RenovoRx Ramps Up U.S. Production of RenovoCath Devices

RenovoRx Inc. is increasing production of its U.S. Food and Drug Administration (FDA)-cleared RenovoCath catheter-based device to meet increased demand for the targeted delivery of diagnostic and/or therapeutic agents from oncologists and interventional radiologists. RenovoCath’s principal manufacturer is Medical Murray Inc., based in North Barrington, Ill.

“As we anticipated, we are seeing growing demand for our proprietary RenovoCath device. We expect first-quarter 2025 revenue from RenovoCath to reach the low six-figure range, with continued sequential growth quarter-over-quarter throughout the remainder of the year,” RenovoRx CEO Shaun Bagai said. “We estimate our initial total addressable market for RenovoCath is approximately $400 million in peak annual U.S. sales. We further believe we can capture this market over time with a very small sales force and/or distribution partners, which will keep our operating expenses low and put us on a path to cash flow positive operations. We are proud to manufacture RenovoCath in the U.S. and will continue to increase production in line with demand over time.”

Based on its FDA clearance, RenovoCath is intended to isolate blood flow and deliver fluids, 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.

In other news, RenovoRx’s management team and board have purchased 143,145 shares of company stock in multiple open market purchases at an average price of $0.8346.

“I, along with other management team members and members of our board of directors, have purchased shares of RenovoRx stock in the open market during our recent open trading window,” Bagai stated. “We are excited about the long-term value proposition of RenovoRx, and have therefore taken the opportunity to increase our equity positions at the company’s current valuation.”

RenovoRx Inc. is a life sciences company developing targeted oncology therapies and commercializing RenovoCath, a local drug delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform is designed to ensure 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.

In addition to the RenovoCath device, RenovoRx is also evaluating its Phase III drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG). IAG is being evaluated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational IAG utilizes RenovoCath, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The combination of intra-arterial infusion of chemotherapy, gemcitabine, and the RenovoCath device is currently being evaluated for treating locally advanced pancreatic cancer by the Center for Drug Evaluation and Research.

The combination product candidate, which is enabled the RenovoCath device, is currently under investigation and has not been approved for commercial 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 implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, certain of these customers have already initiated repeat orders as RenovoRx works to expand the number medical institutions that have initiated the process for RenovoCath purchase orders.