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RenovoRx Announces First Commercial Clinical Use of RenovoCath® in Sarcoma Patient Treatment, Marking Expansion of Targeted Drug-Delivery Device to Other Solid Tumors

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RenovoRx (Nasdaq: RNXT) reported the first commercial clinical use of RenovoCath for localized chemotherapy delivery in a sarcoma patient at CARTI Cancer Center in Little Rock. Treatment began in late June 2026 and is ongoing, delivering chemotherapy near the tumor rather than via systemic intravenous infusion.

CARTI is also using RenovoCath in pancreatic cancer, illustrating broader physician-driven use across solid tumors within the device’s FDA-cleared indications. RenovoCath is cleared for isolation of blood flow and localized infusion, including chemotherapeutic drug delivery. According to RenovoRx, 2025 RenovoCath sales were approximately $1.1 million, with a record $563,000 in Q1 2026.

The company continues to commercialize its TAMP therapy platform and evaluate its intra-arterial gemcitabine (IAG) combination product in the ongoing Phase III TIGeR-PaC trial, targeting locally advanced pancreatic cancer. RenovoRx anticipates full enrollment in the near term and a final data readout in mid to late 2027. IAG is investigational and not yet approved for sale but has received FDA Orphan Drug Designation with potential market exclusivity upon any future approval.

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Positive

  • First commercial sarcoma use of RenovoCath reported at CARTI Cancer Center
  • RenovoCath sales of approximately $1.1 million in full-year 2025
  • Record RenovoCath sales of $563,000 in Q1 2026
  • CARTI using RenovoCath in both pancreatic cancer and sarcoma treatment
  • Phase III TIGeR-PaC trial nearing full enrollment per company expectations
  • IAG with RenovoCath holds FDA Orphan Drug Designation for pancreatic and bile duct cancer

Negative

  • IAG combination product candidate remains investigational and not approved for commercial sale
  • Final Phase III TIGeR-PaC data readout expected only in mid–late 2027
  • Current sarcoma use of RenovoCath disclosed as a single commercial patient case

Market reaction after sarcoma clinical use: RNXT +8.49% in the Aug 6 session

+8.49% 2.2x vol
13 alerts
+8.49% Session close to close
+6.4% Peak in 3 hr 4 min
$52.04M Market Cap
2.2x Rel. Volume

In the Aug 6 session, RNXT gained 8.49%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.4% during that session. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility. Trading volume was elevated at 2.2x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +8.5% in the session following this news. RNXT's May 28 orphan-drug-designation news...
Analysis

The stock moved +8.5% in the session following this news. RNXT's May 28 orphan-drug-designation news was followed by a 6.2% 24-hour gain. This announcement broadened RenovoCath's commercial use beyond pancreatic cancer. The active resale registration remains a structural risk, while clinical validation remains incomplete.

Key Figures

2025 RenovoCath sales: $1.1 million Q1 2026 sales: $563,000 CARTI operating history: 50 years +3 more
6 metrics
2025 RenovoCath sales $1.1 million first full commercial year
Q1 2026 sales $563,000 RenovoCath sales
CARTI operating history 50 years CARTI description
CARTI locations 18 locations across Arkansas
TIGeR-PaC trial phase Phase III IAG evaluation
Market exclusivity seven years upon new drug application approval by the FDA

Historical Context

5 past events · Latest: Jun 11 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jun 11 peer-reviewed publication Positive +1.6% Case study reported reduced tumor metabolic activity after TAMP procedures.
May 28 orphan drug designation Positive +6.2% FDA granted orphan designation for intra-arterial oxaliplatin in pancreatic cancer.
May 26 pharmacokinetic data Positive +3.9% ASCO data indicated reduced systemic exposure with TAMP-delivered gemcitabine.
May 19 healthcare showcase presentation Neutral +2.9% Company scheduled a presentation covering revenue, adoption, and clinical programs.
May 14 first-quarter earnings Positive -4.1% Record revenue and expanding customers coincided with a negative 24-hour reaction.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

RNXT's recent news reactions were generally positive, although its May earnings release diverged with a negative 24-hour reaction.

Key Terms

trans-arterial micro-perfusion, investigational new drug application, 21 cfr 312 pathway, orphan drug designation, +1 more
5 terms
trans-arterial micro-perfusion technical
"RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform"
A targeted medical delivery technique that uses tiny catheters inserted into an artery to drip or spray a drug or therapeutic agent directly into the small blood vessels feeding a specific organ or tumor. Like watering the roots of a single plant instead of the whole garden, it concentrates treatment where needed, which can improve effectiveness and reduce side effects—important for investors because it affects clinical success, regulatory risk, and commercial potential.
investigational new drug application regulatory
"under a U.S. investigational new drug application that is regulated by the FDA"
An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.
21 cfr 312 pathway regulatory
"regulated by the FDA’s 21 CFR 312 pathway"
The 21 CFR 312 pathway is the U.S. Food and Drug Administration’s regulatory route for investigational new drugs and biologics, set out in Title 21, Part 312 of the Code of Federal Regulations. It defines the paperwork, safety monitoring, study protocols, reporting rules and review steps a sponsor must follow to get permission to start and run clinical trials in the United States. For investors it matters because this pathway shapes drug development timelines, regulatory risk and potential costs—like a roadmap and permit system for testing new medicines.
orphan drug designation regulatory
"received Orphan Drug Designation for pancreatic cancer and bile duct cancer"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
temporary vessel occlusion medical
"RenovoCath is also indicated for temporary vessel occlusion"
A temporary vessel occlusion is the deliberate, short-term blocking of a blood vessel during a medical procedure to stop or redirect blood flow, often using a device such as a balloon, clamp, or catheter. Like putting a clamp on a garden hose to control water while you work, it is used to protect tissue, control bleeding, or create a stable treatment environment; its safety, effectiveness, and regulatory outcomes can affect clinical trial results, product approvals, and market acceptance.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Case Marks First Use of RenovoCath in Sarcoma, Showing Real World Potential Beyond Pancreatic Cancer for Expansion of Localized Delivery of Chemotherapy

MOUNTAIN VIEW, Calif., Aug. 06, 2026 (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 the first commercial clinical use of RenovoCath for drug-delivery in the treatment of a patient with sarcoma at the CARTI Cancer Center Little Rock (“CARTI”).

Sarcoma is a cancer that starts in the soft tissues or bones of the body. For this patient’s sarcoma case, CARTI is using RenovoRx’s RenovoCath device to deliver chemotherapy locally near the tumor rather than through traditional systemic intravenous administration. Treatment began in late June 2026 at CARTI and is ongoing.  

CARTI, among RenovoRx's growing base of customers, is concurrently using the RenovoCath device for localized drug delivery in pancreatic cancer treatment, a reflection of the broadening set of tumor types across which the technology is being applied by physicians.

“Sarcoma can be challenging to treat because it often occurs in diverse locations and can be less responsive to systemic chemotherapy,” said Edgar St. Amour, M.D., CARTI interventional radiologist. “Our experience using RenovoCath to deliver chemotherapy at a local level for pancreatic cancer and its potential to reduce toxicity encouraged us to identify other tumors that could benefit from this innovative technology. We are encouraged by the early results we have observed and will continue to monitor the patient’s progress closely.”

“This first commercial sarcoma case marks an important milestone for RenovoRx, demonstrating RenovoCath’s potential as a stand-alone device for treatment of other solid tumors beyond our core focus on locally advanced adenocarcinoma of the pancreas,” said Ramtin Agah, MD, Chief Medical Officer and Executive Chairman of RenovoRx. “We believe targeted, localized delivery may offer advantages over systemic treatment for many other difficult-to-treat solid tumors, and we look forward to working with our cancer center customers like CARTI in the field to find new and broadening uses for RenovoCath within its FDA-cleared fields of use.”

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 select 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 https://renovorx.com/wp-content/uploads/2026/06/IFU-10004-Rev.-H-Universal-IFU.pdf.

About CARTI
Now celebrating 50 years, CARTI is a not-for-profit, multidisciplinary cancer care provider offering leading-edge medical, radiation and surgical oncology, interventional radiology, clinical research trials, imaging, breast care, urology, and an array of specialty services, including audiology, cancer genetics and risk management, dental care, dietetics, and more. With 18 locations across the state and Arkansas’ first cancer-focused surgery center, CARTI makes trusted cancer care accessible for every patient it serves through compassion, innovation and purpose. For more information, visit CARTI.com. 

About RenovoRx, Inc.
RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, 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.

RenovoRx is actively commercializing its TAMP technology and FDA-cleared RenovoCath as a standalone device. For its first full year of commercial efforts in 2025, RenovoRx generated approximately $1.1 million in RenovoCath sales and a record $563,000 of sales in the first quarter of 2026. RenovoRx is actively working to expand the number of medical institutions initiating new RenovoCath orders, including esteemed, high-volume National Cancer Institute-designated centers.

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, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. RenovoRx anticipates full enrollment in the TIGeR-PaC trial in the very near term and final data readout in mid to late 2027.

The IAG combination product candidate, 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.

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

Cautionary Note Regarding Forward-Looking Statements
This press release, the webinar described herein, and statements of the Company’s management and third parties 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 clinical trials and studies (including expectations for full enrollment and data read out), (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 commercialize our RenovoCath and TAMP technology for use in treating pancreatic and other solid tumor cancers, and our expected financial results from such efforts. 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 and other business plans, intellectual property development, clinical trials, our therapy platform, financing plans, objectives, and expected operating results, all of 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,” "aim," "goal," “estimates,” “intends,” and “potential,” or derivatives of these terms or other comparable terminology regarding RenovoRx’s statements about the future, 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 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, needs for additional financing, our ability to obtain additional capital and our ability to maintain the listing of our common stock on Nasdaq; (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, which can be accessed at https://ir.renovorx.com/sec-filings.

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.

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

Media Contact:

STiR Communications
Hannah Williams
T: 803-521-1214
hannah@stir-communications.com


FAQ

What did RenovoRx (RNXT) announce about RenovoCath’s first use in sarcoma?

RenovoRx announced the first commercial clinical use of RenovoCath to deliver localized chemotherapy for a sarcoma patient at CARTI Cancer Center. According to RenovoRx, treatment started in late June 2026 and is ongoing, using targeted arterial delivery instead of traditional systemic intravenous chemotherapy.

How is RenovoCath being used to treat the sarcoma patient at CARTI Cancer Center?

RenovoCath is being used to deliver chemotherapy locally near the tumor through targeted arterial infusion. According to RenovoRx, this approach aims to bathe the tumor region while potentially reducing systemic toxicity compared with standard intravenous chemotherapy, and the patient’s treatment remains ongoing.

What are RenovoRx’s recent RenovoCath sales results for 2025 and Q1 2026 (RNXT)?

According to RenovoRx, RenovoCath generated approximately $1.1 million in sales during its first full commercial year in 2025 and a record $563,000 of sales in the first quarter of 2026. These figures reflect early commercial adoption of the FDA-cleared drug-delivery device.

What is the TIGeR-PaC Phase III trial and timeline for RenovoRx’s IAG therapy?

The TIGeR-PaC trial is a Phase III study of intra-arterial gemcitabine (IAG) delivered via RenovoCath for locally advanced pancreatic cancer. According to RenovoRx, full enrollment is expected in the near term, with final data readout anticipated in mid to late 2027.

Is RenovoRx’s intra-arterial gemcitabine (IAG) with RenovoCath approved for sale?

No, IAG delivered via RenovoCath remains an investigational oncology product candidate and is not approved for commercial sale. According to RenovoRx, it is being evaluated under a U.S. investigational new drug application regulated by the FDA’s 21 CFR 312 pathway in the TIGeR-PaC trial.

What FDA clearances and designations does RenovoCath have as of August 2026?

RenovoCath is FDA-cleared for isolation of blood flow and localized delivery of diagnostic or therapeutic agents, including chemotherapeutic infusion and temporary vessel occlusion. According to RenovoRx, RenovoCath with gemcitabine has FDA Orphan Drug Designation for pancreatic and bile duct cancer, offering potential market exclusivity upon approval.

How does RenovoRx’s TAMP platform aim to improve cancer treatment versus systemic chemotherapy?

RenovoRx’s TAMP platform is designed for targeted drug delivery across the arterial wall near tumors, concentrating therapy at the disease site. According to RenovoRx, this approach may minimize systemic toxicities versus intravenous treatment and could improve safety, tolerance, and efficacy for difficult-to-treat solid tumors.