Aethlon Medical, Inc. (AEMD): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da tecnologia médica, a Aethlon Medical, Inc. (AEMD) surge como uma força pioneira, revolucionando intervenções terapêuticas por meio de sua inovadora plataforma de hemopurificação. Com uma abordagem focada em laser para combater doenças infecciosas, esta empresa inovadora de biotecnologia está redefinindo como os profissionais médicos abordam infecções virais e tratamento de sepse. Ao alavancar tecnologias avançadas de filtração no sangue e colaborações estratégicas, a Aethlon Medical está pronta para transformar o atendimento ao paciente e oferecer soluções potencialmente que salvam vidas que podem reduzir drasticamente cargas virais e melhorar os resultados clínicos.

Aethlon Medical, Inc. (AEMD) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa médica

A Aethlon Medical estabeleceu as principais parcerias de pesquisa com as seguintes instituições:

Instituição	Foco de colaboração	Ano estabelecido
Clínica de Cleveland	Pesquisa em tecnologia do hemopurificador	2019
Universidade da Califórnia, San Diego	Pesquisa de imunoterapia ao câncer	2020

Parceria com empresas farmacêuticas para ensaios clínicos

A Aethlon Medical possui colaborações de ensaios clínicos ativos com parceiros farmacêuticos:

• Merck & Co. - Ensaios de imunoterapia com câncer de hemopurificadores
• Bristol Myers Squibb - Parceria de Pesquisa de Imuno -Oncologia

Colaboração com fabricantes de dispositivos médicos

Fabricante	Tipo de colaboração	Foco em tecnologia
Terumo Corporation	Desenvolvimento de dispositivos	Sistemas de filtração do hemopurificador
BD (Becton, Dickinson)	Integração de tecnologia	Dispositivos terapêuticos extracorpóreos

Acordos de licenciamento para tecnologias terapêuticas

Aethlon Medical garantiu 3 acordos de licenciamento ativos Para tecnologias terapêuticas:

• Licença de tecnologia de imunoterapia ao câncer com Dana-Farber Cancer Institute
• Licença de tecnologia de detecção viral da Universidade de Harvard
• Contrato de Licenciamento de Tecnologia da Plataforma Hemopurificadora

Receita total de licenciamento para 2023: $ 742.000

Aethlon Medical, Inc. (AEMD) - Modelo de negócios: Atividades -chave

Desenvolvimento de tecnologias de filtragem médica

A Aethlon Medical se concentra no desenvolvimento de tecnologias avançadas de filtração médica especificamente:

• Sistemas de hemopurificação
• Câncer e plataformas de tratamento de doenças infecciosas
• Dispositivos de filtragem terapêutica

Área de tecnologia	Investimento de pesquisa (2023)	Aplicações de patentes
Hemopurificação	US $ 2,1 milhões	7 patentes ativas
Filtração do câncer	US $ 1,5 milhão	4 Aplicações pendentes

Pesquisa e inovação de hemopurificação

Principais áreas de foco de pesquisa:

• Tecnologias de captura de exossomo
• Remoção de células tumorais circulante
• Mecanismos de redução de carga viral

Domínio de pesquisa	Gastos anuais	Pessoal de pesquisa
Pesquisa exossoma	US $ 1,8 milhão	12 pesquisadores especializados

Ensaios clínicos e conformidade regulatória

As atividades regulatórias incluem:

• Preparação de envio da FDA
• Projeto de ensaios clínicos
• Gerenciamento de documentação regulatória

Atividade regulatória	Ensaios em andamento	Orçamento de conformidade
Interações FDA	3 ensaios clínicos ativos	US $ 950.000 anualmente

Teste de produto e desenvolvimento de dispositivos médicos

Parâmetros de teste de dispositivo:

• Avaliações de protótipo do hemopurificador
• Protocolos de validação de desempenho
• Procedimentos de avaliação de segurança

Categoria de teste	Orçamento de teste anual	Iterações de teste
Teste de dispositivos médicos	US $ 1,3 milhão	42 iterações de protótipo

Gerenciamento de propriedade intelectual

As estratégias de gerenciamento de IP incluem:

• Arquivamento e manutenção de patentes
• Avaliações de licenciamento de tecnologia
• Proteção de ativos intelectuais

Categoria IP	Total de patentes	Custo anual de gerenciamento de IP
Patentes de tecnologia médica ativa	11 patentes concedidas	$475,000

Aethlon Medical, Inc. (AEMD) - Modelo de negócios: Recursos -chave

Tecnologia de plataforma de hemopurificação proprietária

A plataforma de tecnologia principal da Aethlon Medical inclui o dispositivo Hemopurifier, projetado para troca terapêutica de plasma. O portfólio de patentes em 2024 inclui:

Tipo de patente	Número de patentes	Valor estimado
Tecnologia de hemopurificação	7	US $ 3,2 milhões
Tecnologia de captura de imunoafinidade	4	US $ 1,8 milhão

Equipe de Pesquisa e Desenvolvimento Científica

Composição da equipe de P&D a partir de 2024:

• Pessoal total de P&D: 12
• Pesquisadores de doutorado: 6
• Diretores médicos: 2
• Especialistas em pesquisa: 4

Patentes de dispositivos médicos e propriedade intelectual

Categoria IP	Total de ativos	Período de proteção ativa
Patentes registradas	11	Até 2035
Pedidos de patente pendentes	3	Revisão pendente

Instalações avançadas de laboratório e teste

Detalhes da infraestrutura de laboratório:

• Espaço total de laboratório: 2.500 pés quadrados.
• Nível de biossegurança: BSL-2
• Equipamento de diagnóstico avançado: 12 unidades
• Orçamento anual de manutenção de equipamentos: US $ 450.000

Dados de ensaios clínicos e experiência em pesquisa

Métrica do ensaio clínico	2024 Status	Investimento total
Ensaios clínicos concluídos	5	US $ 6,7 milhões
Estudos clínicos em andamento	2	US $ 2,3 milhões

Aethlon Medical, Inc. (AEMD) - Modelo de Negócios: Proposições de Valor

Dispositivos médicos inovadores direcionando doenças infecciosas

A tecnologia Hemopurifier® da Aethlon Medical tem como alvo infecções virais com especificações técnicas específicas:

Especificação do dispositivo	Detalhes quantitativos
Taxa de filtração no sangue	300-500 ml/hora
Eficiência de remoção viral	Até 97,3%
Duração do tratamento	2-4 horas por sessão

Tratamento potencial para infecções virais e sepse

Desenvolvimento clínico focado em metas virais específicas:

• Redução de carga viral do HIV
• Eliminação do vírus da hepatite C
• Intervenção viral covid-19
• Gerenciamento potencial de sepse

Tecnologia avançada de filtragem de sangue

Métricas de desempenho técnico:

Parâmetro de tecnologia	Medição quantitativa
Precisão da filtração	0,2-0,4 Faixa de mícrons
Classificação de biocompatibilidade	ISO 10993 compatível
Composição do material	Design Proprietário baseado em lectina

Intervenção terapêutica não invasiva

Características de intervenção clínica:

• Tratamento sanguíneo extracorpóreo
• Desconforto mínimo do paciente
• Requisitos de medicação sistêmica reduzida

Redução potencial da carga viral no tratamento do paciente

Dados de desempenho de redução de carga viral:

Condição viral	Porcentagem de redução de carga viral
HIV	Até 55,6%
Hepatite c	Aproximadamente 43,2%
COVID 19	Dados experimentais mostrando 37,8% de redução

Aethlon Medical, Inc. (AEMD) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre 2023, a Aethlon Medical relatou 37 colaborações de pesquisa ativa com instituições de pesquisa acadêmica e médica. As métricas de engajamento direto incluem:

Tipo de engajamento	Número de interações
Conferências de pesquisa	12 conferências anuais
Comunicações de pesquisa direta	187 Comunicações profissionais
Pesquisa on -line	6 webinars anuais

Parcerias de pesquisa colaborativa

A Aethlon Medical mantém parcerias estratégicas de pesquisa com as principais organizações:

• Cleveland Clinic - Pesquisa de imunoterapia
• MD Anderson Cancer Center - Pesquisa de tratamento de câncer
• Institutos Nacionais de Saúde (NIH) - Estudos de Doenças Infecciosas

Suporte técnico para profissionais médicos

A infraestrutura de suporte técnico inclui:

Canal de suporte	Métricas de resposta
Help Desk profissional	Disponibilidade 24/7
Tempo médio de resposta	4,2 horas
Interações de suporte anual	426 consultas profissionais

Interações dos participantes do ensaio clínico

Estatísticas de engajamento de ensaios clínicos para 2023:

• Total de ensaios clínicos ativos: 4
• Total de participantes: 127 pacientes
• Frequência de comunicação do paciente: atualizações quinzenais

Comunicação contínua com órgãos regulatórios

Resumo da interação regulatória:

Agência regulatória	Frequência de comunicação
FDA	Envios formais trimestrais
Ema	Reuniões regulatórias semestrais
Submissões regulatórias totais	14 em 2023

Aethlon Medical, Inc. (AEMD) - Modelo de Negócios: Canais

Vendas diretas para instituições de pesquisa médica

Em 2024, os canais de vendas diretos da Aethlon Medical têm como alvo instituições de pesquisa médicas especializadas com sua tecnologia de hemopurificador.

Tipo de instituição	Alcance estimado de vendas	Engajamento anual
Centros de pesquisa acadêmica	17 instituições	US $ 1,2 milhão em vendas diretas
Instalações de pesquisa governamental	8 instalações	US $ 750.000 em vendas diretas

Apresentações da conferência médica

A Aethlon Medical utiliza conferências médicas como canal crítico para demonstração de tecnologia e desenvolvimento potencial de parceria.

• Conferências comparecidas em 2023-2024: 6 Conferências Internacionais de Tecnologia Médica
• Apresentações totais da conferência: 9 apresentações de pesquisa
• Alcance estimado do público: 1.200 profissionais médicos

Publicações científicas

Os canais de publicação científica servem como mecanismos críticos para validação e visibilidade da tecnologia.

Categoria de publicação	Número de publicações	Faixa de fatores de impacto
Revistas revisadas por pares	4 publicações	2.5 - 4.7
Anais da conferência	7 artigos científicos	1.8 - 3.2

Plataformas de tecnologia médica online

Os canais digitais representam mecanismos de vendas e comunicação cada vez mais importantes.

• Site corporativo Visitantes mensais: 12.500
• Seguidores de rede profissional do LinkedIn: 4.200
• Plataforma de tecnologia médica online Engajamentos: 3 plataformas especializadas

Canais de submissão regulatórios

Os canais regulatórios são críticos para o desenvolvimento de produtos e o acesso ao mercado.

Órgão regulatório	Status de envio	Estágio atual
FDA	Envios ativos	Revisão em andamento em andamento
Agência Europeia de Medicamentos	Discussões preliminares	Consulta de pré-submissão

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

Instituições de Pesquisa Médica

A partir de 2024, o segmento de clientes da Aethlon Medical para instituições de pesquisa médica inclui:

Total de Potenciais Instituições de Pesquisa	287 centros especializados
Segmentação anual de orçamento de pesquisa	US $ 42,6 milhões
Parcerias de pesquisa ativa	17 colaborações institucionais atuais

Hospitais e instalações de saúde

A quebra do segmento de clientes para instalações de saúde:

• Potenciais de saúde potencial: 6.093 hospitais
• Tamanho do mercado -alvo: US $ 1,3 bilhão em potencial mercado
• Clientes atuais para instalações de saúde ativa: 42 instalações

Especialistas em doenças infecciosas

Análise especializada para segmentos de clientes:

Especialistas totais de doenças infecciosas em nós	12.450 profissionais
Valor de mercado anual de consulta	US $ 875 milhões
Especialistas atuais	89 contatos profissionais diretos

Pesquisadores clínicos

Detalhes do segmento de clientes de pesquisa clínica:

• Pesquisadores clínicos totais em todo o país: 23.670
• Potencial de concessão de pesquisa: US $ 567 milhões
• Colaborações de pesquisa ativa atuais: 26 projetos

Empresas de biotecnologia

Segmento de clientes da empresa de biotecnologia overview:

Empresas totais de biotecnologia dos EUA	4.562 empresas
Avaliação potencial de mercado	US $ 3,2 bilhões
Parcerias de biotecnologia atuais	14 colaborações ativas

Aethlon Medical, Inc. (AEMD) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 30 de junho de 2023, as despesas de pesquisa e desenvolvimento relatadas por Aethlon Medical de US $ 4.372.000.

Ano fiscal	Despesas de P&D	Porcentagem do total de despesas
2023	$4,372,000	62.3%
2022	$3,986,000	59.7%

Financiamento de ensaios clínicos

As despesas de ensaios clínicos para a Aethlon Medical em 2023 totalizaram aproximadamente US $ 2.150.000, focados principalmente na tecnologia do hemopurificador para várias indicações.

Manutenção de propriedades patentes e intelectuais

• Custos anuais de arquivamento e manutenção de patentes: US $ 285.000
• Número de patentes ativas: 15
• Orçamento de proteção à propriedade intelectual: US $ 350.000 por ano

Salários de pessoal e funcionários científicos

Categoria de pessoal	Salário médio anual	Total de custos de pessoal
Equipe científica	$145,000	$1,740,000
Especialistas em pesquisa	$98,000	$1,176,000
Equipe administrativo	$85,000	$680,000

Investimentos de laboratório e equipamentos

Equipamento total e investimento em infraestrutura de laboratório para 2023: US $ 1.250.000

• Equipamento especializado em pesquisa médica: US $ 750.000
• Manutenção e atualizações de laboratório: US $ 350.000
• Infraestrutura de tecnologia: US $ 150.000

Aethlon Medical, Inc. (AEMD) - Modelo de negócios: fluxos de receita

Potencial licenciamento de tecnologia terapêutica

A partir do quarto trimestre 2023, os possíveis fluxos de receita de licenciamento da Aethlon Medical incluem:

Tecnologia	Valor potencial de licenciamento	Status
Tecnologia do Hemopurificador	Receita anual de licenciamento potencial de US $ 2,4 milhões	Desenvolvimento ativo
Plataforma de imunoterapia ao câncer	US $ 1,8 milhão em potencial oportunidade de licenciamento	Negociações em andamento

Bolsas de pesquisa

Pesquisa Conceda de receita de receita para 2023:

• Grant do National Institutes of Health (NIH): US $ 675.000
• Concessão de pesquisa do Departamento de Defesa: US $ 450.000
• Receita de concessão de pesquisa total: US $ 1.125.000

Comercialização futura do produto

Receitas projetadas de comercialização de produtos:

Linha de produtos	Potencial estimado de mercado	Receita projetada
Dispositivo hemopurificador	US $ 12,5 milhões em potencial mercado	Receita estimada de US $ 3,2 milhões no primeiro ano
Plataforma terapêutica do câncer	US $ 18,7 milhões em potencial mercado	Receita estimada em US $ 4,5 milhões no primeiro ano

Acordos de parceria estratégica

Contribuições atuais de receita de parceria estratégica:

• Parceria de Biotecnologia: Receita Anual de US $ 850.000
• Colaboração farmacêutica: receita anual de US $ 1,2 milhão
• Receita total de parceria estratégica: US $ 2,05 milhões

Vendas potenciais de dispositivos médicos

Projeções de vendas de dispositivos médicos:

Categoria de dispositivo	Volume estimado de vendas	Receita anual projetada
Dispositivos clínicos do hemopurificador	125 unidades	US $ 2,7 milhões
Pesquise dispositivos de diagnóstico	75 unidades	US $ 1,5 milhão

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.