Spark Biomedical Completes Enrollment for Pivotal Trial
Dallas, TX - Spark Biomedical, a leader in wearable neurostimulation technology, has successfully finished enrollment for its pivotal phase II clinical trial, providing a glimmer of hope for newborns suffering from Neonatal Opioid Withdrawal Syndrome (NOWS). This significant trial explores how non-invasive transcutaneous auricular neurostimulation (tAN) therapy could potentially lessen the reliance on lengthy opioid treatments for infants.
Understanding Neonatal Opioid Withdrawal Syndrome
The trial, which was funded by the National Institute on Drug Abuse (NIDA) as part of the HEAL Initiative, is being conducted at reputable medical institutions including The Medical University of South Carolina, UT Southwestern Medical Center, and the University of Texas Health Science Center at San Antonio. The research specifically targets infants that are over 33 weeks gestational age, many of whom experience severe NOWS symptoms like tremors, irritability, and feeding difficulties due to opioid exposure before birth.
The focus of the study is how administering tAN therapy alongside conventional morphine treatments affects the duration it takes for these infants to be medically ready for discharge. This trial also involves extensive follow-up, with participants being monitored for two years to evaluate their long-term neurodevelopmental outcomes.
Expert Insights from Spark Biomedical
Chief Science Officer Dr. Navid Khodaparast expressed optimism about the trial's significance, stating, "Following FDA Breakthrough Device Designation, the SPROUT trial marks a vital progression toward receiving FDA approval for our non-invasive neurostimulation treatment tailored for NOWS infants. We are truly grateful for the collaboration with our university partners and the support from NIDA in funding this crucial clinical trial."
Empowering Newborns with Innovative Solutions
Each year, thousands of infants enter the world already battling NOWS. CEO Daniel Powell emphasized the trial’s overarching goal to give these newborns a better start. "From the onset of Spark, our vision has been to innovate a specialized neurostimulation platform for those affected most by the opioid crisis. I take great pride in our team's dedication to advancing this novel treatment for Neonatal Opioid Withdrawal Syndrome and I am eager to facilitate the distribution of the Sparrow Fledgling to neonatologists nationwide at the earliest opportunity. Once we finish analyzing the data, we will take the next step in submitting Sparrow Fledgling for FDA approval."
About Spark Biomedical
Spark Biomedical, Inc. is a prominent U.S.-based medical device developer dedicated to harnessing the potential of bioelectronic medicine. Their aim is to introduce innovative wearable neurostimulation solutions for various healthcare challenges in behavioral health, women's health, hemostasis, pediatrics, and chronic pain management. The company's expertise in neuroscience and engineering enables healthcare providers and researchers to access advanced, evidence-based tools designed to tackle complex medical situations beyond the current treatment capabilities.
With backing from federal institutions, including the NIH and DoD, Spark continues to collaborate with private and academic entities, paving the way for enhanced patient care. For more information, visit sparkbiomedical.com.
Contact Information
If you’d like to learn more, please reach out to Udim Obot at udim.obot@sparkbiomedical.com.
Frequently Asked Questions
What is the purpose of the pivotal trial conducted by Spark Biomedical?
The trial aims to explore the effectiveness of non-invasive neurostimulation treatment to aid infants suffering from Neonatal Opioid Withdrawal Syndrome.
How does the tAN therapy work?
Transcutaneous auricular neurostimulation (tAN) therapy is designed to reduce withdrawal symptoms and the dependency on opioid treatments for newborns.
What institutions are involved in this clinical trial?
The trial is being conducted at The Medical University of South Carolina, UT Southwestern Medical Center, and the University of Texas Health Science Center at San Antonio.
What are the symptoms of Neonatal Opioid Withdrawal Syndrome?
Common symptoms include irritability, tremors, poor feeding, and difficulty with sleep, which can severely impact an infant's health.
What are the next steps after the trial completion?
After data analysis, Spark Biomedical will submit their findings for FDA approval to market their neurostimulation device for NOWS infants.
