This federal Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $411,800 to Rekovar Inc., a woman-owned small business in California, to develop the NeoMonki system - a wireless wearable device with AI analytics for monitoring Neonatal Abstinence Syndrome (NAS). The key products and services to be delivered include: A comprehensive NAS monitoring kit consisting of wearable biosensor wristbands, a...
This $318,875 Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), supports the development of a machine learning algorithm to detect opioid withdrawal symptoms and cravings using wearable physiologic sensors. The goal is to enable closed-loop delivery of transcutaneous auricular neurostimulation (TAN) therapy to reduce withdrawal symptoms and cravings, thereby increasing treatment retention for individuals with...
The National Institute on Drug Abuse (NIDA) awarded Labsys LLC a $643,948 Project Grant under the Drug Use and Addiction Research Programs (CFDA 93.279) to develop a wearable continuous drug monitoring device for opioid use disorders (CDM-MOUD). The device utilizes a painless microneedle to monitor medication levels in the interstitial fluid, providing real-time insights into the effectiveness of treatment protocols. The project aims to create an alpha prototype with fentanyl sensing capability,...
The National Institute on Drug Abuse (NIDA) awarded a $800,000 Cooperative Agreement (CFDA 93.279: Drug Use and Addiction Research Programs) to Biosensics LLC to develop ODALERT, a wearable device designed to detect and alert users and first responders of potential opioid overdoses. As initial steps, Biosensics conducted stakeholder interviews and a pilot study to inform the device's design and detection algorithms. In Phase I, they will complete the sensor development, optimize battery, and...
The National Institute of Neurological Disorders and Stroke (NINDS) awarded a $1,278,689 Cooperative Agreement (UG3NS138882) under the Drug Use and Addiction Research Programs (CFDA 93.279) to the University of South Florida (USF) to develop an automated Neonatal Pain Monitoring System (NPMS) that utilizes AI-driven pain biomarker signatures to continuously assess and manage post-operative pain in newborns. The project aims to create a pain management protocol that minimizes post-operative...
The National Institute on Drug Abuse (NIDA) awarded The Washington University a 3-year, $2,337,729 Project Grant under the Drug Abuse and Addiction Research Programs (CFDA 93.279) to study the impact of prenatal opioid exposure on placental and fetal brain development. The project, titled "The Opioid in Pregnancy: Imaging of Oxygenation, Inflammation, and Development in Brain & Placenta" (OPIOID BPP), aims to define the longitudinal effects of prenatal opioid exposure on...
This Project Grant award, with a total funding of $180,059, was provided by the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279). The award supports a study titled "Optimizing Developmental Outcomes in Early Childhood After Neonatal Opioid Withdrawal Syndrome" at the Research Institute at Nationwide Children's Hospital (RINCH), a prominent non-profit research organization. The key objectives of this study are to: 1) engage with...
This federal Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $800,000 to Tenvos Inc., a minority-owned and woman-owned small business, to develop a software-based medical device for detecting opioid use through voice analysis. The key objectives of this 1-year project are to: 1) collect clinical data and patient voice samples to study the correlation between voice patterns and opioid use; 2) validate...
This Project Grant award from the National Institute of Child Health and Human Development (NICHD), under the Child Health and Human Development Extramural Research program (CFDA 93.865), supports the development of an electrochemical assay and point-of-care (POC) instrument for sensitive, real-time measurement of oxytocin levels. The $312,817 award to Giner Inc., a small business R&D firm in Massachusetts, will fund a Phase I program to improve and validate the current assay and build a...
This $1,016,264 Project Grant award from the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279) aims to develop and evaluate digital screening and brief intervention (e-SBI) approaches for addressing perinatal substance use in home visiting programs. The project, led by the non-profit organization Partnership To End Addiction, will pilot test three e-SBI delivery strategies - a single session, a session plus booster, and post-session text...
WIRELESS WITHDRAWAL DETECTION AND MONITORING SYSTEM FOR NEONATAL ABSTINENCE SYNDROME. - PROJECT SUMMARY NEONATAL ABSTINENCE SYNDROME (NAS) IS AN OPIOID WITHDRAWAL SYNDROME THAT DEVELOPS SHORTLY AFTER BIRTH TO IN UTERO-EXPOSED NEONATES. THE COST OF NAS IS HIGH: NEWBORNS WITH NAS ARE TYPICALLY RECEIVE CARE IN THE NEONATAL INTENSIVE CARE UNIT (NICU), WHERE THE DAILY COST OF CARE IS HIGH. NEARLY 22,000 INFANTS ARE BORN WITH NAS EACH YEAR AT A COST OF $1.5 BILLION 1. MOREOVER, MEDICATION-BASED INTERVENTIONS FOR THE TREATMENT OF NAS, USED IN UP TO 80% OF OPIOID-EXPOSED INFANTS, CARRY THEIR OWN RISKS OF TOXICITY AND DRUG INTERACTIONS 2. DESPITE THE MEDICAL COST, HIGH SOCIETAL IMPACT OF NAS, AND THE RISKS OF TREATMENT, THE TOOLS TO ASSESS THE SEVERITY OF NAS CAN BE SUBJECTIVE AND SUFFER FROM EXAMINER BIAS 3. THERE IS AN URGENT NEED FOR INNOVATIVE NEW METHODS TO DIAGNOSE NAS AND ASSESS THE EFFICACY OF RESPONSES TO TREATMENT. FLEXIBLE, LOW-COST WEARABLE DEVICES (WORN ON THE SKIN) THAT CAN REPORT MEASURES OF SYSTEMIC BIOCHEMICAL AND BIOMECHANICAL PROCESSES OFFER A SIMPLE AND ECONOMICAL SOLUTION. IN NAS, SURGES OF SYMPATHETIC NERVOUS SYSTEM ACTIVITY PRODUCE INCREASED HEART RATE, SKIN CONDUCTANCE, UNSTABLE TEMPERATURE, AND TREMOR. THESE MANIFEST IN INCREASED INFANT SWEATING, SEIZURES, TREMORS, UNSTABLE BODY TEMPERATURE, AND MORE-EVENTS THAT MUST CONTINUALLY MONITORED AND ASSESSED BY NURSES. THE UNSUPERVISED, OBJECTIVE DETECTION/QUANTIFICATION OF THE BODILY RESPONSE OF NEONATES SUFFERING FROM NAS COULD DRIVE THE DEVELOPMENT OF NEW, OBJECTIVE SCORING TOOLS THAT CAN GUIDE THE INITIATION, INTENSITY, AND DURATION OF THERAPIES FOR NAS2. SUCH TOOLS COULD SIGNIFICANTLY REDUCE MEDICAL COSTS AND IMPROVE PATIENT OUTCOMES BY REDUCING PATIENT TIME IN NICU, REDUCING NURSE LOAD, IMPROVING OUTPATIENT MONITORING, AND HELPING TO ASSIST IN THE OPTIMIZATION OF PATIENT TREATMENTS. CRITICALLY, WE BELIEVE SUCH A TOOL MAY BE ABLE TO OBJECTIVELY CAPTURE EVENTS THAT MAY GO UNNOTICED BY NURSES OR WHILE THE INFANT IS SLEEPING (MINOR TREMORS, POOR OXYGENATION, TEMPERATURE FLUCTUATIONS, DEHYDRATION). THIS PROPOSAL SEEKS TO DEVELOP, ASSESS, AND COMMERCIALIZE INTERLINKED, INFANT-TARGETED WEARABLE BIOSENSOR- SYSTEMS CAPABLE OF AUTOMATED DIGITAL SCORING, CONTINUOUSLY MONITORING THE BIOCHEMICAL, PSYCHOLOGICAL AND ENVIRONMENTAL TO BIOPHYSICAL PARAMETERS OF OPIOID-DEPENDENT NEONATES WHILE PROVIDING SUGGESTIVE TREATMENT FOR NAS. OUR TEAM AND PARTNERS HAVE OUTSTANDING EXPERIENCE IN ALL AREAS NECESSARY TO THIS INVESTIGATION TO DEVELOP A COMMERCIAL GRADE WEARABLE WRISTBAND MONITORING KIT THAT INCLUDES: (1) INFANT WEARABLE WRISTBAND, (2) IMAGING CAMERA (3) RECHARGING STATION, (4) TABLET APP, AND (5) PATIENT PORTAL TAILORED FOR PROFESSIONAL HEALTHCARE PROVIDERS. OUR BUSINESS UNIT HAS EXTENSIVE NIH FUNDED EXPERIENCE IN WEARABLE BIOSENSING, IN THE DETECTION OF SYMPATHETIC NERVOUS SYSTEM ACTIVITY IN OPIOID WITHDRAWAL, PEDIATRICS, BUSINESS DEVELOPMENT, AND INTELLECTUAL PROPERTY. OUR ACADEMIC PARTNERS HAVE BROAD EXPERIENCE IN NOVEL BIOSENSOR DEVELOPMENT.