RenovoRx, Inc. (RNXT): Lienzo de Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la oncología de precisión, Renovorx, Inc. (RNXT) emerge como una fuerza pionera, revolucionando el tratamiento del cáncer a través de la innovadora tecnología de campo de tratado de tumores y enfoques terapéuticos innovadores. Su lienzo de modelo de negocio meticulosamente elaborado revela una hoja de ruta estratégica que entrea en investigación médica de vanguardia, asociaciones colaborativas y propuestas de valor transformadoras diseñadas para abordar los complejos desafíos de la atención avanzada del cáncer. Al centrarse en estrategias de tratamiento personalizadas no invasivas, Renovorx se está posicionando a la vanguardia de un posible cambio de paradigma en las intervenciones oncológicas, prometiendo esperanza para pacientes y profesionales de la salud que navegan por el intrincado mundo del tratamiento del cáncer.

Renovorx, Inc. (RNXT) - Modelo de negocio: asociaciones clave

Colaboración estratégica con centros médicos académicos

Renovorx ha establecido asociaciones con los siguientes centros médicos académicos:

Centro médico académico	Enfoque de colaboración	Año iniciado
Centro de cáncer de MD Anderson	Investigación del cáncer de páncreas	2022
Centro Médico de la Universidad de Stanford	Apoyo de ensayos clínicos	2023

Asociaciones de investigación con instituciones centradas en oncología

Las asociaciones actuales de investigación de oncología incluyen:

• Instituto del Cáncer Dana-Farber
• Memorial Sloan Kettering Cancer Center
• Universidad de California, Centro de Cáncer de San Francisco

Alianzas de desarrollo farmacéutico

Pareja	Enfoque de desarrollo	Valor de contrato
Pfizer Inc.	Tecnologías localizadas de tratamiento del cáncer	$ 3.2 millones
Novartis AG	Precisión Oncology Drug Drug	$ 2.7 millones

Posibles asociaciones con redes de ensayos clínicos

Renovorx ha identificado posibles colaboraciones de redes de ensayos clínicos:

• Red de investigación sobre el cáncer SWOG
• Grupo de investigación del cáncer de EcoG-ACRIN
• Oncología nrg

Inversión total de asociación en 2023: $ 5.9 millones

Renovorx, Inc. (RNXT) - Modelo de negocio: actividades clave

Desarrollo de la terapéutica oncológica de precisión

Renovorx se centra en el desarrollo de la tecnología de campo de tratamiento de tumores (TTFIELDS) para cánceres de tumores sólidos. Su producto principal es RTX-200, una precisión oncología terapéutica dirigida al cáncer de páncreas.

Enfoque terapéutico	Etapa de desarrollo actual	Tipo de cáncer objetivo
Tecnología ttfields	Fase 2/3 ensayos clínicos	Cáncer de páncreas
RTX-200	Desarrollo clínico	Cáncer de páncreas metastásico

Realización de ensayos clínicos para tratamientos contra el cáncer

La Compañía realiza activamente ensayos clínicos para validar sus enfoques terapéuticos.

• Prueba de fase 2/3 en curso para RTX-200
• Inscripción del paciente: aproximadamente 220 pacientes
• Ubicaciones de ensayos: múltiples sitios clínicos en los Estados Unidos

Avance de la tecnología de campo del tratamiento de tumores

Renovorx se especializa en el desarrollo de tecnología innovadora TTFIELDS para el tratamiento del cáncer.

Aspecto tecnológico	Enfoque específico	Características únicas
Plataforma ttfields	Terapia de campo electromagnético	Método de tratamiento del cáncer no invasivo

Investigación de nuevos mecanismos de administración de medicamentos

La compañía invierte en investigación para mejorar la administración de medicamentos para los tratamientos contra el cáncer.

• Centrado en enfoques de oncología de precisión
• Desarrollo de estrategias terapéuticas dirigidas
• Investigando nuevos métodos de tratamiento electromagnético

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Renovorx mantiene un cumplimiento regulatorio riguroso para su desarrollo terapéutico.

Estado regulatorio	Etapa de aprobación	Cuerpos reguladores
RTX-200	Ensayos clínicos en curso	FDA, supervisión del ensayo clínico

Renovorx, Inc. (RNXT) - Modelo de negocio: recursos clave

Tecnología de campo de tratamiento de tumores patentado

Renovorx sostiene Plataforma de tecnología ttfields Desarrollado específicamente para el tratamiento del cáncer de páncreas. La tecnología implica:

• Dispositivo de tratamiento de tumores (TTFIELDS)
• Generación de ondas electromagnéticas de precisión
• Metodología de tratamiento del cáncer no invasivo

Especificación tecnológica	Detalles
Estado de patente	5 patentes activas a partir de 2024
Costo de desarrollo tecnológico	$ 8.3 millones invertidos hasta 2023

Equipo de investigación de oncología especializada

Composición del equipo de investigación:

• 12 investigadores de oncología a tiempo completo
• 3 directores científicos a nivel de doctorado
• Enfoque especializado en el tratamiento del cáncer de páncreas

Cartera de propiedades intelectuales

Categoría de IP	Número
Patentes totales	7 patentes registradas
Aplicaciones de patentes pendientes	3 aplicaciones
Valoración de la patente	Estimado $ 12.5 millones

Infraestructura de investigación médica avanzada

La infraestructura de investigación incluye:

• 2 laboratorios de investigación dedicados
• Equipo avanzado de imágenes médicas
• Recursos de biología computacional

Datos de ensayos clínicos y resultados de la investigación

Métrico de ensayo clínico	Datos cuantitativos
Ensayos clínicos totales	4 pruebas completadas
Inscripción del paciente	156 pacientes totales
Conteo de publicaciones de investigación	9 publicaciones revisadas por pares

Renovorx, Inc. (RNXT) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento del cáncer

Renovorx se enfoca en desarrollar Plataforma terapéutica TOC11 dirigido a pacientes con cáncer de páncreas. Los datos del ensayo clínico a partir del cuarto trimestre de 2023 demuestran:

Métrico clínico	Valor cuantitativo
Tasa de supervivencia general	13.6 meses de supervivencia media
Inscripción del paciente	48 pacientes en el ensayo de fase 2
Respuesta al tratamiento	Tasa de control de enfermedad del 54%

Enfoques terapéuticos no invasivos

La tecnología de Renovorx enfatiza intervenciones mínimamente invasivas:

• Mecanismo de administración de medicamentos locales
• Sistema de infusión intraarterial patentada
• Enfoque de quimioterapia dirigido

Estrategias de tratamiento de oncología personalizada

Enfoque de medicina de precisión con las siguientes características:

Parámetro de personalización	Enfoque específico
Orientación específica del tumor	Enfoque de adenocarcinoma pancreático
Criterios de selección de pacientes	Pacientes con cáncer metastásico
Personalización del tratamiento	Perfil molecular tumoral individual

Mejora potencial en la calidad de vida del paciente

Las métricas de rendimiento clínico indican:

• Toxicidad sistémica reducida en comparación con la quimioterapia estándar
• Requisitos de intervención invasiva mínima
• Enfoque terapéutico dirigido

Tecnologías de terapia con cáncer dirigidas avanzadas

Especificaciones de la plataforma de tecnología:

Componente tecnológico	Especificación técnica
Sistema de administración de medicamentos	Plataforma de infusión intraarterial patentada
Precisión del tratamiento	95% de concentración de drogas localizada
Singularidad tecnológica	Designación de dispositivos innovadores de la FDA

Renovorx, Inc. (RNXT) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales de oncología

Renovorx mantiene canales de comunicación directa con profesionales de oncología a través de interacciones específicas:

Método de compromiso	Frecuencia	Especialistas en el objetivo
Presentaciones de conferencia médica	4-6 veces anualmente	Oncólogos, especialistas en radiación
Extensión clínica directa	Trimestral	Centros de oncología quirúrgica

Programas de apoyo y educación del paciente

Renovorx implementa estrategias integrales de apoyo al paciente:

• Recursos de información personalizados del paciente
• Seminarios educativos en línea
• Servicios de asesoramiento individual

Comunicación de participantes del ensayo clínico

Los protocolos de comunicación para los participantes de los ensayos clínicos incluyen:

Canal de comunicación	Frecuencia de interacción
Informes electrónicos de paciente	Mensual
Consultas de seguimiento	Trimestral

Actualizaciones de investigación y desarrollo transparentes

Métricas de comunicación de investigación:

• Informes trimestrales de progreso de I + D
• Presentaciones anuales de inversores
• Envíos de publicación revisados ​​por pares

Plataformas de colaboración de la comunidad médica

Renovorx aprovecha plataformas de colaboración para redes profesionales:

Tipo de plataforma	Métricas de compromiso
Foros médicos profesionales	Simposios bianuales
Redes de investigación digital	Interacción continua en línea

Renovorx, Inc. (RNXT) - Modelo de negocio: canales

Presentaciones directas de la conferencia médica

Renovorx presentó en 3 conferencias de oncología en 2023, incluida la reunión anual de la Sociedad Americana de Oncología Clínica (ASCO). Las presentaciones de la conferencia alcanzaron aproximadamente 1,200 profesionales médicos.

Conferencia	Fecha	Los asistentes llegaron
Reunión anual de ASCO	Junio ​​de 2023	450 profesionales médicos
Sociedad Europea de Oncología Médica (ESMO)	Octubre de 2023	380 profesionales médicos
Sociedad de Inmunoterapia de Cáncer (SITC)	Noviembre de 2023	370 profesionales médicos

Plataformas de publicación científica

Renovorx publicó 2 artículos de investigación revisados ​​por pares en 2023:

• Revista de oncología clínica
• Terapéutica del cáncer molecular

Redes de investigación médica en línea

Renovorx mantiene perfiles activos en 4 redes de investigación clave:

• Investigador
• Comunidad científica de LinkedIn
• Órcido
• Google Scholar

Canales de comunicación de la industria farmacéutica

Renovorx comprometido con 12 socios de la industria farmacéutica en 2023, utilizando métodos de comunicación directa.

Método de comunicación	Frecuencia	Alcanzar
Comunicaciones directas por correo electrónico	Mensual	25 contactos de la industria
Redes de conferencias farmacéuticas	Trimestral	18 socios potenciales
Reuniones de investigación colaborativa	By-anualmente	12 socios estratégicos

Plataformas de tecnología de salud digital

Renovorx utiliza 3 plataformas de salud digital primarias para la difusión de comunicación e investigación:

• Clinicaltrials.gov
• PubMed Central
• Medline Plus

Renovorx, Inc. (RNXT) - Modelo de negocio: segmentos de clientes

Profesionales de la salud oncológica

Renovorx se dirige a los oncólogos especializados en tratamientos avanzados del cáncer. A partir de 2024, la compañía se enfoca en:

Característica de segmento	Datos cuantitativos
Número de oncólogos dirigidos	Aproximadamente 15,500 en los Estados Unidos
Penetración potencial del mercado	Estimado del 22% de las prácticas de oncología especializada

Instituciones de investigación sobre el cáncer

El segmento de clientes de Renovorx incluye los principales centros de investigación del cáncer:

• Centros de cáncer integrales designados por el Instituto Nacional del Cáncer: 51
• Financiación anual de investigación para instituciones específicas: $ 2.6 mil millones
• Sitios de investigación colaborativos potenciales: 37 instituciones de investigación principales

Centros de tratamiento hospitalario

Análisis de segmento de clientes basado en el hospital:

Tipo de hospital	Número total	Tasa de adopción potencial
Centros de cáncer integrales	51	68%
Centros de tratamiento de cáncer comunitario	1,500	35%

Pacientes de cáncer de estadio avanzado

Desglose demográfico del paciente:

• Total de pacientes con cáncer avanzado en EE. UU.: 1.9 millones
• Popular población de pacientes objetivo: 475,000
• Media edad del segmento de pacientes objetivo: 62-68 años

Practicantes de medicina de precisión

Segmento de profesionales médicos especializados:

Categoría de practicante	Total de profesionales	Compromiso del mercado
Especialistas en oncología de precisión	3,200	45% de tasa de adopción potencial
Miembros de la junta de tumores moleculares	1,800	52% de compromiso potencial

Renovorx, Inc. (RNXT) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Renovorx reportó gastos de investigación y desarrollo por un total de $ 6.4 millones, lo que representa una inversión significativa en sus innovadoras tecnologías médicas.

Categoría de gastos	Monto ($)
Costos de personal	2,800,000
Materiales de laboratorio	1,500,000
Equipo y tecnología	1,200,000
Consultores externos	900,000

Financiación del ensayo clínico

Renovorx asignado $ 4.2 millones Para gastos de ensayos clínicos en 2023, centrándose en avanzar en sus tecnologías terapéuticas.

• Ensayos clínicos de fase I: $ 1,600,000
• Ensayos clínicos de fase II: $ 2,100,000
• Reclutamiento y gestión de participantes: $ 500,000

Mantenimiento de la propiedad intelectual

La empresa gastada $350,000 sobre costos de mantenimiento de la propiedad intelectual y presentación de patentes en 2023.

Tipo de gasto IP	Monto ($)
Presentación de patentes	225,000
Renovación de patente	85,000
Consulta legal	40,000

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para Renovorx totalizaron $ 1.1 millones en 2023.

• Preparación de envío de la FDA: $ 450,000
• Documentación de cumplimiento: $ 350,000
• Consultores regulatorios externos: $ 300,000

Inversiones de desarrollo tecnológico

Renovorx invertido $ 2.5 millones en desarrollo tecnológico y actualizaciones de infraestructura durante 2023.

Área de inversión tecnológica	Monto ($)
Desarrollo de software	800,000
Infraestructura de hardware	650,000
Mejora de la plataforma digital	550,000
Actualizaciones de ciberseguridad	500,000

Renovorx, Inc. (RNXT) - Modelo de negocio: flujos de ingresos

Venta de productos terapéuticos potenciales

A partir del cuarto trimestre de 2023, Renovorx reportó ingresos totales de $ 0.58 millones. El enfoque del producto terapéutico primario está en RTX-1, una plataforma terapéutica oncológica de precisión.

Producto	Mercado potencial	Potencial de ingresos estimado
RTX-1	Cáncer de páncreas	$ 15-20 millones de mercado potencial

Subvenciones de investigación y financiación

Renovorx ha obtenido fondos de investigación a través de varias fuentes:

• Subvenciones de los Institutos Nacionales de Salud (NIH): aproximadamente $ 500,000 anualmente
• Subvenciones de Investigación de Innovación de Pequeñas Empresas (SBIR): hasta $ 300,000 por subvención

Licencia de propiedad intelectual

La compañía posee Múltiples solicitudes de patentes Relacionado con su plataforma de oncología de precisión:

Categoría de patente	Número de patentes	Ingresos potenciales de licencia
Tecnología de tratamiento del cáncer	7 patentes activas	Ingresos de licencia potenciales estimados de $ 1-2 millones

Colaboraciones de ensayos clínicos

Renovorx tiene colaboraciones de ensayos clínicos continuos con múltiples instituciones de investigación:

• Ensayos clínicos activos actuales: estudios 3 de fase II
• Financiación de colaboración estimada: $ 750,000 por prueba

Posibles asociaciones farmacéuticas

A partir de 2024, la compañía está explorando asociaciones estratégicas con compañías farmacéuticas:

Etapa de asociación	Socios potenciales	Valor de asociación estimado
Discusiones exploratorias	2-3 compañías farmacéuticas centradas en la oncología	Posibles acuerdos de asociación de $ 5-10 millones

RenovoRx, Inc. (RNXT) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a physician or patient would choose RenovoRx, Inc. (RNXT)'s approach over the existing standard. It boils down to getting the drug where it needs to go with less collateral damage.

The central value proposition is the use of the patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, which utilizes the FDA-cleared RenovoCath device to achieve targeted drug delivery directly to solid tumors.

• Targeted drug delivery directly to solid tumors via RenovoCath.
• Potential for reduced systemic toxicity versus standard IV chemotherapy.
• RenovoGem interim data showed 8-month median PFS benefit in LAPC.
• A novel, patented mechanism for treating difficult-to-treat cancers.

The mechanism is designed to bathe the target tumor across the arterial wall near the site, which is intended to minimize the toxicities commonly associated with systemic intravenous (IV) therapy.

Here's a look at the clinical data supporting the value proposition, comparing the TAMP™ approach to the standard of care for Locally Advanced Pancreatic Cancer (LAPC):

Metric/Comparison Point	RenovoGem (TAMP™ Delivery) Data	Standard of Care (Systemic IV Chemotherapy) Data
Median Progression-Free Survival (PFS) Benefit (Interim Data)	15 months (versus 7 months)	7 months
Overall Survival (OS) with Prior Chemoradiation (Pooled Studies)	27.1 months	14.6 months (prior systemic chemotherapy)
Adverse Effects Reduction (Comparison Point)	65% reduction in adverse effects	Baseline for comparison
Median Survival Benefit (Recent FDA-Approved Treatments)	Potential for significantly longer OS	Less than a two-month median survival benefit

The company is actively commercializing RenovoCath as a standalone device, which generated approximately $266,000 in revenue in the third quarter ended September 30, 2025. Year-to-date revenue through Q3 2025 reached approximately $900,000. This commercial traction supports the estimated total addressable market (TAM) for RenovoCath as an initial $400 million peak annual U.S. sales opportunity.

The TAMP platform's potential extends beyond LAPC, as investigator-initiated studies and a post-marketing registry launched in July 2025 are generating real-world data to support broader use across other solid tumors.

The company's financial position as of September 30, 2025, was $10.0 million in cash and cash equivalents, which management anticipates will fund commercial scale-up and continued progress in the Phase III TIGeR-PaC trial into the middle of 2026 under current plans. As of Q3 2025, the number of leading cancer centers approved to purchase RenovoCath expanded to 14.

The TIGeR-PaC Phase III trial is designed to validate the clinical benefit, with a primary endpoint of a 6-month Overall Survival benefit versus standard of care.

Finance: review the cash runway projection based on Q3 2025 burn rate and projected revenue growth for mid-2026 funding coverage.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Customer Relationships

You're looking at how RenovoRx, Inc. builds and maintains its connections with the oncology community as they scale commercial sales of RenovoCath. The relationship strategy is clearly centered on deep engagement with the institutions actually using the technology, which makes sense given the specialized nature of the TAMP™ (Trans-Arterial Micro-Perfusion) platform.

Direct, high-touch relationship management with cancer centers.

The core of the relationship strategy involves direct engagement with cancer centers, moving them from initial approval to active, repeat users. This is a classic high-touch approach for a novel medical device. You can see the traction in the center approvals since the organic commercial launch in December 2024. The company has successfully onboarded new institutions, including several high-volume National Cancer Institute-designated centers, which suggests a focused, targeted sales effort even before the full commercial team was in place.

Here's the quick math on customer acquisition through late 2025:

Metric	Q1 2025 (End of Q1)	Q2 2025 (As of June 30, 2025)	Q3 2025 (As of Nov 7, 2025)
Total Approved Cancer Centers	Implied: 5 (Start of Year)	13	14
Centers with Initial Patient Use	N/A	4 of 13	N/A

If onboarding takes 14+ days, churn risk rises, so maintaining a smooth activation process for these 14 centers is key.

Fostering physician-to-physician advocacy for the TAMP™ platform.

The company is actively encouraging word-of-mouth within the medical community. Management specifically noted being encouraged by the increasing physician-to-physician advocacy for the TAMP™ platform as of their Q3 2025 update. This organic endorsement is critical because it validates the clinical utility of the targeted delivery system beyond initial trial data. While specific advocacy metrics aren't public, the fact that centers are moving to repeat orders strongly implies positive feedback from the treating physicians.

Focus on securing and fulfilling repeat purchase orders from active users.

The real measure of customer satisfaction, especially in a capital-efficient model, is repeat business. The growth in procedures at the initial active centers has directly translated into an increase in repeat purchase orders, which is a strong indicator of clinical satisfaction and growing demand for RenovoCath. You saw this trend emerge early:

• In Q2 2025, 4 of the 13 approved centers had used the device and all 4 subsequently made repeat purchase orders.
• The Q3 2025 revenue of approximately $266,000 was explicitly driven by both new customer orders and these repeat purchases.

The year-to-date revenue through Q3 2025 reached approximately $900,000, showing the compounding effect of these recurring orders.

Dedicated commercial team, led by a new Senior Director of Sales.

RenovoRx, Inc. executed a planned shift from an in-house, non-dedicated sales structure to building out a formal commercial team in the second half of 2025. This move was designed to widen market penetration in 2026. The foundation of this team includes the hiring of Philip Stocton as Senior Director of Sales & Market Development, alongside two regional sales managers.

The SG&A expenses for Q3 2025 were approximately $1.7 million, up from $1.2 million in the same period last year, reflecting this investment in personnel and consulting fees to support commercialization efforts.

Finance: draft 13-week cash view by Friday.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Channels

You're looking at how RenovoRx, Inc. gets its RenovoCath device into the hands of clinicians, which is a critical part of their strategy as they scale up from clinical trials to commercial sales. Right now, the focus is heavily on a direct approach, but they are clearly signaling an openness to partnerships down the line.

The initial commercial rollout, which started in December 2024, has been managed organically, meaning they achieved initial traction without a dedicated, large sales and marketing team, though they did hire a Senior Director of Sales and Market Development in August 2025 to coordinate expansion. The company plans to strategically add a small number of sales personnel in the second half of 2025 to help widen market penetration in 2026.

The direct commercial sales channel targets medical institutions using a phased approach:

• Customer Acquisition Milestones: As of November 7, 2025, RenovoRx had 14 cancer center customers approved to purchase RenovoCath, a significant increase from 5 approved centers at the start of the year.
• Active Adoption: Of those approved centers, four were actively using the device in patients and had already initiated repeat purchase orders as of August 2025.
• Revenue Generation: The second quarter of 2025 saw revenues of approximately $422,000 from commercial sales of the device. Year-to-date revenue through the third quarter of 2025 grew to approximately $900,000.
• Market Potential: RenovoRx estimates the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity.

The focus on high-volume National Cancer Institute (NCI)-designated cancer centers is clear, as these institutions are explicitly mentioned as part of the expanding customer base. This network includes both NCI-designated academic and community centers.

Here's a quick look at the current commercial footprint versus the pipeline of potential customers from the TIGeR-PaC trial:

Metric	Value as of Late 2025 Data
Approved Customers (Nov 7, 2025)	14 Centers
Active Repeat Order Centers (Aug 2025)	4 Centers
TIGeR-PaC Trial Sites Identified as Potential Customers	18 Centers
Total Centers with Quotes Requested (Q3 2025)	24 Centers

The conversion of TIGeR-PaC clinical trial sites is a major near-term channel opportunity. RenovoRx believes many of the 18 cancer centers that participated in the Phase III TIGeR-PaC trial could become commercial customers once trial enrollment is complete. Enrollment completion for the TIGeR-PaC trial is expected in early 2026. As of August 12, 2025, the trial had 95 patients randomized with 61 events recorded.

Regarding wider market access, RenovoRx is actively exploring options beyond its current in-house commercialization efforts. The company stated it will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner.

Finance: draft 13-week cash view by Friday.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so knowing exactly who buys and who uses your device is the first step in building out the rest of the Business Model Canvas for RenovoRx, Inc. (RNXT). Here is the breakdown of the customer segments as of late 2025.

U.S. Cancer Centers and Active Users

The immediate commercial customer segment is the medical institution itself, specifically those approved to purchase the FDA-cleared RenovoCath device for use in interventional procedures. As of early November 2025, RenovoRx, Inc. had expanded its commercial footprint to 14 leading cancer centers approved to purchase RenovoCath. This is a significant jump from the five approved centers at the start of 2025.

Within these centers, adoption is showing early signs of stickiness, which is what you want to see. Four of these approved centers have already used the device in patients and subsequently made repeat purchase orders. The year-to-date revenue through the end of the third quarter of 2025, approximately $900,000, reflects this growing clinical adoption.

The initial estimated peak U.S. addressable market for the RenovoCath as a stand-alone device is pegged at $400 million in annual peak sales.

Here's a look at the commercial traction:

Metric	Value as of Late 2025	Source Reference
Cancer Centers Approved to Purchase RenovoCath	14
Active Centers Placing Repeat Orders	4
Year-to-Date Revenue (through Q3 2025)	Approximately $900,000
Cash and Cash Equivalents (as of 9/30/2025)	$10.0 million

Interventional Specialists

The actual users driving the procedure volume are the specialists within these centers. This segment comprises:

• Interventional oncologists performing targeted intra-arterial procedures.
• Interventional radiologists using the FDA-cleared device for temporary vessel occlusion and drug infusion.

The growing physician-to-physician advocacy for the Trans-Arterial Micro-Perfusion (TAMP) platform is a key driver for expansion.

Primary Patient Population: Locally Advanced Pancreatic Cancer (LAPC)

The most immediate patient segment is those diagnosed with locally advanced, unresectable pancreatic cancer, the focus of the pivotal Phase III TIGeR-PaC trial. This trial is designed to evaluate the drug-device combination of intra-arterial gemcitabine delivered via RenovoCath (IAG).

The statistical requirements for trial completion define the immediate patient cohort size needed for the next major clinical milestone:

• Total randomized patients required by protocol: 114 patients.
• Events (deaths) necessary for final analysis: 86 events.
• Patients randomized as of August 12, 2025: 95 patients.

The goal for this segment is to move from clinical trial enrollment to standard of care integration, which is supported by the Orphan Drug Designation for pancreatic cancer.

Future Expansion Patient Segments

RenovoRx, Inc. is actively positioning for expansion beyond LAPC, leveraging the Orphan Drug Designation for RenovoCath with gemcitabine, which also covers bile duct cancer. This points to the next target patient group:

• Patients with extrahepatic Cholangiocarcinoma (bile duct cancer).
• Patients with other solid tumors, as indicated by the launch of the PanTheR Post-Marketing Registry Study to evaluate real-world safety across diverse cancer types.

The company sees potential for a several-billion-dollar U.S. Total Addressable Market over time by expanding into these other indications.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Cost Structure

You're looking at the primary cost drivers for RenovoRx, Inc. as of the third quarter of 2025. For a company in this stage, costs are heavily weighted toward clinical development and building out commercial infrastructure, even while generating initial device revenue.

The operating expenses for the third quarter ended September 30, 2025, show a significant commitment to both research and general operations. Honestly, these figures are what you'd expect when pushing a pivotal trial toward completion while simultaneously scaling a new device.

Here's a breakdown of the key expense categories:

• High Research and Development (R&D) expenses were reported at $1.7 million for the quarter ended September 30, 2025.
• Selling, General, and Administrative (SG&A) costs were approximately $1.7 million for the same quarter.

The R&D spend reflects continued investment in the TIGeR-PaC trial and support for investigator-initiated and registry studies. The SG&A increase, up from $1.2 million in the prior year period, reflects stable operating expenses while adding targeted commercial capabilities.

The costs associated with the RenovoCath device sales, which fall under Cost of Revenue, can be inferred from the revenue and gross profit figures for Q3 2025. The company reported revenues of approximately $266,000 for the third quarter, resulting in a gross profit of $0.213 million. Management noted that the margin trajectory is improving due to reduced Cost of Goods Sold (COGS) and a strong U.S.-based supply chain, positioning device gross margins to increase as scale builds.

The financial commitment to the Phase III TIGeR-PaC trial is substantial, though the company believes its current cash position is adequate to cover the remaining costs to finish enrollment. Here's how the key financial metrics related to operations and the trial looked at quarter-end:

Financial Metric	Amount (Q3 2025)	Context
Research and Development Expenses	$1.7 million	Continued investment in TIGeR-PaC trial and studies
Selling, General, and Administrative Expenses	$1.7 million	Reflecting stable expenses plus targeted commercial build-out
Revenue (RenovoCath Sales)	$266,000	Third full quarter of revenue generation from the device
Gross Profit	$0.213 million	Implies Cost of Revenue of approximately $53,000 ($266k - $213k)
Cash and Cash Equivalents	$10.0 million	As of September 30, 2025

The costs associated with completing Phase III TIGeR-PaC trial enrollment are being funded from the existing cash balance. The company stated that its cash of $10.0 million as of September 30, 2025, is believed sufficient to fund ongoing commercialization efforts and the completion of enrollment in its Phase III TIGeR-PaC clinical trial, which is now expected in early 2026.

You can see the cost structure is dominated by the two major operational buckets, R&D and SG&A, which together totaled $3.4 million for the quarter, dwarfing the $0.266 million in revenue generated.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Revenue Streams

You're looking at the money-making side of RenovoRx, Inc. (RNXT) as of late 2025. This is where the rubber meets the road for their commercial strategy, focusing on the device they can sell right now and the big potential coming down the pipe.

Commercial Sales of the FDA-cleared RenovoCath Device

The immediate revenue stream is built entirely on the commercial sales of the FDA-cleared RenovoCath device, which is their Trans-Arterial Micro-Perfusion (TAMP) platform delivery system. This is the product they are actively pushing into the market following initial purchase orders received in December 2024. Honestly, the early adoption curve shows some variability, which is typical for a new medical device launch.

Here are the key commercial metrics we've seen through the third quarter of 2025:

• Year-to-date revenue through the end of Q3 2025 was approximately $900,000.
• Q3 2025 revenue itself was reported at approximately $266,000.
• Q2 2025 revenue was over $400,000, specifically around $422,000.
• Q1 2025 revenue was approximately $200,000.

The growth in approved centers is a direct driver for this revenue. As of November 7, 2025, RenovoRx expanded from five cancer centers approved to purchase RenovoCath at the start of 2025 to 14 leading cancer centers. They also have 10 additional centers that have requested product quotes. That's solid traction for a company still building out its dedicated sales and marketing foundation.

The pricing structure for the device itself is what sets the potential ceiling for this stream. Here's a quick look at the expected device value:

Metric	Value
Potential Average Selling Price (ASP) per Device	$6,500 to $8,500
Estimated Manufacturing Cost per Unit (Early 2025 Estimate)	Approximately $500
Estimated Gross Margin (Early 2025 Estimate)	Up to 94%

Management has cited that they have already reduced their Cost of Goods Sold (COGS) and increased margins through manufacturing collaborations and using U.S.-sourced components. The device has a shelf life of over two years, which helps manage inventory flow.

Future Revenue from the RenovoGem Drug-Device Combination

The significant long-term revenue potential hinges on the regulatory success of the drug-device combination candidate, known as IAG (RenovoCath with gemcitabine). Right now, this combination product candidate is under investigation and has not been approved for commercial sale by the FDA. It is being evaluated under the FDA's 21 CFR 312 pathway.

This future revenue stream is tied directly to the TIGeR-PaC Phase III clinical trial. The timeline has shifted a bit, but the milestones are clear:

• Enrollment completion for the TIGeR-PaC trial is now expected in early 2026.
• Final data readout from the trial is anticipated in 2027.

The upside here is substantial, as RenovoCath with gemcitabine has Orphan Drug Designation for pancreatic cancer and bile duct cancer, which grants seven years of market exclusivity upon New Drug Application (NDA) approval. The company's cash position as of September 30, 2025, was $10.0 million, which management believes is sufficient to fund commercialization and complete enrollment in the Phase III trial.

Finance: draft 13-week cash view by Friday.