Commercialization of Image-Guided Liver Surgery

描述（由申请人提供）：在过去的八年中，包括范德比尔特大学和圣路易斯华盛顿大学在内的几家学术机构的工程师和临床医生开发了一种图像引导的肝脏手术系统。2004年中期，在初步调查表明该系统可以在临床环境中更有效地治疗肝癌后，Pathfinder Therapeutics, Inc.成立了一家医疗设备公司，开发用于图像引导治疗的商业集成系统。该公司目前的主要重点是将在学术环境中开发的图像引导肝脏手术技术转化为商业环境，从而可以专门用于执行更高效，更准确的程序并改善患者的治疗效果。自从十多年前在神经外科中使用以来，在该技术被证明是有效的之前，对于图像引导手术是否在特定的外科领域占有一席之地，一直存在不同的观点。为了成功地推广和开发一种有利可图的图像引导肝脏手术产品，我们必须说服外科医生，这应该成为治疗多种肝癌的标准护理。这个快速通道SBIR的I期部分详细说明了必须完成的技术步骤，以创建一个商业质量的原型系统，可以复制分发并用于疗效临床试验。II期临床试验将展示图像引导治疗肝癌的效用和有效性。我们的试验将侧重于证明导致肝功能衰竭的几个因素的改善，包括肿瘤切除后残余功能肝体积的增加和患者在手术室花费的时间的减少。通过这项调查，我们将表明图像引导的肝脏手术应该是肝切除手术的标准护理。这一说法将使我们成功地将图像引导的肝脏手术商业化。

DESCRIPTION (provided by applicant): For the past eight years, an image-guided liver surgery system has been developed by engineers and clinicians at several academic institutions, including Vanderbilt University and Washington University in St. Louis. In mid-2004, after initial investigations demonstrated that the system could be used in a clinical setting to more effectively treat liver cancer, Pathfinder Therapeutics, Inc. was founded as a medical device corporation to develop commercial, integrated systems for use in image-guided therapy. The primary focus of the company at this time is to take the image-guided liver surgery technology developed in the academic environment and translate it to a commercial setting where it can be specifically used to perform more efficient, accurate procedures and improve patient outcomes. Since its use in neurosurgery over ten years ago, there have always been divergent views of whether image-guided surgery has a place in a particular surgical field until the technology is proven to be effective. In order to successfully market and develop a profitable image-guided liver surgery product, we must convince surgeons that this should be the standard of care in treating several forms of liver cancer. The Phase I portion of this fast-track SBIR details the technical steps that must be completed to create a commercial-quality prototype system that can be replicated for distribution and used in an efficacy clinical trial. The clinical trial detailed in the Phase II portion will demonstrate the utility and effectiveness of image-guidance in treating liver cancer. Our trial will focus on demonstrating improvement in several factors that lead to hepatic failure, including increased residual functional liver volume following tumor resection and decreased patient time spent in the operating room. Through this investigation, we will show that image-guided liver surgery should be the standard of care for liver resection procedures. This claim will allow us to successfully commercialize image-guided liver surgery.