The Phase II SBIR project by ActioX LLC builds on the success of Phase I, aiming to revolutionize the field of
precision nutrition through the development of a state-of-the-art microneedle-based wearable sensor platform.
This technology is designed for the concurrent monitoring of critical biomarkers: glucose, ketones, and sodium.
These biomarkers provide essential insights into an individual's metabolic state, facilitating personalized
healthcare interventions. Our long-term goal is to create an integrated "lab-under-the-skin," a miniaturized
wearable sensor that offers continuous, minimally invasive monitoring of a wide array of nutritional and metabolic
parameters. To this end, we plan to integrate advanced data analytics into our mobile application, enhancing the
predictive power of health recommendations derived from biomarker data. In this phase, we are setting specific
aims to refine and validate our multi-analyte sensor, enhancing its accuracy, usability, and data fidelity. Aim 1
focuses on the development of a multimodule printed circuit board (PCB) that combines potentiometric and
amperometric measurements, enabling the precise quantification of our target analytes. This PCB is to be
complemented by an FDA-compliant mobile application, ensuring secure and real-time data transmission and
analysis. Additionally, we aim to scale up the production of microneedle sensors using semi-automatic
manufacturing processes. This step is crucial in transitioning from manual production methods to a more scalable
and economically viable model, ensuring consistent quality and performance of the sensors. We will conduct
rigorous biocompatibility testing, adhering to FDA standards, to verify the safety and comfort of users. This is an
essential milestone toward regulatory approval and commercialization. Aim 3 is centered on conducting a series
of feasibility clinical studies to establish a unified calibration algorithm for our sensors, eliminating the need for
individual recalibrations. This factory-calibration approach is anticipated to streamline the user experience,
making the technology accessible to a broader population. Our research design incorporates a methodical
approach to sensor optimization, combining in-vitro and in-vivo studies. Clinical trials are designed to validate
the multiplexed sensor's performance in real-world settings, capturing a diverse range of human physiological
responses to diet and lifestyle. The anticipated outcomes of this project include a miniaturized, FDA-compliant,
multimodule sensor platform with a robust mobile application, a scalable production process for microneedle
sensors, and comprehensive clinical validation of a multiplexed wearable device. By achieving these aims, we
will enable real-time, individualized monitoring of key biomarkers, empowering users to make informed decisions
about their health and dietary practices. The foundational work from this phase will establish the groundwork for
a comprehensive, user-friendly "lab-under-the-skin," propelling precision nutrition forward and paving the way
for enhanced health outcomes and disease management across diverse populations.
