RenovoRx ramps up production of FDA-cleared RenovoCath

Published 16/04/2025, 13:42
RenovoRx ramps up production of FDA-cleared RenovoCath

MOUNTAIN VIEW, Calif. - RenovoRx, Inc. (NASDAQ:RNXT), a developer of targeted oncology therapies with a market capitalization of $33 million, has announced an increase in production of its FDA-cleared RenovoCath device due to rising demand from oncologists and interventional radiologists. The company’s stock has shown strong momentum with an 8.4% gain over the past week, according to InvestingPro data. The device, manufactured by Medical Murray Inc. in North Barrington, IL, facilitates the targeted delivery of therapeutic agents.

The company forecasts first-quarter 2025 revenue from RenovoCath to be in the low six-figure range, with expectations of continued growth throughout the year. InvestingPro data shows analysts expect revenue growth of nearly 47% for fiscal year 2025, though the company maintains a cautious cash position with a current ratio of 4.1. CEO Shaun Bagai expressed optimism about capturing the estimated $400 million total addressable market for RenovoCath in the U.S., citing a small sales force and distribution partnerships as key to maintaining low operating expenses and achieving cash flow positive operations.

In a separate announcement, RenovoRx disclosed that management and board members recently purchased over 143,000 shares of company stock, with CEO Bagai highlighting their confidence in the long-term value of RenovoRx and its business plan.

RenovoRx also hosted a fireside chat on April 3, 2025, where Bagai discussed commercialization efforts for RenovoCath and progress on the Phase III TIGeR-PaC clinical trial. Dr. Gregory Tiesi, an initial customer of RenovoCath, shared his experience with the device and its impact on patient care.

The RenovoCath device is indicated for various vascular procedures, including arteriography and chemotherapeutic drug infusion. RenovoRx’s TIGeR-PaC trial is evaluating the TAMP therapy platform, which utilizes RenovoCath for intra-arterial administration of chemotherapy for the treatment of locally advanced pancreatic cancer (LAPC).

The company’s investigational drug-device combination product, intra-arterial gemcitabine (IAG), which incorporates RenovoCath, is currently in a Phase III trial and has not yet been approved for commercial sale. However, RenovoCath has already received Orphan Drug Designation for pancreatic and bile duct cancers, potentially granting seven years of market exclusivity upon FDA approval.

This expansion of RenovoCath production and the investment by company insiders are part of RenovoRx’s broader strategy to commercialize its TAMP technology and RenovoCath device. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates rapid cash burn remains a key challenge, with additional metrics and insights available to subscribers. The information in this article is based on a press release statement from RenovoRx, Inc.

In other recent news, RenovoRx has reported its first revenue from the RenovoCath device in the fourth quarter of 2024, totaling approximately $43,000. The company anticipates revenue to increase to the low six-figure range in the first quarter of 2025, with expectations for further growth throughout the year. RenovoRx recently completed its TIGeR-PaC clinical trial enrollment on schedule for 2025, with 90 patients randomized and 50 events having occurred. The second interim analysis will be triggered by the 52nd event, with recommendations from the Data Monitoring Committee expected in the second half of 2025. H.C. Wainwright has maintained a Buy rating on RenovoRx stock, with a price target of $3.00 per share, following a strategic update. RenovoRx has also been recognized for its research in targeted drug delivery, with its TAMP therapy platform set to be honored at the Society of Interventional Radiology 2025 Annual Scientific Meeting. Additionally, the company has launched a public stock offering, with proceeds earmarked for funding its ongoing Phase III TIGeR-PaC study and commercial activities for RenovoCath. RenovoRx has received purchase orders from more than ten medical institutions, including high-volume National Cancer Institute-designated centers, and has seen repeat orders from initial customers.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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