Portable Brain Injury Biomarker Detection System with Integrated Microdialysis Pr

描述(申请人提供)：集成微透析探头的便携式脑损伤生物标记物检测系统项目摘要：SFC Fluidics正在开发一种便携式、完全集成和自动化的医疗设备，用于严重脑损伤患者的临床监测。该仪器将允许自动检测几个小分子生物标记物，葡萄糖、谷氨酸、乳酸、丙酮酸和尿素，以及蛋白质生物标记物S100B。这些生物标志物存在于大脑的细胞外液中，持续实时监测它们的浓度将为脑缺血、缺氧、癫痫、血管痉挛等不良二次损伤提供重要线索，并将有助于神经ICU患者的危重护理。SFC Fluidics将使用一套经过验证的专利技术来开发建议的仪器，并为FDA批准和随后的第三阶段临床试验做好准备。SFC的创新组件技术已被测试并组装成初步原型，其基本功能已在第一阶段展示。在第二阶段，SFC将系统和迭代地改进现有原型的设计和功能，进行广泛的并排、体外和体内测试，并在已建立的大鼠模型中验证性能。这种有针对性的仪器将整合许多临床相关和有用的功能，以显著改变神经创伤患者的危重护理方式。

DESCRIPTION (provided by applicant): Portable Brain Injury Biomarker Detection System with Integrated Microdialysis Probe Project Summary: SFC Fluidics is developing a portable, fully-integrated and automated medical device for clinical monitoring of patients with severe brain injury. The instrument will allow for automated detection of several small molecule biomarkers, glucose, glutamate, lactate, pyruvate and urea, and a protein biomarker, S100B. These biomarkers are present in the extracellular fluid in the brain and continuous real-time monitoring of their concentration will provide important clues about adverse secondary insults like ischemia, hypoxia, seizure, vasospasm and more, and will help in critical care of patients in neuro-ICU. SFC Fluidics will use a suite of proven, patented technologies to develop the proposed instrument and make it ready for FDA approval and subsequent clinical trials in Phase III. SFC's innovative component technologies have been tested and assembled into an initial prototype, whose basic functionality has been demonstrated during Phase I. During Phase II, SFC will systematically and iteratively improve the design and functionality of the existing prototype, conduct extensive side-by-side, in vitro and in vivo testing and validate performance in an established rat model. The targeted instrument will integrate many clinically relevant and useful features to significantly change the modality of critical care of neurotrauma patients.