MOUNTAIN VIEW, Calif., November 4, 2025 — RenovoRx, Inc. (NASDAQ: RNXT), a life sciences company pioneering targeted oncology therapies through its FDA-cleared RenovoCath® drug-delivery device, announced that CEO Shaun Bagai will participate at the Canaccord Genuity MedTech, Diagnostics & Digital Health & Services Forum on November 20, 2025, in New York City. Bagai will highlight RenovoRx’s commercial and clinical advancements, including progress from its ongoing Phase III TIGeR-PaC clinical trial, which evaluates the company’s novel intra-arterial gemcitabine therapy for locally advanced pancreatic cancer (LAPC).
Science Significance
RenovoRx is redefining precision oncology with its Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, designed for targeted therapeutic delivery directly at tumor sites. This method enhances drug concentration near tumors while reducing systemic toxicity, representing a leap in oncologic drug delivery science. The company’s approach merges biomedical engineering with clinical pharmacology, providing a scientifically rigorous alternative to conventional intravenous chemotherapy. By using the RenovoCath® catheter for localized infusion, RenovoRx is advancing the frontier of minimally invasive cancer therapeutics that combine precision, safety, and innovation.
Regulatory Significance
The RenovoCath® device holds U.S. FDA clearance for specific vascular applications, while the company’s drug-device combination therapy (IAG) — involving intra-arterial gemcitabine delivery — is being evaluated under an Investigational New Drug (IND) application regulated by the FDA’s Center for Drug Evaluation and Research (CDER) in accordance with 21 CFR 312. This dual-path regulatory approach demonstrates RenovoRx’s commitment to cGxP principles, ensuring compliance in manufacturing, clinical research, and post-marketing studies. The company’s Orphan Drug Designation for pancreatic and bile duct cancers further reflects its engagement with FDA innovation incentives that support novel therapies targeting high-unmet-need indications.
Business Significance
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RenovoRx is transitioning from clinical-stage innovation to commercial execution. Following its first commercial purchase orders for RenovoCath devices in late 2024, the company reports repeat orders from several National Cancer Institute-designated centers. At the MedTech forum, CEO Shaun Bagai will discuss strategies to expand global market reach, optimize manufacturing scalability, and pursue potential partnerships that leverage the RenovoCath platform. The company’s financial trajectory, rooted in revenue generation through device commercialization, underscores how regulatory-cleared technology can create sustainable value across both clinical and investor communities.
Patients’ Significance
For patients battling locally advanced pancreatic cancer, a disease with devastating prognosis and limited treatment options, RenovoRx’s platform offers new hope through localized therapy that targets tumors while minimizing systemic side effects. By focusing on precision delivery and reduced toxicity, the TAMP™ platform may enable longer survival rates, improved tolerance, and enhanced quality of life. The company’s post-marketing registry study reinforces its patient-centric approach by generating real-world safety and efficacy data, ensuring continuous improvement based on patient outcomes.
Policy Significance
RenovoRx’s development pathway aligns with U.S. healthcare policy objectives that promote innovation in oncology, drug-device integration, and efficient regulatory pathways for rare disease therapies. The company’s engagement in Orphan Drug programs, compliance with cGMP and cGCP standards, and transparent communication through forward-looking statements support the FDA’s broader mission to accelerate access to safe and effective medical technologies. By showcasing its advancements at a premier industry forum, RenovoRx contributes to ongoing policy dialogues on innovation-driven healthcare ecosystems that merge biotechnology, medtech, and data-informed care.
As RenovoRx takes the stage at the Canaccord Genuity MedTech Forum, it exemplifies how science, compliance, and business leadership converge in the pursuit of transformative cancer care. The company’s targeted oncology pipeline, combined with its FDA-cleared delivery platform, reflects a vision where precision therapy and patient safety coexist harmoniously. With its TAMP™ platform and RenovoCath® technology, RenovoRx continues to shape the future of interventional oncology, setting new benchmarks in regulatory excellence, patient-focused innovation, and medtech integration.
Source: RenovoRx, Inc. press release
