Commercialization of Image-Guided Liver Surgery

图像引导肝脏手术的商业化

• 批准号: 7054176
• 负责人: James David Stefansic
• 金额: $ 14.91万
• 依托单位: PATHFINDER THERAPEUTICS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-29 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7054176
• 关键词: clinical trials; image guided surgery /therapy; liver; liver neoplasms; neoplasm /cancer; surgery; university

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.

描述（由申请人提供）：在过去的八年中，工程师和临床医生在几家学术机构（包括范德比尔特大学和圣路易斯的华盛顿大学）开发了图像引导的肝手术系统。在2004年中期，经过初步研究表明，该系统可用于更有效地治疗肝癌的临床环境，探路者Therapeutics，Inc。成立为医疗设备公司，以开发用于图像指导治疗的商业，集成系统。目前，该公司的主要重点是采用在学术环境中开发的图像引导的肝手术技术，并将其转化为商业环境，在该环境中，它可以专门用于执行更有效，准确的程序并改善患者的结果。自从十年前它在神经外科手术中使用以来，一直存在一些不同的看法，即图像指导手术是否在特定的手术领域中占有一席之地，直到该技术被证明是有效的。为了成功营销和开发有利可图的图像引导的肝手术产品，我们必须说服外科医生，这应该是治疗多种肝癌的护理标准。此快速轨道SBIR的第一阶段部分详细介绍了创建商业质量原型系统必须完成的技术步骤，该系统可以复制以进行分发并在功效临床试验中使用。 II期部分中详细介绍的临床试验将证明图像引物在治疗肝癌中的效用和有效性。我们的试验将集中于证明导致肝衰竭的几个因素的改善，包括肿瘤切除后残留的功能性肝脏体积增加以及在手术室花费的时间减少。通过这项研究，我们将表明图像引导的肝脏手术应该是肝切除程序的护理标准。这一主张将使我们能够成功地将图像引导的肝脏手术商业化。