NOU SYSTEMS INC — Department of Defense SBIR Phase I: DHA231-001

Description

Accurate core temperature measurement is critical for safe assessment of warfighter operational readiness since it is a parameter strongly associated with environmental temperature-related injuries and exertional heat exhaustion of thermally burdened soldiers. Yet, this variable is still incredibly challenging to measure accurately, reliably, noninvasively, and cost-effectively. Because of this, it is typically determined indirectly, using other measured parameters (e.g., skin temperature and heart rate). In response to this critical unmet need nou Systems Inc. (nSI) has partnered with state-of-the-art biosensor developers, to create a multimodal sensor platform capable of providing rapid and continuous personalized performance monitoring of essential parameters required to determine operational readiness. The proposed end-to-end solution expands upon existing TRL 4 technology (with all components at TRL 5 or higher); a sophisticated, highly miniaturized platform equipped with ultra-low-power sensing, computation, and wireless communication capabilities. Our smart-pill is already capable of measuring and reporting core temperature and other parameters associated with physical fatigue with medical-grade accuracy. Through this effort we will prime our gastric residence architecture for field use. In addition, we will replicate its temperature and communications module to develop a robust wearable temperature patch for peripheral temperature measurements to complement the measurements reported by our smart pill. Phase I efforts will include design, prototyping, and biosensor laboratory demonstrations to refine our approach. During Phase II, we plan to conduct large animal studies, advancing the technology towards regulatory approval and transition. Phase III will validate the technology in clinical studies for real-time assessment of operational readiness.