Spark Biomedical, a neurostimulation device company based in Dallas, received an SBIR grant totaling $217,690 from the National Institutes of Health HEAL initiative. Spark develop wearables to treat opioid withdrawal symptoms. The company said the money will be used to validate the use of transcutaneous auricular neurostimulation to relieve withdrawal symptoms in infants born with neonatal abstinence syndrome (NAS).
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According to the latest statistics from the National Institute on Drug Abuse, an 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.
“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,” said Daniel Powell, CEO of Spark Biomedical. “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.”
Spark Biomedical's battery-powered wearable device delivers mild electrical stimulation through the skin around the ear, targeting cranial nerve branches. The battery lasts the entire 10-day treatment period, said the company in a press release.
A clinical study, hosted by the Medical University of South Carolina, is set to start in November. The study will be overseen by Principal Investigator Dr. Navid Khodaparast, Spark Biomedical's Chief Science Officer.
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“The incidence of neonatal abstinence syndrome continues to reach new highs and is too debilitating for us to accept current treatment,” said Dr. Khodaparast. “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.”
