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）一期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。令人震惊的是，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；在过去的30年里，这一数据并没有显著变化。大多数胰腺癌病例是在已经发生浸润和转移时通过症状检测诊断出来的，对于晚期、局部浸润性或转移性胰腺肿瘤没有有效的治疗方法。该平台使用非常短暂而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达到治疗效果而不损害周围健康组织所需的电场。该项目的技术目标是开发一种临床可行的脉冲产生系统和内窥镜探头，用于治疗肿瘤疾病。内窥镜为基础的平台将提供一个可行的途径来治疗，监测，并确认治疗的成功，在门诊活检时，不需要额外的外科手术。该项目的更广泛的影响/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灶消融技术进行手术的肿瘤，因为它们靠近神经束和大血管等关键结构。在这项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，并产生用于其他治疗能力所需的工具。该平台是一种非热处理机制，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、脂肪皮肤硬化和心律失常心脏组织。到2016年，全球消融市场预计将增长到124亿美元，该平台具有独特的优势，将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.