RenovoRx is a clinical-stage oncology medical device company commercializing RenovoCath, an FDA-cleared dual-balloon catheter for targeted drug delivery to solid tumors. RenovoCath uses pressure to force chemotherapy across the arterial wall directly at the tumor site — a proprietary approach RenovoRx calls Trans-Arterial Micro-Perfusion (TAMP). Rather than delivering chemotherapy intravenously, TAMP localizes drug delivery near the tumor, which RenovoRx argues achieves higher local drug concentrations while reducing systemic side effects. The device is used primarily by interventional radiologists and oncologists at U.S. cancer centers, and RenovoRx sells RenovoCath directly to those institutions on a per-unit basis. Each device is single-use, and patients typically undergo multiple procedures, creating a recurring revenue pattern per patient. RenovoRx began generating commercial revenue in late 2024 and currently has 12 active U.S. cancer centers using the device commercially. In parallel, RenovoRx is running the TIGeR-PaC Phase III trial, studying the delivery of gemcitabine via RenovoCath in locally advanced pancreatic cancer. An early interim analysis showed a 6-month median overall survival benefit for the TAMP arm versus IV chemotherapy. Enrollment is expected to complete mid-2026, with final data anticipated in 2027. If approved, RenovoRx would sell a co-packaged drug-device combination product and file an NDA; the program has FDA Orphan Drug Designation for pancreatic and bile duct cancers.
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