Full Press Release Details
RenovoRx has initiated its PanTheR post-marketing registry with the first registry-eligible patient procedure completed at the University of Vermont Cancer Center, and two additional sites—Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center—joining ahead of first patient procedures. The registry (NCT06805461) will collect real-world safety, performance, and survival outcomes for patients with solid tumors treated using RenovoCath, the company’s FDA-cleared intra-arterial drug-delivery catheter used within its Trans-Arterial Micro-Perfusion platform.
The core move is a two-track strategy: while the company continues its Phase III TIGeR-PaC trial evaluating intra-arterial gemcitabine delivered via RenovoCath (IAG) under an IND, it is simultaneously building a device-centric evidence base in routine practice. The registry is multi-center and observational, and participating sites purchase the device for use in study patients—an important signal that this is not a subsidized access program but a commercialization-aligned RWE effort designed to standardize technique, document outcomes, and support broader institutional uptake across tumor types. RenovoRx disclosed initial commercial orders for RenovoCath in late 2024; PanTheR now gives the company a structured framework to link utilization to outcomes, which can be persuasive for hospital value analysis committees and payer discussions even absent new labeling.
View the entire article on The Clinical Trial Vanguard