Spark Biomedical Receives FDA Breakthrough Device Designation for Infant Transcutaneous Auricular Neurostimulation (tAN™) Device, The Roo™ System

Breakthrough Designation Helps Advance the Therapy Targeting a Significant Unmet Need in the Treatment of Neonatal Opioid Withdrawal Syndrome

Dallas, Texas, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Spark Biomedical, Inc. announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Roo System: a transcutaneous electrical nerve stimulator that aids in the reduction of signs and symptoms of Neonatal Opioid Withdrawal Syndrome (NOWS). The Roo System is a non-invasive neurostimulation device based on the company’s adult device, The Sparrow Therapy System™.

NOWS results from exposure to prescription or non-prescription opioids such as methadone or heroin during pregnancy. Currently, no nationwide standard of care exists for managing NOWS, although oral morphine weaning for a national average of 21 days is common practice. Including the ROO System in the Breakthrough Device program will ensure impacted neonates have timely access to an FDA cleared technology offering significant advantages over existing alternatives such as morphine weaning.

As recently highlighted by the FDA, there is a growing concern that the opioid crisis is worsening during COVID-19. The American Medical Association has already noted: “that at least 30 states have reported an increase in opioid fatalities since the start of the pandemic.”1

“We know that an increase in opioid misuse can have a direct connection to a rise in NOWS cases,” said Daniel Powell, CEO of Spark Biomedical. “We submitted the Roo System for Breakthrough Device Designation because we see a growing need, and we’re dedicated to getting this solution to the most vulnerable of patients as quickly as possible.”

Spark’s Roo System is designed to be applied by health care professionals in a Neonatal Intensive Care Unit (NICU) environment. The Roo System’s unique non-invasive therapy promotes the release of endogenous opioids (endorphins), supplanting the need for oral morphine. The endorphin release is achieved by safely activating nerve branches on and around the ear of newborn infants. 

 “It is heartbreaking to see babies go through withdrawal,” said Spark’s Chief Technology Officer, Dr. Alejandro Covalin. “It is a privilege to have this opportunity to develop technology to help these babies overcome NOWS and minimize the potentially lifelong consequences of current treatments. Breakthrough Device Designation is evidence of the need for this therapy and will help us expedite the delivery of a life-changing technology to those in dire need.”

In tandem with Breakthrough submission, Spark initiated an NIH/NIDA-funded clinical study with the Medical University of South Carolina to assess the safety and effectiveness of the Roo System in neonates as an adjunctive therapy to the current standard of care, oral morphine. The data from this clinical study, used to support the FDA’s breakthrough decision, demonstrated that the Roo System can significantly reduce the duration of oral morphine use to less than ten days with no adverse events.

Dr. Navid Khodaparast, Spark’s Chief Science Officer and clinical study Principal Investigator stated, “The first days of life are a critical developmental period for all infants, which highlights the importance of safely reducing the potential neurotoxic effects of opioid medications in NOWS treatment.”


About Spark Biomedical

Spark Biomedical, Inc. is a Texas-based medical device company developing wearable neurostimulation solutions for opioid withdrawal relief. The Spark team is dedicated to helping the world overcome, heal, and achieve through the use of wearable neurostimulation.

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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.


1 FDA Insight: Episode 11 – Transcript. FDA Insight: The Opioid Epidemic and COVID-19 Pandemic.



Roo System Prototype

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