This PFI: AIR Technology Translation project focuses on translating a novel technology for non-optical measurement of local tissue biomechanics to fill a key unmet need for real time soft tissue health diagnostic technologies. The translated dual-mode diagnostic probe has the following unique features: 1) It combines both biomechanical and impedance measurement in the same device, which likely enhances sensitivity and specificity; 2) It's detection zone can be designed down to 2 mm in diameter, enabling a minimally invasive profile and fine local analysis; 3) It interrogates tissue through a width and depth equivalent to twice its diameter, enabling identification of deeper tissue phenomena with less invasion; 4) it is real-time, alleviating more costly and time consuming follow-on analysis and permitting instantaneous decision making for the user without risk of losing the location; 5) it can be manufactured very cheaply using flexible electronics. These features will provide improved diagnostic performance over current approaches that utilize only one-mode of sensation in this market space (e.g. Dune Biomedical), and significant time and cost savings compared to traditional excisional tissue biopsies. Furthermore, this technology will enable interrogation without tissue destruction, which is of paramount importance for very sensitive tissue regions (e.g. glands, nerves, lymph nodes) in this market space. The project accomplishes this goal by optimizing the probe geometry, electrical stimulation profiles, and pressure ranges that safely quantify biomechanical and impedance measurement in soft tissues. These results will generate a field serviceable prototype that will establish the foundation for evaluation in potential markets and commercialization.
This proposal will engage the Cornell Center for Technology Commercialization, Cornell biotechnology Institute and partner with the McGovern Business Incubator to provide business development and scale-up guidance, access to financial networks, and connection to future industrial partners that are experienced in navigating the diverse regulatory and manufacturing landscapes as they pertain to the potential to translate the dual-mode along a path that may result in a competitive commercial reality. When successful, the potential economic impact is expected to be widespread, filling needs in markets ranging from food science to cancer margin detection. The first market area of pre-term labor will be focused on in this proposal, and it is anticipated that clinical trials in humans can be initiated within the next 5 years. When successful, this low-cost, quantitative, real-time assessment tool will enhance U.S. competitiveness in medical diagnostic technologies. Societally, access to real-time quantitative diagnostics, especially bringing that technology closer, potentially in the hands of the end-user, provides significant cost and time savings, leading to a better quality of life.
