R. Polsky
Biowear, Inc.,
United States
Keywords: microneedle, point-of-care, biosensor
Summary:
Biowear has developed a microneedle-based wearable patch that can be self-applied in a pain-free manner to measure circulating biomarkers that could serve as a tool for analysis of complex medical conditions and illnesses. Microneedle-enabled analysis systems are advantageous due to their ability to puncture the skin’s stratum corneum and access interstitial fluid (ISF) without irritating deeper layers of the skin associated with pain, blood flow, or sensation. Biowear technology includes 1) Interstitial Fluid Extraction device and 2) In dwelling Coaxial Microneedle electrodes. Blood is the gold-standard for health diagnostics. However, blood is a sub-optimal matrix for frequent sampling and analysis, as blood contains red blood cells that interfere with some diagnostics, and requires piercing of blood vessels, increasing the risk of post-sampling infection. These drawbacks to blood have caused medical diagnostics companies to pursue detection of target analytes in other biofluids. Interstitial fluid collected from the areas surrounding the blood vessels has great diagnostic potential and is currently used as a proxy to blood glucose in the commercially available continuous glucose monitor (CGM). However, ISF remains underutilized for point-of-care diagnostics due to the historical difficulty in acquiring samples. To overcome this barrier, Biowear utilizes a microneedle device that extracts microliter quantities of dermal interstitial fluid within ten minutes in both human and animal models. Notably, our minimally invasive ISF extraction device, has the following advantages compared to the standard blood draw: 1) Reduced pain through reducing the depth of insertion, 2) Reduced chance of infection by preserving the vascular endothelium, and 3) Reduced logistics, as use of the device does not require a phlebotomist. Additionally, the ISF extraction device can be integrated with sensors for direct on-board measurements that can provide instant readouts and thus reduce both the delay time between sample collection and biochemical analysis as well as the labor required to analyze samples.