RenovoRx Highlights Promising Pre-Clinical Data Abstract: TAMP™ Therapy Platform Offers Potential to Improve Localized and Targeted Drug Delivery
RenovoRx recently presented promising pre-clinical data at the SIO 2025 Annual Conference in Las Vegas. The data, derived from a study using the company's patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform, suggests improved drug delivery in tumors with poor blood supply. The study utilized the FDA-cleared RenovoCath device in a porcine model, demonstrating enhanced drug penetration via micro-CT imaging.
Key findings include the ability to isolate blood vessel sections through adjustable occlusion balloons, leading to targeted drug delivery. The study also indicated that pre-application of radiation might enhance drug penetration further. This technique could be particularly beneficial for difficult-to-treat cancers like pancreatic adenocarcinoma.
RenovoRx's CEO, Shaun Bagai, highlighted the potential commercialization of RenovoCath as a stand-alone device for various medical applications. The TAMP therapy platform was also discussed in a panel at SIO 2025, emphasizing its potential to revolutionize cancer treatment.
RenovoRx ha recentemente presentato dati pre-clinici promettenti alla Conferenza Annuale SIO 2025 a Las Vegas. I dati, derivati da uno studio che utilizza la piattaforma terapeutica brevettata Trans-Arterial Micro-Perfusion (TAMP) dell'azienda, suggeriscono un miglioramento nella somministrazione dei farmaci nei tumori con scarsa fornitura di sangue. Lo studio ha utilizzato il dispositivo RenovoCath, approvato dalla FDA, in un modello porcino, dimostrando una maggiore penetrazione del farmaco tramite imaging micro-CT.
I risultati chiave includono la capacità di isolare sezioni dei vasi sanguigni attraverso palloni di occlusione regolabili, portando a una somministrazione mirata del farmaco. Lo studio ha anche indicato che l'applicazione preventiva di radiazioni potrebbe ulteriormente migliorare la penetrazione del farmaco. Questa tecnica potrebbe essere particolarmente vantaggiosa per i tumori difficili da trattare come l'adenocarcinoma pancreatico.
Il CEO di RenovoRx, Shaun Bagai, ha sottolineato il potenziale di commercializzazione di RenovoCath come dispositivo autonomo per varie applicazioni mediche. La piattaforma terapeutica TAMP è stata inoltre discussa in un panel durante il SIO 2025, enfatizzando il suo potenziale di rivoluzionare il trattamento del cancro.
RenovoRx presentó recientemente datos preclínicos prometedores en la Conferencia Anual SIO 2025 en Las Vegas. Los datos, derivados de un estudio que utiliza la plataforma terapéutica patentada Trans-Arterial Micro-Perfusion (TAMP) de la empresa, sugieren una mejora en la entrega de medicamentos en tumores con escaso suministro de sangre. El estudio utilizó el dispositivo RenovoCath, aprobado por la FDA, en un modelo porcino, demostrando una mayor penetración del fármaco a través de imágenes micro-CT.
Los hallazgos clave incluyen la capacidad de aislar secciones de vasos sanguíneos mediante globos de oclusión ajustables, lo que conduce a una entrega de medicamentos dirigida. El estudio también indicó que la aplicación previa de radiación podría mejorar aún más la penetración del fármaco. Esta técnica podría ser particularmente beneficiosa para cánceres difíciles de tratar como el adenocarcinoma pancreático.
El CEO de RenovoRx, Shaun Bagai, destacó el potencial de comercialización de RenovoCath como un dispositivo independiente para diversas aplicaciones médicas. La plataforma terapéutica TAMP también se discutió en un panel en SIO 2025, enfatizando su potencial para revolucionar el tratamiento del cáncer.
RenovoRx는 최근 라스베가스에서 열린 SIO 2025 연례 회의에서 유망한 전임상 데이터를 발표했습니다. 이 데이터는 회사의 특허받은 경동맥 미세 관류(TAMP) 치료 플랫폼을 사용한 연구에서 파생되었으며, 혈액 공급이 부족한 종양에서 약물 전달이 개선되었음을 시사합니다. 이 연구는 FDA 승인을 받은 RenovoCath 장치를 돼지 모델에서 사용하여 마이크로 CT 이미징을 통해 약물 침투가 향상됨을 입증했습니다.
주요 발견 사항으로는 조절 가능한 폐색 풍선을 통해 혈관 섹션을 분리할 수 있는 능력이 포함되어 있으며, 이는 표적 약물 전달로 이어집니다. 연구는 또한 방사선의 사전 적용이 약물 침투를 더욱 향상시킬 수 있음을 나타냈습니다. 이 기술은 췌장 선암과 같은 치료하기 어려운 암에 특히 유익할 수 있습니다.
RenovoRx의 CEO인 Shaun Bagai는 RenovoCath의 다양한 의료 응용 프로그램을 위한 독립형 장치로 상용화할 수 있는 잠재력을 강조했습니다. TAMP 치료 플랫폼도 SIO 2025의 패널에서 논의되었으며, 이는 암 치료를 혁신할 수 있는 잠재력을 강조했습니다.
RenovoRx a récemment présenté des données précliniques prometteuses lors de la Conférence Annuelle SIO 2025 à Las Vegas. Les données, tirées d'une étude utilisant la plateforme thérapeutique brevetée Trans-Arterial Micro-Perfusion (TAMP) de l'entreprise, suggèrent une amélioration de l'administration des médicaments dans les tumeurs avec une mauvaise circulation sanguine. L'étude a utilisé le dispositif RenovoCath, approuvé par la FDA, dans un modèle porcin, démontrant une meilleure pénétration du médicament via l'imagerie micro-CT.
Les résultats clés incluent la capacité d'isoler des sections de vaisseaux sanguins grâce à des ballons d'occlusion ajustables, conduisant à une administration ciblée du médicament. L'étude a également indiqué que l'application préalable de radiations pourrait améliorer encore la pénétration du médicament. Cette technique pourrait être particulièrement bénéfique pour des cancers difficiles à traiter comme l'adénocarcinome pancréatique.
Le PDG de RenovoRx, Shaun Bagai, a souligné le potentiel de commercialisation de RenovoCath en tant que dispositif autonome pour diverses applications médicales. La plateforme thérapeutique TAMP a également été discutée lors d'un panel à SIO 2025, soulignant son potentiel à révolutionner le traitement du cancer.
RenovoRx hat kürzlich vielversprechende präklinische Daten auf der SIO 2025 Jahreskonferenz in Las Vegas präsentiert. Die Daten, die aus einer Studie stammen, die die patentierte Trans-Arterial Micro-Perfusion (TAMP) Therapieplattform des Unternehmens nutzt, deuten auf eine verbesserte Medikamentenabgabe bei Tumoren mit schlechter Blutversorgung hin. Die Studie verwendete das von der FDA genehmigte RenovoCath-Gerät in einem Schweinemodell und zeigte eine verbesserte Arzneimittelpenetration mittels Mikro-CT-Bildgebung.
Zu den wichtigsten Ergebnissen gehört die Fähigkeit, Blutgefäßabschnitte durch einstellbare Okklusionsballons zu isolieren, was zu einer gezielten Medikamentenabgabe führt. Die Studie deutete auch darauf hin, dass die vorherige Anwendung von Strahlung die Arzneimittelpenetration weiter verbessern könnte. Diese Technik könnte insbesondere bei schwer zu behandelnden Krebserkrankungen wie dem Pankreasadenokarzinom von Vorteil sein.
Der CEO von RenovoRx, Shaun Bagai, hob das Potenzial der Kommerzialisierung von RenovoCath als eigenständiges Gerät für verschiedene medizinische Anwendungen hervor. Die TAMP Therapieplattform wurde auch in einem Panel auf der SIO 2025 diskutiert, wobei ihr Potenzial hervorgehoben wurde, die Krebsbehandlung zu revolutionieren.
- Promising pre-clinical data showing improved drug delivery using TAMP therapy.
- FDA-cleared RenovoCath device demonstrated enhanced drug penetration in a porcine model.
- Potential commercialization of RenovoCath as a stand-alone device.
- Technique could benefit difficult-to-treat cancers like pancreatic adenocarcinoma.
- Study results are still pre-clinical and need further validation in human trials.
Insights
The pre-clinical data presented at SIO 2025 represents a significant technical validation for RenovoRx's TAMP therapy platform. The study demonstrates two critical advantages: enhanced drug penetration in microvasculature and precise targeting capability through the dual-balloon system. This is particularly noteworthy for treating hypovascular tumors, which traditionally present significant challenges due to poor drug delivery.
The successful deployment in over 500 procedures provides substantial real-world validation of the technology's safety and feasibility. This extensive clinical experience, combined with positive practitioner feedback, significantly de-risks the commercialization pathway for RenovoCath as a standalone device. The FDA clearance for multiple applications, including arteriography, preoperative occlusion, and chemotherapeutic drug infusion, opens various revenue streams beyond oncology.
The technology's ability to improve drug delivery in poorly vascularized tumors addresses a critical unmet need in oncology. Current treatment methods often struggle with drug penetration in such cases, leading to suboptimal outcomes. The potential synergy with radiation therapy, as suggested in the study, could further enhance treatment efficacy and expand the platform's applications.
From a market perspective, the endorsement from key opinion leaders at prestigious institutions like Columbia University and Oregon Health and Science University strengthens RenovoRx's position in the interventional oncology space. This validation is important for driving adoption among practitioners and potentially establishing TAMP as a standard approach for certain cancer treatments.
Pre-Clinical Data Recently Presented at the SIO 2025 Annual Conference Show that Intra-Arterial Administration of a Drug with the RenovoCath® Delivery System via TAMP May Improve Delivery in Difficult-to-Treat Cancers
The Results of this Pre-clinical Study Support a More Optimized Drug Delivery Method in Tumors that Lack Sufficient Blood Supply for Adequate Drug Penetration During Therapy
The abstract, titled “Micro-CT imaging following intra-arterial delivery of a radiopaque silicone polymer using a double-balloon occlusion catheter in pigs: a model to analyze tissue penetration via the trans-arterial micro perfusion (TAMP) technique,” was presented at SIO 2025 on February 3, 2025 by Paula Novelli, MD, of the University of Pittsburgh Medical Center.
The results of the study support a more optimized drug delivery method for tumors that suffer from limited blood supply and poor drug penetration. The TAMP technique was evaluated in a porcine (pig) model utilizing micro-CT imaging for precise monitoring of drug penetration into tissue.
The pre-clinical data shows that drug delivery with the patented, FDA-cleared dual balloon RenovoCath device via TAMP potentially may improve localized drug delivery by achieving greater drug penetration in the microvasculature near the target tumor. The data shows that, by using RenovoCath, researchers were able to isolate sections of the blood vessel through the adjustment of the distance between the occlusion balloons, thereby excluding any off-target side branches. Researchers were able to confirm the level of penetration into the targeted area utilizing micro-CT imaging. The penetration achieved appears to be consistent with a more optimized drug delivery. The observed effect is expected to be even stronger if radiation is applied beforehand.
“This study highlights that TAMP is an encouraging approach for improving localized drug delivery to difficult-to-treat tumor areas. By understanding how the infusion medium penetrates tissue, techniques can be refined for better clinical outcomes, especially for patients with cancers like pancreatic adenocarcinoma,” said Dr. Ramtin Agah, RenovoRx’s Founder, Chairman of the Board and Chief Medical Officer and one of the study’s authors. “We look forward to continued research in hypovascular tumors using minimally invasive procedures and are also working on a radiation sub-study. With continued investigation, we believe TAMP has the potential to revolutionize how interventional oncologists approach cancer treatment, offering a more targeted, effective solution for challenging cases.”
The procedure in this study utilized a porcine model, where the RenovoCath device was effectively employed to deliver a technique involved inflating the catheter balloons in the splenic artery, the superior mesenteric artery and renal artery. This approach enabled precise side branch exclusion in both vascular regions, ensuring targeted and controlled intervention, allowing for extensive filling of the microvessels with Microfil® (a micro-CT imaging following an injection of a radiopaque silicone rubber imaging reagent) in the perivascular space. In comparison, the control group, where balloons in the splenic arteries were left deflated, showed minimal Microfil filling beyond the main artery, as confirmed by micro-CT imaging. These striking differences highlight the potential of this technique to drive forward the development of targeted therapies, especially for complex cancers like pancreatic adenocarcinoma.
“We are excited to highlight this pre-clinical data abstract presented at SIO 2025. Including procedures performed as part of clinical trials, intra-arterial drug delivery by RenovoCath has been used in over 500 procedures by oncologists and interventional radiologists over the past several years,” said Shaun Bagai, RenovoRx CEO.
Mr. Bagai added, “Based on recent positive feedback we have received from medical practitioners, we have launched an effort to commercialize RenovoCath as a stand-alone device within its FDA-cleared indications for use in temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.”
Additionally, the TAMP therapy platform was the topic of the SIO 2025 panel discussion “Breaking Barriers in Drug Delivery: Trans-Arterial Micro-Perfusion,” where key interventional oncologists including Dr. Novelli, Khashayar Farsad, MD, PhD, Oregon Health and Science University, and David Sperling, MD, FSIR, Columbia University Irving Medical Center discussed their experience with the therapy platform and the RenovoCath device.
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.-F-Universal-IFU.pdf.
About RenovoRx, Inc.
RenovoRx is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel,
RenovoRx’s Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a
The intra-arterial infusion of gemcitabine by the RenovoCath catheter 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 7 years of market exclusivity upon NDA approval by the FDA.
RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, over ten medical institutions have initiated the process for RenovoCath purchase orders. 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 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 pre-clinical and clinical trials and studies, including the overall timing and timing for additional interim data readouts for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath® or TAMP™ as standalone commercial products and our commercialization plans in general, (iii) 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 TIGeR-PaC 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 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.
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KCSA Strategic Communications
Valter Pinto or Jack Perkins
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RenovoRX@KCSA.com
Source: RenovoRx, Inc
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