Innovative, non-invasive, battery-less, disposable cardiac biosensor for hemodynamic monitoring

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7. PROJECT SUMMARY/ABSTRACT This SBIR Phase I project will design and develop an innovative, miniature, battery-less, disposable cardiac biosensor, to provide easy home assessment of heart and lung function. The biosensor will deliver comparable hemodynamic measurements to the gold standard assessments. Economic impetus has led to early discharge of complex and elderly patients with cardiovascular disease. Older adults discharged from hospitals following diagnoses of congestive heart failure exacerbation, myocardial infarction, coronary artery bypass grafting surgery or other high-risk cardiac procedures are at higher risk for re-hospitalizations and increased mortality resulting from gaps in care following hospital discharge. The assessment solutions available for patient monitoring at home, namely, blood pressure, weight, electrocardiograms, have not demonstrated reduction in readmission for any reason or death of any causes after discharge. Invasive implant devices, such as CardioMEMS, have demonstrated that hemodynamic measurements allow more effective management leading to fewer hospitalizations and lower deaths. Thus, aging adults are in need of reliable, robust, safe (non-invasive), and simple technologies that can provide hemodynamic assessment post hospitalization. There is need for meaningful interventions through a phone consultation or outpatient primary care visits that reduce re-admissions and mortality. Using this SBIRs technology, it will be possible for a patient to have access to gold standard hemodynamic measurements, through an integrated, wearable, battery-less, cardiac biosensor. The biosensor’s data can be read with a smart phone using secure near field communication, enabling patients and their health care providers to have easy access to their hemodynamic measurements via a smartphone application. Early objective measurements of hemodynamic changes will lead to early and prompt outpatient interventions. This will improve the quality of life for individuals with chronic cardiovascular conditions enabling them to remain at home longer. We have a multidisciplinary team of scientists and practice stakeholders who will work together to develop and test the conceptual model that will be applicable across diverse patient populations. The overall goal of this project it to demonstrate that new technology can meaningfully accommodate the needs of older adults and address their unique problems and challenges. For the first time there will be a biosensor that truly addresses the market need of an un-obstructive, non-invasive, accurate, absolute and actionable system for post-discharge use at home. This will facilitate close self-monitoring and outpatient monitoring of our most vulnerable patients, while maintaining close supervision by the health care teams. This battery-less, disposable biosensor technology for providing in-depth hemodynamics has additional far reaching benefits. Such a device does not exist today thus opening up numerous commercial possibilities.