STTR Phase I: Chronically implantable sensor array for optimal studies of human diseases in mouse models

这个小企业技术转让（STTR）第一阶段项目旨在优化和测试基于刺激响应水凝胶的连续多分析物传感器的原型。所提出的传感器阵列将能够监测与几种常见人类疾病相关的多种生物标志物，如糖尿病、酮症酸中毒、慢性阻塞性肺病（COPD）甚至肥胖症。在本项目中，第一代有线传感器将通过长期体外和体内（小鼠模型）测试进行验证。虽然本项目的长期（超出当前项目）目标和最终应用将是在人类身上，但在本项目中，我们将专注于开发一种针对动物研究和科学界需求的传感器。这一策略奠定了坚实的基础，并在几年内为传感器的临床研究带来了信心。拟开展的工作将在三个子项目中完成：1）水凝胶传感器在血浆中的长期稳定性验证，2）第一代有线植入式传感器阵列的优化，3）传感器在小鼠模型和基础组织学研究中的长期验证。该团队坚信，他们可以实现这些目标，并在项目结束时开发出一种产品，为动物研究和科学界服务。该项目更广泛的影响/商业潜力源于人类和动物研究市场对连续多分析物传感器的强烈需求和未满足的需求。在试图进入巨大且难以渗透的人类持续代谢传感器市场之前，该团队将首先通过为更容易进入的动物市场提供设备来获得收入，同时不断改进传感器阵列。世界上大约有5000万只研究动物。假设每个传感器的平均销售价格为250美元，并且所提出的技术解决了总市场的1%，年销售额可能超过1亿美元。这项技术将为研究人员提供一种新的工具，可以在许多天内连续监测给定动物的相关生物标志物，这不仅提高了研究动物模型的效率，而且还提供了比目前定期采样所允许的更详细的代谢信息。一个持续的监测系统将节省资金，加快研究，并提供更深入的了解疾病的发病机制和新的潜在治疗方法。

This Small Business Technology Transfer (STTR) Phase I Project aims to optimize and test prototypes of continuous, multi-analyte sensors based on stimuli-responsive hydrogels. The proposed sensor array will be capable of monitoring multiple biomarkers relevant to several common human diseases such as diabetes, ketoacidosis, chronic obstructive pulmonary disease (COPD) and even obesity. During this project, the first generation wired sensors will be validated by long-term in vitro and in vivo (mice models) testing. Although the long-term (beyond current project) goal and final application of the device developed here-in will be in humans, in this project we will focus on developing a sensor targeting needs in animal research and the scientific community. This strategy creates a strong foundation and generates confidence in the sensor for clinical studies in few years. The proposed work will be accomplished within three subprojects: 1) Validation of long-term stability of hydrogel-based sensors in plasma, 2) Optimization of first generation wired implantable sensor array, 3) Long term validation of sensors in mouse models and basic histology studies. The team strongly believes they can accomplish these aims and build a product ready to serve the animal research and scientific community by the end of this project. The broader impact/commercial potential of this project stems from the strong demand and an unmet need for continuous multi-analyte sensor in human and in animal-research market. Before attempting to enter the huge and difficult-to-penetrate human-market for continuous metabolic sensors the team will first generate revenue by providing devices for the more accessible animal market while continuously improving the sensor array. There are approximately 50 million research animals in the world. Assuming an average sales price of $250 per/sensor and the proposed technology addresses 1% of the total market, annual sales could exceed $100 million. This technology will provide researchers with a new tool to continuously monitor relevant biomarkers in a given animal over many days, which not only increases the efficiency of studying animal models but also supplies greater detail of their metabolism than is currently allowed by periodic sampling. A continuous monitoring system would save money, speed research, and provide greater insights into the pathogenesis and new potential therapies of diseases.