INTELLIGENT OPTICAL SYSTEMS, INC. — Department of Health and Human Services SBIR Phase I: 150

Description

Project Summary Accurate and real time blood alcohol monitoring has major implications for research on alcohol use and abuseand for personal and public healthIntelligent Optical SystemsIOSproposes to develop a wearableminimallyinvasive subdermal alcohol concentrationSubDACmonitor based on specific but non enzymatic detectionThe SubDAC monitor will combine two key innovations to overcome the challenges faced by other wearable alcohol monitorsa novel luminescent material developed by IOS under a contract with NASA for specific detection of alcoholsdesigned for the long term stability requirements of space missionsanda low cost microneedle array for subdermal detection to minimize physiological lag timeIOS has recently developed highly specific luminescent sensor materials for volatile alcohol detectionThe heart of a luminescent optical chemical sensor is the sensitive materiala polymer in which a specific luminescent indicator molecule has been immobilizedIn response to a selective and reversible interaction between the target analyteethanoland the indicatorthe luminescence of the sensitive material undergoes a measurable change proportional to the analyte concentrationIn these solid state sensorsthere is no consumption of any reactantand the sensor elements can last for yearsIn additionIOS has developed a low cost method of producing microneedle arrays using direct laser writingThe manufacturing technique is highly versatileallowing for customization of microneedle geometry and mass production of microneedle arraysIn Phase Iwe will optimize our sensor chemistry for sensitivity to physiologically relevant alcohol concentrationsincorporate this chemistry into a biocompatible polymer suitable for microneedle array formationand demonstrate continuous alcohol detection in the target range in vitroIn Phase II a wearable electronic device will be assembledand in vitro testing extendedSafety will be tested in animal modelsAn Investigational Device ExemptionIDEfrom the U SFood and Drug AdministrationFDAwill be obtainedand clinical studies will be initiatedThe ultimate result of this work will be a discretewearable devicethe size of a wrist watch or fitness trackercapable of accuratereal time blood alcohol concentration monitoringThe device will be marketed to individuals for quantifying short term blood alcohol and tracking long term behaviorit will be useful to researchers studying the epidemiology of alcohol abuseand may have applications in court mandated abstinence programs Project Narrative Overconsumption and habitual alcohol use are associated with a vast number of shortand long term health risks and significant societal problemsAccurate and real time monitoring of blood alcohol concentrationBACwould provide fundamental data to researchers studying alcoholismassociated diseasesand public healthIndividual users of our wearable alcohol monitor will have access to real time BAC levelsthe ability to track consumption habits over timeand to understand the statistically projected effects on their long term healthempowering them to make data driven choices about their alcohol consumption