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Small Biz Grant Supports Newborn Opioid Device

Newborn baby

(Christian Bowen, Unsplash)

18 Oct. 2019. A start-up enterprise is developing a nerve stimulation device worn by infants born to mothers with opioid addiction to treat the babies’ withdrawal symptoms. Spark Biomedical Inc. in Houston is receiving a one-year $217,700 grant from National Institute on Drug Abuse, part of National Institutes of Health, to support development and validation of the device.

Spark Biomedical’s device aims to help babies born with neonatal abstinence syndrome, a disorder where the baby suffers withdrawal symptoms from drugs taken by the mother and absorbed in the womb. The company cites data showing as of 2012, a baby with neonatal abstinence syndrome is born every 25 minutes, accounting for 5.8 of every 1,000 births, a sharp increase from 1.2 per 1,000 births in 2000. Currently, says Spark Biomedical, no standard of care exists for the disorder, with treatments ranging from more swaddling, rocking, and breastfeeding of the baby to drug therapy combining oral morphine with a sedative.

The Spark Biomedical device is worn over the baby’s ear, and provides stimulation of brain cells through the skull. The device is based on studies of non-insertive acupuncture, where laser or massage stimulates the targeted acupuncture points instead of needles. The company says early results show these techniques can stimulate neural pathways in the brain in babies with neonatal abstinence syndrome, and research of the technique as a supplement to medication therapy is continuing.

Spark Biomedical, founded in 2018, proposes its device as a more reliable and controllable method for stimulating nerve cells in the brain than acupuncture, since the administration of acupuncture can depend on the skills of the individual practitioner. The battery-powered Spark device delivers mild electrical stimulation through the skin around the ear, aiming for cranial nerve pathways. Treatments last for 10 days.

The project is led by Navid Khodaparast, chief scientist at Spark Biomedical. The company is partnering with Medical University of South Carolina in Charleston, with that team led by pediatrics professor Dorothea Jenkins.

“The incidence of neonatal abstinence syndrome continues to reach new highs and is too debilitating for us to accept current treatment,” says Khodaparast in a company statement. “We have designed a study that will test a safe, therapeutic option to restore quality of life for infants and ultimately, families.”

“If our technology,” adds Spark Biomedical CEO Daniel Powell, “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.”

The award is part of NIH’s Helping to End Addiction Long-term, or HEAL, initiative, but also made as part of NIH’s Small Business Innovation Research, or SBIR, program that sets aside a portion of its overall research funding for small U.S.-based companies with science-based products. NIH says it invests more than $1 billion in SBIR and related Small Business Technology Transfer awards.

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