RenovoRx Increases Production of FDA-Cleared RenovoCath® Delivery System in Response to Strong Demand from Oncology and Interventional Radiology Physicians
RenovoRx (Nasdaq: RNXT) announces increased production of its FDA-cleared RenovoCath® delivery system due to high demand from oncologists and interventional radiologists. The company has expanded its relationship with manufacturing partner Medical Murray, issuing a warrant for up to 709,500 shares of RenovoRx common stock as performance incentives. RenovoRx remains committed to its Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC), using the TAMP™ therapy platform.
The company is exploring commercial opportunities for RenovoCath as a standalone device, with plans to launch during 2025. RenovoRx has promoted Robert Strasser to Vice President of R&D and Operations to support these efforts. The company maintains sufficient cash to fund both the next interim read-out on TIGeR-PaC and RenovoCath go-to-market activities.
RenovoRx (Nasdaq: RNXT) annuncia un aumento della produzione del suo sistema di somministrazione RenovoCath® approvato dalla FDA a causa dell'elevata richiesta da parte di oncologi e radiologi interventisti. L'azienda ha ampliato la sua collaborazione con il partner di produzione Medical Murray, emettendo un warrant per un massimo di 709.500 azioni ordinarie di RenovoRx come incentivi per le prestazioni. RenovoRx rimane impegnata nel suo trial clinico di Fase III TIGeR-PaC per il cancro pancreas localmente avanzato (LAPC), utilizzando la piattaforma terapeutica TAMP™.
L'azienda sta esplorando opportunità commerciali per RenovoCath come dispositivo autonomo, con piani di lancio previsto nel 2025. RenovoRx ha promosso Robert Strasser a Vicepresidente di R&D e Operazioni per supportare questi sforzi. L'azienda mantiene un capitale sufficiente per finanziare sia il prossimo risultato intermedio sul TIGeR-PaC che le attività di lancio di RenovoCath.
RenovoRx (Nasdaq: RNXT) anuncia un aumento en la producción de su sistema de entrega RenovoCath® aprobado por la FDA debido a la alta demanda de oncólogos y radiólogos intervencionistas. La empresa ha ampliado su relación con el socio de fabricación Medical Murray, emitiendo una opción de compra de hasta 709,500 acciones ordinarias de RenovoRx como incentivos por rendimiento. RenovoRx sigue comprometida con su ensayo clínico Fase III TIGeR-PaC para el cáncer de páncreas localmente avanzado (LAPC), utilizando la plataforma de terapia TAMP™.
La compañía está explorando oportunidades comerciales para RenovoCath como dispositivo independiente, con planes de lanzamiento durante 2025. RenovoRx ha promovido a Robert Strasser a Vicepresidente de I+D y Operaciones para apoyar estos esfuerzos. La empresa mantiene suficiente capital para financiar tanto la próxima lectura interina sobre TIGeR-PaC como las actividades de comercialización de RenovoCath.
RenovoRx (Nasdaq: RNXT)는 종양학자 및 중재 방사선과 의사들의 높은 수요로 인해 FDA 승인을 받은 RenovoCath® 전달 시스템의 생산 증대를 발표했습니다. 회사는 제조 파트너인 Medical Murray와의 관계를 강화하고 709,500주의 RenovoRx 보통주를 성과 인센티브로 제공하는 워런트를 발행했습니다. RenovoRx는 TAMP™ 치료 플랫폼을 사용하여 국소 진행성 췌장암(LAPC)에 대한 3상 TIGeR-PaC 임상 시험에 전념하고 있습니다.
회사는 RenovoCath를 독립형 장치로 상업화할 기회를 탐색하고 있으며 2025년 출시를 계획하고 있습니다. RenovoRx는 이러한 노력 지원을 위해 Robert Strasser를 연구개발 및 운영 부사장으로 승진시켰습니다. 회사는 TIGeR-PaC의 다음 중간 결과와 RenovoCath의 시장 출시 활동을 지원할 충분한 자금을 보유하고 있습니다.
RenovoRx (Nasdaq: RNXT) annonce une augmentation de la production de son système de délivrance RenovoCath® approuvé par la FDA en raison d'une forte demande de la part des oncologues et des radiologues interventionnels. L'entreprise a élargi sa relation avec son partenaire de fabrication Medical Murray, en émettant un bon de souscription pour un maximum de 709 500 actions ordinaires de RenovoRx comme incitations à la performance. RenovoRx reste engagé dans son essai clinique de Phase III TIGeR-PaC pour le cancer du pancréas localement avancé (LAPC), en utilisant la plateforme de thérapie TAMP™.
L'entreprise explore des opportunités commerciales pour RenovoCath en tant qu’appareil autonome, avec des plans de lancement prévus pour 2025. RenovoRx a promu Robert Strasser au poste de Vice-président de la R&D et des opérations pour soutenir ces efforts. L'entreprise dispose de suffisamment de liquidités pour financer à la fois le prochain résultat provisoire sur TIGeR-PaC et les activités de mise sur le marché de RenovoCath.
RenovoRx (Nasdaq: RNXT) kündigt eine erhöhte Produktion seines FDA-zugelassenen RenovoCath®-Lieferystems aufgrund der hohen Nachfrage von Onkologen und interventionellen Radiologen an. Das Unternehmen hat seine Zusammenarbeit mit dem Fertigungspartner Medical Murray ausgeweitet und einen Optionsschein für bis zu 709.500 Aktien von RenovoRx als Leistungsanreize ausgegeben. RenovoRx bleibt dem Phase-III-TIGeR-PaC- klinischen Versuch bei lokal fortgeschrittenem Bauchspeicheldrüsenkrebs (LAPC) verpflichtet und nutzt die TAMP™-Therapieplattform.
Das Unternehmen untersucht kommerzielle Möglichkeiten für RenovoCath als eigenständiges Gerät und plant eine Markteinführung im Jahr 2025. RenovoRx hat Robert Strasser zum Vizepräsidenten für F&E und Betrieb befördert, um diese Bemühungen zu unterstützen. Das Unternehmen verfügt über ausreichende Mittel, um sowohl die nächste Zwischenberichterstattung zu TIGeR-PaC als auch die Markteinführungsaktivitäten von RenovoCath zu finanzieren.
- Increased production of FDA-cleared RenovoCath® delivery system due to high demand
- Expanded manufacturing partnership with Medical Murray
- Potential for accelerated revenue generation through standalone RenovoCath sales
- Sufficient cash to fund next TIGeR-PaC trial interim read-out and RenovoCath commercialization efforts
- Potential shareholder dilution due to warrant issuance to Medical Murray
Insights
The increased production of RenovoCath indicates growing market acceptance and potential for expanded applications. This move could significantly impact RenovoRx's revenue stream and market position. The partnership with Medical Murray, including performance-based warrants, demonstrates a strategic approach to scaling manufacturing capabilities.
The exploration of standalone opportunities for RenovoCath beyond current clinical programs suggests potential for market expansion and diversification. This could lead to faster revenue generation, possibly as early as 2025, which is important for a small-cap company like RenovoRx.
The promotion of Robert Strasser to VP of R&D and Operations is a positive step towards commercialization efforts. His experience with major medical device companies like Johnson & Johnson and Boston Scientific adds credibility to RenovoRx's commercial strategy.
However, investors should note that while the company has sufficient cash for near-term milestones, the success of the commercial strategy and the TIGeR-PaC trial results will be critical for long-term growth and profitability.
The increased demand for RenovoCath from oncologists and interventional radiologists is a positive indicator of the device's potential clinical value. The TAMP™ platform's approach of targeted drug delivery could represent a significant advancement in treating locally advanced pancreatic cancer (LAPC), a notoriously difficult-to-treat condition.
The ongoing Phase III TIGeR-PaC trial is a important milestone. If successful, it could position RenovoRx's therapy as a new standard of care for LAPC, potentially offering improved outcomes with reduced toxicity compared to current systemic chemotherapy approaches.
The expansion of clinical trial sites suggests a push to accelerate patient enrollment, which could lead to earlier trial completion and data readout. The next interim analysis, triggered by the 52nd patient death, will be a critical point for investors to assess the therapy's potential efficacy.
While the commercial potential is promising, it's important to note that the full impact on patient outcomes and market adoption will depend on the final results of the TIGeR-PaC trial and potential FDA approval for LAPC treatment.
Company expands relationship with manufacturing partner Medical Murray, and continues active exploration of standalone opportunities for RenovoCath
LOS ALTOS, Calif., Sept. 25, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies based on a local drug-delivery platform, today announced that it is increasing the production of its FDA-cleared RenovoCath catheter-based delivery system due to increased demand for targeted delivery of diagnostic and/or therapeutic agents from oncologists and interventional radiologists.
RenovoRx has signed a new project work order with its principal manufacturing partner, Medical Murray of North Barrington, IL, providing for an expanded relationship and as RenovoRx continues its exploration of commercial opportunities for RenovoCath beyond RenovoRx’s currently ongoing clinical programs. To create performance incentives for Medical Murray, RenovoRx will issue Medical Murray a warrant to purchase up to 709,500 shares of RenovoRx common stock. This warrant vests over time and only if Medical Murray achieves certain manufacturing milestones.
In parallel, RenovoRx remains fully engaged and committed to its ongoing pivotal Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC). As recently announced, additional well known clinical sites are now participating in the study with the goal of accelerating patient enrollment. TIGeR-PaC is using the TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform to evaluate RenovoRx’s first drug-device combination product candidate (intra-arterial infusion of chemotherapy, gemcitabine HCl) to target the tumor in LAPC. The study is comparing treatments with TAMP to the current standard of care (systemic intravenous chemotherapy).
Leesa Gentry, Chief Clinical Officer of RenovoRx, commented, “As we continue to make steady progress with our pivotal Phase III trial in LAPC, we have received feedback from oncology and interventional radiology physicians and key opinion leaders expressing the desire to purchase RenovoCath as a standalone device to be used in clinical practice. RenovoCath has been used in over 500 procedures by interventionalists over the past several years. We have published data from completed early-stage clinical trials that highlight the potential benefits to patients receiving targeted therapy with RenovoCath, including less toxicity and better outcomes, over the current standard of care.”
Shaun Bagai, Chief Executive Officer of RenovoRx, commented, “We announced in our most recent SEC quarterly report that we are actively exploring commercial opportunities to meet what we see as growing demand for our proprietary RenovoCath technology. Beyond LAPC, we believe there are many clinical applications for RenovoCath to improve targeted delivery of diagnostic and therapeutic agents. Securing the manufacturing capacity for this strategy with our partner Medical Murray is a great first step. We are also in active discussions with many interested customers to purchase supplies of RenovoCath as well as potential distribution partners. When launched, we expect our commercial strategy to accelerate our path to revenue generation, which we hope will occur during 2025. At the same time, even without incremental revenues from this commercial strategy, we maintain sufficient cash on hand from our successful fundraisings earlier this year to achieve both our next interim read-out on TIGeR-PaC, which will be triggered by the 52nd event (i.e., patient death), estimated to occur in late 2024 or early 2025, and fund our current efforts for our RenovoCath go to market activities.”
Mr. Bagai continued, “In preparation for commercialization of RenovoCath as a stand-alone device, and in addition to accelerating our manufacturing capacity with Medical Murray, we are pleased to have promoted Robert Strasser to Vice President of R&D and Operations. Bob has been an important part of our interface with Medical Murray and with our commercial strategy plans, and we look forward to his continued contributions in this new role.”
Robert Strasser is a highly experienced, results-oriented, strategic business leader with a proven track record in operations and product commercialization management with prior roles at Cordis (Johnson & Johnson) and Boston Scientific. Mr. Strasser has served as RenovoRx’s Senior Director of R&D and Operations since October 2022, the same year he started managing the Company’s relationship with Medical Murray.
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. RenovoCath is intended for general intravascular and peripheral vascular in arteries for vessel entry and occlusion ranging between 3mm and 11mm in diameter. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.
About the TIGeR-PaC Clinical Trial
TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx’s first product candidate using the TAMP technology, is a novel investigational oncology drug-delivery combination utilizing the Company’s FDA-cleared RenovoCath® device for the intra-arterial administration of chemotherapy, gemcitabine HCl.
The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study is investigating TAMP in LAPC. The study's primary endpoint is a 6-month Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event, which is estimated to occur in late 2024 or early 2025.
About RenovoRx, Inc.
RenovoRx is a life sciences company developing novel targeted oncology therapies based on a local drug delivery platform for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise 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. Our Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational drug-device combination candidate utilizes RenovoCath®, the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of gemcitabine HCl by the RenovoCath catheter is currently being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research (the drug division of FDA).
RenovoRx is also actively exploring other commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device. The intra-arterial infusion of gemcitabine HCl by the RenovoCath catheter is currently under investigation and has not been approved for commercial sale.
RenovoRx is committed to transforming the lives of patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and Twitter.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith and at the investor conference 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 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.
Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T:212-896-1254
RenovoRX@KCSA.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1a532610-6f24-459c-a147-6139c31993ca
FAQ
What is the RenovoCath® delivery system used for?
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