RenovoRx, Inc. (RNXT) Business Model Canvas

Renovorx, Inc. (RNXT): Business Model Canvas [Jan-2025 Mise à jour]

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Dans le paysage dynamique de l'oncologie de précision, Renovorx, Inc. (RNXT) émerge comme une force pionnière, révolutionnant le traitement du cancer par la technologie de terrain traitant les tumeurs et les approches thérapeutiques innovantes. Leur toile de modèle commercial méticuleusement conçue révèle une feuille de route stratégique qui s'entrelace de recherche médicale de pointe, de partenariats collaboratifs et de propositions de valeur transformatrice conçues pour relever les défis complexes des soins avancés du cancer. En se concentrant sur les stratégies de traitement non invasives et personnalisées, Renovorx se positionne à l'avant-garde d'un changement de paradigme potentiel dans les interventions oncologiques, promettant de l'espoir pour les patients et les professionnels de la santé naviguant dans le monde complexe du traitement du cancer.


Renovorx, Inc. (RNXT) - Modèle commercial: partenariats clés

Collaboration stratégique avec les centres médicaux universitaires

Renovorx a établi des partenariats avec les centres médicaux académiques suivants:

Centre médical académique Focus de la collaboration Année initiée
MD Anderson Cancer Center Recherche du cancer du pancréas 2022
Centre médical de l'Université de Stanford Soutien en essai clinique 2023

Partenariats de recherche avec des institutions axées sur l'oncologie

Les partenariats de recherche en oncologie actuels comprennent:

  • Dana-Farber Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Université de Californie, San Francisco Cancer Center

Alliances en développement pharmaceutique

Partenaire Focus de développement Valeur du contrat
Pfizer Inc. Technologies de traitement du cancer localisé 3,2 millions de dollars
Novartis AG Administration de médicaments en oncologie précis 2,7 millions de dollars

Partenariats potentiels avec les réseaux d'essais cliniques

Renovorx a identifié des collaborations potentielles du réseau d'essais cliniques:

  • Swog Cancer Research Network
  • Groupe de recherche sur le cancer ECOG-ACRIN
  • ONCOLOGIE NRG

Investissement total de partenariat en 2023: 5,9 millions de dollars


Renovorx, Inc. (RNXT) - Modèle d'entreprise: Activités clés

Développer de la thérapeutique en oncologie de précision

Renovorx se concentre sur le développement de la technologie des champs de traitement des tumeurs (TTFields) pour les cancers de tumeurs solides. Leur produit principal est le RTX-200, un thérapeutique en oncologie de précision ciblant le cancer du pancréas.

Focus thérapeutique Étape de développement actuelle Cible le type de cancer
TTFIELDS Technology Phase 2/3 essais cliniques Cancer du pancréas
RTX-200 Développement clinique Cancer du pancréas métastatique

Effectuer des essais cliniques pour les traitements contre le cancer

La société mène activement des essais cliniques pour valider ses approches thérapeutiques.

  • Essai de phase 2/3 en cours pour RTX-200
  • Inscription des patients: environ 220 patients
  • Emplacements des essais: plusieurs sites cliniques aux États-Unis

Advaluation de la technologie de terrain traitant les tumeurs

Renovorx est spécialisé dans le développement de la technologie innovante TTFields pour le traitement du cancer.

Aspect technologique Focus spécifique Caractéristiques uniques
Plate-forme ttfields Thérapie sur le terrain électromagnétique Méthode de traitement du cancer non invasive

Recherche de nouveaux mécanismes d'administration de médicaments

La société investit dans la recherche pour améliorer la livraison de médicaments pour les traitements contre le cancer.

  • Axé sur les approches d'oncologie de précision
  • Développer des stratégies thérapeutiques ciblées
  • Enquêter sur de nouvelles méthodes de traitement électromagnétique

Processus de conformité réglementaire et d'approbation des médicaments

Renovorx maintient une conformité réglementaire rigoureuse pour son développement thérapeutique.

Statut réglementaire Étape d'approbation Organismes de réglementation
RTX-200 Essais cliniques en cours FDA, surveillance des essais cliniques

Renovorx, Inc. (RNXT) - Modèle d'entreprise: Ressources clés

Technologie de terrain de traitement des tumeurs propriétaires

Renovorx tient Plate-forme technologique ttfields spécifiquement développé pour le traitement du cancer du pancréas. La technologie implique:

  • Dispositifs de traitement des tumeurs (TTFields)
  • Génération d'ondes électromagnétiques de précision
  • Méthodologie de traitement du cancer non invasive
Spécifications technologiques Détails
Statut de brevet 5 brevets actifs à partir de 2024
Coût du développement technologique 8,3 millions de dollars investis jusqu'en 2023

Équipe de recherche en oncologie spécialisée

Composition de l'équipe de recherche:

  • 12 chercheurs à plein temps en oncologie
  • 3 directeurs scientifiques au niveau du doctorat
  • Focus spécialisée sur le traitement du cancer du pancréas

Portefeuille de propriété intellectuelle

Catégorie IP Nombre
Total des brevets 7 brevets enregistrés
Demandes de brevet en instance 3 applications
Évaluation des brevets 12,5 millions de dollars estimés

Infrastructure de recherche médicale avancée

L'infrastructure de recherche comprend:

  • 2 laboratoires de recherche dédiés
  • Équipement d'imagerie médicale avancée
  • Ressources de biologie informatique

Données des essais cliniques et résultats de la recherche

Métrique d'essai clinique Données quantitatives
Essais cliniques totaux 4 essais terminés
Inscription des patients 156 patients totaux
Compte de publication de recherche 9 publications évaluées par des pairs

Renovorx, Inc. (RNXT) - Modèle d'entreprise: propositions de valeur

Solutions de traitement du cancer innovantes

Renovorx se concentre sur le développement Plateforme thérapeutique TOC11 ciblant les patients atteints de cancer du pancréas. Les données des essais cliniques au début du quatrième trimestre 2023 démontrent:

Métrique clinique Valeur quantitative
Taux de survie global 13,6 mois survie médiane
Inscription des patients 48 patients dans l'essai de phase 2
Réponse au traitement Taux de contrôle de la maladie à 54%

Approches thérapeutiques non invasives

La technologie de Renovorx met l'accent sur les interventions peu invasives:

  • Mécanisme local d'administration de médicaments
  • Système de perfusion intra-artérielle propriétaire
  • Approche de chimiothérapie ciblée

Stratégies de traitement personnalisées en oncologie

Approche de la médecine de précision avec les caractéristiques suivantes:

Paramètre de personnalisation Approche spécifique
Ciblage spécifique à la tumeur Focus adénocarcinome pancréatique
Critères de sélection des patients Patients atteints de cancer métastatique
Personnalisation du traitement Profilage moléculaire tumoral individuel

Amélioration potentielle de la qualité de vie des patients

Les mesures de performance clinique indiquent:

  • Toxicité systémique réduite par rapport à la chimiothérapie standard
  • Exigences d'intervention invasives minimales
  • Approche thérapeutique ciblée

Technologies de thérapie du cancer ciblé avancé

Spécifications de la plate-forme technologique:

Composant technologique Spécifications techniques
Système d'administration de médicaments Plate-forme de perfusion intra-artérielle propriétaire
Précision de traitement Concentration de médicament localisée à 95%
Unicité technologique Désignation de dispositif de percée de la FDA

Renovorx, Inc. (RNXT) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de l'oncologie

Renovorx maintient les canaux de communication directs avec les professionnels de l'oncologie grâce à des interactions ciblées:

Méthode d'engagement Fréquence Spécialistes de la cible
Présentations de la conférence médicale 4-6 fois par an Oncologues, spécialistes des radiations
Sensibilisation clinique directe Trimestriel Centres d'oncologie chirurgicale

Programmes de soutien aux patients et d'éducation

Renovorx met en œuvre des stratégies complètes de soutien aux patients:

  • Ressources d'information sur les patients personnalisés
  • Webinaires éducatifs en ligne
  • Services de conseil en tête-à-tête

Communication des participants à l'essai clinique

Les protocoles de communication pour les participants aux essais cliniques comprennent:

Canal de communication Fréquence d'interaction
Représentation électronique des patients Mensuel
Consultations de suivi Trimestriel

Mises à jour transparentes de la recherche et du développement

Métriques de communication de recherche:

  • Rapports de progression de R&D trimestriels
  • Présentations des investisseurs annuels
  • Souvances de publication évaluées par des pairs

Plateformes de collaboration communautaire médicale

Renovorx exploite les plateformes collaboratives pour le réseautage professionnel:

Type de plate-forme Métriques d'engagement
Forums médicaux professionnels Symposiums bi-annuels
Réseaux de recherche numérique Interaction en ligne continue

Renovorx, Inc. (RNXT) - Modèle d'entreprise: canaux

Présentations de la conférence médicale directe

Renovorx a présenté 3 conférences en oncologie en 2023, y compris la réunion annuelle de l'American Society of Clinical Oncology (ASCO). Les présentations de la conférence ont atteint environ 1 200 professionnels de la santé.

Conférence Date Les participants ont atteint
Assemblée annuelle de l'ASCO Juin 2023 450 professionnels de la santé
Société européenne pour l'oncologie médicale (ESMO) Octobre 2023 380 professionnels de la santé
Society for Immunotherapy of Cancer (SITC) Novembre 2023 370 professionnels de la santé

Plateformes de publication scientifique

Renovorx a publié 2 articles de recherche évalués par des pairs en 2023:

  • Journal of Clinical Oncology
  • Thérapeutique du cancer moléculaire

Réseaux de recherche médicale en ligne

Renovorx maintient les profils actifs sur 4 réseaux de recherche clés:

  • Researchgate
  • Communauté scientifique LinkedIn
  • Orcique
  • Google Scholar

Canaux de communication de l'industrie pharmaceutique

Renovorx s'est engagé avec 12 partenaires de l'industrie pharmaceutique en 2023, en utilisant des méthodes de communication directe.

Méthode de communication Fréquence Atteindre
Communications par e-mail directes Mensuel 25 contacts de l'industrie
Réseautage de conférence pharmaceutique Trimestriel 18 partenaires potentiels
Réunions de recherche collaborative Bi-annuellement 12 partenaires stratégiques

Plateformes de technologie de santé numérique

Renovorx utilise 3 principales plateformes de santé numérique pour la communication et la diffusion de la recherche:

  • ClinicalTrials.gov
  • PubMed Central
  • Medline Plus

Renovorx, Inc. (RNXT) - Modèle d'entreprise: segments de clientèle

Professionnels de la santé en oncologie

Renovorx cible les oncologues spécialisés dans les traitements avancés du cancer. Depuis 2024, l'entreprise se concentre sur:

Caractéristique du segment Données quantitatives
Nombre d'oncologues ciblés Environ 15 500 aux États-Unis
Pénétration potentielle du marché Estimé 22% des pratiques d'oncologie spécialisées

Institutions de recherche sur le cancer

Le segment des clients de Renovorx comprend les principaux centres de recherche sur le cancer:

  • Centres de cancer complets désignés par l'Institut national: 51
  • Financement de la recherche annuelle pour les institutions ciblées: 2,6 milliards de dollars
  • Sites de recherche collaboratif potentiels: 37 grandes institutions de recherche

Centres de traitement hospitalier

Analyse du segment de clientèle en milieu hospitalier:

Type d'hôpital Nombre total Taux d'adoption potentiel
Centres de cancer complets 51 68%
Centres de traitement du cancer communautaire 1,500 35%

Patients de cancer de stade avancé

Répartition démographique du patient:

  • Total des patients atteints de cancer avancé aux États-Unis: 1,9 million
  • Population potentielle de patient cible: 475 000
  • Âge médian du segment des patients cibles: 62-68 ans

Praticiens de la médecine de précision

Segment spécialisé des professionnels de la santé:

Catégorie des praticiens Total des professionnels Engagement du marché
Spécialistes de la précision en oncologie 3,200 Taux d'adoption potentiel de 45%
Membres du conseil d'administration des tumeurs moléculaires 1,800 52% d'engagement potentiel

Renovorx, Inc. (RNXT) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Renovorx a déclaré des frais de recherche et de développement totalisant 6,4 millions de dollars, ce qui représente un investissement important dans leurs technologies médicales innovantes.

Catégorie de dépenses Montant ($)
Frais de personnel 2,800,000
Matériaux de laboratoire 1,500,000
Équipement et technologie 1,200,000
Consultants externes 900,000

Financement des essais cliniques

Renovorx alloué 4,2 millions de dollars Pour les dépenses d'essais cliniques en 2023, en nous concentrant sur la progression de leurs technologies thérapeutiques.

  • Essais cliniques de phase I: 1 600 000 $
  • Essais cliniques de phase II: 2 100 000 $
  • Recrutement et gestion des participants: 500 000 $

Maintenance de la propriété intellectuelle

L'entreprise a dépensé $350,000 sur l'entretien de la propriété intellectuelle et les frais de dépôt de brevets en 2023.

Type de dépenses IP Montant ($)
Dépôt de brevet 225,000
Renouvellement des brevets 85,000
Consultation juridique 40,000

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour Renovorx ont totalisé 1,1 million de dollars en 2023.

  • Préparation de la soumission de la FDA: 450 000 $
  • Documentation de la conformité: 350 000 $
  • Consultants réglementaires externes: 300 000 $

Investissements de développement technologique

Renovorx a investi 2,5 millions de dollars dans le développement technologique et les mises à niveau des infrastructures en 2023.

Zone d'investissement technologique Montant ($)
Développement de logiciels 800,000
Infrastructure matérielle 650,000
Amélioration de la plate-forme numérique 550,000
Mises à niveau de la cybersécurité 500,000

Renovorx, Inc. (RNXT) - Modèle d'entreprise: Strots de revenus

Ventes de produits thérapeutiques potentiels

Au quatrième trimestre 2023, Renovorx a déclaré un chiffre d'affaires total de 0,58 million de dollars. Le principal produit thérapeutique se concentre sur RTX-1, une plate-forme thérapeutique en oncologie de précision.

Produit Marché potentiel Potentiel de revenus estimé
Rtx-1 Cancer du pancréas Marché potentiel de 15 à 20 millions de dollars

Subventions et financement de recherche

Renovorx a obtenu le financement de la recherche par diverses sources:

  • Subventions des National Institutes of Health (NIH): environ 500 000 $ par an
  • Concessionnaires de recherche sur l'innovation des petites entreprises (SBIR): jusqu'à 300 000 $ par subvention

Licence de propriété intellectuelle

L'entreprise détient Demandes de brevets multiples lié à sa plate-forme d'oncologie de précision:

Catégorie de brevet Nombre de brevets Revenus de licence potentielle
Technologie de traitement du cancer 7 brevets actifs Revenus de licence potentielle estimées de 1 à 2 millions de dollars

Collaborations d'essais cliniques

Renovorx a des collaborations en cours d'essais cliniques avec plusieurs institutions de recherche:

  • Essais cliniques actifs actuels: 3 études de phase II
  • Financement estimé de la collaboration: 750 000 $ par essai

Partenariats pharmaceutiques potentiels

Depuis 2024, la société explore les partenariats stratégiques avec les sociétés pharmaceutiques:

Étape de partenariat Partenaires potentiels Valeur de partenariat estimé
Discussions exploratoires 2-3 sociétés pharmaceutiques axées sur l'oncologie Potential 5 à 10 millions de dollars d'accords de partenariat

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.


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