THE MEDICAL UNIVERSITY OF SOUTH CAROLINA

Spark Biomedical Completes Enrollment in Two Pivotal Neurostimulation Trials for Opioid Use Disorder and Neonatal Withdrawal

- Spark Biomedical has completed enrollment for two pivotal clinical trials investigating transcutaneous auricular neurostimulation (tAN) therapy for opioid use disorder in adults and neonatal opioid withdrawal syndrome. - The adult trial, funded by NIDA under the HEAL Initiative, examines whether wearable neurostimulation can improve treatment retention rates in patients with opioid use disorder, where relapse rates exceed 70%. - The pediatric trial focuses on newborns with neonatal opioid withdrawal syndrome, investigating whether tAN therapy combined with morphine treatment can reduce time to medical readiness for discharge. - Both studies represent potential breakthrough approaches to addressing the opioid crisis through non-invasive, drug-free neurostimulation technology that has received FDA Breakthrough Device Designation.