Aethlon Medical, Inc. (AEMD): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la tecnología médica, Aethlon Medical, Inc. (AEMD) emerge como una fuerza pionera, revolucionando las intervenciones terapéuticas a través de su innovadora plataforma de hemopurificación. Con un enfoque centrado en el láser para combatir enfermedades infecciosas, esta innovadora compañía de biotecnología está redefiniendo cómo los profesionales médicos abordan las infecciones virales y el tratamiento de sepsis. Al aprovechar las tecnologías avanzadas de filtración de sangre y las colaboraciones estratégicas, Aethlon Medical está listo para transformar la atención al paciente y ofrecer soluciones potencialmente salvavidas que podrían reducir drásticamente las cargas virales y mejorar los resultados clínicos.

Aethlon Medical, Inc. (AEMD) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación médica

Aethlon Medical ha establecido asociaciones de investigación clave con las siguientes instituciones:

Institución	Enfoque de colaboración	Año establecido
Clínica de Cleveland	Investigación de tecnología hemopurificador	2019
Universidad de California, San Diego	Investigación de inmunoterapia con cáncer	2020

Asociación con compañías farmacéuticas para ensayos clínicos

Aethlon Medical tiene colaboraciones de ensayos clínicos activos con socios farmacéuticos:

• Merck & Co. - Ensayos de inmunoterapia con cáncer hemopurificador
• Bristol Myers Squibb - Asociación de investigación de inmuno -oncología

Colaboración con fabricantes de dispositivos médicos

Fabricante	Tipo de colaboración	Enfoque tecnológico
Terumo Corporation	Desarrollo de dispositivos	Sistemas de filtración del hemopurificador
BD (Becton, Dickinson)	Integración tecnológica	Dispositivos terapéuticos extracorpóeos

Acuerdos de licencia para tecnologías terapéuticas

Aethlon Medical ha asegurado 3 acuerdos de licencia activos Para tecnologías terapéuticas:

• Licencia de tecnología de inmunoterapia con cáncer con el Instituto del Cáncer Dana-Farber
• Licencia de tecnología de detección viral de la Universidad de Harvard
• Acuerdo de licencia de tecnología de la plataforma de la plataforma de hemopurifier

Ingresos totales de licencia para 2023: $ 742,000

Aethlon Medical, Inc. (AEMD) - Modelo de negocio: actividades clave

Desarrollo de tecnologías de filtración médica

Aethlon Medical se enfoca en desarrollar tecnologías de filtración médica avanzada específicamente dirigida:

• Sistemas de hemopurificación
• Plataformas de tratamiento de cáncer y enfermedad infecciosa
• Dispositivos de filtración terapéutica

Área tecnológica	Inversión de investigación (2023)	Solicitudes de patentes
Hemopurificación	$ 2.1 millones	7 patentes activas
Filtración de cáncer	$ 1.5 millones	4 aplicaciones pendientes

Investigación e innovación de hemopurificación

Áreas de enfoque de investigación clave:

• Tecnologías de captura de exosomas
• Extracción de células tumorales circulantes
• Mecanismos de reducción de carga viral

Dominio de la investigación	Gasto anual	Personal de investigación
Investigación exosoma	$ 1.8 millones	12 investigadores especializados

Ensayos clínicos y cumplimiento regulatorio

Las actividades regulatorias incluyen:

• Preparación de sumisión de la FDA
• Diseño de ensayo clínico
• Gestión de la documentación regulatoria

Actividad regulatoria	Pruebas en curso	Presupuesto de cumplimiento
Interacciones de la FDA	3 ensayos clínicos activos	$ 950,000 anualmente

Pruebas de productos y desarrollo de dispositivos médicos

Parámetros de prueba de dispositivo:

• Evaluaciones de prototipo de hemopurificador
• Protocolos de validación de rendimiento
• Procedimientos de evaluación de seguridad

Categoría de prueba	Presupuesto de prueba anual	Prueba de iteraciones
Prueba de dispositivos médicos	$ 1.3 millones	42 iteraciones prototipo

Gestión de propiedad intelectual

Las estrategias de gestión de IP incluyen:

• Potente y mantenimiento
• Evaluaciones de licencia de tecnología
• Protección de activos intelectuales

Categoría de IP	Patentes totales	Costo anual de gestión de IP
Patentes de tecnología médica activa	11 patentes concedidas	$475,000

Aethlon Medical, Inc. (AEMD) - Modelo de negocios: recursos clave

Tecnología de la plataforma de hemopurificación patentada

La plataforma de tecnología central de Aethlon Medical incluye el dispositivo Hemopurifier, diseñado para el intercambio terapéutico de plasma. La cartera de patentes a partir de 2024 incluye:

Tipo de patente	Número de patentes	Valor estimado
Tecnología de hemopurificación	7	$ 3.2 millones
Tecnología de captura de inmunoafinidad	4	$ 1.8 millones

Equipo de Investigación y Desarrollo Científico

Composición del equipo de I + D a partir de 2024:

• Personal total de I + D: 12
• Investigadores de doctorado: 6
• Directores médicos: 2
• Especialistas en investigación: 4

Patentes de dispositivos médicos y propiedad intelectual

Categoría de IP	Activos totales	Período de protección activa
Patentes registradas	11	Hasta 2035
Solicitudes de patente pendientes	3	Revisión pendiente

Instalaciones avanzadas de laboratorio y pruebas

Detalles de la infraestructura de laboratorio:

• Espacio de laboratorio total: 2,500 pies cuadrados.
• Nivel de bioseguridad: BSL-2
• Equipo de diagnóstico avanzado: 12 unidades
• Presupuesto anual de mantenimiento del equipo: $ 450,000

Datos de ensayos clínicos y experiencia en investigación

Métrico de ensayo clínico	Estado 2024	Inversión total
Ensayos clínicos completados	5	$ 6.7 millones
Estudios clínicos en curso	2	$ 2.3 millones

Aethlon Medical, Inc. (AEMD) - Modelo de negocio: propuestas de valor

Dispositivo médico innovador dirigido a enfermedades infecciosas

La tecnología Hemopurifier® de Aethlon Medical se dirige a infecciones virales con especificaciones técnicas específicas:

Especificación del dispositivo	Detalle cuantitativo
Tasa de filtración de sangre	300-500 ml/hora
Eficiencia de eliminación viral	Hasta el 97.3%
Duración del tratamiento	2-4 horas por sesión

Tratamiento potencial para infecciones virales y sepsis

Desarrollo clínico centrado en objetivos virales específicos:

• Reducción de la carga viral del VIH
• Eliminación del virus de la hepatitis C
• Intervención viral covid-19
• Gestión potencial de sepsis

Tecnología avanzada de filtración de sangre

Métricas de rendimiento técnico:

Parámetro tecnológico	Medición cuantitativa
Precisión de filtración	0.2-0.4 rango de micras
Calificación de biocompatibilidad	ISO 10993 Cumplante
Composición de material	Diseño patentado basado en la lectina

Intervención terapéutica no invasiva

Características de intervención clínica:

• Tratamiento de sangre extracorpórea
• Malestar del paciente mínimo
• Requisitos reducidos de medicamentos sistémicos

Reducción potencial de la carga viral en el tratamiento del paciente

Datos de rendimiento de reducción de carga viral:

Condición viral	Porcentaje de reducción de carga viral
VIH	Hasta 55.6%
Hepatitis C	Aproximadamente 43.2%
COVID-19	Datos experimentales que muestran una reducción del 37.8%

Aethlon Medical, Inc. (AEMD) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Aethlon Medical reportó 37 colaboraciones de investigación activa con instituciones de investigación académica y médica. Las métricas de participación directa incluyen:

Tipo de compromiso	Número de interacciones
Conferencias de investigación	12 conferencias anuales
Comunicaciones de investigación directa	187 Comunicaciones profesionales
Investigar seminarios web	6 seminarios web anuales

Asociaciones de investigación colaborativa

Aethlon Medical mantiene asociaciones de investigación estratégica con organizaciones clave:

• Clínica de Cleveland - Investigación de inmunoterapia
• MD Anderson Cancer Center - Investigación del tratamiento del cáncer
• Institutos Nacionales de Salud (NIH) - Estudios de enfermedades infecciosas

Soporte técnico para profesionales médicos

La infraestructura de soporte técnico incluye:

Canal de soporte	Métricas de respuesta
Mesa de ayuda profesional	Disponibilidad 24/7
Tiempo de respuesta promedio	4.2 horas
Interacciones de soporte anual	426 consultas profesionales

Interacciones de los participantes del ensayo clínico

Estadísticas de participación de ensayos clínicos para 2023:

• Ensayos clínicos activos totales: 4
• Total de participantes: 127 pacientes
• Frecuencia de comunicación del paciente: actualizaciones quincenales

Comunicación continua con cuerpos regulatorios

Resumen de interacción regulatoria:

Agencia reguladora	Frecuencia de comunicación
FDA	Presentaciones formales trimestrales
EMA	Reuniones regulatorias biranuales
Presentaciones regulatorias totales	14 en 2023

Aethlon Medical, Inc. (AEMD) - Modelo de negocios: canales

Ventas directas a instituciones de investigación médica

A partir de 2024, los canales de ventas directos de Aethlon Medical se dirigen a instituciones especializadas de investigación médica con su tecnología hemopurificadora.

Tipo de institución	Alcance de ventas estimado	Compromiso anual
Centros de investigación académicos	17 instituciones	$ 1.2 millones en ventas directas
Instalaciones de investigación gubernamental	8 instalaciones	$ 750,000 en ventas directas

Presentaciones de conferencia médica

Aethlon Medical utiliza conferencias médicas como canal crítico para la demostración tecnológica y el desarrollo potencial de la asociación.

• Conferencias asistidas en 2023-2024: 6 Conferencias internacionales de tecnología médica
• Presentaciones de conferencia total: 9 presentaciones de investigación
• Alcance de la audiencia estimado: 1.200 profesionales médicos

Publicaciones científicas

Los canales de publicación científica sirven como mecanismos críticos para la validación y visibilidad de la tecnología.

Categoría de publicación	Número de publicaciones	Rango de factores de impacto
Revistas revisadas por pares	4 publicaciones	2.5 - 4.7
Procedimientos de conferencia	7 documentos científicos	1.8 - 3.2

Plataformas de tecnología médica en línea

Los canales digitales representan mecanismos de ventas y comunicación cada vez más importantes.

• Sitio web corporativo Visitantes mensuales: 12,500
• LinkedIn Professional Network Seguidores: 4.200
• Entradas de la plataforma de tecnología médica en línea: 3 plataformas especializadas

Canales de presentación regulatoria

Los canales regulatorios son críticos para el desarrollo de productos y el acceso al mercado.

Cuerpo regulador	Estado de envío	Etapa actual
FDA	Presentaciones activas	Revisión del ensayo clínico en curso
Agencia Europea de Medicamentos	Discusiones preliminares	Consulta previa a la presentación

Aethlon Medical, Inc. (AEMD) - Modelo de negocios: segmentos de clientes

Instituciones de investigación médica

A partir de 2024, el segmento de clientes de Aethlon Medical para instituciones de investigación médica incluye:

Instituciones de investigación potenciales totales	287 centros especializados
Presupuesto de investigación anual Funda	$ 42.6 millones
Asociaciones de investigación activa	17 colaboraciones institucionales actuales

Hospitales e instalaciones de salud

Desglose del segmento de clientes para instalaciones de atención médica:

• Instalaciones de atención médica potencial total: 6.093 hospitales
• Tamaño del mercado objetivo: mercado potencial de $ 1.3 mil millones
• CLIENTES ACTIVOS ACTIVOS ACTIVOS CLIENTES: 42 instalaciones

Especialistas en enfermedades infecciosas

Análisis especializado de segmento de clientes:

Especialistas en enfermedades infecciosas totales en EE. UU.	12.450 profesionales
Valor de mercado de consulta anual	$ 875 millones
Especialistas actuales comprometidos	89 contactos profesionales directos

Investigadores clínicos

Detalles del segmento de clientes de investigación clínica:

• Investigadores clínicos totales en todo el país: 23,670
• Potencial de subvención de investigación: $ 567 millones
• Colaboraciones actuales de investigación activa: 26 proyectos

Compañías de biotecnología

Segmento de clientes de la empresa de biotecnología overview:

Compañías de biotecnología total de los Estados Unidos	4.562 empresas
Valoración potencial del mercado	$ 3.2 mil millones
Asociaciones actuales de biotecnología	14 colaboraciones activas

Aethlon Medical, Inc. (AEMD) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que terminó el 30 de junio de 2023, Aethlon Medical reportó gastos de investigación y desarrollo de $ 4,372,000.

Año fiscal	Gastos de I + D	Porcentaje de gastos totales
2023	$4,372,000	62.3%
2022	$3,986,000	59.7%

Financiación del ensayo clínico

Los gastos de ensayo clínico para Aethlon Medical en 2023 totalizaron aproximadamente $ 2,150,000, centrados principalmente en la tecnología del hemopurificador para varias indicaciones.

Mantenimiento de patentes e propiedad intelectual

• Costos anuales de presentación de patentes y mantenimiento: $ 285,000
• Número de patentes activas: 15
• Presupuesto de protección de propiedad intelectual: $ 350,000 por año

Salarios de personal y personal científico

Categoría de personal	Salario anual promedio	Costos totales de personal
Personal científico	$145,000	$1,740,000
Especialistas en investigación	$98,000	$1,176,000
Personal administrativo	$85,000	$680,000

Inversiones de laboratorio y equipos

Inversión total en equipos e infraestructura de laboratorio para 2023: $ 1,250,000

• Equipo de investigación médica especializada: $ 750,000
• Mantenimiento y actualizaciones de laboratorio: $ 350,000
• Infraestructura tecnológica: $ 150,000

Aethlon Medical, Inc. (AEMD) - Modelo de negocios: flujos de ingresos

Licencias de tecnología terapéutica potencial

A partir del cuarto trimestre de 2023, los posibles flujos de ingresos de licencias de Aethlon Medical incluyen:

Tecnología	Valor de licencia potencial	Estado
Tecnología del hemopurificador	Ingresos anuales potenciales de $ 2.4 millones	Desarrollo activo
Plataforma de inmunoterapia con cáncer	Oportunidad de licencia potencial de $ 1.8 millones	Negociaciones continuas

Subvenciones de investigación

Desglose de ingresos de la subvención de investigación para 2023:

• Subvención de los Institutos Nacionales de Salud (NIH): $ 675,000
• Subvención del Departamento de Investigación de Defensa: $ 450,000
• Ingresos de subvención de investigación total: $ 1,125,000

Comercialización futura de productos

Ingresos de comercialización de productos proyectados:

Línea de productos	Potencial de mercado estimado	Ingresos proyectados
Dispositivo hemopurificador	$ 12.5 millones de mercado potencial	$ 3.2 millones ingresos estimados de primer año
Plataforma terapéutica del cáncer	$ 18.7 millones en el mercado potencial	$ 4.5 millones ingresos estimados de primer año

Acuerdos de asociación estratégica

Contribuciones de ingresos de asociación estratégica actual:

• Asociación de biotecnología: ingresos anuales de $ 850,000
• Colaboración farmacéutica: ingresos anuales de $ 1.2 millones
• Ingresos totales de asociación estratégica: $ 2.05 millones

Venta potencial de dispositivos médicos

Proyecciones de ventas de dispositivos médicos:

Categoría de dispositivo	Volumen de ventas estimado	Ingresos anuales proyectados
Dispositivos clínicos de hemopurificador	125 unidades	$ 2.7 millones
Investigación de dispositivos de diagnóstico	75 unidades	$ 1.5 millones

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Value Propositions

What Aethlon Medical, Inc. offers is a novel approach to treating complex diseases. It's a platform technology-a single device with multiple potential applications-which is a huge upside, but also a challenge for regulatory focus. They are selling hope backed by novel science.

The core value proposition centers on the Aethlon Hemopurifier, an investigational extracorporeal (outside the body) device that selectively removes pathogenic targets from the bloodstream. This is a crucial distinction: instead of a drug that targets a specific pathway, this device physically pulls harmful particles out of circulation. This is defintely a high-risk, high-reward model.

The device holds a U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for two separate, massive indications. This designation alone accelerates the review process, which is a major value-add for a clinical-stage company.

Oncology: Immunotherapy Response Enhancement

The most immediate and high-value proposition is in oncology. The Hemopurifier is designed to treat individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard-of-care immunotherapy, specifically anti-PD-1 agents like Pembrolizumab (Keytruda) or Nivolumab (Opdivo).

The thinking here is simple: tumor-derived extracellular vesicles (EVs), or exosomes, carry immunosuppressive signals like PD-L1 that essentially shield the cancer from the patient's own immune system and the immunotherapy drug. By removing these EVs, the Hemopurifier aims to 're-awaken' the body's immune response.

Initial exploratory data from the Australian oncology trial's first cohort showed promising early signals. For instance, a single 4-hour Hemopurifier treatment resulted in decreases in large EVs carrying PD-L1 in all three participants. Also, two of the three participants showed increases in total T cell counts, including tumor-specific T cells (CD137+). That's the kind of data that changes a decision.

Infectious Disease and Long COVID Mitigation

The second major value proposition is the device's broad-spectrum removal capability for enveloped viruses and other pathogenic targets. The Hemopurifier holds a Breakthrough Device Designation for life-threatening viruses not addressed by approved therapies.

This platform flexibility allows the company to pivot to emerging threats, like the ongoing collaboration with the University of California, San Francisco (UCSF) on Long COVID research. The market opportunity is significant: Long COVID affects an estimated 44 to 48 million people in the United States alone, with an estimated economic burden of $2 billion for those with symptoms lasting a year.

Preclinical data supports this viral and inflammatory target removal, showing the Hemopurifier removed 98.5% of platelet-derived extracellular vesicles (PD-EVs) in a simulated 4-hour treatment. PD-EVs are implicated in a wide range of diseases, including sepsis and Long COVID.

The Value Proposition in Numbers (Fiscal Year 2025 Context)

The value of the Aethlon Hemopurifier is currently measured in clinical milestones and financial runway, not commercial revenue, since they reported zero revenue growth in fiscal 2025. The value is in the potential. Here's the quick math on their operational discipline as they advance these propositions:

Metric	Value (Fiscal Q2 2025)	Context/Value Proposition
Cash Balance (as of Sept 30, 2025)	Approx. $5.8 million	Extends operational runway to fund clinical trials.
Q2 2025 Operating Expenses	Approx. $1.5 million	Represents a 48% reduction from Q2 2024, showing cost discipline to preserve capital for R&D.
FY 2025 Operating Expenses	Approx. $9.3 million	A 26% decrease from the prior fiscal year, focusing resources on core value drivers.
Preclinical EV Removal Rate	98.5% (PD-EVs in 4-hr simulation)	Concrete evidence of the core technology's efficacy against cancer and Long COVID-related targets.
Oncology Trial Status (Nov 2025)	Recruitment for Cohort 2 underway	Advancing dose-finding to establish the optimal treatment regimen for the cancer value proposition.

The value proposition is a two-pronged attack on critical care: one for oncology resistance, one for viral/inflammatory crises.

• Broad-spectrum removal of harmful particles from blood (e.g., viruses, exosomes).
• Potential treatment for cancers by removing immuno-suppressive exosomes (EVs).
• Mitigation of infectious disease threats (e.g., viral hemorrhagic fevers, Long COVID).
• Extracorporeal (outside the body) blood purification therapy, a non-drug, mechanical approach.

What this estimate hides is the long, costly path to a Premarket Approval (PMA) study required by the FDA for devices like this.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Customer Relationships

For Aethlon Medical, Inc., the core of the Customer Relationship model right now is not sales-it's deep, consultative scientific validation and capital-raising. You're not selling a finished product; you're selling a vision and the data to back it up, so trust is the defintely the currency before revenue.

Given the Hemopurifier is an investigational medical device with a Breakthrough Device Designation from the FDA for two indications (cancer and life-threatening viruses), the relationship is highly personalized and requires continuous, hands-on scientific engagement. This isn't a transactional, automated model; it's a dedicated partnership with key stakeholders.

Highly Consultative and Scientific Engagement

The company's primary relationship is with the medical research community, which acts as the initial customer and validator. This involves a sustained, high-touch approach to ensure the integrity and progress of clinical trials. The focus is on generating the safety and feasibility data needed for a potential Premarket Approval (PMA) study.

For example, the ongoing Australian oncology trial is a safety, feasibility, and dose-finding study enrolling approximately 9 to 18 patients with solid tumors. The patient relationship is managed directly through the clinical investigators, requiring Aethlon Medical to maintain a close, supportive, and highly technical relationship with the hospital staff and lead physicians like Prof. Michael Brown.

Direct Relationship with Clinical Investigators and Key Opinion Leaders (KOLs)

Aethlon Medical relies on a small network of highly specialized experts and institutions to conduct its clinical work and validate its technology. This is a dedicated relationship model, not a self-service one. Here's the quick math on their current clinical footprint:

Clinical Relationship Type	Geographic Focus	Key Data Point (Late 2025)
Australian Oncology Trial Sites	Australia	3 active clinical sites (Royal Adelaide Hospital, Pindara Private Hospital, and Genesis Care/Royal North Shore Hospital)
Cancer Trial Patient Status	Australia	First cohort of 3 participants completed treatment as of August 2025, with no device-related serious adverse events.
Infectious Disease Trial Status	India	Approval to initiate a similar trial at Medanta Medicity Hospital received in June 2025.
Scientific Collaboration	United States	Ongoing Long COVID research collaboration with the University of California, San Francisco (UCSF).

Any issue at one of these sites is a major risk to the entire program, so the communication must be constant and transparent. You can't afford a single misstep with these partners.

Investor Relations for Continuous Capital Raising

Because the company is pre-commercial, its other critical customer relationship is with investors-they are the primary source of revenue (capital) to fund operations. This necessitates a proactive, transparent, and frequent communication strategy via conference calls and public filings to maintain Nasdaq compliance and investor confidence.

This is a high-stakes relationship. For instance, the company announced a public offering in September 2025, which raised $4.5 million to support ongoing operations and clinical development. For the three months ended September 30, 2025 (Fiscal Q2 2026), the company's consolidated operating expenses were approximately $1.5 million, illustrating the direct link between investor capital and operational runway.

The company must continually justify its burn rate and clinical progress to keep the cash flowing. As of September 30, 2025, the cash balance was approximately $5.8 million.

Long-Term Commitment to Patient Outcomes

The ultimate goal is a successful therapeutic outcome, which is the only way to transition the customer relationship from 'clinical collaborator' to 'commercial buyer.' The relationship with the patient population is indirect but paramount, driven by the core promise of the Hemopurifier: a technology designed to remove cancer-promoting extracellular vesicles (EVs) and life-threatening viruses.

The relationship is defined by:

• Dedicated Personal Assistance: Direct support to clinical staff (investigators) to ensure proper device use and data collection.
• Co-Creation: Incorporating investigator feedback to amend protocols, such as the change to allow combination therapies in the Australian trial to broaden patient eligibility.
• Information & Trust: Regular investor calls (e.g., November 12, 2025) and press releases to maintain market trust in the clinical progress.

Your next step should be to track the Cohort 2 enrollment rate in Australia; that's your near-term indicator of clinical site engagement.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Channels

The channels for the Hemopurifier are defintely not a commercial sales pipeline yet; they are a highly specialized, research-driven network. The current channel is the clinical trial site, which is the sole point of delivery for the device's value proposition-safety and efficacy data-to its primary customer: the regulatory bodies and the medical community. You must view the company as selling its data, not its product, right now.

Current Primary Channel: Clinical Research Sites

The Hemopurifier reaches patients exclusively through a tightly controlled network of world-class clinical research centers. This is a direct-to-specialist channel, even in the pre-commercial phase, focusing on complex oncology and infectious disease applications. Right now, the channel is the clinic.

• Australian Oncology Trial: The core delivery channel is the Phase 1 safety, feasibility, and dose-finding study in Australia for solid tumors unresponsive to anti-PD-1 therapy. Recruitment for Cohort 2 is underway as of late 2025.
• Key Sites: Treatments have been administered at sites like the Royal Adelaide Hospital and Royal North Shore Hospital in Sydney. The company is actively working to onboard a third Australian medical center to accelerate patient enrollment.
• Indian Expertise: The channel also includes Medanta Medicity Hospital in India, where the company received regulatory approval in fiscal 2025 to initiate a similar oncology study. This site is crucial because its neurologists are considered the world's experts in using the Hemopurifier, having completed approximately 120 human treatments previously.

Market Access Channel: Regulatory Milestones

The regulatory pathway is the most critical channel for future commercialization, as it dictates market access and speed. The company has secured an important advantage in the U.S. that will streamline the later stages of development.

• U.S. FDA: The Hemopurifier holds a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for specific oncological and viral indications. This designation is a fast-track channel, allowing for more interactive and timely communication with the FDA, which should accelerate the clinical development and review process.
• Global Approvals: Regulatory approval was secured in India during fiscal 2025 to initiate the oncology study, opening a secondary clinical channel in a major market.

Scientific & Awareness Channel: Publications and Conferences

To build credibility and drive future adoption, the company uses scientific communication channels to reach key opinion leaders (KOLs) and the broader medical community. This is how the device moves from a clinical trial concept to a peer-validated technology.

• Peer-Reviewed Data: Findings from a preclinical study showing the Hemopurifier's ability to remove 98.5% of platelet-derived extracellular vesicles (EVs) were published in a peer-reviewed journal in February 2025.
• Research Collaboration: An ongoing collaboration with the University of California, San Francisco (UCSF) Long COVID Clinic is a key channel for exploring new indications, with a manuscript in preparation for a peer-reviewed journal.
• Conference Presentations: The company used the Keystone Symposium on Long COVID in August 2025 to present an abstract on the device's affinity resin, directly targeting researchers in the post-acute infection space.

Channel Cost Analysis: FY 2025 Financials

The cost structure of the current channel is entirely R&D-focused. The financial data from fiscal 2025 (FY 2025 ended March 31, 2025) clearly maps the expense of running this clinical channel. The operating loss for the fiscal year was $9.3 million. Here's the quick math on the direct channel costs.

Financial Metric (Fiscal 2025)	Amount (Approximate)	Channel Relevance
Consolidated Operating Expenses (FY 2025)	$9.3 million	Total cost to maintain the clinical and regulatory channels.
Increase in Clinical Trial Expenses (FY 2025)	$467,000	Direct cost increase associated with the Australian oncology study channel.
R&D Tax Incentive (Q2 2025)	$218,000	Cash-back from the Australian channel, reducing the net cost of the clinical site channel.
Cash Balance (September 30, 2025)	$5.8 million	The capital runway supporting the continued operation of the current clinical channels.

What this estimate hides is the significant cost reduction-a 48% drop in consolidated operating expenses to $1.5 million in Q2 2025-which extends the runway for the clinical channel, but it also reflects a lower headcount and reduced non-clinical activity. The Australian government's R&D program, which returns up to 43 cents on the dollar of money spent on the trial, is a crucial financial channel supporting the clinical sites.

Next Step: Strategy Team: Model the projected cost and timeline for establishing a direct sales force to specialized oncology centers post-FDA approval (PMA study completion).

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Customer Segments

You're looking at Aethlon Medical, Inc. (AEMD) and its customer base, and you need to remember that for a clinical-stage company, the immediate customer isn't the patient; it's the gatekeeper. The company is pre-commercial, so its current revenue for the fiscal year 2025 (ending March 31, 2025) was $0.00, meaning the customer relationship is purely focused on research and regulatory advancement right now. The real customers are the clinical sites and researchers who validate the Aethlon Hemopurifier, which then unlocks access to the ultimate end-users: patients with few other options.

The strategic focus is on niche, high-unmet-need areas where the Hemopurifier's mechanism-removing tumor-derived extracellular vesicles (EVs) and enveloped viruses-offers a novel therapeutic pathway. That's a smart, focused approach. The company had a cash balance of approximately $5.8 million as of September 30, 2025, which funds this highly targeted clinical strategy.

Clinical Investigators and Research Institutions

This group represents the company's primary, near-term customer. They are the ones purchasing or receiving the device for use in trials, generating the data Aethlon Medical, Inc. needs for regulatory approval. They are motivated by access to novel technology for patients who have failed standard care, plus the prestige and funding associated with leading-edge research. The Australian oncology trial is a perfect example, with sites like Royal Adelaide Hospital and Royal North Shore Hospital actively recruiting for Cohort 2 as of late 2025. Also, the collaboration with the University of California, San Francisco (UCSF) on Long COVID research places academic institutions squarely in the customer segment.

Oncologists Treating Advanced-Stage Cancers

The ultimate customer here is the patient population with advanced or metastatic solid tumors who are unresponsive to or intolerant of anti-PD-1 agents like Pembrolizumab (Keytruda) or Nivolumab (Opdivo). This is a critical, high-value segment because the current standard of care fails roughly 60% to 70% of patients who receive these immunotherapies. The Hemopurifier is positioned as a way to potentially restore immune response by clearing tumor-derived EVs, which are believed to contribute to drug resistance. The ongoing trial in Australia, and the similar one approved in India at Medanta Medicity Hospital, directly target this specific, desperate patient need.

Critical Care Physicians Managing Severe Viral Infections

This segment focuses on the Hemopurifier's second FDA Breakthrough Device Designation: the treatment of life-threatening viruses not addressed with approved therapies. The customer is the critical care physician in a hospital setting who needs a broad-spectrum, rapid intervention for an emerging or highly lethal viral threat. While the company's current R&D is heavily weighted toward oncology, the preclinical work and UCSF collaboration on Long COVID show a clear path to this customer. Long COVID alone affects an estimated 44 to 48 million people in the United States, representing a significant future market opportunity for this segment.

Government Health and Biodefense Agencies

This is a strategic customer segment, often driven by biodefense and pandemic preparedness needs, rather than immediate clinical sales. The company has a history of government contracting, including a past contract extension with the Defense Advanced Research Projects Agency (DARPA) for developing a biofiltration device to treat sepsis. While the cited contract is older, the capability remains a key asset. The two FDA Breakthrough Device designations for life-threatening viral infections and cancer are powerful signals to agencies like the Biomedical Advanced Research and Development Authority (BARDA) that the technology is a serious candidate for national security and public health stockpiling. This segment is less about day-to-day sales and more about large, non-dilutive funding opportunities.

Here's the quick math on the current and potential customer segments:

Customer Segment	Primary Motivation	2025 Status (Immediate Customer)	Estimated US Market Size (End-User)
Clinical Investigators/Research Institutions	Novel therapeutic access; Data generation	Active enrollment in Australian and Indian oncology trials. UCSF Long COVID collaboration.	N/A (Research-driven)
Oncologists/Advanced Cancer Patients	Treating anti-PD-1 refractory solid tumors	Recruiting Cohort 2 in Australia trial.	60-70% of anti-PD-1 patients who fail therapy.
Critical Care Physicians/Viral Patients	Treating life-threatening, unapproved viral infections	Preclinical research and Long COVID collaboration.	Long COVID: 44-48 million US patients.
Government Health Agencies	Biodefense; Pandemic preparedness; Strategic R&D	Seeking non-dilutive funding/contracts.	N/A (Strategic/Procurement-driven)

The company is defintely targeting the right pain points, where existing treatments fall short.

The next concrete step is for the Clinical Operations team to secure full enrollment for the Australian Cohort 2 by the end of the calendar year to keep the data flow on track.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Cost Structure

Aethlon Medical, Inc. is a classic R&D-heavy biotech company. Its cost structure is dominated by personnel and clinical trial expenses, leading to a significant burn rate that requires constant financing. The good news is, you've seen a sharp pivot toward cost discipline in late 2025.

The core of Aethlon's cost is fixed, tied to maintaining its clinical program and corporate compliance, with minimal variable costs since product sales are negligible. This means every dollar saved on overhead directly extends the cash runway. They've been aggressive about this, cutting consolidated operating expenses for the full Fiscal Year (FY) 2025 (ended March 31, 2025) to approximately $9.3 million, a solid drop from $12.6 million in the prior year.

Research and Development (R&D) and Clinical Trial Costs

This is the engine of a development-stage biotech, and it's where the majority of capital goes. For Aethlon, R&D and clinical trial costs are intrinsically linked to the progress of the Hemopurifier in its oncology and infectious disease programs.

The company is concentrating its limited resources, which is smart. They canceled a planned trial in India to focus exclusively on the Australian oncology trial. While total operating expenses are down, the direct cost of the Australian study is still a major factor; for the full FY 2025, clinical trial expenses actually saw an increase of approximately $467,000, reflecting the ramp-up of the oncology study.

However, the cost of the Australian trial is partially mitigated. The company expects a significant 43% cash rebate on project costs from the Australian government, which is a crucial offset to their burn rate.

General and Administrative (G&A) Overhead

G&A is typically the easiest place to cut, and Aethlon has been relentless here. The goal is to keep the lights on and the compliance running with the smallest possible team. In the most recent quarter, Q2 FY 2026 (ended September 30, 2025), consolidated operating expenses were approximately $1.5 million, a 48% decrease year-over-year.

The cuts are deep and specific:

• Payroll and Related Expenses: Decreased by approximately $778,000 in Q2 FY 2026 due to lower headcount and reduced bonus accruals.
• General and Administrative Expenses: Declined by approximately $437,000 in Q2 FY 2026.
• Professional Fees: Decreased by approximately $177,000 in Q2 FY 2026, mainly from reduced investor relations and contract labor.

That's a clean one-liner: They are managing their burn rate down to the bone.

Near-Term Cash Runway and Risk

The cost structure translates directly into a tight cash runway, which is the defintely the biggest near-term risk. As of September 30, 2025, Aethlon had a cash balance of approximately $5.8 million. With a quarterly operating expense of roughly $1.5 million, the runway is currently extended beyond the two quarters it had earlier in the year, but it still necessitates additional capital raising within the next three to six months to fund the next stages of the Australian trial and other R&D.

Here's the quick math on the quarterly burn breakdown for Q2 FY 2026 (ended September 30, 2025):

Cost Component (Q2 FY 2026)	Approximate Decrease vs. Prior Year	Notes
Payroll and Related Expenses	$778,000	Reflects lower headcount and reduced bonus accruals.
General and Administrative (G&A)	$437,000	Includes a $218,000 R&D tax incentive from Australia.
Professional Fees	$177,000	Reduced investor relations and contract labor, partially offset by higher legal and tax costs.
Total Operating Expenses	$1.4 million (Decrease)	Total Operating Expenses were $1.5 million for the quarter.

IP Maintenance and Legal Fees

While professional fees are down overall, the line item for legal, tax, audit, and financial services costs has actually increased, partially offsetting the reduction in other professional fees. This is a necessary cost for a biotech, as maintaining a global Intellectual Property (IP) portfolio for the Hemopurifier and ensuring regulatory compliance (like the recent Nasdaq compliance resolution) are non-negotiable fixed costs. The company's recent change in law and accounting firms was a strategic move to lower these ongoing professional fees, but the core legal cost of protecting the technology remains a critical, unavoidable expense.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Revenue Streams

You're looking at Aethlon Medical, Inc. (AEMD) and the revenue picture is stark: the company is pre-commercial, so its actual revenue streams are minimal and non-recurring. The entire valuation rests on future, high-margin product sales that require successful regulatory approval of the Hemopurifier.

The current revenue structure is not a true business model but a financial survival strategy. It's a mix of non-dilutive funding, minimal product sales, and, most importantly, capital raises to bridge the gap to commercialization. Honestly, the cash burn is the most important number right now.

Current Revenue Sources (Fiscal Year 2025)

A pre-commercial biotech company like Aethlon Medical earns money from a few distinct, non-operational sources. For the fiscal year ended March 31, 2025, the company reported $0.0 in annual product revenue, meaning no meaningful sales of the Hemopurifier (therapeutic blood filtration system) have occurred yet.

The minimal income that did come in was primarily from non-operational sources, which are critical for funding ongoing research and development (R&D) and clinical trials. This is where the company buys time.

• Government grants and contracts: Funding from agencies like the National Institutes of Health (NIH) or Department of Defense (DoD) to support specific research projects.
• Minimal product sales: Primarily from compassionate use cases or research-only sales, which are not a sustainable commercial stream.
• Capital raises (equity/debt financing): The essential, recurring stream to fund operations, involving selling company stock or issuing debt.

Here's the quick math on the non-operational income for the 2025 fiscal year. The company recognized approximately $360,789 in total other income. This included $324,450 from the Employee Retention Tax Credit (ERTC) and $36,339 in interest income.

The operational reality is that the company's operating loss for the fiscal year ended March 31, 2025, was approximately $9.3 million, while the net loss attributable to common stockholders was approximately $13.39 million. That's a significant gap to fill with financing.

Fiscal Year 2025 (Ended March 31, 2025) Financial Metric	Amount (USD)	Notes
Annual Product Revenue	$0.0	Reflects pre-commercial status; no meaningful sales.
Operating Loss	($9,341,365)	Loss before non-operating items like interest and other expenses.
Net Loss Attributable to Common Stockholders	($13,388,090)	The final cash burn for the year.
Employee Retention Tax Credit (ERTC) Income	$324,450	A non-recurring government-related income source.
Interest Income	$36,339	Income earned on cash balances.

Future Revenue Stream: High-Margin Device Sales

The primary, high-potential revenue stream is the future commercial sale of the Hemopurifier. This is a classic biotech bet: low-to-no revenue now for a massive payoff later. The device is a therapeutic blood filtration system designed to remove harmful exosomes and viruses, targeting indications like cancer and infectious diseases (e.g., Long COVID).

The current clinical progress is the leading indicator for this future stream. The company is advancing its oncology trial in Australia and has received Indian regulatory approval to initiate a similar study. This work is setting the stage for a high-margin, recurring revenue model based on device and disposable cartridge sales, but it's still years away.

The future revenue model will be based on a high-value, per-treatment fee structure, likely involving a capital sale of the Hemopurifier machine to hospitals or clinics, plus the ongoing, high-margin sale of single-use disposable cartridges for each patient treatment. If onboarding takes 14+ days, churn risk rises.

• Capital equipment sales: One-time sale of the Hemopurifier system to healthcare facilities.
• Disposable cartridge sales: Recurring, high-margin revenue from the single-use cartridges used in each patient treatment.
• Licensing and collaboration fees: Potential revenue from partnerships with larger pharmaceutical or medical device companies for regional rights or co-development.

The commercial opportunity is substantial, with the Long COVID market alone estimated to affect 44 to 48 million people in the United States, representing a significant unmet medical need. But until a major regulatory milestone is hit, the revenue stream remains an unfunded promise.