The goal of this Phase I SBIR is to develop a non-invasive wearable dermal device (?Band-Aid?) capable of extracting and sensing ethanol from interstitial space using reverse iontophoresis (not sweat!) and transmitting the results wirelessly to a Bluetooth? capable device. The proposed band-aid patch will be easily applied to the epidermis, and will provide monitoring of ethanol levels in a cost-effective, discreet form factor that is readily disguised under clothing. The device will be inconspicuous when applied by the end-user leading to enhanced usage and compliance. Our approach is based on our existing biosensor platform which is readily adaptable to meet the deliverables of this proposal. Our technology has an exceptionally small footprint, is cheap to manufacture, and is designed to communicate via Bluetooth? protocols. The patch has five independent potentiostat circuits built into the device that allow for averaging of the ethanol reading. These five sensors result in a ?voting scheme? that reduces false positives and false negatives which often plague other ethanol sensing modalities, most especially sweat sensors. The extension of the existing platform to a ?band-aid? patch form factor based on reverse iontophoretic sampling represents a next generation approach to non-invasive analyte detection and monitoring. As part of this effort, we will re-engineer AOx into a next-generation enzyme with enhanced activity and stability profiles specifically designed for use in diagnostic devices. Our approach is based on Design-Zyme's proven platform for oxidase enzyme stabilization. This is a novel undertaking, as this approach has not been specifically used to enhance the performance of AOx. This approach to enzyme re-engineering is unique and innovative in the diagnostic field and will positively impact the performance of the final Phase II device. During Phase I of this SBIR, we will demonstrate that the prototype device shows a linear response to ethanol in vitro and preliminary in vivo rodent models. During Phase II, we will optimize the device sampling, sensitivity, calibration and lifetime, its manufacturing process, and demonstrate the device utility in a number of animal models. The 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 trials. Design-Zyme LLC will take the lead on this project with the goal of rapidly developing the wearable ethanol sensor for commercialization. Design-Zyme LLC has established itself as a manufacturer of high-quality, high- purity, high-activity stabilized enzymes for monitoring and biosensing applications and a commercialization entity for wearable sensors. The 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 performance. Sensor sales in FY2009 were $6.9 billion and are projected to exceed $14 billion by FY2020.
Alcohol (ethanol) is the most abused drug worldwide, and alcohol related diseases contribute to a high percentage of all US hospital admissions (> 20%) and deaths (~100,000) annually. Wearable alcohol sensors offer an inexpensive, cost effective platform to monitor alcohol consumption in patients with medical conditions for which consuming alcohol complicates the progression of a disease and/or compromises treatment. The development of practical devices with applications in clinical monitoring, disease diagnosis, and personal wearables represents the next generation of alcohol monitoring.