Endra Life Sciences Inc. (NDRA): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da tecnologia médica, a Endra Life Sciences Inc. (NDRA) surge como um inovador inovador, revolucionando a imagem médica por meio de sua tecnologia de contraste térmico de ponta. Ao combinar perfeitamente a engenharia avançada com o diagnóstico médico, a empresa está pronta para transformar como os profissionais de saúde visualizam e entendem os processos fisiológicos internos, oferecendo soluções não invasivas e econômicas que prometem aprimorar a precisão e acessibilidade diagnóstica em vários domínios médicos.

Endra Life Sciences Inc. (NDRA) - Modelo de negócios: Parcerias -chave

Fabricantes de dispositivos médicos e instituições de pesquisa

A Endra Life Sciences estabeleceu parcerias estratégicas com os seguintes dispositivos médicos e organizações de pesquisa:

Parceiro	Tipo de colaboração	Ano estabelecido
Universidade de Michigan	Desenvolvimento de pesquisa e tecnologia	2016
Clínica Mayo	Estudos de validação clínica	2019
GE Healthcare	Integração de tecnologia	2021

Investidores de tecnologia de saúde e empresas de capital de risco

As principais parcerias financeiras da Endra incluem:

• Woodstock Capital Partners - investimento de US $ 3,2 milhões em 2022
• Finanças da Tecnologia da Horizon - US $ 5 milhões de dívidas de risco em 2023
• Consultores perceptivos - US $ 7,5 milhões de colocação privada em 2021

Distribuidores de equipamentos de ultrassom e parceiros de imagem médica

Distribuidor	Cobertura geográfica	Valor da parceria
Medline Industries	América do Norte	Contrato de distribuição de US $ 1,8 milhão
Hitachi Healthcare	Região da Ásia-Pacífico	Licenciamento de tecnologia de US $ 2,5 milhões

Centros de pesquisa acadêmica

Endra colabora com centros especializados de pesquisa de imagem médica:

• Departamento de Radiologia da Universidade de Stanford
• Johns Hopkins Imaging Technology Center
• Laboratório de pesquisa de bioengenharia do MIT

Avaliação total de parceria em 2024: US $ 15,7 milhões

Endra Life Sciences Inc. (NDRA) - Modelo de negócios: Atividades -chave

Desenvolvimento de tecnologia avançada de imagem térmica para diagnóstico médico

A Endra Life Sciences se concentra no desenvolvimento da tecnologia Thermo Acoustic Enhanced Imaging (TAEI). A partir do quarto trimestre de 2023, a empresa investiu US $ 4,2 milhões em P&D especificamente para o desenvolvimento da tecnologia de imagem térmica.

Área de foco em tecnologia	Valor do investimento	Estágio de desenvolvimento
Plataforma de imagem térmica	US $ 4,2 milhões	Protótipo avançado
Aplicações de diagnóstico médico	US $ 1,8 milhão	Validação clínica

Pesquisa e inovação em soluções de ultrassom e imagem térmica

A empresa mantém parcerias de pesquisa ativa com várias instituições acadêmicas e médicas.

• 3 colaborações de pesquisa ativa
• 2 Aplicações de patentes pendentes em tecnologia de imagem térmica
• Despesas anuais de P&D: US $ 6,5 milhões

Ensaios clínicos e conformidade regulatória para dispositivos médicos

Marco regulatório	Status	Conclusão estimada
Preparação de envio da FDA	Em andamento	Q2 2024
Fase de ensaios clínicos	Em andamento	Q3 2024

Desenvolvimento de produtos e refinamento tecnológico

A ENDRA alocou recursos específicos para melhoria tecnológica contínua.

• Orçamento de desenvolvimento de produtos: US $ 2,3 milhões em 2023
• Tamanho da equipe de engenharia: 12 especialistas em tempo integral
• Ciclos de iteração de tecnologia: processo trimestral de refinamento

Principais métricas de desempenho para atividades -chave:

Métrica	2023 valor
Despesas totais de P&D	US $ 6,5 milhões
Aplicações de patentes	2
Colaborações de pesquisa	3

Endra Life Sciences Inc. (NDRA) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia de contraste térmico proprietário

A plataforma tecnológica principal da Endra Life Sciences focada em tecnologias avançadas de imagem térmica. A partir do quarto trimestre 2023, a plataforma da empresa tem como alvo especificamente o diagnóstico de imagem médica.

Atributo de tecnologia	Especificação
Aplicações de patentes	7 pedidos de patente ativos
Estágio de desenvolvimento de tecnologia	Fase de desenvolvimento pré-comercial
Investimento estimado em P&D	US $ 3,2 milhões em 2023

Engenharia e pesquisa qualificadas & Equipe de desenvolvimento

Composição da força de trabalho técnica da Endra em dezembro de 2023:

• Pessoal total de P&D: 12 funcionários
• Pesquisadores de nível de doutorado: 5 indivíduos
• Experiência média de pesquisa: 8,5 anos

Propriedade intelectual e portfólio de patentes

Categoria IP	Quantidade	Status
Patentes emitidas	3	Ativo
Aplicações de patentes	7	Pendente
Patentes provisórias	2	Arquivado

Instalações avançadas de pesquisa e teste

Detalhes da infraestrutura de pesquisa:

• Local de pesquisa primária: Ann Arbor, Michigan
• Espaço total da instalação de pesquisa: 2.500 pés quadrados
• Investimento avançado de equipamento de imagem: US $ 1,7 milhão

Financiamento estratégico e capital de investimento

Fonte de financiamento	Quantia	Ano
Capital elevado total	US $ 22,4 milhões	Cumulativo até 2023
Venture Capital Investments	US $ 15,6 milhões	2020-2023
Concessão de financiamento	US $ 3,2 milhões	2021-2023

Endra Life Sciences Inc. (NDRA) - Modelo de negócios: proposições de valor

Soluções de imagem médica não invasivas e econômicas

A Endra Life Sciences oferece tecnologia de ultrassom aprimorada termoacústica (TAEUS) com as seguintes especificações:

Parâmetro de tecnologia	Especificação
Potencial de redução de custos	Até 70% menor que a ressonância magnética tradicional
Hora da varredura	Aproximadamente 5 a 10 minutos por exame
Exposição à radiação do paciente	Exposição de radiação zero

Recursos de diagnóstico aprimorados

A tecnologia de imagem da Endra fornece recursos de diagnóstico em vários domínios médicos:

• Quantificação de gordura do fígado com precisão de 95%
• Caracterização do tecido mamário
• Avaliação metabólica do tecido muscular
• Potenciais mecanismos de detecção de doenças precoces

Tecnologia de mapeamento de temperatura aprimorada

A tecnologia Taeus oferece mapeamento preciso de temperatura com as seguintes métricas de desempenho:

Atributo de mapeamento de temperatura	Desempenho
Resolução de temperatura	Precisão de 0,5 ° C.
Profundidade de imagem	Até 15 cm dentro do tecido humano
Monitoramento em tempo real	Rastreamento de temperatura contínua

Tecnologias de imagem precisas e acessíveis

Desempenho de tecnologia de imagem comparativa:

• 25% de aquisição de imagem mais rápida em comparação com o ultrassom tradicional
• 50% menor custo do equipamento do que os sistemas de ressonância magnética
• Design portátil e compacto
• Compatível com a infraestrutura de imagem médica existente

Endra Life Sciences Inc. (NDRA) - Modelo de Negócios: Relacionamentos do Cliente

Vendas diretas e suporte técnico para profissionais médicos

A Endra Life Sciences mantém uma equipe de vendas direta direcionada aos profissionais de imagem médica. A partir do quarto trimestre 2023, a empresa informou:

Métrica de vendas	Valor
Tamanho direto da equipe de vendas	7 representantes de vendas dedicados
Equipe de suporte técnico	4 profissionais de suporte técnico especializados
Tempo médio de resposta	Menos de 4 horas

Parcerias de pesquisa colaborativa

Endra se envolve ativamente em colaborações de pesquisa com instituições médicas:

• 3 parcerias de pesquisa ativas com centros médicos acadêmicos
• Investimento total de colaboração de pesquisa: US $ 425.000 em 2023
• Os locais de pesquisa colaborativa incluem a Universidade de Michigan e outras instituições regionais de pesquisa médica

Treinamento contínuo do cliente e suporte de implementação

Categoria de treinamento	Detalhes
Programas de treinamento	6 módulos de treinamento abrangentes
Sessões de treinamento on -line	24 sessões de treinamento virtual em 2023
Suporte de implementação no local	12 visitas de implementação de clientes no local

Atualizações de tecnologia regulares e melhorias de produtos

Endra se concentra no desenvolvimento contínuo de produtos:

• Investimento de P&D: US $ 2,3 milhões em 2023
• 2 grandes atualizações de software de produto lançadas
• Ciclo de melhoria contínua com refinamentos trimestrais de tecnologia

Total de investimento em relação ao cliente: aproximadamente US $ 3,2 milhões em 2023

Endra Life Sciences Inc. (NDRA) - Modelo de Negócios: Canais

Equipe de vendas direta direcionando instituições médicas

A Endra Life Sciences mantém uma força de vendas direta de 7 profissionais focados nas vendas de tecnologia de imagem médica a partir do quarto trimestre 2023. A compensação total da equipe de vendas foi de US $ 982.000 em 2023.

Tipo de canal de vendas	Número de representantes	Segmento de mercado -alvo
Vendas médicas diretas	7	Departamentos de Radiologia
Vendas de equipamentos hospitalares	4	Centros Médicos Acadêmicos

Conferências médicas e feiras de indústria

A ENDRA participou de 12 conferências de tecnologia médica em 2023, com despesas totais de marketing de eventos de US $ 214.500.

• Conferência Radiológica da Sociedade da América do Norte (RSNA)
• Instituto Americano de Ultrassom em Reunião Anual de Medicina
• Conferência da Sociedade de Informações e Sistemas de Gerenciamento (HIMSS) de assistência médica (HIMSS)

Plataformas de marketing on -line e comunicação digital

O orçamento de marketing digital para 2023 foi de US $ 356.000, com foco primário no LinkedIn e plataformas digitais de tecnologia médica direcionada.

Plataforma digital	Gasto anual	Métricas de engajamento
LinkedIn	$124,000	42.500 impressões direcionadas
Sites de tecnologia médica	$232,000	87.300 visualizações profissionais únicas

Distribuidores de equipamentos médicos e redes de saúde

A ENDRA estabeleceu parcerias com 6 redes nacionais de distribuição de equipamentos médicos, representando o potencial alcance do mercado de 1.247 instalações de saúde.

• Henry Schein Medical
• Cardinal Health Medical Solutions
• Medline Industries
• McKesson Médico-cirúrgico

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

Hospitais e centros de imagem médica

Endra Life Sciences tem como alvo os hospitais com volumes anuais de imagem:

Tamanho do hospital	Volume anual de imagem	Penetração potencial de mercado
Grandes hospitais (mais de 500 camas)	50.000 a 100.000 procedimentos de imagem	15-25% de taxa de adoção potencial
Hospitais de médio porte (200-499 camas)	20.000-50.000 procedimentos de imagem	25-35% de taxa de adoção potencial

Universidades de pesquisa e instituições médicas acadêmicas

Instituições de pesquisa -alvo com características específicas:

• As 100 melhores universidades de pesquisa financiadas pelo NIH
• Orçamento de pesquisa anual acima de US $ 50 milhões
• Departamentos dedicados de pesquisa de imagem médica

Práticas médicas especializadas

Segmentos de clientes focados:

Tipo de prática especializada	Contagem potencial de clientes	Procedimentos de imagem anuais
Clínicas de Radiologia	3.500 em todo o país	10.000 a 25.000 procedimentos
Centros de Oncologia	1.200 centros especializados	5.000 a 15.000 procedimentos

Departamentos de diagnóstico de imagem

Aparelhamento do segmento de clientes:

• Centros de imagem ambulatorial: 6.800 instalações
• Departamentos de imagem hospitalar: 4.500 departamentos
• Centros de diagnóstico privados: 2.300 centros

Investidores de tecnologia médica

Cenário de investimento para endra:

Categoria de investidores	Valor potencial de investimento	Nível de juros
Empresas de capital de risco	US $ 500.000 - US $ 5 milhões	Alto interesse em tecnologia médica
Investidores de private equity	US $ 1 milhão - US $ 10 milhões	Interesse moderado a alto

Endra Life Sciences Inc. (NDRA) - Modelo de negócios: Estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 31 de dezembro de 2023, a Endra Life Sciences registrou despesas de P&D de US $ 4,7 milhões.

Ano fiscal	Despesas de P&D
2023	US $ 4,7 milhões
2022	US $ 5,2 milhões

Ensino clínico e custos de conformidade regulatória

O ensaio clínico e as despesas de conformidade regulatória da Endra em 2023 totalizaram aproximadamente US $ 2,3 milhões.

• Custos de envio da FDA: US $ 350.000
• Gerenciamento de ensaios clínicos: US $ 1,5 milhão
• Documentação regulatória: US $ 450.000

Investimentos de fabricação e produção

As despesas de capital para infraestrutura de fabricação em 2023 foram de US $ 1,1 milhão.

Categoria de investimento	Quantia
Equipamento	$750,000
Atualizações da instalação	$350,000

Despesas de vendas e marketing

As despesas de vendas e marketing para 2023 foram de US $ 1,8 milhão.

• Marketing digital: US $ 450.000
• Participação de conferência e evento: US $ 350.000
• Compensação da equipe de vendas: US $ 1.000.000

Custos de sobrecarga operacional e pessoal

A sobrecarga operacional total para 2023 foi de US $ 3,2 milhões.

Categoria de custo	Quantia
Salários de pessoal	US $ 2,5 milhões
Despesas do escritório	$450,000
Infraestrutura de tecnologia	$250,000

Endra Life Sciences Inc. (NDRA) - Modelo de negócios: fluxos de receita

Vendas e licenciamento de dispositivos médicos

A partir do quarto trimestre de 2023, a Endra Life Sciences registrou receita total de US $ 0,4 milhão. A receita primária de dispositivos médicos da empresa vem de sua plataforma de tecnologia Thermo Acoustic Enhanced Ultrassom (TAEUS).

Fonte de receita	2023 quantidade
Vendas de dispositivos médicos	US $ 0,4 milhão
Potencial de licenciamento	Ainda não monetizado

Contratos de desenvolvimento de tecnologia

A ENDRA garantiu contratos de pesquisa e desenvolvimento com valor potencial, particularmente em tecnologias de imagem médica.

• Parcerias de pesquisa em andamento com instituições médicas
• Oportunidades potenciais de pesquisa de contrato em diagnóstico imagens

Vendas de equipamentos de diagnóstico de imagem

A tecnologia TAEUS da empresa tem como alvo vários mercados de diagnóstico de imagem com possíveis fluxos de receita.

Segmento de mercado	Foco potencial de receita
Imagem hepática	Entrada primária no mercado
Imagem da mama	Oportunidade secundária de mercado

Serviço recorrente e receita de suporte

A partir de 2024, a Endra está desenvolvendo modelos de receita recorrentes através de:

• Contratos de manutenção de equipamentos
• Assinaturas de atualização de software
• Serviços de suporte técnico

Subsídios de pesquisa e colaborações

Endra buscou oportunidades de financiamento de pesquisa para apoiar o desenvolvimento de tecnologia.

Fonte de financiamento	Valor potencial
NIH Grants	Oportunidades de financiamento potenciais
Colaborações acadêmicas	Suporte de validação de tecnologia

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

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

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

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

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

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

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

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

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

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

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

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

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

The key performance metrics that drive this efficiency are:

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

Finance: draft 13-week cash view by Friday.

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

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

High-Touch Regulatory Engagement

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

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

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

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

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

Professional B2B Sales

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

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

Automated/Digital

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

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

Investor Communications

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Each unit was priced at $6.57.

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

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

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

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

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

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

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

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

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

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

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

Finance: draft 13-week cash view by Friday.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The current revenue structure is built on these key elements:

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

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