RenovoRx receives New 510(k) clearance from US FDA

The company’s RenovoCath Delivery System designed for targeted treatment of solid tumours

RenovoRx a biopharmaceutical company and innovator in targeted cancer therapy announced 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. 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 tumours via arteries. This new design provides a 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 tumour location," said Shaun Bagai, Chief Executive Officer 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 the company's novel therapy platform designed to deliver well-established chemotherapeutic agents for the localized treatment of solid cancer tumours.  It is under clinical investigation for increasing survival and improving quality of life. This platform technology may enable physicians to isolate the anatomy and micro-perfuse targeted tissue with small molecule chemotherapy.

As of August 15, 2021, the Phase 3 TIGeR-PaC clinical trial -- a randomized study utilizing the RenovoTAMP platform to evaluate RenovoGem -- reached 44 per cent patient enrollment for the treatment of pancreatic cancer. TIGeR-PaC is currently enrolling locally advanced, pancreatic cancer patients. In clinical studies conducted to date, chemotherapy delivered with the RenovoTAMP platform was associated with more than half the patients living more than two years.  Pancreatic cancer patients treated standard-of-care typically live 12 to 15 months after diagnosis.