RenovoRx is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted drug-delivery offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.
In addition to the RenovoCath device, RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
The combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA.
RenovoRx is also actively commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, several of these customers have already initiated repeat orders in parallel to RenovoRx expanding the number of medical institutions initiating new RenovoCath orders, including several esteemed, high-volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner.
Key Highlights
- Developing combination therapies based on proprietary Trans-Arterial Micro-Perfusion (TAMPTM) platform: FDA Orphan Drug Designation granted to first oncology combination product candidate (intra-arterial gemcitabine delivered via RenovoCath (IAG)) in pancreatic and bile duct cancers.
- Commercializing FDA-cleared RenovoCath: Customer demand and reimbursement dynamics driving organic growth.
- Continuing to grow and protect strong intellectual property portfolio in drug delivery with 19 patents in multiple countries across the globe, including 9 U.S. patents as well as 7 U.S. patents pending.
- Advancing ongoing Phase III TIGeR-PaC clinical trial for the treatment of locally advanced pancreatic cancer (LAPC): In Q2 2025, the 52nd event was triggered in the 2nd pre-planned interim analysis to be reviewed by the independent Data Monitoring Committee (DMC), and the DMC recommended a continuation of the trial. The first of two pre-planned interim analyses was completed in March 2023, and the DMC recommended a continuation of the study. The primary endpoint of the trial is prespecified to detect a significant overall survival benefit. Secondary endpoints include reduced side effects versus standard of care and additional efficacy measures.
- Pursuing initial ~$400M potential peak annual U.S. revenue opportunity for RenovoCath as a stand-alone device.
- In July 2025, launched registry study, PanTheR, to evaluate cancer treatment delivered by RenovoCath in solid tumors and expand safety and performance data of RenovoCath, and its associated patient survival outcomes.
- Led by experienced Leadership Team and Board of Directors: Expertise in clinical development and commercial execution at scale