RenovoRx Initiates Multi-Center Registry Study for RenovoCath Device

 RenovoRx Inc. has officially kicked off the PanTheR Post-Marketing Registry Study for RenovoCath, its patented, U.S. Food and Drug Administration (FDA)-cleared drug delivery device.

The study will serve as a critical tool for understanding RenovoCath’s safety and effectiveness in a real-world setting, providing valuable insights into long-term effectiveness and patient outcomes, according to the company. Patient enrollment is expected to begin before the end of September. Each cancer center participating in the registry study will purchase RenovoCath devices for use in the study from RenovoRx.

“PanTheR marks a significant step forward in our commitment to better understand and demonstrate the long-term safety and therapeutic potential of our RenovoCath device,” RenovoRx Chief Clinical Officer Leesa Gentry stated. “By collaborating with leading cancer centers across the U.S, this is a low-cost study that will yield valuable data. By gathering real-world data across diverse cancer types and clinical environments, PanTheR aims to advance innovation and inform evidence-based treatment strategies, which will ultimately enhance care and potentially improve outcomes for future patients facing solid tumors.”

A registry or post-approval study is a clinical trial that collects data on a medical device’s long-term use and performance (i.e., RenovoCath) after it has been cleared by the FDA. PanTheR is a multi-center, post-marketing observational registry study evaluating 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 RenovoCath’s use and generate additional safety information across a broader range of solid tumors. This data may be used to inform future clinical trial designs, RenovoRx executives said.

The first of multiple clinical sites to initiate patient enrollment in the PanTheR study is the University of Vermont (UVM) Cancer Center, with Dr. Conor O’Neill, assistant professor at the UVM Larner College of Medicine and surgical oncologist at the UVM Medical Center, serving as principal investigator. Additional clinical sites in the post-marketing registry study are expected to initiate enrollment soon.

“We are very pleased that the UVM Cancer Center has been initiated to begin enrollment in the PanTheR study,” Gentry said. “The UVM Cancer Center offers leading-edge care, provided by highly skilled oncologists priding themselves on using the latest research and education for informed care. We believe our study will be an excellent fit within University of Vermont’s oncology program.”

“We are proud to be part of this important study that holds the potential to transform the way we treat solid tumors,” Dr. O’Neill added. “I believe the RenovoCath device offers a novel approach for drug delivery, which may have the potential to improve patient outcomes. This study emphasizes our strong commitment to continually advance treatment options offered to our patients by offering access to the latest innovations that have the potential to transform the treatment paradigm for solid tumors.”

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 Mountain View, Calif.-based life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath. Its 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 treatment offers the potential for increased safety, tolerance, and improved efficacy. RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx received its first commercial purchase orders for RenovoCath devices. 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.