In this Commercialization Readiness Pilot (CRP) Program project, Arborsense will develop field-ready wearable alcohol bio-monitors that are robust and comfortable to wear continuously while maintaining the functionality and performance demonstrated in Phase II, and conduct a field compliance study for 4 weeks to establish product- market fit. Excessive alcohol consumption is the fourth leading preventable cause of death in the US. Alcohol- related deaths have accelerated significantly in the past two decades as has the prevalence of other alcohol- related harms such as alcohol use disorder and alcohol-related liver disease. Arborsense?s wearable alcohol bio-monitor will address the unmet need for a continuous, convenient-to-use, and discreet device for monitoring alcohol consumption without discomfort or stigma. This will lead to better awareness and compliance with respect to alcohol use amongst the general public. Arborsense received an NSF Phase I SBIR grant (IIP-1548317) with which we demonstrated proof-of-concept graphene alcohol sensors and their feasibility in human volunteer tests. This led to an NIAAA Phase II SBIR grant (R44AA026119) that allowed us to build light, standalone, and wrist- worn sensor modules integrated with self-calibration electronics and Bluetooth transceiver to transmit data wirelessly to our custom Android app. In Phase II, we collaborated with the University of Michigan to validate these sensor modules in large scale human subject tests (82 human participants; more than 150 sensors tested in over 300 individual tests on multiple body locations). We have shown that our current modules can continuously and reliably detect drink events with peak BAC level >0.03% when benchmarked with legal grade breathalyzer and have very low false positives and low false negatives. In this CRP program, we will collaborate with Sundberg-Ferar (a Michigan based industrial design firm) and incorporate robustness, ergonomic refinements, and aesthetics to develop a rugged and high-fidelity system that will be utilized for a multi-week wear study through the University of Michigan. We will also engage with our strategic partners during the design process to incorporate features necessary for market acceptance. The successful performance of our bio- monitors in these real-world tests in terms of functionality and usability is a key milestone towards market approval and production development and will continue to provide investment momentum.

Public Health Relevance

Excessive alcohol consumption is the fourth leading preventable cause of death in the US and presents a broad public health challenge worthy of urgent attention. Through the NIAAA Phase II grant, Arborsense developed a convenient, continuous and unobtrusive wearable alcohol monitoring device and demonstrated its functionality and performance in large scale human subject tests. The proposed project is aimed at developing a rugged, refined and ergonomic system geared for long-term wear tests and eventual production development.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44AA026119-04
Application #
10137829
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Murray, Gary
Project Start
2017-08-10
Project End
2022-06-30
Budget Start
2020-09-10
Budget End
2021-06-30
Support Year
4
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Arborsense, Inc.
Department
Type
DUNS #
079736137
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109