RenovoRx Expands Production of RenovoCath to Meet High Demand

RenovoRx Boosts RenovoCath Production Amid Growing Demand

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a pioneering firm in life sciences, is responding to a significant uptick in demand from the oncology and interventional radiology sectors by expanding its production capabilities. This decision aligns with their commitment to developing innovative targeted oncology therapies using a localized drug delivery approach.

New Manufacturing Partnership

In a strategic move, RenovoRx has formalized a project work order with its primary manufacturing partner, Medical Murray. This partnership aims to enhance manufacturing capabilities while exploring commercial opportunities for the RenovoCath delivery system beyond existing clinical programs. As an incentive for Medical Murray, RenovoRx will issue a warrant for the purchase of up to 709,500 shares of its common stock, contingent on achieving specific manufacturing milestones.

Expanding Clinical Studies

In conjunction with scaling production, RenovoRx is deeply engaged in its pivotal Phase III TIGeR-PaC clinical trial, focusing on locally advanced pancreatic cancer (LAPC). Recent announcements indicate that notable clinical sites have joined the trial, fostering faster patient enrollment. This study utilizes the TAMP™ (Trans-Arterial Micro-Perfusion) platform, assessing the efficacy of RenovoRx's initial drug-device combination candidate in delivering gemcitabine HCl directly to the tumor.

Insights from Leadership

Leesa Gentry, the Chief Clinical Officer of RenovoRx, emphasized the positive feedback from healthcare professionals. Many oncologists and interventional radiologists have expressed interest in acquiring RenovoCath for clinical application as a standalone device. This endorsement follows successful usage in over 500 interventional procedures, where data from preliminary trials demonstrated improved patient outcomes and reduced toxicity compared to standard treatment options.

Path to Commercial Opportunities

CEO Shaun Bagai highlighted the firm’s ongoing exploration of commercial avenues in light of rising interest in RenovoCath technology. The company is currently in discussions with prospective customers and distribution partners, aiming to expedite revenue generation which they anticipate might materialize as early as 2025. Bagai also reassured stakeholders that their financial position remains robust, bolstered by recent fundraising activities to support both the TIGeR-PaC trial and market preparations for RenovoCath.

Leadership Changes to Support Growth

In anticipation of RenovoCath’s commercialization, RenovoRx has elevated Robert Strasser to Vice President of R&D and Operations. His extensive background in operations management, notably from previous roles at industry leaders like Johnson & Johnson and Boston Scientific, positions him well to support the company's strategic aspirations with Medical Murray.

Understanding RenovoCath's Functionality

RenovoCath, which has received FDA clearance, serves critical functions including the isolation of blood flow to deliver essential diagnostic and therapeutic agents directly to targeted sites. Its capabilities extend to temporary vessel occlusion for various clinical applications, thereby enhancing treatment strategy in interventional radiology.

The TIGeR-PaC Clinical Study in Detail

The TIGeR-PaC clinical trial is a multi-center, randomized investigation of TAMP therapy for LAPC. The regimen involves intra-arterial chemotherapy using the FDA-cleared RenovoCath device. Following a successful interim analysis in 2023, the study is poised for further exploration of treatment effectiveness, with primary goals focused on overall survival benefits and reduced adverse effects.

About RenovoRx, Inc.

RenovoRx aims to transform cancer treatment paradigms by leveraging its proprietary TAMP technology and RenovoCath delivery system. The firm is dedicated to ensuring more effective therapeutic delivery while mitigating potential side effects associated with traditional systemic therapies. With a firm commitment to innovation, RenovoRx continues to explore a wide range of clinical applications for its technologies.

Frequently Asked Questions

What is the RenovoCath delivery system?

The RenovoCath delivery system is a catheter-based device designed for the targeted delivery of therapeutic agents directly to specific vascular sites, improving treatment efficiency for cancer patients.

How is RenovoRx addressing increased demand for RenovoCath?

RenovoRx is increasing production through its partnership with Medical Murray, which includes issuing warrants tied to manufacturing milestones to enhance production output.

What are the primary benefits of using RenovoCath?

RenovoCath has shown potential benefits such as reduced toxicity and improved patient outcomes when delivering localized treatments, as evidenced by prior clinical studies.

What are the future commercialization plans for RenovoRx?

RenovoRx is actively seeking partners for distribution and exploring various commercial strategies to capitalize on the anticipated demand for RenovoCath.

How does the TIGeR-PaC trial relate to RenovoCath?

The TIGeR-PaC clinical trial investigates the use of RenovoCath in delivering gemcitabine HCl for LAPC, a promising area for targeted cancer therapy.

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