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

这个小企业创新研究（SBIR）第一阶段项目的重点是开发一种用于治疗胰腺癌的微创内窥镜手术设备。令人担忧的是，今年将有超过38，000名美国人死于胰腺癌，诊断后的平均生存时间通常为6-9个月;这一统计数据在过去30年中没有显着变化。大多数胰腺癌病例在浸润和转移已经发生时通过症状检测来诊断，对于晚期、区域浸润性或转移性胰腺肿瘤没有有效的治疗方法。所提出的平台使用非常短暂但强烈的脉冲电场来破坏实体肿瘤内的细胞膜。该项目的研究目标是精确定义在不损伤周围健康组织的情况下实现治疗效果所需的电场。本项目的技术目标是开发一种临床可行的脉冲发生系统和内窥镜探头，用于治疗肿瘤疾病。基于内窥镜的平台将提供一种可行的途径来治疗，监测，并在门诊活检时确认治疗的成功，而无需额外的外科手术。该项目的商业潜力在于，该技术有助于治疗目前无法通过手术切除或其他局部消融技术进行手术的肿瘤，因为它们靠近神经束和主要血液等关键结构船舶.该提案中取得的科学成果将增强我们对高频电场如何影响细胞和组织的理解，并为它们在其他治疗能力中的使用提供必要的工具。所提出的平台是一种非热处理机制，并且不受局部血管引起的热沉效应的影响。我们的概念验证实验将加速基于内窥镜的拟议技术的商业化，并展示治疗其他疾病组织的潜力，包括肺癌和结直肠癌，静脉湿疹，脂肪皮炎和心肌组织。预计到2016年，全球消融市场将增长至124亿美元，拟议的平台具有独特的优势，可以获得可观的市场份额。

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.