RenovoRx, Inc. is a clinical-stage biopharmaceutical firm dedicated to developing therapies for solid tumor malignancies. The company's primary investigational therapy, RenovoGem, is ...
RenovoCath is a novel, FDA-cleared catheter device indicated for temporary vessel occlusion and delivery of diagnostic and/or therapeutic agents, including chemotherapeutic drugs, to selected sites in the peripheral vascular system. It is designed for arteries 3mm and larger and can occlude vessels ranging from 3mm to 11mm in diameter. The device enables the TAMP therapy platform by allowing targeted delivery of chemotherapy directly to tumor sites, potentially reducing systemic side effects and improving efficacy. It is commercially available and used in interventional procedures.
Price Range: Not publicly disclosed; sold under B2B contracts to hospitals and clinical facilities.
Pain Points: Limitations of systemic chemotherapy (severe side effects, poor tumor penetration); lack of precise delivery methods for difficult-to-reach tumors; need for repeatable and controllable occlusion during interventional procedures.
Solutions: Enables trans-arterial micro-perfusion (TAMP) for localized delivery; isolates blood flow to minimize systemic exposure; allows higher local drug concentration with reduced toxicity; offers a safe and repeatable occlusion mechanism.
Raw material suppliers (medical-grade polymers, metals, adhesives)Component manufacturers (balloon, tubing, connectors)Device assembly and sterilization facilitiesQuality assurance and regulatory complianceDistribution channels (medical device distributors)End users: hospitals, interventional radiology suites, oncology centers
RenovoGem (also referred to as IAG) is a combination oncology product candidate that integrates the RenovoCath device with the chemotherapeutic agent gemcitabine. It is designed to deliver gemcitabine directly into the arteries near pancreatic tumors via the TAMP therapy platform, potentially improving efficacy and reducing systemic toxicity compared to standard intravenous gemcitabine. RenovoGem is currently being evaluated in the Phase III TIGeR-PaC clinical trial for the treatment of locally advanced pancreatic cancer. The product has not yet received FDA approval for commercial sale.
Price Range: Not applicable; investigational product not yet commercialized.
Pain Points: Poor outcomes with systemic chemotherapy for LAPC; high toxicity and patient tolerability issues; limited drug penetration into pancreatic tumors; lack of effective localized treatment options.
Solutions: Direct intra-arterial delivery to bathe the tumor with high drug concentration; potential for improved overall survival; reduced systemic side effects; novel therapeutic approach for an unmet medical need.
Target Users: Patients with unresectable, locally advanced pancreatic cancer; oncologists and clinical trial investigators; hospital systems participating in the TIGeR-PaC study; future patients if approved.
Supply Chain
Gemcitabine active pharmaceutical ingredient (API) suppliersDevice manufacturing (RenovoCath)Drug-device combination assemblyClinical trial logistics and site managementRegulatory oversight (FDA IND)Potential future commercialization network
Medical Murray, Inc.Backup/Secondary Contract Manufacturer (Undisclosed)Aptyx (formerly Argos Corporation)Specialty Catheter Material Suppliers (Various)Gemcitabine Drug Suppliers (Generic Market)UnconfirmedOxaliplatin Drug Suppliers (Generic Market)Unconfirmed
Downstream
8
City of Hope Cancer CenterMoffitt Cancer CenterSCRI Oncology Partners (Sarah Cannon Research Institute)Johns Hopkins MedicineAtrium Health - Levine Cancer InstituteAdditional 11+ Active U.S. Cancer Centers (Undisclosed)Imugene LimitedASX:IMUDirect Sales Model (No Intermediary Distributors)
