SBIR Phase I: Advanced Optical Instruments for Monitoring Asthma and Treatments

这项小企业创新研究（SBIR）一期项目将开发一种诊断仪器，用于检测呼出气体中的分子物种，如一氧化氮，作为气道炎症的生物标志物，以评估哮喘治疗的有效性和依从性。该项目将制造出一种适合临床使用的生物传感器。临床前研究将在I期研究期间进行，以确保建立适当的方案。接下来的二期项目将包括临床试验，为FDA的批准做准备。该项目的商业应用将在生物医学诊断设备和仪器领域。希望该项目开发的仪器能够在每年10亿美元的哮喘诊断和治疗监测市场中占有很好的份额。

This Small Business Innovation Research (SBIR) Phase I project will develop a diagnostic instrument to detect molecular species, such as nitric oxide, in exhaled breath as a biomarker of airway inflammation to assess the effectiveness and compliance of asthma therapies. This project will result in the fabrication of a biosensor suitable for clinical use. Pre-clinical studies will be performed during the Phase I research to ensure that a proper protocol has been established. The follow on Phase II project will incorporate clinical trials in preparation for FDA approval. The commercial applications of this project will be in the area of biomedical diagnostic devices and instrumentation. It is hoped that the instrument developed in the course of this project will acquire a good share of the $1 billion a year asthma diagnosis and treatment monitoring market.