RenovoRx Announces First RenovoCath Revenues & Phase III Trial Update
RenovoRx, Inc. (Nasdaq: RNXT), a leading life sciences company focused on developing innovative targeted oncology therapies, has announced its financial results and key business updates for the fourth quarter and the full fiscal year ending December 31, 2024. The company is actively commercializing its proprietary RenovoCath® device, an FDA-cleared drug-delivery platform, which has now begun generating revenue. This marks a significant milestone in RenovoRx’s evolution as a commercial-stage company.
First Revenue Generation and Financial Overview
The fourth quarter of 2024 was a transformative period for RenovoRx as the company recorded its first revenue from sales of the RenovoCath device as a standalone product. CEO Shaun Bagai expressed confidence in the company’s commercial strategy, stating that significant revenue growth is expected in the coming quarters. Importantly, he emphasized that this growth could be achieved without substantial increases in capital expenditures, regardless of whether the company pursues self-commercialization or partners with a larger organization with an established sales infrastructure.
RenovoRx successfully raised $12.1 million through a public offering in February 2025. Coupled with its cash balance of $7.2 million at the end of 2024, these resources fully fund the company’s operational plan. The management anticipates that increased RenovoCath sales will gradually reduce the company’s burn rate as it strategically deploys available cash to maximize shareholder value.
Market Potential and Revenue Projections
The market opportunity for RenovoCath is substantial. Internal analyses suggest an estimated total addressable market (TAM) of $400 million in peak annual U.S. sales for its initial indications. However, the potential extends well beyond this, with additional clinical applications potentially expanding the TAM to several billion dollars over time. RenovoRx aims to capitalize on this opportunity by targeting the top 200 high-volume treatment centers with a lean commercial team.
For the first quarter of 2025, RenovoRx projects revenue in the low six-figure range, with sequential quarter-over-quarter growth expected throughout the year. This momentum underscores the increasing adoption of RenovoCath and validates the company’s commercialization efforts.
RenovoCath Commercialization Progress
In December 2024, RenovoRx received its first commercial purchase orders for RenovoCath, leading to approximately $43,000 in revenue for the fourth quarter. The company is witnessing strong organic demand, with over ten medical institutions initiating the purchase order process. Several renowned, high-volume National Cancer Institute-designated centers have already placed orders, and the usage of RenovoCath by initial customers has led to repeat purchases.
RenovoRx also anticipates that the 20 cancer centers involved in its ongoing TIGeR-PaC clinical trial will likely become customers after completing the trial’s enrollment phase later in 2025. This expectation further strengthens the company’s revenue projections and commercial strategy.
A key driver of RenovoCath adoption is existing reimbursement support. The Centers for Medicare and Medicaid Services (CMS) currently provide a reimbursement code for procedures using specialty pressure-mediated delivery catheters, which includes RenovoCath. This favorable reimbursement environment incentivizes hospitals and treatment centers to adopt advanced technology like RenovoCath, thereby accelerating market penetration.
Progress on the Phase III TIGeR-PaC Clinical Trial
RenovoRx continues to advance its pivotal Phase III TIGeR-PaC clinical trial, which evaluates the safety and efficacy of RenovoCath in targeted intra-arterial chemotherapy delivery. During the fourth quarter of 2024, the company expanded its trial network by adding several prestigious clinical oncology sites. These new sites include the Sarah Cannon Research Institute Oncology Partners in Nashville, TN, and the Northwell Health Cancer Institute Clinical Site in New Hyde Park, NY.
Patient enrollment remains a top priority, and RenovoRx expects to complete full enrollment in 2025. According to the current trial protocol and statistical analysis plan, 114 randomized patients are required, with 86 events (deaths) necessary for the final analysis. As of March 28, 2025, 90 patients have been randomized, and 50 events have been recorded. A second interim analysis will be triggered by the 52nd event.
Following the occurrence of the 52nd event, the data analysis process is expected to take several months. This will include a thorough review by the TIGeR-PaC Data Monitoring Committee, which will assess the trial’s progress and provide recommendations. RenovoRx anticipates reaching this milestone in the second quarter of 2025, with the committee’s recommendations expected in the latter half of the year.
Upcoming Fireside Chat and Strategic Update
To provide further insights into its business trajectory, RenovoRx will host a fireside chat featuring CEO Shaun Bagai on April 3, 2025, at 12:00 p.m. ET. The discussion will highlight the progress of RenovoCath’s commercialization, revenue trends, and key developments in the TIGeR-PaC trial.
A notable addition to the event is Dr. Gregory Tiesi, MD, FACS, FSSO, Medical Director of Hepatobiliary Surgery at Hackensack Meridian Jersey Shore University Medical Center. Dr. Tiesi, one of the early adopters of RenovoCath, will share his perspectives on the impact of RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP™) therapy platform and its potential to enhance patient care. Hackensack Meridian Jersey Shore University Medical Center began using RenovoCath in December 2024, and Dr. Tiesi’s insights will offer valuable real-world context on the device’s clinical adoption.
A Transformative Year for RenovoRx
The fourth quarter and full-year 2024 marked a turning point for RenovoRx as it transitioned into a revenue-generating company. With strong early adoption of RenovoCath, expanding clinical trial enrollment, and a well-funded operational plan, the company is positioned for sustained growth in 2025 and beyond.
Key takeaways from RenovoRx’s latest update include:
- The first commercial sales of RenovoCath, generating $43,000 in Q4 2024 revenue.
- Anticipation of continued revenue growth throughout 2025, with initial estimates in the low six-figure range for Q1.
- A well-defined commercial strategy targeting high-volume treatment centers.
- Ongoing progress in the Phase III TIGeR-PaC trial, with full enrollment expected in 2025.
- The second interim analysis projected for mid-2025, with potential key recommendations from the Data Monitoring Committee.
- A strong financial position, with $12.1 million raised in a public offering and a $7.2 million cash balance at the end of 2024.
As the company scales its commercialization efforts and advances its clinical pipeline, RenovoRx remains focused on delivering innovative oncology solutions that improve patient outcomes while driving long-term value for shareholders. Investors and stakeholders can look forward to further updates in the upcoming fireside chat, where management will provide additional insights into the company’s strategic vision and commercial momentum.
