Spark Biomedical announced today that the FDA granted breakthrough device designation to its transcutaneous electrical nerve stimulator designed to reduce signs and symptoms of neonatal opioid withdrawal syndrome (NOWS).

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.

The Roo system is a non-invasive neurostimulation device based on the company’s adult device, the Sparrow therapy system. Intended to be applied by healthcare professionals in a neonatal intensive care unit, the system is designed to promote 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, according to the Dallas, Texas-based company.

In tandem with its FDA breakthrough submission, Spark began 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 use of 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, according to the company.

“We know that an increase in opioid misuse can have a direct connection to a rise in NOWS cases,” said Spark Biomedical CEO Daniel Powell in a news release. “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.”

“It is heartbreaking to see babies go through withdrawal,” added Spark’s chief technology officer, 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.”