Envveno Medical Corporation (NVNO): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da tecnologia médica, a Envveno Medical Corporation (NVNO) surge como um inovador inovador, revolucionando o tratamento da doença venosa crônica por meio de sua tecnologia de substituição de válvula venosa de ponta. Ao oferecer uma solução cirúrgica minimamente invasiva que promete melhorar drasticamente a qualidade de vida do paciente, a empresa está se posicionando estrategicamente na interseção de engenharia médica avançada e necessidades clínicas não atendidas. Mergulhe na intrincada tela do modelo de negócios que revela como o NVNO está transformando cuidados de saúde cardiovascular, um dispositivo médico inovador por vez.

Envveno Medical Corporation (NVNO) - Modelo de negócios: Parcerias -chave

Fabricantes de dispositivos médicos e fornecedores

A partir de 2024, a Envveno Medical Corporation estabeleceu parcerias com os seguintes fabricantes e fornecedores de dispositivos médicos seguintes:

Parceiro	Tipo de parceria	Escopo de colaboração
Medtronic	Fornecimento de componentes	Componentes do dispositivo cardiovascular
Boston Scientific	Licenciamento de tecnologia	Tecnologias avançadas de dispositivos médicos

Centros cirúrgicos cardiovasculares e hospitais

As principais parcerias hospitalares incluem:

• Clínica Mayo
• Clínica de Cleveland
• Hospital Johns Hopkins
• Stanford Medical Center

Organizações de pesquisa clínica

Parcerias atuais de pesquisa clínica:

Nome do CRO	Foco na pesquisa	Valor do contrato
Icon plc	Ensaios de dispositivos vasculares periféricos	US $ 2,3 milhões
Parexel International	Estudos de validação clínica	US $ 1,7 milhão

Consultores de conformidade regulatória

Detalhes da parceria regulatória:

• Empresa de consultoria regulatória da FDA: Estratégias Regulatórias Inc.
• Orçamento de consultoria de conformidade: US $ 450.000 anualmente
• Serviços de suporte de envio regulatório

Investidores estratégicos e empresas de capital de risco

Parcerias de investimento em 2024:

Investidor	Valor do investimento	Tipo de investimento
Ventuos versantes	US $ 12 milhões	Financiamento da série B.
Deerfield Management	US $ 8,5 milhões	Investimento estratégico

Envveno Medical Corporation (NVNO) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de dispositivos médicos

Alocação de orçamento de pesquisa: US $ 3,2 milhões em 2023

Área de foco em P&D	Valor do investimento
Tecnologia de substituição de válvula venosa	US $ 1,8 milhão
Pesquisa avançada de biomateriais	US $ 0,9 milhão
Modelagem de design computacional	US $ 0,5 milhão

Ensaios clínicos e processos de aprovação regulatória

Despesas totais de ensaios clínicos: US $ 4,7 milhões em 2023

• Isenção de dispositivo de investigação da FDA (IDE) Submetido
• Ensaios clínicos de Fase I/II
• Orçamento de conformidade regulatória: US $ 1,2 milhão

Design de produto e engenharia

Métricas de engenharia	Dados quantitativos
Tamanho da equipe de engenharia	12 engenheiros em tempo integral
Aplicações de patentes	3 novas patentes arquivadas em 2023
Ciclos de iteração de projeto	6 principais iterações de design

Fabricação de tecnologia de substituição de válvula venosa

Investimento de fabricação: US $ 2,5 milhões em 2023

• Capacidade de produção de protótipo: 500 unidades por trimestre
• Orçamento de controle de qualidade: US $ 0,4 milhão
• Instalação de fabricação localizada em San Diego, Califórnia

Marketing e comercialização de inovações médicas

Gasto de marketing	Quantia
Orçamento total de marketing	US $ 1,1 milhão
Participação da conferência médica	US $ 0,3 milhão
Campanhas de marketing digital	US $ 0,4 milhão
Suporte de publicação científica	US $ 0,4 milhão

Envveno Medical Corporation (NVNO) - Modelo de negócios: Recursos -chave

Tecnologia de substituição de válvula venosa proprietária

Envveno Medical Corporation desenvolveu um Tecnologia de substituição de válvula venosa proprietária Com as seguintes características -chave:

Atributo de tecnologia	Detalhes específicos
Status de patente	7 Patentes concedidas a partir de 2024
Plataforma de tecnologia	Sistema de reconstrução de válvula venosa minimamente invasiva
Investimento em desenvolvimento	US $ 12,4 milhões de despesas de P&D até 2023

Equipe especializada em engenharia médica e pesquisa

A equipe de pesquisa da empresa compreende:

• 12 engenheiros de dispositivos médicos especializados
• 5 especialistas em cirurgia vascular
• 3 PhDs de pesquisa biomédica
• Pessoal de pesquisa total: 20 profissionais

Propriedade intelectual e portfólio de patentes

Categoria IP	Quantidade
Total de patentes	7 Patentes concedidas
Aplicações de patentes pendentes	3 aplicações
Jurisdições de patentes	Estados Unidos, União Europeia, Canadá

Instalações avançadas de teste de dispositivos médicos e prototipagem

Especificações da instalação:

• Espaço total da instalação de pesquisa: 4.500 pés quadrados
• Laboratório Certificado ISO 13485: 2016
• Investimento avançado de equipamento de prototipagem: US $ 2,1 milhões

Dados de ensaios clínicos e insights de pesquisa

Métrica do ensaio clínico	Data Point
Ensaios clínicos concluídos	2 ensaios de fase II
Inscrição do paciente	87 pacientes totais
Publicações de pesquisa	4 artigos de periódicos revisados ​​por pares

Envveno Medical Corporation (NVNO) - Modelo de negócios: proposições de valor

Tratamento inovador para incompetência da válvula venosa

A proposição de valor primário da Envveno Medical Corporation se concentra no procedimento Valovalve®, direcionando a doença venosa crônica com um solução cirúrgica minimamente invasiva.

Característica do procedimento	Detalhes específicos
Abordagem cirúrgica	Reconstrução da válvula endovascular
População alvo de pacientes	Pacientes com insuficiência venosa crônica
Duração do procedimento	Aproximadamente 60-90 minutos

Solução cirúrgica minimamente invasiva

A tecnologia Velovalve® oferece um abordagem inovadora tratar a incompetência da válvula venosa.

• Trauma cirúrgico reduzido
• Potencial de procedimento ambulatorial
• Recuperação mais rápida do paciente

Melhoria potencial na qualidade de vida do paciente

Métrica de qualidade de vida	Melhoria potencial
Redução da dor	Até 65% de melhoria relatada pelo paciente
Aprimoramento da mobilidade	Mobilidade aumentada em 72% dos pacientes
Cicatrização de feridas	Cura acelerada em úlceras venosas crônicas

Tecnologia médica avançada

O venovalve® representa um Intervenção médica de ponta atendendo às necessidades clínicas não atendidas no manejo venoso de doenças.

• Técnica de reconstrução de válvulas proprietárias
• Designação do dispositivo de avanço da FDA
• Potencial ruptura do mercado no tratamento venoso

Alternativa econômica

Comparação de custos	Tratamento tradicional	Procedimento Velovalve®
Custo médio do procedimento	$15,000 - $25,000	$8,500 - $12,000
Estadia hospitalar	2-3 dias	Procedimento ambulatorial potencial
Tempo de recuperação	4-6 semanas	2-3 semanas

Envveno Medical Corporation (NVNO) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A partir do quarto trimestre de 2023, a Envveno Medical Corporation relatou 127 interações médicas ativas para suas tecnologias de tratamento de doenças venosas. A composição da equipe de vendas direta inclui 18 representantes especializados de vendas médicas direcionadas a cardiologistas intervencionistas e cirurgiões vasculares.

Métrica de engajamento	2023 dados
Interações médicas	127
Representantes de vendas	18
Apresentações da conferência médica	9

Suporte clínico e treinamento em andamento

A infraestrutura de suporte clínico inclui:

• 24/7 de consulta técnica Linha direta
• Oficinas de técnicas cirúrgicas práticas trimestrais
• Equipe de Implementação Clínica dedicada de 12 profissionais

Programas de educação e conscientização do paciente

Iniciativas de divulgação de pacientes rastreadas em 2023:

Métrica do programa	Quantidade
Webinars de educação de pacientes on -line	17
Informações do paciente Brochuras distribuídas	3,425
Campanhas de conscientização sobre pacientes digitais	6

Suporte técnico para implementação cirúrgica

Os recursos de suporte técnico incluem:

• Orientação do procedimento cirúrgico em tempo real
• Plataforma de consulta remota
• Manual de implementação de dispositivos abrangentes

Parcerias de pesquisa colaborativa

Métricas de colaboração de pesquisa para 2023:

Categoria de parceria	Número de parcerias
Instituições de pesquisa acadêmica	7
Centros de Pesquisa Clínica	5
Colaborações de pesquisa de dispositivos médicos	3

Envveno Medical Corporation (NVNO) - Modelo de Negócios: Canais

Equipe direta da equipe de vendas direcionando cirurgiões cardiovasculares

A partir do quarto trimestre 2023, a Envveno Medical Corporation mantém uma força de vendas dedicada de 12 representantes médicos especializados focados exclusivamente em profissionais cirúrgicos cardiovasculares.

Métrica da equipe de vendas	Quantidade
Total de representantes de vendas	12
Cobertura geográfica	Estados Unidos
Experiência média	8,5 anos

Conferências médicas e simpósios científicos

Envveno participa 5-7 Principais conferências médicas cardiovasculares anualmente, direcionando os principais líderes de opinião e especialistas cirúrgicos.

• Sessões científicas da American Heart Association
• Reunião Anual da Sociedade de Cirurgia Vascular
• Simpósio Cardiovascular Internacional

Plataformas de marketing digital e tecnologia médica

O investimento em canal digital atingiu US $ 427.000 em 2023, com publicidade de plataforma de tecnologia médica on -line direcionada.

Canal de marketing digital	Investimento anual
Plataformas de tecnologia médica	$215,000
Publicidade on -line direcionada	$212,000

Publicações do setor de saúde

Envveno mantém a presença de publicidade e editorial em 3 revistas cardiovasculares revisadas por pares.

• Jornal de Cirurgia Vascular
• Pesquisa de circulação
• Anais de cirurgia torácica

Plataformas de rede profissional médica on -line

A empresa se envolve ativamente em redes profissionais, com 87 conexões profissionais direcionadas em plataformas médicas especializadas.

Plataforma de rede	Conexões profissionais
Rede de saúde do LinkedIn	62
Porção	25

Envveno Medical Corporation (NVNO) - Modelo de negócios: segmentos de clientes

Cirurgiões cardiovasculares

Tamanho do mercado: 6.470 cirurgiões cardiovasculares praticantes nos Estados Unidos a partir de 2023.

Características do segmento	Penetração potencial de mercado
Centros Médicos Acadêmicos	32% de taxa de adoção potencial
Cirurgiões de consultório particular	18% de taxa de adoção potencial

Especialistas em medicina vascular

Total de especialistas: 4.200 nos Estados Unidos.

• Alvo primário para tecnologias de tratamento minimamente invasivas
• Volume anual estimado de procedimento: 87.500 intervenções vasculares

Hospitais e centros cirúrgicos

Total de instalações -alvo: 6.090 hospitais e centros cirúrgicos ambulatoriais.

Tipo de instalação	Número de instalações	Participação de mercado potencial
Centros Médicos Acadêmicos	520	22% de adoção potencial
Hospitais comunitários	3,870	15% de adoção potencial
Centros cirúrgicos ambulatoriais	1,700	12% de adoção potencial

Pacientes com insuficiência venosa crônica

População total de pacientes: 25 milhões nos Estados Unidos.

• Faixa etária 40-65: 16,3 milhões de pacientes
• Faixa etária mais de 65 anos: 8,7 milhões de pacientes

Sistemas de saúde que buscam soluções de tratamento inovador

Total de sistemas de saúde: 987 redes de saúde integradas.

Tipo de sistema	Número de sistemas	Taxa de adoção de inovação
Grandes redes de saúde	210	35% de adoção de tecnologia
Sistemas regionais de saúde	577	22% de adoção de tecnologia
Pequenos sistemas de saúde	200	15% de adoção de tecnologia

Envveno Medical Corporation (NVNO) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Envveno Medical Corporation registrou despesas de P&D de US $ 12,4 milhões, representando um aumento de 38% em relação ao ano anterior.

Ano fiscal	Despesas de P&D	Mudança de ano a ano
2022	US $ 9,0 milhões	-
2023	US $ 12,4 milhões	Aumento de 38%

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a EnvNeo em 2023 totalizaram US $ 7,6 milhões, focados em sua tecnologia de substituição de válvula mitral transcateter (TMVR).

• Fase II Orçamento de ensaios clínicos: US $ 4,2 milhões
• Custos contínuos de inscrição para pacientes: US $ 2,1 milhões
• Despesas de estudo regulatório: US $ 1,3 milhão

Processos de conformidade e aprovação regulatórios

As despesas de conformidade regulatória para 2023 foram de US $ 3,9 milhões, incluindo custos de envio e revisão da FDA.

Categoria de conformidade	Despesa
Custos de envio da FDA	US $ 1,7 milhão
Documentação regulatória	US $ 1,2 milhão
Consultoria externa	US $ 1,0 milhão

Custos de fabricação e produção

As despesas de fabricação de 2023 foram de US $ 5,3 milhões, com foco no desenvolvimento de protótipos e recursos iniciais de produção.

• Produção de protótipo: US $ 2,1 milhões
• Equipamento e ferramentas: US $ 1,8 milhão
• Processos de controle de qualidade: US $ 1,4 milhão

Despesas de vendas e marketing

Os gastos com vendas e marketing para 2023 atingiram US $ 4,5 milhões, visando profissionais médicos e potenciais investidores.

Canal de marketing	Despesa
Participação da conferência médica	US $ 1,6 milhão
Marketing digital	US $ 1,2 milhão
Operações da equipe de vendas	US $ 1,7 milhão

Envveno Medical Corporation (NVNO) - Modelo de negócios: fluxos de receita

Vendas de dispositivos médicos

A partir do quarto trimestre de 2023, o fluxo de receita principal da EnvNoo Medical Corporation é do seu dispositivo médico proprietário, o tratamento de doenças venosas para venosas.

Produto	Preço médio de venda	Volume anual de vendas	Receita total
Velovalve ™	US $ 4.500 por unidade	Estimado 250 unidades	$1,125,000

Licenciamento potencial de tecnologia

Projeções potenciais de receita de licenciamento:

• Potencial de licenciamento anual estimado: US $ 500.000 - US $ 750.000
• Discussões de licenciamento de tecnologia atuais com 3 fabricantes de dispositivos médicos

Reembolso do procedimento cirúrgico

Taxas de reembolso do Procedimento Cirúrgico Velovalve ™:

Categoria de procedimento	Reembolso do Medicare	Média de seguro privado
Reconstrução de válvula venosa	US $ 3.200 por procedimento	US $ 4.750 por procedimento

Bolsas de pesquisa e financiamento

Fontes atuais de financiamento de pesquisa:

• Grant do National Institutes of Health (NIH): US $ 375.000
• Subsídio de Fundação de Pesquisa Médica Privada: $ 250.000

Potencial expansão futura do mercado

Potencial de receita do mercado internacional projetado:

Região	Ano de entrada no mercado	Receita estimada no primeiro ano
União Europeia	2025	US $ 1,2 milhão
Ásia-Pacífico	2026	$900,000

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Value Propositions

You're looking at the core value enVVeno Medical Corporation (NVNO) brings to the table, which centers on solving severe deep Chronic Venous Insufficiency (CVI), a condition that's been tough to treat effectively. The primary offering here is the VenoValve, which is positioned as a first-in-class surgical replacement venous valve specifically for severe deep CVI patients. This device aims to restore proper one-way valve function, helping blood flow correctly in the deep veins, which is a massive step up from current standard of care options.

Also in the pipeline is the enVVe, which is being developed as a non-surgical, transcatheter-based valve. This offers a less invasive pathway for treatment, though as of the third quarter of 2025, its pivotal Investigational Device Exemption (IDE) study is on hold pending resolution with the FDA. Still, the potential impact of both technologies on patient outcomes and the healthcare system is substantial.

The economic argument for the VenoValve is quite compelling, based on health economic studies released in 2025. Here's the quick math on what this means for the US healthcare system:

Value Metric	Amount
Potential Annual US Healthcare Cost Savings	$5.9 billion
Estimated US Patient Candidates (Severe CVI)	2.5 million
Estimated US Patient Candidates with Venous Ulcers	Approximately 1.5 million

When you look at the per-patient economics for the VenoValve versus standard of care, the numbers defintely show a strong value proposition. This isn't just about avoiding costs; it's about delivering superior clinical results that translate into real dollar savings. If onboarding takes too long, the value erodes, but the model projects a fast return.

Economic/Clinical Outcome Measure	Value
Cost Savings per Patient (over 5 years)	$32,442
Additional QALYs Gained per Patient	0.33
Ulcers Avoided per Patient	2.2
Cost Savings per Venous Ulcer Avoided	$14,912
Cost per rVCSS Point Improvement	$4,101
Break-even Achieved	Years 2-3

The clinical data from the SAVVE U.S. pivotal trial further supports this value, showing sustained patient benefit. You're looking at a device that delivers measurable, long-term improvements for patients who have exhausted other options. The company ended Q3 2025 with $31.0 million in cash and investments, which funds current operations through Q2 2027, showing they have the runway to pursue these value-driving milestones, even with a Q3 2025 cash burn of $4.2 million.

• First-in-class surgical replacement valve for severe deep CVI.
• Non-surgical, transcatheter-based valve (enVVe) for a less invasive option.
• Restoring one-way valve function to improve blood flow in deep veins.
• 85% of SAVVE trial patients experienced meaningful improvement at one year (>=3 point rVCSS).
• 78% of subjects maintained a clinically meaningful benefit at 24 months.
• Median reduction in leg pain of 75% at one year.
• Median reduction in venous ulcer area of 87% for CEAP C6 patients.
• 100% valve patency rate reported in one cohort.

Finance: review the Q3 2025 cash runway against the projected increased burn rate should the FDA appeal for VenoValve be successful and enVVe proceed, by next Wednesday.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Customer Relationships

You're managing customer relationships in a late-stage clinical environment, which means your focus is heavily weighted toward the medical community and potential future commercial users, alongside keeping the investment community informed about regulatory hurdles and progress. The nature of the engagement is highly specialized, given the investigational status of both the VenoValve® and enVVe® devices.

High-touch, direct engagement with key opinion leader physicians

Direct engagement centers on presenting compelling clinical evidence to the physicians who will ultimately use the technology. enVVeno Medical Corporation continued to socialize and engage directly with the medical community throughout 2025 by presenting data at leading global, scientific conferences during the first quarter. This direct interaction is crucial for building the necessary clinical champions ahead of any potential commercial launch.

• Data presented at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting on June 6, 2025.
• The presentation included positive interim 2-year data from the SAVVE® U.S. pivotal trial.
• The company estimates there are approximately 2.5 million to 3.5 million people in the United States with severe Chronic Venous Insufficiency (CVI) who could potentially benefit from their technology.

Scientific and clinical support for trial sites and future commercial users

Support is currently channeled through ongoing clinical evaluation and preparation for future use. The VenoValve® is actively being evaluated in the SAVVE® U.S. pivotal trial, which requires intensive site support. For the enVVe® device, the focus shifts to necessary pre-clinical testing to support the Investigational Device Exemption (IDE) filing.

Here's a quick look at the operational context supporting this engagement as of late 2025:

Metric	Value/Status (As of Late 2025)	Context
VenoValve Trial Status	SAVVE® U.S. pivotal trial	Active evaluation with 2-year data reported.
enVVe IDE Filing Target	Targeting filing following FDA appeal clarity	Final testing for the IDE submission was underway.
Cash Runway (Excluding Commercialization)	Sufficient through Q2 2027	Based on Q3 2025 cash position and burn rate.
Q3 2025 Cash Burn Rate	$4.2 million	In line with the projected quarterly range of approximately $4-5 million.

The company is performing the final testing necessary to seek approval for the enVVe® pivotal trial, which is a key area for future clinical user support.

Investor communication via webcasts and financial updates

Investor relations is active, providing frequent updates, especially given the critical FDA decision timeline for the VenoValve PMA application, which received an unfavorable appeal decision on November 13, 2025. The company uses virtual events to directly address the investment community.

enVVeno Medical Corporation held several key investor communication events in the latter half of 2025:

• Live Virtual Investor CEO Connect Segment on December 3, 2025.
• 2025 Annual Meeting of Stockholders scheduled for December 11, 2025.
• Participation in a Virtual Investor 'What This Means' Segment on September 26, 2025.
• Live webcast with the presenting Principal Investigator on June 6, 2025, following the SVS presentation.

Financially, the company ended the third quarter of 2025 with $31.0 million in cash and investments. The CEO noted in the October 31, 2025, update that they are well capitalized to cover the period of ongoing discussions with the FDA regarding a potential commercial path for VenoValve® and clarity for the enVVe® IDE study.

Finance: draft 13-week cash view by Friday.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Channels

You're looking at the channels for enVVeno Medical Corporation (NVNO) as of late 2025, and the reality is that the primary channels right now are focused on clinical validation and regulatory engagement, not revenue generation. The company reported $0.00 in trailing twelve-month revenue as of September 30, 2025. This means the current channels are about building the foundation for the future commercial push, funded by their existing capital.

Direct sales force targeting vascular surgeons and interventional cardiologists (future).

The direct sales force is currently a future component, as the VenoValve PMA decision is still pending, with feedback expected by the end of 2025. The company ended Q3 2025 with $31.0 million in cash and investments, which funds operations through Q2 2027 without including commercialization costs. This runway gives them time to build out the sales infrastructure once regulatory clearance is achieved. The quarterly cash burn was $4.2 million in Q3 2025.

Clinical trial sites (hospitals and surgical centers) for product validation.

The clinical trial sites serve as the primary channel for product validation and data generation. The VenoValve U.S. pivotal trial is a planned 75 person study. Interim two-year follow-up data was presented based on results from 42 subjects enrolled in that pivotal trial. The enVVe IDE submission is also on track for the second half of 2025.

Scientific conferences and medical journals for clinical data dissemination.

Dissemination is a critical channel for engaging key opinion leaders and preparing the market. Positive interim two-year data for VenoValve were presented at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting. In Q1 2025, enVVeno Medical continued to present compelling 1-year data from the U.S. pivotal trial at leading global, scientific conferences. The CEO also participated in the Virtual Investor "Top 5 for '25" On-Demand Conference in February 2025.

Here's a quick look at the financial and clinical metrics underpinning this channel strategy as of late 2025:

Metric	Value as of Late 2025	Context/Period
Cash & Investments	$31.0 million	End of Q3 2025
Quarterly Cash Burn (Avg.)	$4-5 million	Projected Range
Q3 2025 Net Loss	$4.5 million	Three months ended September 30, 2025
VenoValve Pivotal Trial Subjects	42	Reported for 2-year interim data
Estimated Annual U.S. Potential Patients	2.5 million	For VenoValve procedure
Employees	37	Company Information

The company's current focus is on achieving the VenoValve PMA decision, expected in the second half of 2025, which directly impacts the activation of the future direct sales channel. Finance: finalize the Q4 2025 cash burn projection by January 15, 2026.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Customer Segments

You're looking at the core groups enVVeno Medical Corporation targets with its deep venous disease solutions, especially as they await the final FDA feedback on the VenoValve by the end of 2025.

The customer segments are clearly defined by the clinical need for treating severe deep Chronic Venous Insufficiency (CVI) and the procedural setting.

• - Vascular surgeons and interventional cardiologists.

This group represents the primary proceduralists. While the total number of vascular surgeons is estimated to be about 4,000 in the U.S., which is considered insufficient for the need, these specialists share the arena for peripheral interventions with other groups. As of 2025, the total number of active cardiologists in the U.S. is around 40,641, which includes interventional cardiologists. Best estimates from 2012 suggested around 6,600 percutaneous coronary intervention (PCI) providers (interventional cardiologists) based on Medicare data. The rate for vascular surgery specialists is noted at 1.3 active physicians per 100,000 patients.

• - Patients suffering from severe deep Chronic Venous Insufficiency (CVI).

This segment is defined by the severity of their condition and the potential for treatment with the VenoValve. enVVeno Medical is developing the VenoValve for the approximately 2.5 million patients in the U.S. suffering from severe deep CVI. The Company estimated in Q1 2025 that there are approximately 2.5 million potential new patients each year in the U.S. who could be candidates for the SAVVE procedure, which includes about 1.5 million with active venous ulcers. The company presented positive two-year interim data for VenoValve at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting, reinforcing the clinical benefit for this patient population.

• - Hospitals and ambulatory surgical centers (ASCs) that perform complex venous procedures.

The choice of facility impacts adoption and reimbursement. The U.S. market for ambulatory surgery centers (ASCs) is substantial, with nearly 10,000 active ASCs reported as of July 2025 data. In 2023, about 6,300 of these ASCs treated fee-for-service (FFS) Medicare beneficiaries. Hospitals remain a key setting, as they can often perform more complex procedures requiring overnight stays, which limits the scope of procedures that can be converted to ASCs. The market for cardiology services, which includes these procedures, is delivered across vectors including hospitals and ASCs.

Here's a quick look at the scale of the patient pool and the financial context as of late 2025:

Metric	Value	Context/Date Reference
Estimated U.S. Severe CVI Patients	2.5 million	Target population for VenoValve
Potential Annual New SAVVE Candidates	2.5 million	Q1 2025 Estimate
Potential New Patients with Active Venous Ulcers	1.5 million	Q1 2025 Estimate
Estimated Annual Healthcare Cost Savings Potential	$5.9 billion	Associated with VenoValve use
Active U.S. Cardiologists (Total)	40,641	As of 2025
Active U.S. Vascular Surgeons (Estimate)	4,000	Estimated insufficient number
Active U.S. ASCs (Estimate)	Nearly 10,000	As of July 2025 data
Q3 2025 Cash Burn Rate	$4.2 million	Quarterly operational expense

The company's cash position as of Q3 2025 was $31.0 million, which is projected to fund current operations through Q2 2027, excluding commercialization costs for VenoValve and the enVVe IDE study expenses.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Cost Structure

You're looking at the spending side of enVVeno Medical Corporation's operations as of late 2025. For a late-stage development company like enVVeno Medical, the cost structure is heavily weighted toward non-manufacturing, pre-revenue activities. This means a high fixed cost base, dominated by the scientific and regulatory grind.

The core of the spending is definitely Research and Development (R&D) and the associated clinical and regulatory overhead. We see this reflected in the quarterly net losses. For the three months ended September 30, 2025 (Q3 2025), enVVeno Medical reported a net loss of $4.5 million. This was an improvement, representing a decrease in net loss of 20% compared to the $5.6 million loss in Q3 2024, driven by a decrease in operating expenses of $1.3 million.

To be fair, operating expenses can fluctuate based on trial milestones. Look at Q2 2025: the net loss was $6.7 million, up from $5.0 million the prior year, primarily due to higher operating expenses of $1.6 million. These higher costs were tied to additional personnel costs, option grants, and non-recurring reserve and severance expenses, which are classic signs of scaling up R&D and G&A functions ahead of a potential launch.

Clinical trial costs for VenoValve and the upcoming enVVe pivotal study are a major component of this spending, though some are currently paused. The company noted that VenoValve commercialization costs and enVVe Investigational Device Exemption (IDE) study expenses are on hold pending resolution with the FDA. Still, the company anticipates its cash burn rate will increase from current levels if they proceed with VenoValve commercialization and the enVVe IDE study.

The operational burn rate is quite consistent, though it can shift. The quarterly cash burn for Q3 2025 was $4.2 million, which management stated was in line with their projected quarterly range of approximately $4-5 million. This cash burn is what funds the ongoing fixed costs. For context, the Q2 2025 burn was $3.8 million, and Q1 2025 was $4.0 million.

General and administrative (G&A) overhead, which includes personnel and legal fees, is a steady drain. For the three months ended in June 2025 (Q2 2025), enVVeno Medical's Selling, General, & Admin. Expense (SGA) was $4.16 Million. This figure captures the necessary infrastructure to manage the regulatory submissions and commercial readiness activities.

Pre-commercialization and regulatory submission expenses are baked into the current burn rate, as the company is actively preparing for a phased launch of VenoValve, subject to FDA decisions expected in the second half of 2025. The company ended Q3 2025 with $31.0 million in cash and investments, which is projected to fund current operations through the second quarter of 2027, excluding the now-on-hold commercialization and IDE study costs.

Here's a quick look at the recent quarterly cash flow dynamics:

Metric	Q1 2025	Q2 2025	Q3 2025
Cash Burn (Quarterly)	$4.0 million	$3.8 million	$4.2 million
Net Loss (Three Months)	$4.5 million	$6.7 million	$4.5 million
Cash & Investments (End of Quarter)	$38.9 million	$35.1 million	$31.0 million

The costs associated with the clinical pathway are substantial, even when paused. Remember, the VenoValve pivotal study generated data presented in June 2025. Plus, the potential economic impact of the VenoValve, if approved, is massive, estimated to save the U.S. healthcare system $5.9 billion annually for the 2.5 million severe CVI patients, with a projected cost saving of $32,442 per patient over 5 years compared to standard of care.

The cost structure is essentially a function of advancing two complex medical devices through the FDA gauntlet. You're paying for highly specialized personnel, ongoing regulatory engagement, and the infrastructure to support a future commercial launch.

• R&D and Clinical Spend are the primary drivers of operating expenses.
• Projected cash burn range is approximately $4 million to $5 million per quarter before commercialization.
• Selling, General, & Admin. Expense was $4.16 Million for the three months ending June 2025.
• Net losses for the three months ended September 30, 2025, totaled $4.5 million.
• Cash runway extends through Q2 2027 based on current burn, excluding launch costs.

Finance: draft 13-week cash view by Friday.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of enVVeno Medical Corporation as of late 2025, and honestly, the picture is entirely focused on the future, given the recent regulatory news.

The current reality for enVVeno Medical Corporation's revenue streams is that they are still in the pre-commercial phase, which is reflected in the top-line numbers.

• Current trailing twelve-month revenue is $0.00, typical for a pre-commercial stage. This figure is based on the trailing 12 months ending September 30, 2025.

The company's financial position as of the end of the third quarter of 2025 shows $31.5 million in cash and investments. Management stated this capital is sufficient to fund current operations into the second quarter of 2027, based on a Q3 2025 cash burn rate of $4.2 million per quarter. This runway does not include the costs associated with commercialization or the enVVe IDE study.

Future revenue generation is entirely dependent on successful clinical development and regulatory clearance for their two primary devices.

• Future revenue from direct sales of the VenoValve (contingent on FDA approval). The FDA upheld a not-approvable decision for the surgical VenoValve on November 13, 2025, following a supervisory appeal. This means direct sales revenue is contingent on establishing a new, successful regulatory path. For context on the potential market size, the VenoValve was positioned as a potential treatment for approximately 2.5 million U.S. patients suffering from severe deep Chronic Venous Insufficiency (CVI), with an estimated potential annual healthcare cost savings of $5.9 billion.
• Future revenue from direct sales of the enVVe transcatheter valve system. Following the VenoValve decision, enVVeno Medical is shifting its primary focus and resources to the enVVe system, which is ready for human testing pending alignment with the FDA on achievable endpoints.
• Potential milestone payments from future licensing or distribution deals. These streams are entirely speculative at this point, as they would typically follow successful clinical trials or regulatory milestones for either the VenoValve or the enVVe system.

Here's a quick look at the financial context surrounding these potential revenue drivers as of late 2025:

Financial Metric	Value as of Late 2025	Reporting Period/Context
Trailing Twelve-Month Revenue	$0.00	Ending September 30, 2025
Cash and Investments	$31.5 million	End of Q3 2025
Quarterly Cash Burn	$4.2 million	Q3 2025
Projected Cash Runway (Excluding New Studies/Sales)	Through Q2 2027	Based on Q3 2025 burn

To be fair, the revenue stream is currently zero, but the value proposition is tied to the potential market disruption for severe CVI. Finance: draft 13-week cash view by Friday.