DermiSense is developing a flexible, bio-inert organic composite microneedle platform to interface with the dermal interstitium (just below the skin). The platform does not cause pain, does not interface with the blood, and does not require complex chemistry or processing equipment to manufacture or use. It does allow the transport of water vapor and oxygen, is able to be printed upon, and can be used nearly anyplace on the body to access dermal ISF. The sub-millimeter microstructured needles can be used to wick ISF from within the skin and operate directly on the user, or saturated with ISF and measured off-body with common analytical chemistry tools. The unique design of this wicking platform enables 300% fluid extraction rates compared to typical microneedles, opening the possibility to track the 93% similarity between proteins in dermal ISF and in blood plasma and serum.
DermiSense’s demonstrated platform enables the painless and continuous extraction of ISF to measure proteins, cytokines, and lymph to investigate physiology, pharmacokinetics, and immune response. Current medical practice to investigate such conditions requires drawing and often separating whole blood; an invasive and painful process requiring much more time and training than the DermiSense microneedle system.
Microneedle patches could be placed on trauma victims to monitor physiological compensation, or could be worn by athletes to optimize their training and recovery. Continuous monitoring of critical populations could enable early detection of infection, or track the progression/remission of disease. Access to circulating drugs could enable faster and more accurate clinical trials and the earlier identification of promising treatments.
The ability to analyze the human interstitium by measuring and influencing the analytes and drugs it contains opens bold new possibilities for optimizing human performance as well as the detection and treatment of disease.
DermiSense’s zero-power extraction method can be combined with commercial colorimetric sensors, lateral flow immunoassays, or state-of-the-art electrochemical sensors. Colorimetric lateral flow immunoassays are used frequently in clinical and home testing such as in urine drug test strips, home pregnancy tests, and infectious disease testing. They can clearly signal the presence of the target substance in a predefined concentration range and clearly communicate to the user. The passive microneedles can be connected to commercial electronics for additional powered sensing with optical and electrical sensors, enabling broad signal multiplexing and a dramatically expanded suite of sensing capabilities.
The initial DermiSense platform has demonstrated human ISF extraction in a clinical setting and has shown the ability to detect chemical changes to trial participants collected fluid. Unlike most microneedle technologies, our microneedle test strip is flexible, porous, and allows the passage of moisture and oxygen to the skin. These key attributes allow for better conformality on the user’s skin and accelerated ISF extraction rates of the same sample volume compared to other microneedle platforms. These material characteristics also allow for extended wear of the platform with up to 72 hours of continuous wear, with a faster extraction rate for faster decision making.