RenovoRx’s PanTheR Post-Marketing Registry Study Progresses with First Clinical Procedure and Addition of Two Participating Clinical Sites

Rhea-AI Summary

RenovoRx (NASDAQ:RNXT) announced significant progress in its PanTheR Post-Marketing Registry Study for the FDA-cleared RenovoCath drug-delivery device. The first patient procedure was successfully completed at the University of Vermont Cancer Center, and two additional clinical sites - Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center - have joined the registry study.

The PanTheR study (NCT06805461) aims to gather expanded safety and performance data of RenovoCath and its survival outcomes in patients with solid tumors. The study is led by Principal Investigators Dr. Ripal Gandhi, Dr. Paula Novelli, and Dr. Conor O'Neill at their respective institutions. This real-world data collection will help guide future treatment decisions and enhance safety protocols for cancer patients.

Positive

• First registry-eligible patient procedure successfully completed
• Expansion to three major clinical sites for the registry study
• FDA-cleared status of RenovoCath device demonstrates regulatory compliance
• Study aims to improve drug-delivery and survival outcomes for solid tumor patients

Negative

• Additional clinical sites still pending procedure initiation
• Long-term safety and survival outcomes data not yet available

Insights

Medical Technology Analyst

RenovoRx advances its post-marketing registry study for RenovoCath with first patient procedure and expansion to three clinical sites, potentially enhancing cancer treatment delivery methods.

RenovoRx has reached a significant milestone in its PanTheR Post-Marketing Registry Study (NCT06805461) with the first registry-eligible patient procedure successfully completed at the University of Vermont Cancer Center. This development is accompanied by the expansion of the study to include two additional prestigious clinical sites: Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center.

The registry study represents a critical phase in establishing the real-world effectiveness of the RenovoCath technology—an FDA-cleared drug-delivery device designed for targeted oncology therapies. Unlike conventional clinical trials, registry studies collect data from routine clinical practice, providing valuable insights into how medical devices perform in everyday treatment settings across diverse patient populations.

From a technical perspective, the RenovoCath device employs a specialized catheter design that enables localized drug delivery directly to tumor sites. This targeted approach potentially offers two significant advantages: higher concentration of therapeutic agents at the tumor site and reduced systemic toxicity compared to traditional chemotherapy delivery methods. For patients with solid tumors, particularly those in difficult-to-access locations, this approach could represent a meaningful advancement in treatment delivery precision.

The expansion to multiple sites with distinguished principal investigators—including interventional radiologists Dr. Ripal Gandhi and Dr. Paula Novelli, alongside surgical oncologist Dr. Conor O'Neill—suggests growing clinical interest in this technology. The multi-disciplinary nature of the investigator team also indicates the potential for RenovoCath to be integrated into various treatment protocols and medical specialties.

What's particularly notable is the study's focus on gathering data across a broader range of solid tumors. This suggests RenovoRx is positioning RenovoCath as a platform technology with applications beyond a single cancer type, which could significantly expand its market potential if supported by positive outcomes data.

First Registry-Eligible Patient Procedure Commenced at the University of Vermont Cancer Center

Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center Join the University of Vermont Cancer Center as Participating Clinical Sites

The PanTheR Study is Gathering Expanded Safety and Performance Data of the FDA-Cleared RenovoCath^® Device and its Associated Survival Outcomes in Patients Diagnosed with Solid Tumors

MOUNTAIN VIEW, Calif., Sept. 25, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, today announced that the first registry-eligible patient procedure in its PanTheR Post-Marketing Registry Study (NCT06805461) has been successfully completed at the University of Vermont Cancer Center.

RenovoRx also announced that Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center have joined the University of Vermont Cancer Center as participating clinical sites in the PanTheR registry study. The Principal Investigators at the first three PanTheR clinical sites include Dr. Ripal Gandhi, interventional radiologist at Baptist Health Miami Cancer Institute, Dr. Paula Novelli, interventional radiologist at University of Pittsburgh Medical Center, and Dr. Conor O’Neill, surgical oncologist at the University of Vermont Cancer Center. The study has commenced at the University of Vermont Cancer Center with Dr. O’Neill’s team, with the additional two sites expected to initiate patient procedures soon.

These milestones underscore the important role of the PanTheR study in assessing the safety and effectiveness of RenovoCath in real-world settings. RenovoRx plans to issue additional updates as patient enrollment accelerates and cancer treatments delivered with RenovoCath expand across a broader range of solid tumors and participating sites.

“We are pleased to be the first site to initiate cancer treatment delivery by RenovoCath in the important PanTheR registry study,” said Dr. Conor O’Neill of the University of Vermont Cancer Center. “This study provides a crucial opportunity to evaluate how RenovoCath can improve drug-delivery in patients diagnosed with solid tumors, while potentially, and importantly, improving survival and quality of life outcomes. By contributing to this registry study, we aim to generate meaningful real-world data that can guide future treatment decisions for patients with difficult-to-treat cancers.”

The PanTheR study reinforces RenovoRx’s commitment to innovation and the potential of RenovoCath to improve outcomes for patients diagnosed with solid tumors. By capturing real-world data and evaluating long-term safety and survival outcomes, PanTheR will enhance safety protocols and help shape future clinical trials and targeted drug-delivery applications for RenovoCath.

About the PanTheR Post-Marketing Registry Study
A post-marketing registry study is a clinical study that involves collecting data on the long-term use and performance of a medical device, such as RenovoCath, after it has been cleared for market by the FDA. PanTheR is a multi-center, post-marketing observational registry study designed to evaluate the long-term safety of and survival outcomes for patients diagnosed with solid tumors who are treated using RenovoCath for targeted drug-delivery. PanTheR will capture real-world data on the utilization of RenovoCath and generate additional safety information across a broader range of solid tumors. This data may be used to inform future clinical trial designs. Cancer centers participating in the registry study will purchase RenovoCath devices from RenovoRx for use in the study.

About RenovoCath
Based on its FDA clearance, RenovoCath^® is intended for the isolation of blood flow and delivery of fluids, 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. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

About RenovoRx, Inc.
RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath^®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for 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 drug-delivery offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.

In addition to the RenovoCath device, RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

The combination product candidate, which is enabled by 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 actively commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, several of these customers have already initiated repeat orders in parallel to RenovoRx expanding the number of medical institutions initiating new RenovoCath orders, including several esteemed, high-volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner.

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.

Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith described herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies, including the anticipated benefits of the PanTheR registry study described herein, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iii) our efforts to explore commercialization strategies utilizing our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our exploration of commercial opportunities for our TAMP technology may not lead to viable, revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of our preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.

Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T:212-896-1254
RenovoRX@KCSA.com

FAQ

What is the purpose of RenovoRx's PanTheR Post-Marketing Registry Study?

The PanTheR study aims to evaluate the safety and effectiveness of RenovoCath in real-world settings, gathering expanded data on the FDA-cleared drug-delivery device and its survival outcomes in patients with solid tumors.

Which clinical sites are participating in RenovoRx's PanTheR study?

Three clinical sites are participating: University of Vermont Cancer Center (where the first procedure was completed), Baptist Health Miami Cancer Institute, and University of Pittsburgh Medical Center.

Who are the Principal Investigators for RNXT's PanTheR study?

The Principal Investigators are Dr. Ripal Gandhi (Baptist Health Miami), Dr. Paula Novelli (University of Pittsburgh), and Dr. Conor O'Neill (University of Vermont Cancer Center).

What is RenovoCath and what is it used for?

RenovoCath is a patented, FDA-cleared drug-delivery device designed to improve drug delivery in patients diagnosed with solid tumors, with the potential to improve survival and quality of life outcomes.

How will the data from RNXT's PanTheR study be used?

The real-world data will be used to enhance safety protocols, guide future treatment decisions, and help shape future clinical trials and targeted drug-delivery applications for RenovoCath.