RenovoRx RenovoCath Delivery System Cleared by FDA for Targeted Treatment of Solid Tumors

September 7, 2021—RenovoRx, Inc. announced it has received a new 510(k) clearance from the FDA for the RenovoCath delivery system, which is the device component of the company’s initial product, RenovoGem. RenovoRx received its initial 510(k) for the RenovoCath delivery system in 2014.

According to the company, the drug/device combination used in RenovoRx’s transarterial microperfusion (RenovoTAMP) therapy platform is a dual-balloon infusion catheter delivering chemotherapy directly to tumors via arteries. This new design provides a more targeted delivery of therapy that can translate into more effective treatment with fewer side effects, the company believes.

RenovoTAMP is a therapy platform designed to deliver well-established chemotherapeutic agents for the localized treatment of solid cancer tumors. It is under clinical investigation for increasing survival and improving quality of life. This platform technology may enable physicians to isolate the anatomy and microperfuse targeted tissue with small molecule chemotherapy.

The phase 3 TIGeR-PaC clinical trial is a randomized study utilizing the RenovoTAMP platform to evaluate RenovoGem for the treatment of pancreatic cancer. The study currently has approximately 30 active clinical sites and is expected to include approximately 200 participants in the United States and Europe. The trial, which is currently enrolling locally advanced, pancreatic cancer patients, reached 44% patient enrollment as of August 15. More information is available at the company’s website for the trial.

The company advised that in clinical studies conducted to date, chemotherapy delivered with the RenovoTAMP platform was associated with more than half the patients living > 2 years. The company noted that pancreatic cancer patients treated with standard-of-care typically live 12 to 15 months after diagnosis.