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.

Strategically, PanTheR is a practical hedge against the timelines and binary risk of the TIGeR-PaC readout. Device clearance already covers isolation of blood flow and local infusion in the peripheral vasculature, including chemotherapeutic drug delivery. By anchoring that clearance in real-world oncology settings and tracking survival alongside safety, RenovoRx is targeting operational adoption rather than waiting for drug-device combination data to unlock demand. The tension is that RWE from heterogeneous solid tumors is inherently noisy, and any signal will need rigorous methodology, consistent procedural training, and transparent analyses to influence guidelines or coverage. Still, for interventional oncology teams seeking to localize therapy and mitigate systemic toxicity, standardized registry protocols can lower barriers to trial-like execution without the overhead of a randomized study.

For sites, PanTheR brings a structured way to capture outcomes and operationalize the TAMP technique, which could streamline IR workflows and credentialing. Because devices are purchased for study use, procurement and supply chain stakeholders will scrutinize procedural throughput, complication rates, and downstream resource utilization. CROs and data vendors may see opportunities in registry build-out, eSource integration, and longitudinal follow-up infrastructure, particularly if the program expands beyond early KOL centers. Regulators continue to signal openness to device RWE for post-market surveillance and, in some cases, to inform label evolution; PanTheR aligns with that direction but will be judged on data completeness, adjudication rigor, and tumor-specific consistency. For sponsors watching the local-delivery space, the approach underscores growing interest in platformizable, site-operated delivery technologies that can be layered with approved agents.

Next, watch the cadence of site activations and case volume, the mix of tumor types treated, and early safety summaries that speak to reproducibility outside controlled trials. The critical converging milestone will be clarity on TIGeR-PaC timing and interim signals; convergence of positive randomized data with robust registry outcomes could accelerate payer acceptance and pathway inclusion, while weak combination results would shift more weight onto the device-only value proposition. Expect RenovoRx to pursue additional NCI-designated centers, further standardize training to reduce inter-operator variability, and explore coding and payment pathways that reward localized delivery. The open questions are whether PanTheR can generate tumor-specific survival signals compelling enough to change institutional practice and whether the company can scale beyond early adopters without a commercial partner.

Source link: https://www.globenewswire.com/news-release/2025/09/25/3156272/0/en/RenovoRx-s-PanTheR-Post-Marketing-Registry-Study-Progresses-with-First-Clinical-Procedure-and-Addition-of-Two-Participating-Clinical-Sites.html

Jon Napitupulu
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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.