LYNNTECH INC. — Department of Defense SBIR Phase II: DHP15-012

Description

About 40% of trauma-related deaths are associated with rapid onset of coagulopathy. The vast majority of trauma patients are coagulopathic at the time of death. In Phase I, Lynntech demonstrated strong proof-of-concept for developing a novel, easy-to-use and cost effective device for quantitative real-time detection of a biomarker of coagulopathy, using human unprocessed whole blood as the input sample. In this proposed Phase II effort, we will expand the biomarker panel to include a second protein involved in the hemostatic mechanism. Subsequently, the biosensors will be optimized for industry standard accuracy, reproducibility, stability and shelf life. A prototype compact coagulopathy monitor and associated disposable microfluidic multiplexed biomarker analysis cartridges will then be fabricated and functionally optimized for continuous and simultaneous analysis of Lynntechs biomarker panel in human whole blood. The potential clinical utility of our prototype coagulopathy monitor will be demonstrated through a limited single-center pilot non-interventional human clinical trial. Successful conclusion of this Phase II will enable the follow-on Phase III effort to focus on multicenter human clinical trials, FDA regulatory clearance and commercial deployment of our coagulopathy monitoring product. Lynntechs proposed device will provide actionable knowledge to medical caregivers, resulting in better clinical management of trauma induced coagulopathy.