Commercialization of Image-Guided Liver Surgery

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.