Spark Biomedical Completes Enrollment for Pivotal Trial in Neonatal Opioid Withdrawal Treatment

Clinical enrollment concludes for Spark Biomedical’s pivotal trial investigating a non-invasive, drug-free neurostimulation treatment for newborns born with NOWS.

/EIN News/ -- Dallas, TX, March 24, 2025 (GLOBE NEWSWIRE) -- Spark Biomedical, a leader in wearable neurostimulation technology, has completed enrollment for its pivotal phase II clinical trial, offering hope to newborns with Neonatal Opioid Withdrawal Syndrome (NOWS). This trial investigated how non-invasive transcutaneous auricular neurostimulation (tAN®) therapy could reduce the need for prolonged opioid treatment for NOWS. Funded by the National Institute on Drug Abuse (NIDA) under the HEAL Initiative, the trial was conducted at The Medical University of South Carolina, UT Southwestern Medical Center, and the University of Texas Health Science Center at San Antonio. 

The study focused on infants over 33 weeks gestational age, many of whom endured severe withdrawal symptoms such as tremors, irritability, and difficulty feeding as a result of in-utero opioid exposure. It examined how transcutaneous auricular neurostimulation (tAN) therapy, when combined with current morphine treatments, affected the time required for medical readiness for discharge. Participants are now being monitored for two years to assess long-term neurodevelopmental outcomes.  

About the study Chief Science Officer Dr. Navid Khodaparast shared, "Following FDA Breakthrough Device Designation, the SPROUT trial was the next step in moving us closer towards an FDA approval of a non-invasive neurostimulation treatment for NOWS infants. Spark extends our gratitude to all our university partners and NIDA for funding this important clinical trial." 

Each year, thousands of infants begin life in the grips of NOWS. Spark Biomedical's CEO, Daniel Powell, emphasized how this clinical trial aimed to provide these newborns with a better start: "Since the first days of Spark, we've had the vision to create a version of our neurostimulation platform designed specifically for the most vulnerable victims of the opioid epidemic. I am immensely proud of the work this team has done to advance our novel treatment for Neonatal Opioid Withdrawal Syndrome and look forward to getting the Sparrow Fledgling into the hands of Neonatologists across the country as fast as possible." Once data analysis is complete, the next step will be to submit Sparrow Fledgling to the Food and Drug Administration for approval. 

About Spark Biomedical 

Spark Biomedical, Inc. Is a leading U.S.-based medical device developer, committed to unlocking the potential of bioelectronic medicine and bringing to market novel wearable neurostimulation treatment options in behavioral health, women's health, hemostasis, pediatrics, and chronic pain. Spark leverages its neuroscience and engineering expertise to empower healthcare providers and researchers with innovative, evidence-based tools designed to address complex care situations which exceed the capabilities of existing treatment options. Spark has received funding from federal institutions, such as the NIH and DoD, and continues to partner with private and academic institutions. Spark Biomedical is empowering a better way forward for the future of patient care and medical technology. For more information, visit sparkbiomedical.com. 

For more information, please contact Udim Obot at udim.obot@sparkbiomedical.com  
 

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Udim Obot
                    Spark Biomedical
                    6823360535
                    udim.obot@sparkbiomedical.com