I-Corps: Translation Potential of a Full Thickness, Flexible Biopsy Device

This I-Corps project is based on the translation from lab to market of a novel, flexible, biopsy instrument that can collect full thickness samples from tumors growing in tubular (hollow) organs in the body. Some examples of such organs include: the tube connecting the kidneys to the urinary bladder (ureter), ducts and organs within the gastrointestinal system (pancreas, colon, esophagus), and the windpipe (trachea and bronchi). With this device, it will be possible to get a precise and accurate estimation of cancer depth of invasion (T stage). This solution addresses tubular cancers that are hard to reach and sample properly. Current devices can only grab surface cells; however, this device is capable of obtaining a full-thickness sample. The top 6 cancers diagnosed in the U.S. originate from tubular organs systems (head and neck, gastrointestinal, and respiratory tract), and almost 25-50% are inaccurately staged. The commercialization of this technology has the potential to benefit society by improving cancer staging and decision-making, ensuring greater treatment accuracy, and improving outcomes for cancer patients. This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of a novel biopsy instrument that obtains full thickness biopsies of target organs. Cancer staging is performed in combination with imaging and histopathological information using the tumor, node, metastasis (TNM) system. This technology has the ability to perform a tru-cut core-biopsy using a long, narrow-caliber, flexible biopsy instrument that is compatible with existing endoscopes. The benefits of this approach include precise and adequate tissue sampling, accurate treatment selection, appropriate utilization and management of resources, lower healthcare costs, and improved patient outcomes. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.