FUNDS TO VALIDATE TRANSCUTANEOUS AURICULAR NEUROSTIMULATION FOR RELIEVING WITHDRAWAL SYMPTOMS IN INFANTS BORN WITH NEONATAL ABSTINENCE SYNDROME (NAS)

Dallas, TX, October 18, 2019  — Spark Biomedical, Inc., a neurostimulation device company developing solutions for opioid withdrawal, 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.”

About Spark Biomedical, Inc.

Spark Biomedical, Inc. is a Texas-based medical device company developing wearable neurostimulation solutions for opioid withdrawal and addiction. The Spark team is dedicated to bringing novel solutions to alleviate the opioid epidemic and helping individuals through the essential first step of reducing the debilitating symptoms of withdrawal.

About MUSC Children’s Health

MUSC Children’s Health is changing what’s possible for children and their families by providing the pediatric clinical and research expertise every child deserves and needs. From promoting healthy lifestyles to offering life-saving treatments, Children’s Health delivers comprehensive and compassionate care to children throughout South Carolina and beyond.

Our integrated children’s health care system consists of the MUSC Children’s Hospital, located on the Charleston peninsula; the Charles P. Darby Research Institute, where pediatric research teams conduct significant and ongoing efforts; the R. Keith Summey Medical Pavilion in North Charleston, which offers an ambulatory care and surgery center, specialty care and after hours clinics; and finally, expanded depth and breadth of expertise in multiple neighborhood locations throughout the Lowcountry, offering primary, urgent and specialty care in person or via telehealth. For more information, visit http://musckids.org

The research reported in this publication is supported by the National Institute on Drug Abuse of the National Institutes of Health under award number 1R43DA050360-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Contact:

Jackie Powell
Marketing & Public Relations
Spark Biomedical
832.792.0666
Jackie.powell@sparkbiomedical.com
www.sparkbiomedical.com

Spark Biomedical, Inc. is a Texas-based medical device company and developer of a wearable, over-the-ear, neurostimulation solution for opioid withdrawal and addiction relief. The Phoenix™ device delivers mild electrical stimulation to cranial nerve branches for the treatment of symptoms associated with opioid withdrawal. The company’s vision, to ignite a brighter future through neurostimulation, is fueled by its unique blend of scientific expertise, technical innovation, and deep medical device industry experience. For more information, visit www.sparkbiomedical.com or follow us on LinkedIn

Contact jackie.powell@sparkbiomedical.com