First Patient Treated in RenovoCath Clinical Trial

RenovoRx Inc.’s study of its U.S. Food and Drug Administration (FDA)-cleared drug delivery device, RenovoCath, has marked a major milestone with the first patient treatment at the University of Vermont Cancer Center.

RenovoRx also announced that Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center have joined the University of Vermont Cancer Center as participating clinical sites in the PanTheR registry study. Principal investigators at the first three PanTheR clinical sites include Dr. Ripal Gandhi, interventional radiologist at Baptist Health Miami Cancer Institute; Dr. Paula Novelli, interventional radiologist at University of Pittsburgh Medical Center; and Dr. Conor O’Neill, surgical oncologist at the University of Vermont Cancer Center. The study began at the University of Vermont Cancer Center with Dr. O’Neill’s team; the additional two sites are expected to initiate patient procedures soon.

The PanTheR study is assessing the safety and effectiveness of RenovoCath in real-world settings. RenovoRx plans to issue additional updates as patient enrollment accelerates and cancer treatments delivered with RenovoCath expand across a broader range of solid tumors and participating sites.

“We are pleased to be the first site to initiate cancer treatment delivery by RenovoCath in the important PanTheR registry study,” Dr. O’Neill said. “This study provides a crucial opportunity to evaluate how RenovoCath can improve drug-delivery in patients diagnosed with solid tumors, while potentially, and importantly, improving survival and quality of life outcomes. By contributing to this registry study, we aim to generate meaningful real-world data that can guide future treatment decisions for patients with difficult-to-treat cancers.”

The PanTheR study aims to determine the potential of RenovoCath to improve outcomes for patients diagnosed with solid tumors. By capturing real-world data and evaluating long-term safety and survival outcomes, PanTheR will enhance safety protocols and help shape future clinical trials and targeted drug-delivery applications for RenovoCath.

A post-marketing registry study is a clinical study that involves collecting data on the long-term use and performance of a medical device, such as RenovoCath, after it has been cleared by the FDA. PanTheR is a multi-center, post-marketing observational registry study designed to evaluate the long-term safety of and survival outcomes for patients diagnosed with solid tumors who are treated using RenovoCath for targeted drug-delivery. PanTheR will capture real-world data on the use of RenovoCath and generate additional safety information across a broader range of solid tumors. This data may be used to inform future clinical trial designs.

Based on its FDA clearance, RenovoCath is intended to isolate blood flow and fluid delivery, including diagnostic and/or therapeutic agents, to selected peripheral vascular system sites. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

RenovoRx Inc. is a life sciences company developing targeted oncology therapies and commercializing RenovoCath. The company’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 approach to targeted drug-delivery offers the potential for increased safety, tolerance, and improved efficacy.

In addition to the RenovoCath device, RenovoRx is also evaluating its 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 combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for 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 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.