STTR Phase I: A novel Occlusion Balloon Microcatheter for Improved Delivery of Embolization Therapy to Tumors of the Liver

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is the improvement and expansion of tumor embolization therapy, a highly targeted technique based on direct injection of drug and agents that stop blood flow into the blood vessels of a tumor. Since the anti-tumor agents are held within the tumor, the drug concentration is over 10 times higher than standard therapy and there are minimal toxic side-effects. It is not surprising that this method has superior efficacy than standard systemic chemotherapy for certain types of cancers. Presently, the delivery dynamics associated with direction injection of anti-cancer agents into tumor vasculature are largely unknown. The innovation of this NSF project will further our understanding of this important technique. The initial application includes primary and metastatic tumors in the liver where the market potential includes 500K cases per year in the US and 1M cases per year in the EU, a market potential of $1.5B per year. This method promises to be a revolutionary improvement in cancer therapy, most notably, cancers in the liver, lung, kidney, bone and pancreas and result in longer survival and a better quality of life for people living with cancer. The proposed project aims to develop and test a trans-femoral catheter based delivery device for embolization therapy in cancers of the liver that improves efficacy and reproducibility. Current delivery catheters present significant shortcomings including: subjective procedural endpoints, bypass of embolic agents to non-target sites and incomplete filling of tumor vasculature with anti-cancer agents. These problems result in a tumor response that is not reproducible and fails to reach the efficacy potential of this technique. The objective of this project is to develop a balloon microcatheter that creates a temporary occlusion in the hepatic artery, stops all flow moving into the tumor from this source and causes a significant pressure drop in the vascular space distal to the occlusion balloon. It is believed that this situation will causes flow reversal of arterial branches moving away from the tumor and thereby eliminate bypass. It is further believed that the sharp reduction of blood flow into the tumor will allow the tumor to absorb the flow as embolization progresses for a longer period of time, thereby allowing more particles to enter the tumor. It is still further believed that the isolation of the vasculature distal to the occlusion will allow a pressure measurement through the catheter to signal a quantitative endpoint. This hypothesis will be tested in a porcine animal model using contrast, pressure and necropsy studies.