Air Option 1: Technology Translation Dual Mode Electromechanical Assessment of Soft Tissue Character In Situ

这个PFI: AIR技术翻译项目的重点是翻译一种用于局部组织生物力学的非光学测量的新技术，以填补实时软组织健康诊断技术的关键未满足需求。翻译双模诊断探头具有以下独特特点：1)在同一设备中结合了生物力学和阻抗测量，可能提高了灵敏度和特异性；2)检测区域直径可小至2mm，可实现微创剖面和精细局部分析；3)它通过相当于其直径两倍的宽度和深度来询问组织，从而能够识别更深层的组织现象，并且入侵较小；4)实时性强，减轻了后续分析的成本和耗时，允许用户在不丢失位置的情况下进行即时决策；5)使用柔性电子元件可以非常便宜地制造它。这些功能将提供更好的诊断性能，比目前的方法，利用单一模式的感觉在这个市场空间（如沙丘生物医学），并显著节省时间和成本相比，传统的切除组织活检。此外，这项技术将使审讯不破坏组织，这对非常敏感的组织区域（如腺体、神经、淋巴结）在这个市场空间中至关重要。该项目通过优化探针几何形状、电刺激剖面和压力范围来实现这一目标，从而安全地量化软组织中的生物力学和阻抗测量。这些结果将产生一个现场可用的原型，为潜在市场的评估和商业化奠定基础。该提案将与康奈尔技术商业化中心、康奈尔生物技术研究所和麦戈文企业孵化器合作，提供商业发展和扩大规模的指导、进入金融网络、与未来的工业合作伙伴建立联系，这些合作伙伴在驾驭不同的监管和制造环境方面经验丰富，因为他们有可能将双模式转化为一条可能导致竞争激烈的商业现实的道路。一旦成功，预计潜在的经济影响将是广泛的，填补从食品科学到癌症边缘检测等市场的需求。该提案将重点关注早产的第一个市场领域，预计在未来5年内可以启动人体临床试验。一旦成功，这种低成本、定量、实时的评估工具将提高美国在医疗诊断技术方面的竞争力。在社会方面，获得实时定量诊断，特别是使该技术更接近最终用户，可以节省大量成本和时间，从而提高生活质量。

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.