RenovoRx (NASDAQ: RNXT) shares are rallying premarket after the company said it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary RenovoCath Delivery System.
The RenovoCath Delivery System is the device component of the company's initial product, RenovoGem, and is designed to treat solid tumors.
“Our novel RenovoTAMP therapy platform isolates the region of disease enabling delivery of the optimal dose of targeted chemotherapy to the tumor location,” said Shaun Bagai, CEO at RenovoRx.
“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.”
RenovoTAMP is RenovoRx's therapy platform designed to deliver chemotherapeutic agents for localised treatment of solid cancer tumors. It is under clinical investigation for increasing survival and improving quality of life.
As of August 15, the Phase 3 TIGeR-PaC clinical trial, a randomized study utilizing the RenovoTAMP platform to evaluate RenovoGem, reached 44% patient enrollment to treat pancreatic cancer.
RenovoRx's share price is trading at $11.09 premarket, up 40.56% from Monday's close.
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