Spark Biomedical Breakthrough Status for Roo System

FDA has granted Spark Biomedical a Breakthrough Device Designation for the Roo System: a transcutaneous electrical nerve stimulator that aids in reducing signs and symptoms of neonatal opioid withdrawal syndrome, which results from exposure to prescription or non-prescription opioids or heroin during pregnancy. The device is based on the company’s Sparrow Therapy System for adults.

The therapy is designed to be applied by health care professionals in a neonatal intensive care unit setting. It promotes the release of endogenous opioids (endorphins), Spark says, adding that it supplants the need for oral morphine. “The endorphin release is achieved by safely activating nerve branches on and around the ear of newborn infants,” it says.

Spark says the breakthrough designation is based on data from a clinical study, which demonstrated that the Roo System can significantly reduce the duration of oral morphine use to less than ten days with no adverse events.