Wearable Continuous Drug Monitoring Device for Personal Medications in Opioid Use Disorders (CDM-MOUD)

ABSTRACT LabSys’s objective is to create a transformative wearable patch, designed as a low-cost Continuous Drug Monitoring Device for Opioid Use Disorders (CDM-MOUD). Our state-of-the-art patch utilizes a microneedle—so fine that it is painless—to monitor medication levels directly within the interstitial fluid, a technique that has been shown to reliably mirror blood concentrations. Our proprietary detection method can secure both sensitivity and specificity of the opioids at concerned concentration range. This approach promises a leap forward in managing OUD by providing uninterrupted insights into the effectiveness of treatment protocols. In our upcoming Phase I research, our specific aims focus on engineering an alpha prototype with fentanyl sensing capability. This initial model will integrate our patented electrochemical sensor technology with low-power electrochemical impedance spectroscopy, coupled with seamless wireless communication for real-time data transmission. This endeavor is not just about technology; it's about people. As we refine our prototype, evaluating critical factors such as accuracy, response time, and device longevity, we will engage with the potential customers. We will tailor the patch to the nuanced needs of customers to ensure our product aligns with the real-world demands. Our vision extends into Phase II, where we will further adapt our prototype for broader clinical use, pursuing the FDA's “Breakthrough Devices Program” participation to meet rigorous regulatory standards, and clinical trials to ensure the highest standards of patient safety and product efficacy. LabSys's mission through this project is to empower individuals battling OUD with discreet, continuous health monitoring, as essential as a glucose monitor. Our products will empower patient-centered care, fostering better outcomes and facilitating a more personalized approach to treatment. We believe that our CDM-MOUD has the potential to revolutionize opioid treatment and offer a new beacon of hope for millions affected by the opioid crisis, particularly, disadvantaged populations in low-resource settings.