enVVeno Medical Corporation (NVNO): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama de tecnología médica en rápida evolución, Envveno Medical Corporation (NVNO) emerge como un innovador innovador, revolucionando el tratamiento de enfermedades venosas crónicas a través de su tecnología de reemplazo de válvulas venosas de vanguardia. Al ofrecer una solución quirúrgica mínimamente invasiva que promete mejorar drásticamente la calidad de vida del paciente, la compañía se está posicionando estratégicamente en la intersección de la ingeniería médica avanzada y las necesidades clínicas no satisfechas. Coloque en el intrincado lienzo de modelo de negocio que revela cómo NVNO está transformando la atención médica cardiovascular, un dispositivo médico innovador a la vez.

Envveno Medical Corporation (NVNO) - Modelo de negocios: asociaciones clave

Fabricantes y proveedores de dispositivos médicos

A partir de 2024, Envveno Medical Corporation ha establecido asociaciones con los siguientes fabricantes y proveedores de dispositivos médicos clave:

Pareja	Tipo de asociación	Alcance de la colaboración
Medtrónico	Suministro de componentes	Componentes del dispositivo cardiovascular
Boston Scientific	Licencias de tecnología	Tecnologías avanzadas de dispositivos médicos

Centros y hospitales quirúrgicos cardiovasculares

Las asociaciones clave del hospital incluyen:

• Clínica de mayonesa
• Clínica de Cleveland
• Hospital Johns Hopkins
• Centro Médico de Stanford

Organizaciones de investigación clínica

Asociaciones actuales de investigación clínica:

Nombre de Cro	Enfoque de investigación	Valor de contrato
Ícono plc	Pruebas de dispositivos vasculares periféricos	$ 2.3 millones
Parexel International	Estudios de validación clínica	$ 1.7 millones

Consultores de cumplimiento regulatorio

Detalles de la asociación regulatoria:

• FDA Regulatory Consulting Firm: Regulatoratory Strategies Inc.
• Presupuesto de consultoría de cumplimiento: $ 450,000 anualmente
• Servicios de soporte de presentación regulatoria

Inversores estratégicos y empresas de capital de riesgo

Asociaciones de inversión a partir de 2024:

Inversor	Monto de la inversión	Tipo de inversión
Versant Ventures	$ 12 millones	Financiación de la Serie B
Administración de Deerfield	$ 8.5 millones	Inversión estratégica

Envveno Medical Corporation (NVNO) - Modelo de negocio: actividades clave

Investigación y desarrollo de dispositivos médicos

Asignación de presupuesto de investigación: $ 3.2 millones en 2023

Área de enfoque de I + D	Monto de la inversión
Tecnología de reemplazo de válvula venosa	$ 1.8 millones
Investigación avanzada de biomateriales	$ 0.9 millones
Modelado de diseño computacional	$ 0.5 millones

Ensayos clínicos y procesos de aprobación regulatoria

Gastos totales de ensayos clínicos: $ 4.7 millones en 2023

• Solicitud de exención de dispositivos de investigación de la FDA (IDE) presentada
• Ensayos clínicos de fase I/II en curso
• Presupuesto de cumplimiento regulatorio: $ 1.2 millones

Diseño e ingeniería de productos

Métricas de ingeniería	Datos cuantitativos
Tamaño del equipo de ingeniería	12 ingenieros a tiempo completo
Solicitudes de patentes	3 nuevas patentes presentadas en 2023
Ciclos de diseño de iteración	6 iteraciones de diseño principales

Fabricación de tecnología de reemplazo de válvulas venosas

Inversión de fabricación: $ 2.5 millones en 2023

• Capacidad de producción prototipo: 500 unidades por trimestre
• Presupuesto de control de calidad: $ 0.4 millones
• Instalación de fabricación ubicada en San Diego, California

Marketing y comercialización de innovaciones médicas

Gasto de marketing	Cantidad
Presupuesto total de marketing	$ 1.1 millones
Participación de la conferencia médica	$ 0.3 millones
Campañas de marketing digital	$ 0.4 millones
Apoyo de publicación científica	$ 0.4 millones

Envveno Medical Corporation (NVNO) - Modelo de negocios: recursos clave

Tecnología de reemplazo de válvula venosa patentada

Envveno Medical Corporation ha desarrollado un Tecnología de reemplazo de válvula venosa patentada Con las siguientes características clave:

Atributo tecnológico	Detalles específicos
Estado de patente	7 patentes otorgadas a partir de 2024
Plataforma tecnológica	Sistema de reconstrucción de válvulas venosas mínimamente invasivas
Inversión de desarrollo	$ 12.4 millones de gastos de I + D hasta 2023

Equipo especializado de Ingeniería Médica e Investigación

El equipo de investigación de la compañía comprende:

• 12 ingenieros especializados de dispositivos médicos
• 5 especialistas en cirugía vascular
• 3 doctorados en investigación biomédica
• Total de personal de investigación: 20 profesionales

Propiedad intelectual y cartera de patentes

Categoría de IP	Cantidad
Patentes totales	7 patentes otorgadas
Aplicaciones de patentes pendientes	3 aplicaciones
Jurisdicciones de patente	Estados Unidos, Unión Europea, Canadá

Instalaciones avanzadas de pruebas de dispositivos médicos y prototipos

Especificaciones de la instalación:

• Espacio total de la instalación de investigación: 4,500 pies cuadrados
• ISO 13485: Laboratorio certificado de 2016
• Inversión de equipos de prototipos avanzados: $ 2.1 millones

Datos de ensayos clínicos e información de investigación

Métrico de ensayo clínico	Punto de datos
Ensayos clínicos completados	2 pruebas de fase II
Inscripción del paciente	87 pacientes en total
Publicaciones de investigación	4 artículos de revistas revisados ​​por pares

Envveno Medical Corporation (NVNO) - Modelo de negocio: propuestas de valor

Tratamiento innovador para la incompetencia de la válvula venosa

La propuesta de valor principal de Envveno Medical Corporation se centra en el procedimiento VENOVOVE®, dirigido a la enfermedad venosa crónica con un Solución quirúrgica mínimamente invasiva.

Procedimiento característico	Detalles específicos
Enfoque quirúrgico	Reconstrucción de la válvula endovascular
Población de pacientes objetivo	Pacientes con insuficiencia venosa crónica
Duración del procedimiento	Aproximadamente 60-90 minutos

Solución quirúrgica mínimamente invasiva

La tecnología VENOVOVE® ofrece un enfoque innovador Para tratar la incompetencia de la válvula venosa.

• Trauma quirúrgico reducido
• Potencial de procedimiento ambulatorio
• Recuperación más rápida del paciente

Mejora potencial en la calidad de vida del paciente

Métrica de calidad de vida	Mejora potencial
Reducción del dolor	Hasta 65% de mejora informada por el paciente
Mejora de la movilidad	Aumento de la movilidad en el 72% de los pacientes
Curación de heridas	Curación acelerada en úlceras venosas crónicas

Tecnología médica avanzada

El Venovalve® representa un intervención médica de vanguardia abordar las necesidades clínicas no satisfechas en el manejo de enfermedades venosas.

• Técnica de reconstrucción de válvulas patentada
• Designación de dispositivos innovadores de la FDA
• Potencial interrupción del mercado en el tratamiento venoso

Alternativa rentable

Comparación de costos	Tratamiento tradicional	Procedimiento VENOVOVE®
Costo de procedimiento promedio	$15,000 - $25,000	$8,500 - $12,000
Estadía en el hospital	2-3 días	Procedimiento para pacientes ambulatorios potenciales
Tiempo de recuperación	4-6 semanas	2-3 semanas

Envveno Medical Corporation (NVNO) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, Envveno Medical Corporation reportó 127 interacciones médicas activas para sus tecnologías de tratamiento de enfermedades venosas. La composición del equipo de ventas directas incluye 18 representantes especializados de ventas médicas dirigidas a cardiólogos intervencionistas y cirujanos vasculares.

Métrico de compromiso	2023 datos
Interacciones médicas	127
Representantes de ventas	18
Presentaciones de conferencia médica	9

Apoyo clínico y capacitación en curso

La infraestructura de soporte clínico incluye:

• Línea directa de consulta técnica 24/7
• Talleres de técnica quirúrgica trimestral
• Equipo especializado de implementación clínica dedicada de 12 profesionales

Programas de educación y concientización del paciente

Iniciativas de divulgación de pacientes rastreadas en 2023:

Métrico de programa	Cantidad
Seminarios web de educación para pacientes en línea	17
Folletos de información del paciente distribuidos	3,425
Campañas de concientización sobre el paciente digital	6

Soporte técnico para la implementación quirúrgica

Los recursos de soporte técnico incluyen:

• Orientación de procedimiento quirúrgico en tiempo real
• Plataforma de consulta remota
• Manual de implementación integral del dispositivo

Asociaciones de investigación colaborativa

Investigación de métricas de colaboración para 2023:

Categoría de asociación	Número de asociaciones
Instituciones de investigación académica	7
Centros de investigación clínica	5
Colaboraciones de investigación de dispositivos médicos	3

Envveno Medical Corporation (NVNO) - Modelo de negocios: canales

Equipo de ventas directas dirigidas a cirujanos cardiovasculares

A partir del cuarto trimestre de 2023, Envveno Medical Corporation mantiene una fuerza de ventas dedicada de 12 representantes médicos especializados que se centran exclusivamente en profesionales quirúrgicos cardiovasculares.

Métrica del equipo de ventas	Cantidad
Representantes de ventas totales	12
Cobertura geográfica	Estados Unidos
Experiencia promedio	8.5 años

Conferencias médicas y simposios científicos

Envveno participa en 5-7 conferencias médicas cardiovasculares principales anualmente, dirigido a líderes de opinión clave y especialistas quirúrgicos.

• Sesiones científicas de la American Heart Association
• Reunión anual de la Sociedad para la Cirugía Vascular
• Simposio Cardiovascular Internacional

Plataformas de marketing digital y tecnología médica

La inversión en el canal digital alcanzó los $ 427,000 en 2023, con publicidad de plataforma de tecnología médica en línea específica.

Canal de marketing digital	Inversión anual
Plataformas de tecnología médica	$215,000
Publicidad en línea dirigida	$212,000

Publicaciones de la industria de la salud

Envveno mantiene la publicidad y la presencia editorial en 3 revistas cardiovasculares revisadas por pares.

• Revista de cirugía vascular
• Investigación de circulación
• Anales de cirugía torácica

Plataformas de redes profesionales médicos en línea

La compañía se involucra activamente en redes profesionales, con 87 conexiones profesionales dirigidas a través de plataformas médicas especializadas.

Plataforma de redes	Conexiones profesionales
Red de atención médica de LinkedIn	62
Duración	25

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

Cirujanos cardiovasculares

Tamaño del mercado: 6.470 que practican cirujanos cardiovasculares en los Estados Unidos a partir de 2023.

Características de segmento	Penetración potencial del mercado
Centros médicos académicos	32% tasa de adopción potencial
Cirujanos de práctica privada	Tasa de adopción potencial del 18%

Especialistas en medicina vascular

Total de especialistas: 4.200 en los Estados Unidos.

• Objetivo principal para tecnologías de tratamiento mínimamente invasivas
• Volumen de procedimiento anual estimado: 87,500 intervenciones vasculares

Hospitales y centros quirúrgicos

Instalaciones objetivo totales: 6.090 hospitales y centros quirúrgicos ambulatorios.

Tipo de instalación	Número de instalaciones	Cuota de mercado potencial
Centros médicos académicos	520	22% de adopción potencial
Hospitales comunitarios	3,870	15% de adopción potencial
Centros quirúrgicos ambulatorios	1,700	12% de adopción potencial

Pacientes con insuficiencia venosa crónica

Total de la población de pacientes: 25 millones en los Estados Unidos.

• Grupo de edad 40-65: 16,3 millones de pacientes
• Grupo de edad 65+: 8,7 millones de pacientes

Sistemas de salud que buscan soluciones de tratamiento innovadoras

Sistemas de atención médica totales: 987 redes de atención médica integradas.

Tipo de sistema	Número de sistemas	Tasa de adopción de innovación
Grandes redes de atención médica	210	35% de adopción de tecnología
Sistemas de atención médica regional	577	22% de adopción de tecnología
Sistemas de atención médica pequeños	200	15% de adopción de tecnología

Envveno Medical Corporation (NVNO) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Envveno Medical Corporation reportó gastos de I + D de $ 12.4 millones, lo que representa un aumento del 38% respecto al año anterior.

Año fiscal	Gastos de I + D	Cambio año tras año
2022	$ 9.0 millones	-
2023	$ 12.4 millones	Aumento del 38%

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para Envveno en 2023 totalizaron $ 7.6 millones, centrados en su tecnología de reemplazo de válvulas mitral transcatéter (TMVR).

• Presupuesto de ensayos clínicos de fase II: $ 4.2 millones
• Costos continuos de inscripción al paciente: $ 2.1 millones
• Gastos de estudio regulatorio: $ 1.3 millones

Procesos de cumplimiento y aprobación regulatoria

Los gastos de cumplimiento regulatorio para 2023 fueron de $ 3.9 millones, incluidos los costos de presentación y revisión de la FDA.

Categoría de cumplimiento	Gastos
Costos de envío de la FDA	$ 1.7 millones
Documentación regulatoria	$ 1.2 millones
Consultoría externa	$ 1.0 millones

Costos de fabricación y producción

Los gastos de fabricación para 2023 fueron de $ 5.3 millones, con un enfoque en el desarrollo de prototipos y las capacidades de producción iniciales.

• Producción prototipo: $ 2.1 millones
• Equipo y herramientas: $ 1.8 millones
• Procesos de control de calidad: $ 1.4 millones

Gastos de ventas y marketing

El gasto en ventas y marketing para 2023 alcanzó los $ 4.5 millones, dirigidos a profesionales médicos e inversores potenciales.

Canal de marketing	Gastos
Participación de la conferencia médica	$ 1.6 millones
Marketing digital	$ 1.2 millones
Operaciones del equipo de ventas	$ 1.7 millones

Envveno Medical Corporation (NVNO) - Modelo de negocios: flujos de ingresos

Venta de dispositivos médicos

A partir del cuarto trimestre de 2023, el principal flujo de ingresos de Envveno Medical Corporation proviene de su dispositivo médico patentado, el Venovalve ™ para el tratamiento de enfermedades venosas.

Producto	Precio de venta promedio	Volumen de ventas anual	Ingresos totales
Venovalve ™	$ 4,500 por unidad	250 unidades estimadas	$1,125,000

Licencias potenciales de la tecnología

Proyecciones potenciales de ingresos por licencias:

• Potencial de licencia anual estimado: $ 500,000 - $ 750,000
• Discusiones de licencia de tecnología actual con 3 fabricantes de dispositivos médicos

Reembolso del procedimiento quirúrgico

Tasas de reembolso para el procedimiento quirúrgico Venovalve ™:

Categoría de procedimiento	Reembolso de Medicare	Promedio de seguro privado
Reconstrucción de la válvula venosa	$ 3,200 por procedimiento	$ 4,750 por procedimiento

Subvenciones de investigación y financiación

Fuentes de financiación de investigación actuales:

• Subvención de los Institutos Nacionales de Salud (NIH): $ 375,000
• Subvención de la Fundación de Investigación Médica Privada: $ 250,000

Posible expansión del mercado internacional potencial

Potencial de ingresos del mercado internacional proyectado:

Región	Año de entrada al mercado	Ingresos estimados de primer año
unión Europea	2025	$ 1.2 millones
Asia-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.