Bioelectronic Fusion Sensor System Navy STTR FY2014.A Sol No.: Navy STTR FY2014.A Topic No.: N14A-T019 Topic Title: Bioelectronic Fusion Sensor System Proposal No.: N14A-019-0155 Firm: Sentient Corporation 850 Energy Drive Suite 307 Idaho Falls, Idaho 83401 Contact: Jennifer Haggerty Phone: (716) 830-4515 Web Site: www.sentientscience.com Abstract: To address the Navy's need for a common, scalable, platform for multi-modal 1pA level current sensing for Electrocardiogram (ECG), Electroencephalogram (EEG), and Electrodermal Response (EDR) to be fielded as a miniature wearable device with non-contact electrodes, Sentient and the State University of New York (SUNY) propose to develop the Bioelectronic Fusion Sensor System (BioFuSenS) that will assess a subject's stress, fatigue and resilience. BioFuSenS will be modular, real-time, low cost, low bandwidth, open standards-based, including autonomous prediction, health monitoring and management. Innovation is based on an ultra-sensitive, multi-channel, compact low power integrated circuit (IC), combined with mechanical sensing, a Bayesian-based data-model fusion algorithm, and ground truth data model. BioFuSenS is supported by "Predict-Acquire-Confirm-Control" process for monitoring center or remote operation. Energy harvesting for full power management and immunity to motion artifacts and muscle noises through robust and accurate data-model fusion is enabled, addressing the requirements of the Navy. In Phase I, we demonstrate feasibility through transistor-level IC simulations, thorough nonlinear systems analysis, and data-model fusion and noise handling simulations for ECG sensing. In Phase II, we will develop/validate a prototype, demonstrate multi-modal, model-based detection with noise filtering, and optimize the design to meet size, weight, power, and cost (SWAP-C) requirements. Benefits: The overarching benefit of our BioFuSenS for both military and civilian health care, is that it enables real-time health monitoring anywhere, at any time with minimal need for patient interaction with the system. This improved data availability will drive better clinical decision-making, less false alarms, shorten hospital stays and will ultimately result in better health outcomes and more efficient use of health system resources. Monitoring of patient biosignals can be done outside of the clinic, which reduces costs for the patient and providers because, for example, healthcare providers can detect and mitigate an emerging problem to prevent readmission to the clinic. Longer term, development of new drug and treatments are likely to encompass comprehensive health solutions, including patient-centric combinations of therapies and services that drive enhanced outcomes or health system savings. One specific area where data from wearable biosensors could be useful is in performance-based contracts between biopharma companies and payers, allowing an objective measure of treatment success to be agreed by all parties. Integration of biosensors with data and informatics tools is essential to fully understand the complex data resulting from continuous monitoring, and our BioFuSenS does just that. Model based means reusable value across healthcare stakeholders, including providers, payers, and the pharmaceutical industry. The treatment of congestive heart failure, arrhythmia approved under the FDA's 510(k) process, costs $39 billion each year in the United States alone; even a small percentage decrease in such a large figure would be significant. Lower return patients will be important as the Center for Medicare and Medicaid Services (CMS) has been to imposing financial penalties on hospitals with high re-admission rates since 2012. Return