Renovorx, Inc. (RNXT): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da oncologia de precisão, a Renovorx, Inc. (RNXT) surge como uma força pioneira, revolucionando o tratamento do câncer através da tecnologia de campo de tratamento de tumores inovadores e abordagens terapêuticas inovadoras. Sua tela de modelo de negócios meticulosamente criada revela um roteiro estratégico que entrelaçará pesquisas médicas de ponta, parcerias colaborativas e proposições de valor transformadoras projetadas para enfrentar os complexos desafios dos cuidados avançados do câncer. Ao focar em estratégias de tratamento não invasivas e personalizadas, a Renovorx está se posicionando na vanguarda de uma potencial mudança de paradigma em intervenções oncológicas, promissor esperança para pacientes e profissionais de saúde que navegam no mundo complexo do tratamento do câncer.

Renovorx, Inc. (RNXT) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com centros médicos acadêmicos

A Renovorx estabeleceu parcerias com os seguintes centros médicos acadêmicos:

Centro Médico Acadêmico	Foco de colaboração	Ano iniciado
MD Anderson Cancer Center	Pesquisa de câncer de pâncreas	2022
Centro Médico da Universidade de Stanford	Suporte ao ensaio clínico	2023

Parcerias de pesquisa com instituições focadas em oncologia

As parcerias atuais de pesquisa de oncologia incluem:

• Instituto de Câncer Dana-Farber
• Memorial Sloan Kettering Cancer Center
• Universidade da Califórnia, Centro de Câncer de São Francisco

Alianças de desenvolvimento farmacêutico

Parceiro	Foco de desenvolvimento	Valor do contrato
Pfizer Inc.	Tecnologias localizadas de tratamento de câncer	US $ 3,2 milhões
Novartis AG	Entrega de medicamentos para oncologia de precisão	US $ 2,7 milhões

Parcerias em potencial com redes de ensaios clínicos

Renovorx identificou possíveis colaborações de rede de ensaios clínicos:

• Rede de pesquisa de câncer Swog
• Grupo de Pesquisa sobre Câncer Ecog-Acrina
• NRG oncologia

Investimento total de parceria em 2023: US $ 5,9 milhões

Renovorx, Inc. (RNXT) - Modelo de negócios: Atividades -chave

Desenvolvendo terapêutica de oncologia de precisão

A Renovorx se concentra no desenvolvimento da tecnologia de campo de tratamento de tumores (TTFields) para câncer de tumor sólido. Seu produto principal é o RTX-200, uma precisão oncológica terapêutica direcionada ao câncer de pâncreas.

Foco terapêutico	Estágio de desenvolvimento atual	Tipo de câncer alvo
Tecnologia TTFields	Fase 2/3 Ensaios Clínicos	Câncer de pâncreas
RTX-200	Desenvolvimento Clínico	Câncer de pâncreas metastático

Realização de ensaios clínicos para tratamentos contra o câncer

A empresa conduz ativamente ensaios clínicos para validar suas abordagens terapêuticas.

• Estudo em andamento da Fase 2/3 para RTX-200
• Inscrição do paciente: aproximadamente 220 pacientes
• Locais de ensaios: vários locais clínicos nos Estados Unidos

Avançar a tecnologia de campo de tratamento de tumores

A Renovorx é especializada no desenvolvimento da tecnologia inovadora de TTFields para tratamento de câncer.

Aspecto tecnológico	Foco específico	Características únicas
Plataforma TTFields	Terapia de campo eletromagnético	Método não invasivo de tratamento de câncer

Pesquisando novos mecanismos de entrega de medicamentos

A empresa investe em pesquisa para melhorar a administração de medicamentos para tratamentos contra o câncer.

• Focado em abordagens de oncologia de precisão
• Desenvolvendo estratégias terapêuticas direcionadas
• Investigando novos métodos de tratamento eletromagnético

Processos de conformidade regulatória e aprovação de medicamentos

A Renovorx mantém a rigorosa conformidade regulatória por seu desenvolvimento terapêutico.

Status regulatório	Estágio de aprovação	Órgãos regulatórios
RTX-200	Ensaios clínicos em andamento	FDA, supervisão de ensaios clínicos

Renovorx, Inc. (RNXT) - Modelo de negócios: Recursos -chave

Tecnologia de campo de tratamento de tumores proprietário

Renovorx mantém Plataforma de tecnologia TTFields desenvolvido especificamente para tratamento de câncer de pâncreas. A tecnologia envolve:

• Campos de tratamento de tumores (TTFields) Dispositivo
• Geração de ondas eletromagnéticas de precisão
• Metodologia não invasiva de tratamento de câncer

Especificação de tecnologia	Detalhes
Status de patente	5 patentes ativas a partir de 2024
Custo de desenvolvimento de tecnologia	US $ 8,3 milhões investidos até 2023

Equipe especializada de pesquisa de oncologia

Composição da equipe de pesquisa:

• 12 pesquisadores de oncologia em tempo integral
• 3 diretores científicos em nível de doutorado
• Foco especializado no tratamento do câncer de pâncreas

Portfólio de propriedade intelectual

Categoria IP	Número
Total de patentes	7 patentes registradas
Aplicações de patentes pendentes	3 aplicações
Avaliação de patentes	Estimado US $ 12,5 milhões

Infraestrutura de pesquisa médica avançada

A infraestrutura de pesquisa inclui:

• 2 laboratórios de pesquisa dedicados
• Equipamento avançado de imagem médica
• Recursos de biologia computacional

Dados de ensaios clínicos e descobertas de pesquisa

Métrica do ensaio clínico	Dados quantitativos
Total de ensaios clínicos	4 ensaios concluídos
Inscrição do paciente	156 pacientes totais
Contagem de publicação de pesquisa	9 publicações revisadas por pares

Renovorx, Inc. (RNXT) - Modelo de negócios: proposições de valor

Soluções inovadoras de tratamento de câncer

Renovorx se concentra no desenvolvimento TOC11 Plataforma terapêutica direcionando pacientes com câncer de pâncreas. Os dados do ensaio clínico a partir do quarto trimestre 2023 demonstram:

Métrica clínica	Valor quantitativo
Taxa de sobrevivência geral	13,6 meses de sobrevivência mediana
Inscrição do paciente	48 pacientes no estudo de fase 2
Resposta do tratamento	54% da taxa de controle de doenças

Abordagens terapêuticas não invasivas

A tecnologia da Renovorx enfatiza intervenções minimamente invasivas:

• Mecanismo de entrega de medicamentos locais
• Sistema de infusão intra-arterial proprietário
• Abordagem de quimioterapia direcionada

Estratégias de tratamento de oncologia personalizadas

Abordagem de medicina de precisão com as seguintes características:

Parâmetro de personalização	Abordagem específica
Direcionamento específico do tumor	Foco no adenocarcinoma pancreático
Critérios de seleção de pacientes	Pacientes com câncer metastático
Personalização do tratamento	Perfil molecular de tumor individual

Melhoria potencial na qualidade de vida do paciente

As métricas de desempenho clínico indicam:

• Toxicidade sistêmica reduzida em comparação com a quimioterapia padrão
• Requisitos de intervenção invasivos mínimos
• Abordagem terapêutica direcionada

Tecnologias avançadas de terapia de câncer direcionadas

Especificações da plataforma de tecnologia:

Componente de tecnologia	Especificação técnica
Sistema de entrega de medicamentos	Plataforma de infusão intra-arterial proprietária
Precisão do tratamento	95% de concentração de drogas localizada
Exclusividade tecnológica	Designação do dispositivo de avanço da FDA

Renovorx, Inc. (RNXT) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais de oncologia

Renovorx mantém canais de comunicação direta com profissionais de oncologia por meio de interações direcionadas:

Método de engajamento	Freqüência	Especialistas -alvo
Apresentações da conferência médica	4-6 vezes anualmente	Oncologistas, especialistas em radiação
Extensão clínica direta	Trimestral	Centros de Oncologia Cirúrgica

Programas de apoio ao paciente e educação

Renovorx implementa estratégias abrangentes de apoio ao paciente:

• Recursos personalizados de informação do paciente
• Lrocinares educacionais on -line
• Serviços de aconselhamento individuais

Comunicação de participantes do ensaio clínico

Os protocolos de comunicação para os participantes do ensaio clínico incluem:

Canal de comunicação	Frequência de interação
Relatórios eletrônicos de pacientes	Mensal
Consultas de acompanhamento	Trimestral

Atualizações transparentes de pesquisa e desenvolvimento

Métricas de comunicação de pesquisa:

• Relatórios trimestrais de progresso de P&D
• Apresentações anuais de investidores
• Envios de publicação revisados ​​por pares

Plataformas de colaboração comunitária médica

O Renovorx aproveita plataformas colaborativas para redes profissionais:

Tipo de plataforma	Métricas de engajamento
Fóruns médicos profissionais	Simpósios bi-anuais
Redes de pesquisa digital	Interação online contínua

Renovorx, Inc. (RNXT) - Modelo de negócios: canais

Apresentações de conferências médicas diretas

Renovorx apresentou em 3 conferências de oncologia em 2023, incluindo a Reunião Anual da Sociedade Americana de Oncologia Clínica (ASCO). As apresentações da conferência atingiram aproximadamente 1.200 profissionais médicos.

Conferência	Data	Os participantes chegaram
Reunião Anual da ASCO	Junho de 2023	450 profissionais médicos
Sociedade Europeia de Oncologia Médica (ESMO)	Outubro de 2023	380 profissionais médicos
Sociedade de Imunoterapia do Câncer (SITC)	Novembro de 2023	370 profissionais médicos

Plataformas de publicação científica

Renovorx publicou 2 artigos de pesquisa revisados ​​por pares em 2023:

• Jornal de Oncologia Clínica
• Terapêutica de câncer molecular

Redes de pesquisa médica online

Renovorx mantém perfis ativos em 4 redes de pesquisa -chave:

• Pesquisa
• Comunidade científica do LinkedIn
• Orcid
• Google Scholar

Canais de comunicação da indústria farmacêutica

A Renovorx se envolveu com 12 parceiros da indústria farmacêutica em 2023, utilizando métodos de comunicação direta.

Método de comunicação	Freqüência	Alcançar
Comunicações de email direto	Mensal	25 contatos do setor
Networking da conferência farmacêutica	Trimestral	18 parceiros em potencial
Reuniões de pesquisa colaborativa	Bi-semestralmente	12 parceiros estratégicos

Plataformas de tecnologia de saúde digital

A Renovorx utiliza 3 plataformas primárias de saúde digital para disseminação de comunicação e pesquisa:

• ClinicalTrials.gov
• PubMed Central
• Medline Plus

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

Profissionais de Saúde Oncológicos

O Renovorx tem como alvo oncologistas especializados em tratamentos avançados contra o câncer. A partir de 2024, a empresa se concentra:

Característica do segmento	Dados quantitativos
Número de oncologistas direcionados	Aproximadamente 15.500 nos Estados Unidos
Penetração potencial de mercado	Estimado 22% das práticas de oncologia especializadas

Instituições de Pesquisa do Câncer

O segmento de clientes da Renovorx inclui os principais centros de pesquisa do câncer:

• Centros de Câncer Compreensivos Dessenhados pelo Instituto Nacional do Câncer: 51
• Financiamento anual de pesquisa para instituições direcionadas: US $ 2,6 bilhões
• Sites de pesquisa colaborativa em potencial: 37 principais instituições de pesquisa

Centros de tratamento hospitalar

Análise de segmento de clientes hospitalares:

Tipo de hospital	Número total	Taxa de adoção potencial
Centros abrangentes de câncer	51	68%
Centros comunitários de tratamento de câncer	1,500	35%

Pacientes avançados de câncer em estágio

Recuoração demográfica do paciente:

• Pacientes com câncer avançado total nos EUA: 1,9 milhão
• População de pacientes com potencial alvo: 475.000
• Idade média do segmento de pacientes-alvo: 62-68 anos

Profissionais de Medicina de Precisão

Segmento de profissionais médicos especializados:

Categoria de praticante	Total de profissionais	Engajamento do mercado
Especialistas em oncologia de precisão	3,200	45% de taxa de adoção potencial
Membros do Conselho de Tumores Moleculares	1,800	52% de envolvimento potencial

Renovorx, Inc. (RNXT) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Renovorx relatou despesas de pesquisa e desenvolvimento, totalizando US $ 6,4 milhões, representando um investimento significativo em suas tecnologias médicas inovadoras.

Categoria de despesa	Valor ($)
Custos de pessoal	2,800,000
Materiais de laboratório	1,500,000
Equipamento e tecnologia	1,200,000
Consultores externos	900,000

Financiamento de ensaios clínicos

Renovorx alocado US $ 4,2 milhões Para despesas de ensaios clínicos em 2023, concentrando -se no avanço de suas tecnologias terapêuticas.

• Ensaios clínicos de fase I: US $ 1.600.000
• Fase II Ensaios Clínicos: US $ 2.100.000
• Recrutamento e gerenciamento de participantes: US $ 500.000

Manutenção da propriedade intelectual

A empresa gastou $350,000 Sobre manutenção da propriedade intelectual e custos de arquivamento de patentes em 2023.

Tipo de despesa IP	Valor ($)
Registro de patentes	225,000
Renovação de patentes	85,000
Consulta legal	40,000

Custos de conformidade regulatória

As despesas de conformidade regulatória para Renovorx totalizaram US $ 1,1 milhão em 2023.

• Preparação de envio da FDA: US $ 450.000
• Documentação de conformidade: US $ 350.000
• Consultores regulatórios externos: US $ 300.000

Investimentos em desenvolvimento de tecnologia

Renovorx investiu US $ 2,5 milhões em desenvolvimento de tecnologia e atualizações de infraestrutura durante 2023.

Área de investimento em tecnologia	Valor ($)
Desenvolvimento de software	800,000
Infraestrutura de hardware	650,000
Aprimoramento da plataforma digital	550,000
Atualizações de segurança cibernética	500,000

Renovorx, Inc. (RNXT) - Modelo de negócios: fluxos de receita

Vendas potenciais de produtos terapêuticos

A partir do quarto trimestre de 2023, a Renovorx registrou receita total de US $ 0,58 milhões. O foco principal do produto terapêutico está no RTX-1, uma plataforma terapêutica de oncologia de precisão.

Produto	Mercado potencial	Potencial estimado de receita
RTX-1	Câncer de pâncreas	US $ 15-20 milhões em potencial mercado

Bolsas de pesquisa e financiamento

A Renovorx garantiu financiamento de pesquisa por meio de várias fontes:

• Institutos Nacionais de Saúde (NIH) Subsídios: aproximadamente US $ 500.000 anualmente
• Subsídios de pesquisa em pequenas empresas (SBIR): até US $ 300.000 por concessão

Propriedade intelectual de licenciamento

A empresa possui Vários pedidos de patente Relacionado à sua plataforma de oncologia de precisão:

Categoria de patentes	Número de patentes	Potencial receita de licenciamento
Tecnologia de tratamento do câncer	7 patentes ativas	Receita de licenciamento potencial estimada em US $ 1-2 milhões

Colaborações de ensaios clínicos

A Renovorx tem colaborações em andamento em andamento com várias instituições de pesquisa:

• Ensaios clínicos ativos atuais: Estudos 3 Fase II
• Financiamento estimado de colaboração: US $ 750.000 por teste

Parcerias farmacêuticas em potencial

A partir de 2024, a empresa está explorando parcerias estratégicas com empresas farmacêuticas:

Estágio de parceria	Parceiros em potencial	Valor estimado da parceria
Discussões exploratórias	2-3 Empresas farmacêuticas focadas em oncologia	Potenciais contratos de parceria de US $ 5 a 10 milhões

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.