Commercialization of Image-Guided Liver Surgery

描述（由申请人提供）：在过去的八年中，几个学术机构的工程师和临床医生开发了图像引导肝脏手术系统，包括范德比尔特大学和圣路易斯的华盛顿大学。2004年年中，在初步研究表明该系统可用于临床环境，以更有效地治疗肝癌后，Pathfinder Therapeutics，Inc.是一家医疗器械公司，致力于开发用于图像引导治疗的商业集成系统。目前，该公司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，专门用于执行更高效、准确的手术并改善患者预后。自从十多年前在神经外科中使用以来，在该技术被证明有效之前，对于图像引导手术是否在特定手术领域中占有一席之地一直存在分歧。为了成功地营销和开发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，这应该是治疗几种形式肝癌的标准护理。该快速SBIR的第一阶段部分详细介绍了创建商业质量原型系统所必须完成的技术步骤，该原型系统可以复制用于分销和用于疗效临床试验。II期部分详细介绍的临床试验将证明图像引导治疗肝癌的实用性和有效性。我们的试验将集中于证明导致肝功能衰竭的几个因素的改善，包括肿瘤切除后剩余功能性肝脏体积的增加和手术室患者时间的减少。通过这项调查，我们将表明，图像引导下的肝脏手术应该是肝切除术的标准护理。这一声明将使我们能够成功地将图像引导肝脏手术商业化。

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.