PROJECT SUMMARY Neonatal abstinence syndrome (NAS) is an opioid withdrawal syndrome that develops shortly after birth to in utero-exposed neonates. Newborns with NAS typically receive care in the Neonatal Intensive Care Unit (NICU), where the daily cost of care is high, costing $1.5 billion per the 22,000 infants born with NAS each year. [1] Although there are medication-based interventions for the treatment of NAS, which are used in up to 80% of opioid-exposed infants, these treatments carry their own risks of toxicity and drug interactions. [2] Despite the steep medical costs and the risks of treatment, current tools to assess the severity of NAS are subjective and suffer from examiner bias. [3] There is an urgent need for innovative new methods to reliably diagnose NAS and thoroughly assess the efficacy of responses to treatment. Rekovar has worked diligently to develop Neomonki (Neonatal Monitoring Kit), a simple economical solution to objectively assess and treat NAS. Neomonki is an affordable, wearable monitoring device that reports measures of behavioral and physiological symptoms correlating to NAS that may otherwise go unnoticed to healthcare professionals. Neomonki consists of wireless wearable wristbands fitted with biosensor technology, a tablet fitted with Rekovar’s healthcare portal enhanced with robust encryption/data collection capabilities, a charging dock station which powers the tablet and allows easy access to recharge the wristbands, a camera attached to the dock station to analyze imaging properties, and a portable cart which holds the dock station and allows for easy repositioning of Neomonki. Neomonki will revolutionize neonatal healthcare with a cutting- edge AI clinical algorithm that analyzes biosensor and imaging data to deliver predictive NAS analytics and enhance diagnostic decision-making. Rekovar has successfully pursued several objectives to enhance the performance of Neomonki, including size reduction and improved functionality and safety features. Rekovar has also made strides in improving Neomonki’s software graphical user interface, ensuring that it is user- friendly and functional. However, the success of the device is contingent upon the development of the AI algorithm for assessing patient symptoms and prescribing appropriate treatments. This proposal revolves around the collection of data in clinical trials to develop, optimize, and refine an algorithm for assessing NAS symptoms in neonatal patients with the Neomonki. This will be done in two phases: i) the collection of data in clinical trials and development/validation of the algorithm, and ii) submitting a central IRB submission to deploy Neomonki in clinical trials collecting efficacy and safety data for premarket de novo approval. These clinical trials will compare the performance of Neomonki against the currents standards of care used by participating hospitals. A key milestone of this stage of the project is to assess whether the optimized automated...