Commercialization of Image-Guided Liver Surgery

图像引导肝脏手术的商业化

• 批准号: 7387862
• 负责人: James David Stefansic
• 金额: $ 96.39万
• 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 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7387862
• 关键词: Ablation; Address; Anatomic Surface; Anatomy; Attention; Biomechanics; Cancer Intervention; Caring; Clinical; Clinical Trials; Computer software; Conduct Clinical Trials; Development; Devices; Distributed Systems; Effectiveness; Engineering; Ensure; Environment; Excision; Funding; Goals; Hand; Hepatic; Image; Image-Guided Surgery; Institution; Investigation; Investments; Lasers; Lead; Liver; Liver Failure; Localized; Magnetic Resonance Imaging; Malignant neoplasm of liver; Marketing; Medical Device; Mind; Nurses; Operating Rooms; Operative Surgical Procedures; Organ Model; Outcome; Palpation; Patients; Phase; Physicians; Positioning Attribute; Procedures; Process; Protocols documentation; Purpose; Quality Control; Range; Research Personnel; Residual state; Resolution; Scientist; Seeds; Shipping; Ships; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Standards of Weights and Measures; Surgeon; System; Techniques; Technology; Testing; Therapeutic; Time; Tomogram; Training; Translating; Ultrasonography; United States Food and Drug Administration; Universities; Washington; Work; cancer therapy; commercialization; image guided therapy; improved; investigator training; neurosurgery; programs; prototype; research clinical testing; tomography; tool; tumor

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）：在过去的八年里，包括范德比尔特大学和圣路易斯华盛顿大学在内的多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。 2004 年中期，在初步研究表明该系统可以用于临床环境中以更有效地治疗肝癌后，Pathfinder Therapeutics, Inc. 作为一家医疗设备公司成立，致力于开发用于图像引导的商业集成系统治疗。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，专门用于执行更高效、更准确的手术并改善患者的治疗效果。自从十多年前应用于神经外科以来，在该技术被证明有效之前，对于图像引导手术是否在特定外科领域占有一席之地，一直存在不同的看法。为了成功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，这应该成为治疗多种肝癌的标准治疗方法。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必须完成的技术步骤，该原型系统可以复制以进行分发并用于功效临床试验。第二阶段详细的临床试验将证明图像引导治疗肝癌的实用性和有效性。我们的试验将重点证明导致肝衰竭的几个因素的改善，包括肿瘤切除后残余功能性肝脏体积的增加以及患者在手术室的时间减少。通过这项调查，我们将表明图像引导肝脏手术应该成为肝脏切除手术的标准治疗方法。这一主张将使我们能够成功地将图像引导肝脏手术商业化。