The MarginGuide: a medical device to improve the results of cancer surgery

ended

SurGuide is a medical device company which aims to improve the results of oral cancer surgery. In the operating room, the surgeon has to rely on his hands and eyes to distinguish tumour from healthy tissue. This is very difficult. In only 15% of the cases, the tumour is removed with an adequate margin. When after surgery, during histopathological assessment, an inadequate margin is detected, the patient will receive adjuvant treatment (i.e. radiotherapy, additional surgery). This often causes lasting additional morbidity, with a negative effect on the quality of life. A fast and reliable methodology is needed to assess tumour removal with adequate margin, during surgery. The MarginGuide is being developed to meet this clinical need. It is a novel tool based on Raman spectroscopy; an optical technology. The MarginGuide consists of a Raman spectroscopic work station, a user-interface, and a fiber-optic probe employing disposable fiber-optic needles. It will be used to rapidly inspect the resection surfaces of the tissue that has been removed by the surgeon and will pinpoint locations where additional tissue should be removed to obtain an adequate margin. A proof-of-concept instrument is currently being tested. SurGuide expects to raise the success rate of oral cancer surgery from the current 15% to over 50%. No other device is able to measure the surgical margin in oral cancer surgery, which gives SurGuide a unique market position and the possibility to gain a dominant market share. Although, this is an ideal starting point, some market barriers still exist. In this project, SurGuide carries out a feasibility assessment covering a business feasibility study and partly a technological feasibility study. The objective of the feasibility assessment is to refine the business plan and the implementation plan for successful commercialization and to optimize the optical technology for the MarginGuide.