RenovoRx Shares Up After a New 510(k) Clearance from FDA for its Proprietary RenovoCath Delivery System

Sep 7, 2021 By MarketDepth

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RenovoRx, Inc. (NASDAQ: RNXT) shares spiked more than 25% Tuesday after the clinical-stage biopharmaceutical company announced that it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary RenovoCath Delivery System.

Targeted Therapy with Less Side Effects

The Company focuses on developing therapies for the treatment of solid tumors. Its lead product candidate is RenovoGem, a drug and device combination consisting of intra-arterial gemcitabine and RenovoCath. The RenovoCath Delivery System is the device component of the Company’s initial product, RenovoGem™. This drug/device combination used in RenovoRx’s Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform is a dual-balloon infusion catheter delivering chemotherapy directly to tumors via arteries. This new design provides more targeted delivery of therapy which the Company believes can translate into more effective treatment with fewer side effects. RenovoRx received its initial 510(k) for the RenovoCath delivery system in 2014.

“Our novel RenovoTAMP therapy platform isolates the region of disease enabling delivery of the optimal dose of targeted chemotherapy to the tumor location. We believe this new design cleared through the FDA 510(k) process will further improve RenovoTAMP’s targeted delivery. Our focus is maximizing patient survival while minimizing side effects for cancer patients.”

Shaun Bagai, Chief Executive Officer at RenovoRx

As of August 15, 2021, the Phase 3 TIGeR-PaC clinical trial, a randomized study utilizing the RenovoTAMP platform to evaluate RenovoGem, reached 44 percent patient enrollment for the treatment of pancreatic cancer.