RenovoRx, Inc. (Nasdaq: RNXT), headquartered in California, is a clinical-stage biopharmaceutical company that is pioneering the use of targeted intra-arterial chemotherapy for treating solid tumors. Its novel drug-device platform, RenovoTAMP™ (Trans-Arterial Micro-Perfusion), is designed to deliver chemotherapeutic agents directly into tumors via the arteries, reducing systemic toxicity and increasing local efficacy. This approach marks a significant departure from conventional systemic therapies and is showing promise particularly in treating difficult-to-reach cancers like locally advanced pancreatic cancer (LAPC).
At the heart of RenovoRx’s platform is the RenovoCath® delivery system, an FDA-cleared catheter that facilitates targeted delivery of fluids to isolated segments of the arterial system. By isolating the tumor region and delivering chemotherapy directly to the tumor bed, RenovoCath optimizes drug exposure to malignant tissues while minimizing exposure to healthy organs. This localized approach is designed to enhance the therapeutic index of existing chemotherapies without the need to develop new cytotoxic agents.
RenovoRx’s lead clinical program is RenovoGem™, a combination product that pairs the RenovoCath device with intra-arterial gemcitabine. RenovoGem is being evaluated in the Phase III TIGeR-PaC trial for patients with LAPC. The trial, enrolling across multiple U.S. centers including Johns Hopkins, is designed to assess overall survival benefits compared to systemic chemotherapy. Interim pharmacokinetic data from this trial demonstrated that the TAMP approach achieved higher drug concentrations at tumor sites with reduced systemic toxicity.
The company has also received Orphan Drug Designation from the U.S. Food and Drug Administration for RenovoGem in both pancreatic and bile duct cancers. These designations grant up to seven years of market exclusivity upon approval, in addition to potential benefits like tax credits and waiver of certain FDA fees.
RenovoRx is not only focused on its clinical pipeline but is actively commercializing its FDA-cleared RenovoCath device. In December 2024, the company announced its first RenovoCath purchase orders, which marked its transition from a purely clinical entity into a commercial-stage company. In Q1 2025, RenovoRx reported $200,000 in device sales, exceeding internal projections for its first full quarter of commercial activity. Orders came from a variety of U.S. cancer treatment centers, including repeat purchases from National Cancer Institute-designated centers, indicating early validation and traction in the oncology and interventional radiology communities.
Following initial sales, RenovoRx increased U.S. production capacity of RenovoCath to meet growing demand. The company also launched a post-marketing registry study in July 2025 to collect real-world data on patient outcomes and use patterns, further supporting RenovoCath’s clinical and commercial positioning.
In May 2025, RenovoRx expanded its intellectual property portfolio with a new U.S. patent (No. 12,290,564) that covers novel methods related to its TAMP platform, extending patent protection through November 2037. The company now holds 19 issued patents and 12 pending applications globally. This robust patent estate strengthens RenovoRx’s long-term position, particularly as it explores new indications and therapeutic combinations beyond gemcitabine.
What sets RenovoRx apart from its peers is the integration of a proprietary delivery system with approved chemotherapeutic agents. Unlike competitors focused solely on new molecular entities or systemic regimens, RenovoRx leverages its delivery platform to repurpose existing drugs with precision targeting. This reduces developmental risk while enabling superior tumor penetration. The RenovoTAMP approach is especially advantageous for tumors with poor vascular access, where systemic treatments often fall short.
The company operates in a competitive field with players like NovoCure, TriSalus Life Sciences, and AngioDynamics also targeting solid tumors. However, RenovoRx’s intra-arterial approach, combined with its early commercialization success and orphan drug advantages, places it in a distinctive niche. As of August 2025, the company is preparing to release its Q2 financial results, where further updates on RenovoCath sales, TIGeR-PaC enrollment, and pipeline expansion are anticipated.
Looking ahead, RenovoRx is positioning itself to expand its RenovoTAMP platform to additional indications such as cholangiocarcinoma, hepatocellular carcinoma, and other hard-to-treat solid tumors. With commercial revenue now supporting its growth and strong clinical data emerging, RenovoRx appears poised to redefine targeted chemotherapy delivery for the next generation of cancer care.
