RenovoRx Expands U.S. Commercialization Efforts for the RenovoCath® Device with Growing Customer Demand and Key Leadership Hire

Rhea-AI Summary

RenovoRx (NASDAQ:RNXT) announced significant expansion of its commercialization efforts for its RenovoCath® FDA-cleared drug-delivery device. The company has grown its customer base to thirteen cancer centers, including several National Cancer Institute (NCI)-designated and community centers, up from five centers in Q1 2025.

Four active customers are currently using RenovoCath and have placed repeat orders. The company has also appointed Philip Stocton as Senior Director of Sales and Market Development, bringing over 25 years of MedTech experience to lead commercialization efforts.

RenovoRx expects additional growth potential from 18 cancer centers currently participating in its Phase III TIGeR-PaC trial, which is anticipated to complete enrollment by early 2026. The RenovoCath device enables targeted locoregional delivery of chemotherapy through the company's Trans-Arterial Micro-Perfusion (TAMP) therapy platform.

Positive

• Customer base expanded to 13 cancer centers from 5 in Q1 2025
• 100% repeat order rate from active customers
• Potential expansion to 18 additional cancer centers post-TIGeR-PaC trial completion
• Hired experienced MedTech leader with 25 years of industry expertise
• Commercial growth achieved without large capital outlays

Negative

• Only 4 out of 13 approved centers are currently active users
• Phase III TIGeR-PaC trial enrollment still ongoing

Insights

Medical Device Industry Analyst

RenovoRx shows promising commercial traction for RenovoCath with expanding customer base and strategic leadership hire to drive growth.

RenovoRx is showing meaningful early commercial traction for its RenovoCath device, a specialized catheter designed for targeted drug delivery to tumors. The company has expanded from just 5 centers in Q1 2025 to 13 cancer centers now approved to purchase the device, including prestigious National Cancer Institute (NCI)-designated academic centers. Most significantly, four active customers have already placed repeat orders - a critical early validation of product-market fit and clinical utility.

The company's Trans-Arterial Micro-Perfusion (TAMP) approach addresses a significant clinical need by enabling localized chemotherapy delivery directly to tumors, potentially reducing systemic toxicity compared to traditional intravenous administration. This approach aligns with the broader oncology trend toward targeted therapies that maximize efficacy while minimizing side effects.

The hiring of Philip Stocton as Senior Director of Sales represents a strategic investment in commercial infrastructure. His 25-year background in medical device sales and specific expertise in interventional oncology positions RenovoRx to leverage his established relationships and domain knowledge. That Stocton was previously consulting for RenovoRx suggests a thoughtful leadership transition with minimal onboarding friction.

Looking ahead, RenovoRx has identified a significant commercial opportunity with the 18 cancer centers currently participating in their Phase III TIGeR-PaC trial. These centers represent pre-qualified potential customers already familiar with the technology, potentially accelerating the sales cycle once trial enrollment completes later this year or early next. The company appears to be executing a capital-efficient commercialization strategy, focusing on high-value centers rather than building an expensive direct sales force immediately.

RenovoRx increases its commercial footprint to thirteen leading National Cancer Institute-designated and community centers approved to purchase RenovoCath

Four active cancer center customers are currently purchasing and have made repeat orders of RenovoCath for interventional radiology procedures

RenovoRx hires Senior Director of Sales and Market Development to coordinate, execute, and expand commercialization strategy

MOUNTAIN VIEW, Calif., Aug. 06, 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 strong progress in its commercialization efforts, including its growing customer base and the hiring of experienced medical device sales leader Philip Stocton as Senior Director of Sales and Market Development to lead the execution of RenovoRx’s commercialization efforts.

Since launching its commercial efforts in December 2024, RenovoRx has established commercial momentum for RenovoCath, with thirteen cancer center customers approved to purchase the device, including several high-volume, National Cancer Institute (NCI)-designated academic and community centers, an increase from five centers in the first quarter of 2025. Four of these thirteen cancer centers have used the device in patients, and all have made repeat purchase orders subsequently.

This momentum highlights the growing clinical demand across the United States for novel, localized solid tumor drug-delivery options beyond methods like systemic intravenous delivery of chemotherapy. RenovoRx believes that many of the 18 cancer centers that have used RenovoCath as part of its ongoing, pivotal Phase III TIGeR-PaC trial could also be potential customers for RenovoCath after the completion of TIGeR-PaC enrollment, which is expected later this year or early next year.

Additionally, to coordinate, execute, and expand its commercial efforts for RenovoCath, RenovoRx has hired Philip Stocton as Senior Director of Sales and Market Development. Mr. Stocton brings over 25 years of experience in MedTech sales, marketing, and leadership from various commercial positions at Terumo, Johnson & Johnson, Varian (acquired by Siemens), and, most recently, Sirtex Medical. Over the past 10 years, he has specialized in interventional oncology in both domestic and international roles. Prior to his hiring, Mr. Stocton had been consulting for RenovoRx in connection with its RenovoCath commercial launch planning efforts.

Dr. Gregory Tiesi, MD, FACS, FSSO, Chief of Hepatobiliary Surgery at Hackensack Meridian Jersey Shore University Medical Center and Assistant Professor, Hackensack Meridian School of Medicine stated, “At Hackensack Meridian Health, we are committed to bringing medical innovations to our patients, ensuring they receive the most advanced treatment options available. Our priority is to personalize care and improve outcomes for cancer patients. We are proud to be the first medical institution in New Jersey to offer RenovoRx’s Trans-Arterial Micro-Perfusion (or TAMP) therapy platform using the RenovoCath device, enabling targeted locoregional delivery of chemotherapy. This approach to targeted delivery offers the potential to reduce systemic toxicity and associated side effects and to enhance the quality of life for patients undergoing treatment. Importantly, TAMP also gives our patients who have run out of treatment options, hope and a chance to continue to fight.”

“We are encouraged by the growing clinical adoption with our expanding RenovoCath customer base among leading cancer centers, which highlights the urgent need for effective localized drug-delivery that offer the potential to improve safety, efficacy, and quality-of-life for oncology patients,” said Shaun Bagai, CEO of RenovoRx.

Mr. Bagai continued, “We are also excited to announce that Phil Stocton has joined our team as our Senior Director of Sales and Market Development. Phil brings extensive expertise in interventional oncology, and his experience will be invaluable as we scale our efforts and continue advancing our mission to improve outcomes for patients facing difficult-to-treat cancers. While we remain committed to building sales momentum without large capital outlays by our company, securing Phil full-time was an easy call and an investment in our future growth. We look forward to working with him as he leads the growth of our commercialization efforts with our in-house RenovoRx Team and without large expense outlays.”

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 treatment 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 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 and others made in connection therewith 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 pre-clinical and clinical trials and studies, including the overall timing and timing for enrollment in and additional interim data readouts for our ongoing TIGeR-PaC Phase III clinical trial study, (ii) the anticipated benefits of the hiring of Mr. Stockton as described herein, (iii) the potential of RenovoCath® or TAMP™ as standalone commercial products, our anticipated timing for revenue generation from RenovoCath sales, and our commercialization plans in general, and (iv) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases. 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, commercial 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 significant 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 execution of our commercial strategy for RenovoCath or our TAMP technology may not lead to viable or repeating 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 and timing for completion of enrollment) for the TIGeR-PaC trial and any other 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 scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs, (xviii) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately, (xix) the pricing, coverage, and reimbursement of our product candidates, if approved, and (xx) 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

How many cancer centers are currently approved to use RenovoRx's RenovoCath device?

13 cancer centers are approved to purchase RenovoCath, including several National Cancer Institute (NCI)-designated academic and community centers.

Who is RenovoRx's new Senior Director of Sales and Market Development?

Philip Stocton was hired as Senior Director of Sales and Market Development, bringing over 25 years of MedTech experience from companies including Terumo, Johnson & Johnson, Varian, and Sirtex Medical.

What is the current status of RenovoRx's TIGeR-PaC trial?

The Phase III TIGeR-PaC trial is ongoing, with enrollment expected to complete by late 2025 or early 2026. Currently, 18 cancer centers are participating in the trial.

How many cancer centers are actively using the RenovoCath device?

Four cancer centers are actively using the RenovoCath device, and all of them have made repeat purchase orders.

What is the purpose of RenovoRx's RenovoCath device?

RenovoCath is an FDA-cleared drug-delivery device that enables targeted locoregional delivery of chemotherapy through Trans-Arterial Micro-Perfusion (TAMP) therapy, aiming to reduce systemic toxicity and improve patient quality of life.