Regulatory

New U.S. Patent Issued to RenovoRx for Drug Therapy Platform

The company is evaluating a Phase III drug-device combination oncology product candidate under an investigational FDA application.

By: Michael Barbella

Managing Editor

RenovoRx Inc. has been awarded a new U.S. patent that protects drug delivery methods using its Trans-Aterial Micro-Perfusion (TAMP) therapy platform, enabled by the firm’s proprietary RenovoCath drug delivery device.

U.S. patent 12,290,564, “Methods for Treating Tumors,” covers new methods for treating a tumor by locally delivering drugs to an arterial or blood vessel region that is near the tumor after treating the area to reduce the microvasculature. The new patent provides legal protections through November of 2037.

“The issuance of this new patent highlights the innovation behind our TAMP therapy platform and strengthens our competitive position,” RenovoRx CEO Shaun Bagai said. “This marks our ninth U.S. patent and 19th global patent which further expands our growing IP portfolio. Our IP portfolio is an essential asset as we advance and scale our commercialization of RenovoCath as a stand-alone device, which we began generating revenues in December of 2024.”

This latest protection gives RenovoRx 19 total issued patents and 12 pending patents. RenovoRx’s intellectual property portfolio provides key support to the company’s continuing commercialization of RenovoCath, according to bigwigs.

Related: RenovoRx Ramps Up U.S. Production of RenovoCath Devices

“The expansion of our IP portfolio also supports our ongoing Phase III clinical trial. TIGeR-PaC is evaluating our investigational drug-device combination product candidate using the TAMP therapy platform enabled by RenovoCath for the intra-arterial administration of chemotherapy (intra-arterial gemcitabine (IAG)), versus systemic chemotherapy delivery, for the treatment of locally advanced pancreatic cancer,” Bagai stated.

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

The TIGeR-PaC is an ongoing Phase III randomized multi-center trial evaluating the proprietary TAMP therapy platform for treating locally advanced pancreatic cancer (LAPC). RenovoRx’s first investigational drug-device combination product candidate uses the TAMP therapy platform enabled with the RenovoCath  device for intra-arterially administering chemotherapy (intra-arterial gemcitabine, known as IAG).

RenovoRx Inc. develops targeted oncology therapies and commercializes RenovoCath. Its patented Trans-Arterial Micro-Perfusion 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 approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to provide solutions to target diagnostic and therapeutic agent delivery.

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 uses RenovoCath. The combination of intra-arterial infusion of chemotherapy, gemcitabine, and the RenovoCath device is currently being evaluated for treating LAPC by the Center for Drug Evaluation and Research (the drug division of FDA).

The combination product candidate enabled by the RenovoCath device is currently under investigation and has not been approved for commercial sale. RenovoRx is also implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as stand-alone product. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices.

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