Spark Biomedical, Inc. is a neurostimulation device company developing solutions for opioid withdrawal. Today the company announced they received a $217,690 SBIR grant from the National Institutes of Health HEAL initiative. The grant (1R43DA050360-01) will be used to validate the use of neurostimulation to relieve withdrawal symptoms in infants born with neonatal abstinence syndrome (NAS).
The latest National Institute on Drug Abuse statistics estimated 32,000 babies were born with NAS in the United States in 2014, a more than 5-fold increase since 2004. That equates to a baby born every 15 minutes in opioid withdrawal. NAS is a condition where a fetus is exposed to opioids or other substances in the womb and experiences withdrawal symptoms hours after birth. Common symptoms include disturbances in the gastrointestinal, autonomic and central nervous system, leading to a range of symptoms including irritability, high-pitched cry, inadequate sleep and poor feeding.
Spark Biomedical’s neurostimulation solution is a small wearable device that delivers mild electrical stimulation through the skin around the ear, targeting cranial nerve branches. The system is powered by a small rechargeable battery designed to deliver therapy throughout the 10-day treatment period.
The clinical study, expected to commence November 2019, will be overseen by Principal Investigator Dr. Navid Khodaparast, Spark Biomedical’s Chief Science Officer. The Medical University of South Carolina (MUSC) will host the study with Co-Principal Investigators Dr. Dorothea Jenkins, Professor and Neonatologist, and Dr. Bashar Badran, Assistant Professor.
Dr. Khodaparast commented, “The incidence of neonatal abstinence syndrome continues to reach new highs and is too debilitating for us to accept current treatment. We have designed a study that will test a safe, therapeutic option to restore quality of life for infants and ultimately, families. In addition to our adult clinical trial beginning in October, we look to quickly follow with this study and extend the indication into the neonatal segment.”
Dr. Jenkins stated, “MUSC’s vision is to lead health innovation for all the lives we touch, and that means finding new ways of treating clinical conditions that produce higher quality care and better outcomes for our patients. We are very excited to see how this new therapy can help the most vulnerable victims of the opioid crisis overcome withdrawal soon after their birth.”
Daniel Powell, CEO of Spark Biomedical, explained, “These are the most innocent and often overlooked victims of the opioid epidemic, whose first days on earth include experiencing the painful process of withdrawal. The current NAS treatment is to administer either morphine or methadone every few hours to titrate these infants down over a couple of weeks, simply because there are no other options. That, to us, is just not acceptable. If our technology can reduce or prevent the pain as well as the need to use opioids on a newborn, we believe it could give these infants a significantly better start in life and set them on a better path from the beginning.”