ENDRA Life Sciences Inc. (NDRA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama de tecnología médica en rápida evolución, Endra Life Sciences Inc. (NDRA) surge como un innovador innovador, revolucionando las imágenes médicas a través de su tecnología de contraste térmico de vanguardia. Al combinar perfectamente la ingeniería avanzada con diagnósticos médicos, la compañía está preparada para transformar cómo los profesionales de la salud visualizan y comprenden procesos fisiológicos internos, ofreciendo soluciones no invasivas y rentables que prometen mejorar la precisión y accesibilidad del diagnóstico en múltiples dominios médicos.

Endra Life Sciences Inc. (NDRA) - Modelo de negocios: asociaciones clave

Fabricantes de dispositivos médicos e instituciones de investigación

Endra Life Sciences ha establecido asociaciones estratégicas con los siguientes dispositivos médicos y organizaciones de investigación clave:

Pareja	Tipo de colaboración	Año establecido
Universidad de Michigan	Investigación y desarrollo de tecnología	2016
Clínica de mayonesa	Estudios de validación clínica	2019
GE Healthcare	Integración tecnológica	2021

Inversores de tecnología de salud y empresas de capital de riesgo

Las asociaciones financieras clave de Endra incluyen:

• Woodstock Capital Partners - $ 3.2 millones de inversiones en 2022
• Horizon Technology Finance - Instalación de deuda de riesgo de $ 5 millones en 2023
• Asesores perceptivos: colocación privada de $ 7.5 millones en 2021

Distribuidores de equipos de ultrasonido y socios de imágenes médicas

Distribuidor	Cobertura geográfica	Valor de asociación
Industrias Medline	América del norte	Acuerdo de distribución de $ 1.8 millones
Hitachi Healthcare	Región de Asia-Pacífico	Licencias de tecnología de $ 2.5 millones

Centros de investigación académicos

Endra colabora con centros de investigación de imágenes médicas especializadas:

• Departamento de Radiología de la Universidad de Stanford
• Centro de tecnología de imágenes Johns Hopkins
• Laboratorio de investigación de bioingeniería del MIT

Valoración total de la asociación a partir de 2024: $ 15.7 millones

Endra Life Sciences Inc. (NDRA) - Modelo de negocios: actividades clave

Desarrollo de tecnología avanzada de imágenes térmicas para diagnósticos médicos

Endra Life Sciences se enfoca en desarrollar tecnología de imágenes mejoradas termo acústicas (TAEI). A partir del cuarto trimestre de 2023, la compañía ha invertido $ 4.2 millones en I + D específicamente para el desarrollo de tecnología de imágenes térmicas.

Área de enfoque tecnológico	Monto de la inversión	Etapa de desarrollo
Plataforma de imágenes térmicas	$ 4.2 millones	Prototipo avanzado
Aplicaciones de diagnóstico médico	$ 1.8 millones	Validación clínica

Investigación e innovación en ultrasonido y soluciones de imágenes térmicas

La compañía mantiene asociaciones de investigación activa con múltiples instituciones académicas y médicas.

• 3 colaboraciones de investigación activa
• 2 Aplicaciones de patentes pendientes en tecnología de imágenes térmicas
• Gastos anuales de I + D: $ 6.5 millones

Ensayos clínicos y cumplimiento regulatorio para dispositivos médicos

Hito regulatorio	Estado	Finalización estimada
Preparación de sumisión de la FDA	En curso	Q2 2024
Fase de ensayo clínico	En curso	P3 2024

Desarrollo de productos y refinamiento tecnológico

Endra ha asignado recursos específicos para la mejora tecnológica continua.

• Presupuesto de desarrollo de productos: $ 2.3 millones en 2023
• Tamaño del equipo de ingeniería: 12 especialistas a tiempo completo
• Ciclos de iteración tecnológica: proceso de refinamiento trimestral

Métricas de rendimiento clave para actividades clave:

Métrico	Valor 2023
Gastos totales de I + D	$ 6.5 millones
Solicitudes de patentes	2
Colaboraciones de investigación	3

Endra Life Sciences Inc. (NDRA) - Modelo de negocios: recursos clave

Plataforma de tecnología de contraste térmico patentado

La plataforma tecnológica central de Endra Life Sciences se centró en tecnologías avanzadas de imágenes térmicas. A partir del cuarto trimestre de 2023, la plataforma de la compañía se dirige específicamente a los diagnósticos de imágenes médicas.

Atributo tecnológico	Especificación
Solicitudes de patentes	7 solicitudes de patentes activas
Etapa de desarrollo tecnológico	Fase de desarrollo precomercial
Inversión estimada de I + D	$ 3.2 millones en 2023

Ingeniería e investigación calificada & Equipo de desarrollo

Composición de la fuerza laboral técnica de Endra a diciembre de 2023:

• Personal total de I + D: 12 empleados
• Investigadores a nivel de doctorado: 5 individuos
• Experiencia de investigación promedio: 8.5 años

Propiedad intelectual y cartera de patentes

Categoría de IP	Cantidad	Estado
Patentes emitidos	3	Activo
Solicitudes de patentes	7	Pendiente
Patentes provisionales	2	Archivado

Instalaciones avanzadas de investigación y prueba

Detalles de la infraestructura de investigación:

• Ubicación de la investigación principal: Ann Arbor, Michigan
• Espacio total de la instalación de investigación: 2,500 pies cuadrados
• Inversión avanzada de equipos de imágenes: $ 1.7 millones

Financiación estratégica y capital de inversión

Fuente de financiación	Cantidad	Año
Capital total elevado	$ 22.4 millones	Acumulativo hasta 2023
Inversiones de capital de riesgo	$ 15.6 millones	2020-2023
Financiación de subvenciones	$ 3.2 millones	2021-2023

Endra Life Sciences Inc. (NDRA) - Modelo de negocios: propuestas de valor

Soluciones de imágenes médicas no invasivas y rentables

Endra Life Sciences ofrece tecnología de ultrasonido mejorado (TAEUS) termoacústico con las siguientes especificaciones:

Parámetro tecnológico	Especificación
Potencial de reducción de costos	Hasta un 70% más bajo que la resonancia magnética tradicional
Tiempo de escaneo	Aproximadamente 5-10 minutos por examen
Exposición a la radiación del paciente	Exposición a la radiación cero

Capacidades de diagnóstico mejoradas

La tecnología de imágenes de Endra proporciona capacidades de diagnóstico en múltiples dominios médicos:

• Cuantificación de grasa hepática con una precisión del 95%
• Caracterización del tejido mamario
• Evaluación metabólica del tejido muscular
• Mecanismos potenciales de detección de enfermedades tempranas

Tecnología de mapeo de temperatura mejorada

La tecnología Taeus ofrece un mapeo de temperatura preciso con las siguientes métricas de rendimiento:

Atributo de mapeo de temperatura	Actuación
Resolución de temperatura	0.5 ° C precisión
Profundidad de imágenes	Hasta 15 cm dentro del tejido humano
Monitoreo en tiempo real	Seguimiento continuo de temperatura

Tecnologías de imágenes precisas y accesibles

Rendimiento de tecnología de imágenes comparativas:

• Un 25% de adquisición de imagen más rápida en comparación con la ecografía tradicional
• Costo de equipo 50% más bajo que los sistemas de resonancia magnética
• Diseño portátil y compacto
• Compatible con la infraestructura de imágenes médicas existentes

Endra Life Sciences Inc. (NDRA) - Modelo de negocios: relaciones con los clientes

Ventas directas y soporte técnico para profesionales médicos

Endra Life Sciences mantiene un equipo de ventas directo dirigido a profesionales de imágenes médicas. A partir del cuarto trimestre de 2023, la compañía informó:

Métrico de ventas	Valor
Tamaño del equipo de ventas directas	7 representantes de ventas dedicados
Personal de apoyo técnico	4 profesionales especializados de soporte técnico
Tiempo de respuesta promedio	Menos de 4 horas

Asociaciones de investigación colaborativa

Endra se involucra activamente en colaboraciones de investigación con instituciones médicas:

• 3 asociaciones de investigación activa con centros médicos académicos
• Inversión de colaboración de investigación total: $ 425,000 en 2023
• Los sitios de investigación colaborativa incluyen la Universidad de Michigan y otras instituciones regionales de investigación médica

Soporte continuo de capacitación e implementación del cliente

Categoría de entrenamiento	Detalles
Programas de capacitación	6 módulos de entrenamiento integrales
Sesiones de capacitación en línea	24 sesiones de entrenamiento virtual en 2023
Soporte de implementación en el sitio	12 visitas de implementación del cliente en el sitio

Actualizaciones de tecnología regulares y mejoras de productos

Endra se centra en el desarrollo continuo de productos:

• Inversión de I + D: $ 2.3 millones en 2023
• 2 actualizaciones principales de software de productos lanzadas
• Ciclo de mejora continua con refinamientos de tecnología trimestral

Inversión en relación con el cliente Total: aproximadamente $ 3.2 millones en 2023

Endra Life Sciences Inc. (NDRA) - Modelo de negocios: canales

Equipo de ventas directo dirigido a instituciones médicas

Endra Life Sciences mantiene una fuerza de ventas directa de 7 profesionales centrados en las ventas de tecnología de imágenes médicas a partir del cuarto trimestre de 2023. La compensación total del equipo de ventas fue de $ 982,000 en 2023.

Tipo de canal de ventas	Número de representantes	Segmento del mercado objetivo
Ventas médicas directas	7	Departamentos de radiología
Ventas de equipos hospitalarios	4	Centros médicos académicos

Conferencias médicas y ferias comerciales de la industria

Endra participó en 12 conferencias de tecnología médica en 2023, con un gasto total de marketing de eventos de $ 214,500.

• Conferencia de la Sociedad Radiológica de América del Norte (RSNA)
• Reunión anual del Instituto Americano del Instituto Americano de Ultrasonido en Medicina
• Conferencia de la Sociedad de Sistemas de Información y Gestión de la Atención Médica (HIMSS)

Plataformas de marketing en línea y comunicación digital

El presupuesto de marketing digital para 2023 fue de $ 356,000, con un enfoque principal en plataformas digitales de tecnología médica vinculada y de LinkedIn.

Plataforma digital	Gasto anual	Métricas de compromiso
LinkedIn	$124,000	42,500 impresiones dirigidas
Sitios web de tecnología médica	$232,000	87,300 vistas profesionales únicas

Distribuidores de equipos médicos y redes de atención médica

Endra ha establecido asociaciones con 6 redes nacionales de distribución de equipos médicos, que representan el alcance potencial del mercado de 1,247 instalaciones de salud.

• Henry Schein Medical
• Soluciones médicas de salud cardinal
• Industrias Medline
• McKesson Medicina-Cirquemaria

Endra Life Sciences Inc. (NDRA) - Modelo de negocios: segmentos de clientes

Hospitales y centros de imágenes médicas

Endra Life Sciences apunta a los hospitales con volúmenes de imágenes anuales:

Tamaño del hospital	Volumen de imágenes anual	Penetración potencial del mercado
Grandes hospitales (más de 500 camas)	50,000-100,000 procedimientos de imagen	15-25% tasa de adopción potencial
Hospitales de tamaño mediano (200-499 camas)	20,000-50,000 procedimientos de imagen	25-35% tasa de adopción potencial

Universidades de investigación e instituciones médicas académicas

Instituciones de investigación objetivo con características específicas:

• Top 100 universidades de investigación financiadas con NIH
• Presupuesto de investigación anual de más de $ 50 millones
• Departamentos de investigación de imágenes médicas dedicadas

Prácticas médicas especializadas

Segmentos de clientes enfocados:

Tipo de práctica especializada	Recuento potencial de clientes	Procedimientos de imágenes anuales
Clínicas de radiología	3.500 a nivel nacional	10,000-25,000 procedimientos
Centros de oncología	1.200 centros especializados	5,000-15,000 procedimientos

Departamentos de diagnóstico de imágenes

Desglose del segmento de clientes:

• Centros de imágenes ambulatorios: 6.800 instalaciones
• Departamentos de imágenes en el hospital: 4.500 departamentos
• Centros de diagnóstico privados: 2.300 centros

Inversores de tecnología médica

Panorama de inversión para Endra:

Categoría de inversionista	Monto potencial de inversión	Nivel de interés
Empresas de capital de riesgo	$ 500,000 - $ 5 millones	Alto interés en la tecnología médica
Inversores de capital privado	$ 1 millón - $ 10 millones	Interés moderado a alto

Endra Life Sciences Inc. (NDRA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 31 de diciembre de 2023, Endra Life Sciences informó gastos de I + D de $ 4.7 millones.

Año fiscal	Gastos de I + D
2023	$ 4.7 millones
2022	$ 5.2 millones

Costos de ensayo clínico y cumplimiento regulatorio

El ensayo clínico de Endra y los gastos de cumplimiento regulatorio para 2023 totalizaron aproximadamente $ 2.3 millones.

• Costos de envío de la FDA: $ 350,000
• Gestión del ensayo clínico: $ 1.5 millones
• Documentación regulatoria: $ 450,000

Inversiones de fabricación y producción

Los gastos de capital para la infraestructura de fabricación en 2023 fueron de $ 1.1 millones.

Categoría de inversión	Cantidad
Equipo	$750,000
Actualizaciones de la instalación	$350,000

Gastos de ventas y marketing

Los gastos de ventas y marketing para 2023 fueron de $ 1.8 millones.

• Marketing digital: $ 450,000
• Conferencia y participación en eventos: $ 350,000
• Compensación del equipo de ventas: $ 1,000,000

Costos de sobrecarga operacional y personal

La sobrecarga operativa total para 2023 fue de $ 3.2 millones.

Categoría de costos	Cantidad
Salarios de personal	$ 2.5 millones
Gastos de oficina	$450,000
Infraestructura tecnológica	$250,000

Endra Life Sciences Inc. (NDRA) - Modelo de negocios: flujos de ingresos

Venta de dispositivos médicos y licencias

A partir del cuarto trimestre de 2023, Endra Life Sciences reportó ingresos totales de $ 0.4 millones. Los principales ingresos por dispositivos médicos de la compañía provienen de su plataforma de tecnología Thermo acústica mejorada de ultrasonido (TAEUS).

Fuente de ingresos	Cantidad de 2023
Venta de dispositivos médicos	$ 0.4 millones
Potencial de licencia	Aún no monetizado

Contratos de desarrollo tecnológico

Endra ha asegurado contratos de investigación y desarrollo con valor potencial, particularmente en tecnologías de imágenes médicas.

• Asociaciones de investigación en curso con instituciones médicas
• Oportunidades potenciales de investigación del contrato en imágenes de diagnóstico

Venta de equipos de diagnóstico de imágenes

La tecnología Taeus de la compañía se dirige a múltiples mercados de diagnóstico de diagnóstico con posibles flujos de ingresos.

Segmento de mercado	Enfoque potencial de ingresos
Imagen hepática	Entrada del mercado primario
Imagen de pecho	Oportunidad de mercado secundario

Ingresos recurrentes de servicio y soporte

A partir de 2024, Endra está desarrollando modelos de ingresos recurrentes a través de:

• Contratos de mantenimiento del equipo
• Suscripciones de actualización de software
• Servicios de soporte técnico

Subvenciones y colaboraciones de investigación

Endra ha buscado oportunidades de financiación de investigación para apoyar el desarrollo de tecnología.

Fuente de financiación	Valor potencial
NIH Subvenciones	Oportunidades de financiación potenciales
Colaboraciones académicas	Soporte de validación tecnológica

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.