Aethlon Medical, Inc. (AEMD): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de la technologie médicale, Aethlon Medical, Inc. (AEMD) émerge comme une force pionnière, révolutionnant les interventions thérapeutiques grâce à sa plate-forme d'hémopurification révolutionnaire. Avec une approche axée sur le laser pour lutter contre les maladies infectieuses, cette entreprise de biotechnologie innovante redéfinit la façon dont les professionnels de la santé abordent les infections virales et le traitement de la septicémie. En tirant parti des technologies avancées de filtration sanguine et des collaborations stratégiques, Aethlon Medical est sur le point de transformer les soins aux patients et d'offrir des solutions potentiellement vitales qui pourraient réduire considérablement les charges virales et améliorer les résultats cliniques.

Aethlon Medical, Inc. (AEMD) - Modèle commercial: partenariats clés

Collaboration stratégique avec les institutions de recherche médicale

Aethlon Medical a établi des partenariats de recherche clés avec les institutions suivantes:

Institution	Focus de la collaboration	Année établie
Clinique de Cleveland	Recherche technologique d'hémopurificateur	2019
Université de Californie, San Diego	Recherche d'immunothérapie contre le cancer	2020

Partenariat avec les sociétés pharmaceutiques pour les essais cliniques

Aethlon Medical a des collaborations d'essais cliniques actifs avec des partenaires pharmaceutiques:

• Miserrer & Co. - essais d'immunothérapie contre le cancer de l'hémopurificateur
• Bristol Myers Squibb - Partenariat de recherche sur immuno-oncologie

Collaboration avec les fabricants d'appareils médicaux

Fabricant	Type de collaboration	Focus technologique
Terumo Corporation	Développement de dispositifs	Systèmes de filtration d'hémopurificateur
BD (Becton, Dickinson)	Intégration technologique	Dispositifs thérapeutiques extracorporels

Accords de licence pour les technologies thérapeutiques

Aethlon Medical a obtenu 3 accords de licence actifs Pour les technologies thérapeutiques:

• Licence de technologie d'immunothérapie contre le cancer avec Dana-Farber Cancer Institute
• Licence de technologie de détection virale de l'Université de Harvard
• Contrat de licence de technologie de la plate-forme d'hémopurificateur

Revenu total de licences pour 2023: 742 000 $

Aethlon Medical, Inc. (AEMD) - Modèle d'entreprise: activités clés

Développement de technologies de filtration médicale

Aethlon Medical se concentre sur le développement de technologies de filtration médicale avancées ciblant spécifiquement:

• Systèmes d'hémopurification
• Cancer et plateformes de traitement des maladies infectieuses
• Dispositifs de filtration thérapeutique

Zone technologique	Investissement en recherche (2023)	Demandes de brevet
Hémopurification	2,1 millions de dollars	7 brevets actifs
Filtration du cancer	1,5 million de dollars	4 applications en attente

Recherche et innovation de l'hémopurification

Les principaux domaines de la recherche de recherche:

• Technologies de capture des exosomes
• Élimination des cellules tumorales en circulation
• Mécanismes de réduction de la charge virale

Domaine de recherche	Dépenses annuelles	Personnel de recherche
Recherche d'exosomes	1,8 million de dollars	12 chercheurs spécialisés

Essais cliniques et conformité réglementaire

Les activités réglementaires comprennent:

• Préparation de la soumission de la FDA
• Conception d'essais cliniques
• Gestion de la documentation réglementaire

Activité réglementaire	Procès en cours	Budget de conformité
Interactions de la FDA	3 essais cliniques actifs	950 000 $ par an

Tests de produits et développement de dispositifs médicaux

Paramètres de test de périphérique:

• Évaluations du prototype d'hémopurificateur
• Protocoles de validation des performances
• Procédures d'évaluation de la sécurité

Catégorie de test	Budget de test annuel	Tester les itérations
Test de dispositifs médicaux	1,3 million de dollars	42 Itérations du prototype

Gestion de la propriété intellectuelle

Les stratégies de gestion de la propriété intellectuelle comprennent:

• Dépôt et entretien des brevets
• Évaluations des licences technologiques
• Protection intellectuelle des actifs

Catégorie IP	Total des brevets	Coût annuel de gestion de la propriété intellectuelle
Brevets de technologie médicale active	11 brevets accordés	$475,000

Aethlon Medical, Inc. (AEMD) - Modèle d'entreprise: Ressources clés

Technologie de plate-forme d'hémopurification propriétaire

La plate-forme technologique principale d'Aethlon Medical comprend le dispositif d'hémopurificateur, conçu pour l'échange de plasma thérapeutique. Le portefeuille de brevets à partir de 2024 comprend:

Type de brevet	Nombre de brevets	Valeur estimée
Technologie d'hémopurification	7	3,2 millions de dollars
Technologie de capture d'immunoaffinité	4	1,8 million de dollars

Équipe de recherche et développement scientifique

Composition de l'équipe R&D à partir de 2024:

• Personnel total de R&D: 12
• Rechercheurs de doctorat: 6
• Directeurs médicaux: 2
• Spécialistes de la recherche: 4

Brevets et propriété intellectuelle des dispositifs médicaux

Catégorie IP	Actif total	Période de protection active
Brevets enregistrés	11	Jusqu'en 2035
Demandes de brevet en attente	3	Examen en attente

Installations avancées de laboratoire et de test

Détails de l'infrastructure de laboratoire:

• Espace total de laboratoire: 2 500 pieds carrés.
• Niveau de biosécurité: BSL-2
• Équipement de diagnostic avancé: 12 unités
• Budget annuel de maintenance de l'équipement: 450 000 $

Données d'essai cliniques et expertise en recherche

Métrique d'essai clinique	Statut 2024	Investissement total
Essais cliniques terminés	5	6,7 millions de dollars
Études cliniques en cours	2	2,3 millions de dollars

Aethlon Medical, Inc. (AEMD) - Modèle d'entreprise: propositions de valeur

Dispositif médical innovant ciblant les maladies infectieuses

La technologie Aethlon Medical Heopurifier® cible les infections virales avec des spécifications techniques spécifiques:

Spécification de l'appareil	Détail quantitatif
Taux de filtration du sang	300-500 ml / heure
Efficacité d'élimination virale	Jusqu'à 97,3%
Durée du traitement	2 à 4 heures par session

Traitement potentiel pour les infections virales et la septicémie

Le développement clinique s'est concentré sur des cibles virales spécifiques:

• Réduction de la charge virale du VIH
• Élimination du virus de l'hépatite C
• Intervention virale Covid-19
• Gestion potentielle de la septicémie

Technologie de filtration sanguine avancée

Métriques de performance technique:

Paramètre technologique	Mesure quantitative
Précision de filtration	Plage de 0,2-0,4 micron
Cote de biocompatibilité	Conforme ISO 10993
Composition des matériaux	Conception de la lectine propriétaire

Intervention thérapeutique non invasive

Caractéristiques d'intervention clinique:

• Traitement sanguin extracorporel
• Inconfort minimal des patients
• Exigences de médicaments systémiques réduits

Réduction potentielle de la charge virale dans le traitement du patient

Données de performance de réduction de la charge virale:

Condition virale	Pourcentage de réduction de la charge virale
VIH	Jusqu'à 55,6%
Hépatite C	Environ 43,2%
COVID 19	Données expérimentales montrant une réduction de 37,8%

Aethlon Medical, Inc. (AEMD) - Modèle d'entreprise: relations clients

Engagement direct avec la communauté de la recherche médicale

Au quatrième trimestre 2023, Aethlon Medical a signalé 37 collaborations de recherche active avec des établissements de recherche universitaires et médicaux. Les mesures d'engagement direct comprennent:

Type d'engagement	Nombre d'interactions
Conférences de recherche	12 conférences annuelles
Communications de recherche directes	187 Communications professionnelles
Webinaires de recherche	6 webinaires annuels

Partenariats de recherche collaborative

Aethlon Medical entretient des partenariats de recherche stratégique avec les organisations clés:

• Clinic Cleveland - Recherche d'immunothérapie
• MD Anderson Cancer Center - Recherche de traitement du cancer
• National Institutes of Health (NIH) - Études de maladies infectieuses

Soutien technique aux professionnels de la santé

L'infrastructure de soutien technique comprend:

Canal de support	Métriques de réponse
Assistance professionnelle	Disponibilité 24/7
Temps de réponse moyen	4,2 heures
Interactions de soutien annuelles	426 Consultations professionnelles

Interactions des participants aux essais cliniques

Statistiques d'engagement des essais cliniques pour 2023:

• Essais cliniques actifs totaux: 4
• Total des participants: 127 patients
• Fréquence de communication des patients: mises à jour bihebdomadaires

Communication continue avec les organismes de réglementation

Résumé d'interaction réglementaire:

Agence de réglementation	Fréquence de communication
FDA	Soumissions formelles trimestrielles
Ema	Réunions de réglementation bi-annuelles
Total des soumissions réglementaires	14 en 2023

Aethlon Medical, Inc. (AEMD) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de recherche médicale

En 2024, les canaux de vente directs d'Aethlon Medical ciblent les institutions de recherche médicale spécialisées avec leur technologie d'hémopurificateur.

Type d'institution	Réalisation des ventes estimées	Engagement annuel
Centres de recherche universitaires	17 institutions	1,2 million de dollars de ventes directes
Installations de recherche gouvernementales	8 installations	750 000 $ en ventes directes

Présentations de la conférence médicale

Aethlon Medical utilise des conférences médicales comme canal critique pour la démonstration technologique et le développement potentiel de partenariat.

• Conférences assistées en 2023-2024: 6 Conférences internationales de technologie médicale
• Présentations totales de la conférence: 9 présentations de recherche
• Reach du public estimé: 1 200 professionnels de la santé

Publications scientifiques

Les canaux de publication scientifique servent de mécanismes critiques pour la validation technologique et la visibilité.

Catégorie de publication	Nombre de publications	Plage du facteur d'impact
Journaux évalués par des pairs	4 publications	2.5 - 4.7
Actes de conférence	7 articles scientifiques	1.8 - 3.2

Plateformes de technologie médicale en ligne

Les canaux numériques représentent des mécanismes de vente et de communication de plus en plus importants.

• Visiteurs mensuels du site Web de l'entreprise: 12 500
• LinkedIn Professional Network Followers: 4 200
• Engagements de plate-forme de technologie médicale en ligne: 3 plateformes spécialisées

Canaux de soumission réglementaires

Les canaux de réglementation sont essentiels pour le développement de produits et l'accès au marché.

Corps réglementaire	Statut de soumission	Étape actuelle
FDA	Soumissions actives	Examen des essais cliniques en cours
Agence européenne des médicaments	Discussions préliminaires	Consultation de pré-submission

Aethlon Medical, Inc. (AEMD) - Modèle d'entreprise: segments de clientèle

Institutions de recherche médicale

En 2024, le segment de clientèle d'Aethlon Medical pour les institutions de recherche médicale comprend:

Institutions de recherche potentielles totales	287 centres spécialisés
Ciblage du budget de recherche annuel	42,6 millions de dollars
Partenariats de recherche actifs	17 collaborations institutionnelles actuelles

Hôpitaux et établissements de santé

Répartition du segment des clients pour les établissements de santé:

• Installations totales de soins de santé potentiels: 6 093 hôpitaux
• Taille du marché cible: 1,3 milliard de dollars de marché potentiel
• Clients actuels de soins de santé actifs: 42 installations

Spécialistes des maladies infectieuses

Analyse spécialisée du segment de la clientèle:

Spécialistes totaux de maladies infectieuses aux États-Unis	12 450 professionnels
Valeur de marché de consultation annuelle	875 millions de dollars
Spécialistes engagés actuels	89 Contacts professionnels directs

Chercheurs en clinique

Détails du segment des clients de recherche clinique:

• Total des chercheurs cliniques à l'échelle nationale: 23 670
• Potentiel de subvention de recherche: 567 millions de dollars
• Collaborations actuelles de recherche active: 26 projets

Biotechnology Companies

Segment de clientèle de l'entreprise de biotechnologie overview:

Total des entreprises de biotechnologie américaines	4 562 entreprises
Évaluation potentielle du marché	3,2 milliards de dollars
Partenariats biotechnologiques actuels	14 collaborations actives

Aethlon Medical, Inc. (AEMD) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 30 juin 2023, Aethlon Medical a signalé des frais de recherche et de développement de 4 372 000 $.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses totales
2023	$4,372,000	62.3%
2022	$3,986,000	59.7%

Financement des essais cliniques

Les dépenses d'essai cliniques pour Aethlon Medical en 2023 ont totalisé environ 2 150 000 $, principalement axée sur la technologie de l'hémopurificateur pour diverses indications.

Entretien de la propriété brevet et intellectuelle

• Coûts annuels de dépôt et d'entretien des brevets: 285 000 $
• Nombre de brevets actifs: 15
• Budget de protection de la propriété intellectuelle: 350 000 $ par an

Personnel et salaires du personnel scientifique

Catégorie du personnel	Salaire annuel moyen	Total des coûts du personnel
Personnel scientifique	$145,000	$1,740,000
Spécialistes de la recherche	$98,000	$1,176,000
Personnel administratif	$85,000	$680,000

Investissements en laboratoire et en équipement

Investissement total d'équipement et d'infrastructure de laboratoire pour 2023: 1 250 000 $

• Équipement de recherche médicale spécialisée: 750 000 $
• Entretien et mises à niveau en laboratoire: 350 000 $
• Infrastructure technologique: 150 000 $

Aethlon Medical, Inc. (AEMD) - Modèle d'entreprise: Strots de revenus

Licence de technologie thérapeutique potentielle

Depuis le quatrième trimestre 2023, les sources de revenus potentielles d'Aethlon Medical ont été:

Technologie	Valeur de licence potentielle	Statut
Technologie d'hémopurificateur	2,4 millions de dollars de revenus potentiels de licence annuelle	Développement actif
Plateforme d'immunothérapie contre le cancer	1,8 million de dollars d'opportunité de licence potentielle	Négociations en cours

Subventions de recherche

La rupture des revenus des subventions de recherche pour 2023:

• GRANTIF NATIONAL INSTITUTS DE SANTÉ (NIH): 675 000 $
• Subvention de recherche du ministère de la Défense: 450 000 $
• Revenu total de subventions de recherche: 1 125 000 $

Future commercialisation des produits

Revenus de commercialisation des produits projetés:

Gamme de produits	Potentiel de marché estimé	Revenus projetés
Dispositif d'hémopurificateur	Marché potentiel de 12,5 millions de dollars	3,2 millions de dollars de revenus estimés de première année
Plate-forme thérapeutique contre le cancer	Marché potentiel de 18,7 millions de dollars	4,5 millions de dollars de revenus estimés de première année

Accords de partenariat stratégique

Contributions de revenus de partenariat stratégique actuels:

• Biotechnology Partnership: 850 000 $ Revenus annuels
• Collaboration pharmaceutique: 1,2 million de dollars de revenus annuels
• Revenus de partenariat stratégique total: 2,05 millions de dollars

Ventes potentielles de dispositifs médicaux

Projections de vente de dispositifs médicaux:

Catégorie d'appareil	Volume des ventes estimées	Revenus annuels prévus
Dispositifs cliniques d'hémopurificateur	125 unités	2,7 millions de dollars
Recherchez des dispositifs de diagnostic	75 unités	1,5 million de dollars

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.