RenovoRx, Inc. (Nasdaq: RNXT) is increasing production of its FDA-cleared RenovoCath delivery system to meet growing demand from oncologists and interventional radiologists for targeted delivery of diagnostic and therapeutic agents. The company is actively exploring commercial opportunities for RenovoCath beyond its current clinical programs.
Manufacturing Expansion
RenovoRx has signed a new project work order with Medical Murray, its principal manufacturing partner, to expand their relationship. As part of the agreement, RenovoRx may issue Medical Murray warrants to purchase up to 709,500 shares of RenovoRx common stock, vesting upon achievement of specific manufacturing milestones. This move aims to incentivize and secure the necessary manufacturing capacity for RenovoCath.
TIGeR-PaC Clinical Trial
RenovoRx remains committed to its pivotal Phase III TIGeR-PaC clinical trial, which is evaluating TAMP (Trans-Arterial Micro-Perfusion) therapy for locally advanced pancreatic cancer (LAPC). The trial uses RenovoRx’s drug-device combination, involving intra-arterial infusion of gemcitabine HCl, targeting tumors in LAPC. The study compares TAMP therapy to the current standard of care, systemic intravenous chemotherapy. Additional clinical sites are participating to accelerate patient enrollment.
RenovoCath as a Standalone Device
Leesa Gentry, Chief Clinical Officer of RenovoRx, noted the interest from oncology and interventional radiology physicians in purchasing RenovoCath as a standalone device for clinical practice. "RenovoCath has been used in over 500 procedures by interventionalists over the past several years," Gentry stated, highlighting data from early-stage clinical trials suggesting potential benefits, such as reduced toxicity and improved outcomes, compared to standard of care.
Commercial Strategy
Shaun Bagai, CEO of RenovoRx, indicated that the company is actively exploring commercial opportunities to meet the growing demand for RenovoCath technology. "Beyond LAPC, we believe there are many clinical applications for RenovoCath to improve targeted delivery of diagnostic and therapeutic agents," Bagai said. The company anticipates potential revenue generation from this commercial strategy in 2025 and has sufficient cash to achieve the next interim readout on TIGeR-PaC, expected in late 2024 or early 2025.
About RenovoCath
RenovoCath is FDA-cleared for isolating blood flow and delivering fluids, including diagnostic and therapeutic agents, to selected sites in the peripheral vascular system. It is also indicated for temporary vessel occlusion in applications like arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The device is designed for general intravascular and peripheral vascular use in arteries with diameters between 3mm and 11mm.
