de dollars.

Catégorie de coûts	Montant
Salaires du personnel	2,5 millions de dollars
Dépenses de bureau	$450,000
Infrastructure technologique	$250,000

Endra Life Sciences Inc. (NDRA) - Modèle d'entreprise: Strots de revenus

Ventes et licences de dispositifs médicaux

Au quatrième trimestre 2023, Endra Life Sciences a déclaré un chiffre d'affaires total de 0,4 million de dollars. Les revenus principaux de dispositifs médicaux de l'entreprise proviennent de sa plate-forme de technologie d'échographie améliorée par thermo acoustique (Taeus).

Source de revenus	2023 Montant
Ventes de dispositifs médicaux	0,4 million de dollars
Potentiel de licence	Pas encore monétisé

Contrats de développement technologique

ENRA a obtenu des contrats de recherche et de développement avec une valeur potentielle, en particulier dans les technologies d'imagerie médicale.

• Partenariats de recherche en cours avec des institutions médicales
• Possibilités de recherche contractuelle potentielle en imagerie diagnostique

Ventes d'équipements d'imagerie diagnostique

La technologie Taeus de l'entreprise cible plusieurs marchés d'imagerie diagnostique avec des sources de revenus potentielles.

Segment de marché	Focus des revenus potentiels
Imagerie hépatique	Entrée du marché primaire
Imagerie mammaire	Opportunité de marché secondaire

Service récurrent et revenus de soutien

En 2024, ENDRA développe des modèles de revenus récurrents à travers:

• Contrats de maintenance de l'équipement
• Abonnements à mise à jour logicielle
• Services de support technique

Grants de recherches et collaborations

Endra a poursuivi des opportunités de financement de la recherche pour soutenir le développement technologique.

Source de financement	Valeur potentielle
Subventions NIH	Possibilités de financement potentiels
Collaborations académiques	Support de validation technologique

ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Value Propositions

You're looking at the core benefits ENDRA Life Sciences Inc. (NDRA) is delivering to its customers, which are primarily in the clinical and pharmaceutical trial spaces. This is where the rubber meets the road for their TAEUS technology.

Non-Invasive Liver Fat Assessment: Provides MRI-like data at the point of care

ENDRA Life Sciences Inc. positions its Thermo-Acoustic Enhanced UltraSound (TAEUS) as a non-invasive method to assess liver fat content, characterizing tissue in a way similar to Magnetic Resonance Imaging (MRI) but at the bedside. The technology uses a unique combination of radio frequency and ultrasound. The company has expanded its intellectual property, holding 85 issued patents globally as of the second quarter of 2025. Furthermore, ENDRA Life Sciences operates under a Quality Management System compliant with ISO 13485:2016, with a certificate effective from 2025-04-02 to 2028-04-01.

The 2025 feasibility study results show the TAEUS thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard, achieving a Pearson correlation coefficient of 0.89. The device is being developed to make liver fat detection as routine and accessible as measuring blood pressure, essentially acting as a "blood pressure cuff" for the liver.

The accuracy at critical thresholds identified in the 2025 study of 40 subjects is detailed below:

Liver Fat Fraction (LFF) Range	Positive Predictive Value (PPV)	Accuracy	Negative Predictive Value (NPV)
12-17%	100%	95%	94%
20-22%	90%	94%	94%

Cost-Effective Diagnostic Tool: Low-cost alternative to MRI-PDFF for MASLD/MASH screening

The primary financial value proposition is the dramatic cost reduction compared to the current standard. An MRI-PDFF exam can cost in excess of $2,500 per exam. ENDRA Life Sciences Inc. anticipates its point-of-care solution will cost less than $200 per exam, which is less than 8% of the MRI-PDFF cost, or 50x less expensive overall. This cost structure is critical for a company that reported $0.0 in revenue for the first quarter of 2025, reflecting its pre-commercial status, and which had an EBITDA of -$8.39 million over the last twelve months.

Integration and Scalability: Designed to augment ~400,000 existing cart-based ultrasound systems

The TAEUS technology is designed to work in concert with the approximately 400,000 cart-based ultrasound systems already in use globally. The next-generation device is being optimized for scalability through a compact, ergonomic design. The company is also planning to offer TAEUS Liver through a monthly subscription model to remove upfront capital investment barriers for customers.

Clinical Trial Efficiency: Reduces imaging costs and complexity for pharma trials

For drug developers running trials for metabolic dysfunction-associated steatotic liver disease (MASLD/MASH) and obesity medications, the cost and logistical burden of imaging are significant. The anticipated cost of less than $200 per TAEUS exam directly reduces imaging costs in these trials. This enables frequent, longitudinal monitoring, such as every 8 weeks, which is impractical with MRI. The company is planning a hypothesis-driven, statistically powered prospective multisite clinical trial enrolling approximately 250 subjects to support its De Novo submission to the FDA. The company has shown progress in cost management, with its cash burn from operations decreasing 30% to $1.2 million in the third quarter of 2025, down from $1.7 million in the same quarter of 2024. Total operating expenses for Q3 2025 were $1.4 million.

The key performance metrics that drive this efficiency are:

• TAEUS tracks MRI-PDFF closely across the full spectrum, including the critical 12-22% range.
• Enables frequent monitoring, impractical with MRI.
• The 2025 feasibility study involved 40 subjects with BMI ranging from 21 to 47.
• The company closed a private placement in October 2025, generating gross proceeds of approximately $4.9 million.

Finance: draft 13-week cash view by Friday.

ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so the relationship strategy needs to be laser-focused on the few entities that matter most right now: regulators and early adopters in clinical trials. Here's the quick math on how ENDRA Life Sciences Inc. is managing those critical connections as of late 2025.

High-Touch Regulatory Engagement

The relationship with the U.S. Food and Drug Administration (FDA) is paramount for the TAEUS® Liver device's De Novo submission. This is not a broad, automated process; it's direct, high-touch engagement.

• The planned pivotal clinical trial is designed to enroll approximately 250 subjects.
• ENDRA Life Sciences Inc. plans to engage the FDA in 2026 regarding the pivotal study design, endpoints, and statistical plan.
• A single-site clinical feasibility study of the 2025 redesigned TAEUS® device was completed, involving 40 subjects with BMI ranging from 21 to 47.
• The company's intellectual property portfolio included 85 issued patents globally as of the second quarter of 2025.

The performance data from the feasibility study directly informs this high-stakes dialogue:

LFF Range (Steatosis Grade)	Average PPV	NPV	Accuracy
12-17% (Grade 1-2)	100.0%	94%	95%
20-22% (Grade 2-3)	90.0%	94%	94%

This precision is positioned against the gold standard, where an MRI-PDFF exam can cost over $2,500, while ENDRA Life Sciences Inc. anticipates its solution will cost less than $200.

Professional B2B Sales

For future commercialization, the relationship management shifts to professional B2B interactions with healthcare providers. The strategy targets specific, high-value users first.

• The go-to-market strategy identifies four key customer segments.
• These segments include Pharmaceutical companies and clinical research organizations (CROs) for GLP-1 trials.
• Other segments are concierge practices, bariatric/metabolic/endocrinology clinics, and primary care.
• The TAEUS® system is designed to work in concert with around 400,000 cart-based ultrasound systems currently in use globally.

Automated/Digital

To drive low-friction adoption once regulatory clearance is achieved, the plan leans heavily on a recurring revenue model rather than large capital outlays by the customer.

• ENDRA Life Sciences Inc. plans to offer TAEUS® Liver through a monthly subscription model.
• This model is specifically intended to eliminate the need for upfront capital investments by the end-user.

Investor Communications

Investor relationships are managed through regular, data-driven updates, especially following financing and clinical progress. The company reported its third quarter 2025 financial results on November 14, 2025.

Key financial and operational metrics shared with investors in late 2025 include:

Metric	Value (Q3 2025)	Comparison/Context
Net Loss	$1.6 million	Decrease from $2.78 million (Q1 2025 OpEx) or $2.4 million (Q3 2024)
Cash Burn from Operations	$1.2 million	Decrease of 30% from $1.7 million (Q3 2024)
Total Operating Expenses	$1.4 million	For the three months ended September 30, 2025
Cash and Cash Equivalents	$0.8 million	As of September 30, 2025
PIPE Gross Proceeds (Oct 2025)	$4.9 million	Potential for up to an additional $9.5 million in future proceeds

Analyst sentiment shows an average rating consensus score of 2, while insider ownership stood at 43.35% as of late 2025.

ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Channels

Clinical Research Sites: Multi-site feasibility and pivotal trials for data generation and exposure.

ENDRA Life Sciences Inc. completed a single-site clinical feasibility study of the TAEUS® Liver device in 2025, involving 40 subjects with BMI ranging from 21 to 47.

The performance of the TAEUS thermo-acoustic fat fraction (TAFF) measurement against the MRI-PDFF gold standard at key Liver Fat Fraction (LFF) thresholds was as follows:

LFF Threshold Range	Positive Predictive Value (PPV)	Negative Predictive Value (NPV)	Accuracy
12-17%	100%	94%	95%
20-22%	90%	94%	94%

The preliminary study results demonstrated a Pearson correlation coefficient of 0.89 between the TAEUS Liver device and MRI-PDFF.

A second feasibility study has begun in London, Ontario, Canada, with completion expected in the coming months.

The planned pivotal trial is a prospective multisite clinical trial intended to enroll approximately 250 subjects.

ENDRA Life Sciences Inc. plans to engage the FDA in 2026 regarding the pivotal study design, endpoints, and statistical plan.

The company also activated a post market clinical study at LMU University Hospital in Munich, Germany.

Direct Sales Force (Future): Establishing distribution channels for product launch post-clearance.

To accelerate market penetration post-clearance, ENDRA Life Sciences Inc. plans to offer TAEUS Liver through a monthly subscription model.

This model will be supported by a focused small direct sales team.

Regulatory Submissions: The official De Novo pathway for US market clearance.

ENDRA Life Sciences Inc.'s De Novo request for the TAEUS liver system advanced to substantive review with the FDA on August 29, 2023.

The company completed a pre-submission meeting with the FDA on December 5, 2025, concerning the clinical trial design supporting the U.S. De Novo filing.

The company plans to engage the FDA in 2026 on pivotal study design in support of a future De Novo submission.

The De Novo pathway is used to classify novel medical devices for which there is no legally marketed predicate device.

Strategic Financial Partners: Arca and institutional investors for capital and treasury management.

ENDRA Life Sciences Inc. secured aggregate commitments of $4.9 million in a private placement financing that closed on or about October 23, 2025.

The offering involved the sale of 744,340 shares of common stock (or prefunded warrants) and accompanying warrants to purchase up to 1,488,680 shares.

Each unit was priced at $6.57.

The warrants are exercisable at $6.32 per share and expire in five years.

If all warrants are fully exercised for cash, total gross proceeds could reach up to $14.4 million.

The proceeds will launch a Digital Asset Treasury (DAT) strategy directed by Arca Investment Management, LLC (Arca).

The company also highlighted alignment with the Arca U.S. Treasury Fund (ARCU) for capital preservation and yield generation.

The cash burn from operations for the third quarter of 2025 was $1.2 million, a 30% decrease from $1.7 million in the same quarter of 2024.

Total operating expenses for the third quarter of 2025 were $1.4 million.

Cash and cash equivalents as of September 30, 2025, were $0.8 million.

The company anticipates its solution will cost less than $200 per exam, contrasting with an MRI-PDFF exam cost of over $2,500.

The company's negative free cash flow for the last twelve months was -$5.1 million.

The company has expanded its intellectual property portfolio to 85 issued patents globally as of Q2 2025.

The market for steatotic liver disease (SLD) and MASH affects over two billion people globally.

Finance: draft 13-week cash view by Friday.

ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Customer Segments

You're looking at the core groups ENDRA Life Sciences Inc. (NDRA) is targeting with its TAEUS^® technology, which aims to be the "blood pressure cuff" for the liver, focusing on early detection of Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction Associated Steatohepatitis (MASH).

The overall market context is massive; obesity, type 2 diabetes, and related metabolic diseases add in excess of $800 billion annually to U.S. healthcare costs, creating an urgent need for better diagnostics like the one ENDRA Life Sciences Inc. is developing. As of late 2025, the company's market capitalization stood at just $6.95 million, reflecting its pre-commercial status while advancing clinical validation.

The go-to-market strategy focuses on four priority segments, with the initial push heavily weighted toward clinical trials and specialized care settings:

• Pharmaceutical Companies/CROs: Need for efficient patient monitoring in metabolic drug trials.
• Bariatric, Metabolic, and Endocrinology Clinics: Specialists managing obesity and diabetes patients.
• Concierge Medical Practices: High-end practices focused on comprehensive metabolic assessments.
• General Healthcare Providers (Future): Primary care physicians for routine liver health screening.

The value proposition driving adoption in these segments is a significant cost reduction compared to the current gold standard, Magnetic Resonance Imaging (MRI-PDFF) test, which can cost over $2,500 per exam. ENDRA Life Sciences Inc. anticipates its point-of-care solution would cost less than $200 per exam.

Here is a snapshot of the relevant data points informing the segment strategy as of late 2025:

Metric/Segment Focus	Associated Real-Life Number/Amount (2025 Data)	Context/Relevance
U.S. Metabolic Disease Annual Cost	$800 billion	Total economic burden driving demand for early screening.
MRI-PDFF Cost per Exam (Benchmark)	Over $2,500	Cost ENDRA Life Sciences Inc. aims to undercut significantly.
Projected TAEUS Cost per Exam	Less than $200	The expected cost advantage for customer segments.
Pivotal Trial Size (Planned)	Approximately 250 subjects	Scale of study needed to support De Novo FDA submission.
Q3 2025 Cash Burn from Operations	$1.2 million	Reflects current lean operating model supporting commercial prep.
Accuracy at 12-17% Liver Fat Threshold	100% Positive Predictive Value	Critical for patient enrollment in MASLD/MASH trials.
Company Market Capitalization (Dec 2025)	$6.95 million	Reflects current valuation while advancing commercialization.

The focus on Pharmaceutical Companies/CROs is directly tied to the need for accurate, frequent monitoring in trials for obesity medications, such as GLP-1 drugs. The company's 2025 feasibility study demonstrated high accuracy at critical thresholds, such as 100% positive predictive value at the 12-17% liver fat fraction range, which separates mild from more severe steatotic liver disease.

For specialized clinics, the appeal is a non-invasive, point-of-care tool to manage their patient populations, which are often dealing with the underlying conditions driving MASLD. The company's Q3 2025 net loss narrowed to $1.6 million, showing progress in cost management as they prepare for broader commercial rollout.

The planned regulatory path involves a statistically powered, hypothesis-driven, multicenter pivotal trial involving about 250 subjects to support a De Novo submission, which will generate the necessary evidence for adoption by all targeted segments.

ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Cost Structure

Research and Development (R&D) remains the primary cost driver for ENDRA Life Sciences Inc., focusing heavily on clinical trials and product refinement for the TAEUS® technology.

The company is advancing toward a hypothesis-driven, statistically powered prospective clinical trial, which is expected to be a multicenter study enrolling approximately 250 subjects to support a De Novo filing with the U.S. Food and Drug Administration (FDA). ENDRA Life Sciences plans to engage with the FDA in 2026 regarding pivotal study design.

Total Operating Expenses (OpEx) for the third quarter of 2025 were $1.4 million, which reflects the impact of cost-optimization measures partially offset by capital raising expenses. This OpEx figure is down from $1.5 million in the same quarter of the prior year.

Metric	Q3 2025 Amount	Comparison Period Amount
Total Operating Expenses	$1.4 million	$1.5 million (Q3 2024)
Cash Burn from Operations	$1.2 million	$1.7 million (Q3 2024)

The cash burn from operations for the third quarter of 2025 showed a 30% decrease compared to the same quarter in 2024, stemming from streamlined staffing and a leaner operating model.

Regulatory and IP Maintenance costs are tied to advancing the TAEUS® platform toward broader regulatory clearances and maintaining its global patent portfolio. The company holds a portfolio of issued and pending patents across the United States, Europe, and Asia.

General and Administrative (G&A) costs reflect overhead and staffing expenses that have been streamlined as part of cost-optimization initiatives.

Capital Raising Costs are associated with the October 2025 private investment in public equity (PIPE) financing. The initial closing of the PIPE generated gross proceeds of approximately $4.9 million before placement agent fees and expenses. The total potential gross proceeds from the financing, including future warrant exercises, was up to $14.4 million.

The allocation of the initial net proceeds from the October 2025 financing included specific planned expenditures:

• The majority of net proceeds were intended to launch the Digital Asset Treasury (DAT) strategy, initially placing approximately $3.5 million under management with Arca Investment Management.
• Fees associated with the DAT management include a 1.25%-1.75% annual management fee and a 10%-15% performance fee.
• Spending on the TAEUS liver device pilot validation imaging study was capped at up to $750,000 from the Offering, with a total cap of no more than $1 million.

The shares and warrants in the offering were sold at a combined purchase price of $6.57.

ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of ENDRA Life Sciences Inc. (NDRA) as of late 2025, and honestly, it's a story of transition-moving from pure development spend to a multi-pronged financial engine.

Product Sales (Future): Right now, the TAEUS device sales revenue stream is strictly future-facing, pending regulatory clearance. For the first quarter of 2025, product revenue was exactly $0.00. That's consistent with the pre-commercial status management confirmed. The company's focus remains on advancing the TAEUS platform for metabolic liver disease diagnostics.

Subscription/Usage Fees (Planned): The plan definitely includes recurring revenue. Management has emphasized a subscription model as a key component of the go-to-market strategy for the next-generation TAEUS, aiming for a low-friction adoption path. This recurring stream is designed to support the device post-launch, but we don't have a specific dollar projection for it yet.

Non-Dilutive Financial Yield: This is where things get interesting, as ENDRA Life Sciences Inc. is actively generating returns internally through its Digital Asset Treasury (DAT) strategy, which they call the "Yield-to-Innovation" model. This is designed to be a stable, non-dilutive source of capital. As of October 21, 2025, the company had already purchased 78,863.1 HYPE tokens, valued at approximately $3 million, as a foundational step in this DAT strategy. The yield enhancement techniques include staking and decentralized finance participation.

Here's a quick look at the financial foundation supporting this strategy, based on Q1 2025 results:

Metric	Value (Q1 2025)	Context
Quarterly Revenue	$0.00	Pre-commercial status confirmed.
Cash & Equivalents (3/31/25)	$2.06 million	Before subsequent ATM proceeds.
Cash & Equivalents (4/30/25)	$2.5 million	After $0.8 million in ATM proceeds.
Total Operating Expenses	$1.5 million	Down from $2.8 million in Q1 2024.

Potential Warrant Exercises: The company secured funding in October 2025 that included warrants. While the total gross proceeds from the full exercise of all warrants from that specific deal could reach up to $14.4 million, the potential proceeds from warrant exercises are cited as up to $9.5 million in future funds. This capital is a crucial backstop for operations and advancing the TAEUS imaging study.

The current revenue structure is built on these key elements:

• Product Sales: $0 in Q1 2025; pending regulatory clearance.
• DAT Initial Purchase: $3 million in HYPE tokens as of October 21, 2025.
• DAT Yield: Stable, non-dilutive returns from institutional treasury program.
• Warrant Proceeds: Potential for up to $9.5 million in future cash infusions.
• Future Model: Reliance on a planned subscription model for recurring income.

The DAT strategy is definitely a core part of the current financial picture, aiming to power innovation while the core medical device revenue stream is still in development. Finance: draft 13-week cash view by Friday.