STTR Phase I: An Endoscopic-Based INSPIRE Platform for Treating and Monitoring Unresectable Pancreatic Cancer

This Small Business Innovation Research (SBIR) Phase I project focuses on the development of a minimally invasive endoscopic surgical device for the treatment of pancreatic cancer. Alarmingly, more than 38,000 Americans will die this year from pancreatic cancer and the average survival time following diagnosis will typically be 6-9 months; a statistic that has not changed significantly over the last 3 decades. Most cases of pancreatic cancer are diagnosed by symptomatic detection once infiltration and metastasis has already occurred, with no effective therapies for late-stage, regionally infiltrative, or metastatic pancreatic tumors. The proposed platform uses very brief, yet intense pulsed electric fields to disrupt the membrane of cells within a solid tumor. The research objectives of this project are to precisely define the electric field necessary to achieve a therapeutic effect without damaging surrounding healthy tissue. The technical objectives of this project are to develop a clinically viable pulse generation system and endoscopic probe for the treatment of oncological disease. The endoscopic-based platform will provide a feasible avenue to treat, monitor, and confirm the success of the therapy at the time of outpatient biopsy without additional surgical procedures. The broader impact/commercial potential of this project is that technology facilitates the treatment of tumors currently inoperable with surgical resection or other focal ablation technologies due to their proximity to critical structures such as nerve bundles and major blood vessels. The scientific results achieved in this proposal will enhance our understanding of how high frequency electric fields affect cells and tissues and produce the tools necessary for their use in other therapeutic capacities. proposed platform is a non-thermal treatment mechanism and is immune to heat-sink effects caused by local blood vessels. Our proof-of-concept experiments will accelerate the commercialization of the endoscopic-based proposed technology and demonstrate the potential to treat other diseases tissues including lung and colorectal cancers, venous eczema, lipodermatosclerosis, and arrhythmic cardiac tissue. The global ablation market is anticipated to grow to $12.4 billion by 2016 and the proposed platform is uniquely positioned to gain a significant market share.