Design-Zyme LLC — Department of Health and Human Services SBIR Phase I: 450

Description

Project Abstract The goal of this Phase I SBIR is to develop a non invasive wearable dermal deviceBand Aidcapable of extracting and sensing ethanol from interstitial space using reverse iontophoresisnot sweat!and transmitting the results wirelessly to a Bluetoothcapable deviceThe proposed band aid patch will be easily applied to the epidermisand will provide monitoring of ethanol levels in a cost effectivediscreet form factor that is readily disguised under clothingThe device will be inconspicuous when applied by the end user leading to enhanced usage and complianceOur approach is based on our existing biosensor platform which is readily adaptable to meet the deliverables of this proposalOur technology has an exceptionally small footprintis cheap to manufactureand is designed to communicate via BluetoothprotocolsThe patch has five independent potentiostat circuits built into the device that allow for averaging of the ethanol readingThese five sensors result in avoting schemethat reduces false positives and false negatives which often plague other ethanol sensing modalitiesmost especially sweat sensorsThe extension of the existing platform to aband aidpatch form factor based on reverse iontophoretic sampling represents a next generation approach to non invasive analyte detection and monitoringAs part of this effortwe will re engineer AOx into a next generation enzyme with enhanced activity and stability profiles specifically designed for use in diagnostic devicesOur approach is based on Design Zymeandapos s proven platform for oxidase enzyme stabilizationThis is a novel undertakingas this approach has not been specifically used to enhance the performance of AOxThis approach to enzyme re engineering is unique and innovative in the diagnostic field and will positively impact the performance of the final Phase II deviceDuring Phase I of this SBIRwe will demonstrate that the prototype device shows a linear response to ethanol in vitro and preliminary in vivo rodent modelsDuring Phase IIwe will optimize the device samplingsensitivitycalibration and lifetimeits manufacturing processand demonstrate the device utility in a number of animal modelsThe goal at the end of Phase II is to have an optimized device that can be deployed in animal models and be ready for human clinical trialsDesign Zyme LLC will take the lead on this project with the goal of rapidly developing the wearable ethanol sensor for commercializationDesign Zyme LLC has established itself as a manufacturer of high qualityhighpurityhigh activity stabilized enzymes for monitoring and biosensing applications and a commercialization entity for wearable sensorsThe Design Zyme LLC and Caltech teams have made several significant advancements towards the development wearable sensors based on cutting edge electronics and that incorporate stabilized proteins for enhanced performanceSensor sales in FYwere $billion and are projected to exceed $billion by FYProject Narrative Alcoholethanolis the most abused drug worldwideand alcohol related diseases contribute to a high percentage of all US hospital admissionsandgtand deathsannuallyWearable alcohol sensors offer an inexpensivecost effective platform to monitor alcohol consumption in patients with medical conditions for which consuming alcohol complicates the progression of a disease and or compromises treatmentThe development of practical devices with applications in clinical monitoringdisease diagnosisand personal wearables represents the next generation of alcohol monitoring