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

这个PFI：空气技术翻译项目专注于翻译一项用于局部组织生物力学的非光学测量的新技术，以满足实时软组织健康诊断技术的关键需求。转换后的双模诊断探头具有以下独特功能：1)它在同一设备中结合了生物力学和阻抗测量，从而可能提高灵敏度和特异性；2)它的检测区域可以设计为直径2 mm，实现微创轮廓和精细的局部分析；3)它可以通过相当于其直径两倍的宽度和深度询问组织，从而能够以更小的侵入性识别更深的组织现象；4)它是实时的，减少了更昂贵和耗时的后续分析，并使用户能够即时做出决定，而不存在失去位置的风险；5)它可以使用灵活的电子设备以很低的成本制造。这些功能将提供比目前在该市场空间仅使用一种感觉模式的方法(例如沙丘生物医学)更好的诊断性能，并与传统的切除组织活检相比显著节省时间和成本。此外，这项技术将能够在不破坏组织的情况下进行讯问，这对这个市场空间中非常敏感的组织区域(如腺体、神经、淋巴结)至关重要。该项目通过优化探头几何形状、电刺激曲线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可现场使用的原型，为在潜在市场进行评估和商业化奠定基础。这项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，提供业务发展和扩大指导、金融网络接入以及与未来工业合作伙伴的联系，这些合作伙伴在驾驭多样化的监管和制造环境方面经验丰富，因为它们与将双模式转化为可能导致竞争性商业现实的道路的潜力有关。如果成功，潜在的经济影响预计将是广泛的，满足从食品科学到癌症边缘检测等市场的需求。这项提案将重点放在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。如果成功，这种低成本、定量、实时的评估工具将增强美国在医疗诊断技术方面的竞争力。在社会上，获得实时定量诊断的机会，特别是使这项技术更接近并可能掌握在最终用户手中，可以显著节省成本和时间，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.