In response to the escalating opioid crisis in the United States, there is an urgent need for effective intervention strategies. Opioid overdoses can induce dangerous respiratory depression, leading to critical hypoxia and potential mortality. Current harm reduction measures include the provision of naloxone to drug users, their supporters, and first responders to swiftly counteract opioid effects. However, these interventions may be insufficient given that more than half of opioid-induced fatalities occur at home, often unwitnessed. To address this urgent public health issue, BioSensics and Baylor College of Medicine (BCM) present ODAlert—an innovative wearable device designed to detect and alert users and first responders of potential opioid overdoses. Affixed to the user's abdomen via a biocompatible patch, ODAlert continually monitors respiratory patterns, issuing an auditory alarm and contacting first responders upon detection of respiratory cessation. As initial steps for developing ODAlert, we performed stakeholder interviews with 10 adults with opioid use disorder (OUD) and 10 clinical experts who treat OUD to guide the design of ODAlert such as sensor placement, form factor, and functionality. Based on these surveys, an optimal sensor was identified; namely, a wearable device affixed to the user's abdomen via a biocompatible patch. We developed algorithms for detection of respiratory cessation using a reference wearable device on the abdomen with over 92% sensitivity and specificity in a 10-adult pilot study. Moreover, we submitted a Pre-submission request to the FDA (Q222234) and received feedback about the clinical validation study design to support a De Novo application for ODAlert. Encouraged by these initial results, we are now applying for Blueprint funding to facilitate development, clinical validation, market readiness, FDA approval and commercialization of ODAlert. In Phase I, we will complete the development of ODAlert sensor, optimize battery, deploy real-time algorithms, and secure IDE and IRB approval. In Phase II, we will complete the development of ODAlert and its mobile app, conduct a clinical validation study with opioid- experienced adults (n=30) via a cross-over randomized study, and also evaluate ODAlert's performance in a 6- week study on adults (n=60) with OUD for submission as a part of the De Novo application to the FDA. ODAlert can have significant multiple-level impact: 1) Public health: It introduces a warning system for opioid overdoses, aiming to reduce mortality rates; 2) Technological innovation: ODAlert represents a leap in wearable healthcare tech, inspiring potential life-saving devices; 3) Policy and regulatory: Securing FDA approval for ODAlert can inform policy around wearable-based health devices and set a precedent; 4) Clinical practice: If widely accepted, ODAlert will transform care standards for overdose-prone patients; 5) Patient self-management: ODAlert can empower individuals with OUD by provi...