APDI provides $200,000 in grants to advance pediatric substance use disorder devices

Sep 4 2024

The Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children's National Hospital and funded through the Food and Drug Administration (FDA), announces today the recipients of grants totaling $200,000 to advance pediatric medical devices that improve the monitoring, diagnosis or treatment of youth suffering from substance use disorder and addiction. Selected by a panel of expert judges, each awardee receives $50,000 and opportunities for APDI support services across all phases of the medical device product lifecycle, including facilitating access to technical assistance from the National Institute on Drug Abuse (NIDA). 

The four pediatric innovations selected for their potential impact on the issue of adolescent substance misuse are: 

AltruMed, Philadelphia, Pa. – Creators of DOVE, an innovative, shoulder-mounted device designed as a safety tool for those most at risk from overdose toxicity. Smaller than a matchbox, DOVE employs multi-modal sensing to detect severe respiratory depression and alerts bystanders and first responders. 

Levl, Brooklyn, N.Y. – Developing a remote therapeutic monitoring platform designed to address the critical challenges associated with stimulant medication treatment for adolescents with attention-deficit/hyperactivity disorder, a group at greater risk for substance abuse. Based on collected patient data, Levl's proprietary, early risk detection mechanism is designed to enhance the safety and effectiveness of stimulant medication treatments in response to the rise in misuse and diversion among youth. 

Sibel Health, Chicago, Ill. – Providers of the FDA-cleared ANNE platform that includes advanced wearable sensors, artificial intelligence-enabled data analytics and an integrated mobile software and cloud platform for adolescents ages 12 and up. Grant funds will be used to modify the existing monitoring solution for use by patients and healthcare providers to detect opiate-induced respiratory depression in high-risk adolescents. 

Toivoa, Washington, D.C. – Developer of an evidence-based digital therapeutic platform that aims to increase access to care, reduce wait times, provide caregiver tools and offer personalized mental health support. Grant funds will be used for platform modifications that address mental health challenges for adolescents with dual diagnoses, including mental health and substance use disorder, and to address the support needs of caregivers. 

ADPI developed this funding initiative in response to the alarming rate of illicit drug use by U.S. youth –- about 3.6 million among ages 12 to 17 in 2022, as reported by the National Institutes of Health. That year, fatalities from drug overdose averaged 22 per week among youth ages 12 to 18, with most having no history of treatment for a substance use problem or prior nonfatal overdose. 

Recognizing that drug overdose is now the third leading cause of death among adolescents, we see an urgent need to support new technologies that can help families and providers address this problem. We look forward to working with these grantees and see great potential in the lifesaving and life-changing impact that their technologies could make possible." 

Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children's National and APDI principal investigator and program director

APDI's grant awards follow the National Advisory Council on Drug Abuse (NACDA) approval in May 2024 of the concept "Promoting Medical Device Development for Youth Affected by Drug Addiction and Substance Misuse," which describes potential funding opportunities. APDI aims to provide early support to promising innovations, recognizing that additional funding may be available from NIDA in the future. 

APDI is one of five nonprofit consortia in the FDA's Pediatric Device Consortia grant program that receives funding to provide a platform of services, expertise and grants to support pediatric innovators in bringing medical devices to the market that specifically address the unmet needs of children. Along with Children's National, APDI members include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center, MedStar Health Research Institute, MedTech Color and OrthoPediatrics Corp.