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Minneapolis-based NightWare, developer of a “smartwatch therapeutic” for those with PTSD-driven traumatic nightmares, has received “breakthrough therapy designation” from the U.S. Food and Drug Administration for its development-stage application.

NightWare also is launching two clinical trials for its digital intervention, one of which is being conducted within Department of Veterans Affairs hospitals.

“We’re FDA regulated but because this is a low-risk treatment, digital-therapeutic, we are enrolling for a virtual clinical trial and anyone in the United States can enroll [at],” CEO Grady Hannah said Wednesday.

Hannah said Nightware has been running on several-hundred thousand in invested capital since 2017 and that the app was invented by a computer science graduate student in 2016.

“[Breakthrough status] is a really nice thing...because we have, internally, had a lot of discussions around the reasons why we thought this was a significant and important advance in medical technology,” Dr. Daniel Karlin, chief medical officer at NightWare, told MobiHealthNews. “We’re engaged with the agency in trying to generate a body of evidence that doesn’t just show efficacy, but shows efficacy versus sham, versus placebo … and we’re doing it quickly because among veterans with PTSD, there’s a suicide per hour. We believe that this may reduce suicide, so we have an obligation to get this to folks as fast as we can.”

NightWare’s product is an app for the Apple watch that uses the device’s biometric sensors to monitor the sleeping wearer’s heart rate and movement, he said. Within just a night or two of sleep, the app’s machine learning component is trained to detect when the wearer is distressed by a nightmare. At this point the smartwatch vibrates to interrupt the wearer’s dreaming, but not enough to wake them up or disrupt their circadian sleep pattern.

“We’re … asking questions about nightmares and obviously we help to reduce nightmares, but the endpoint we’re actually looking at is sleep quality,” Karlin told MobiHealthNews. “If we’re waking someone up too much, we’re not going to make them better. The goal is not just to reduce nightmare, but to improve sleep.”

NightWare has been conducting trials of the app with the VA, and will soon launch a new 240-participant blinded, randomized, placebo-controlled trial in Minnesota VA hospitals.

Should the therapy prove effective among this population, Karlin and Hannah noted that these hands-on trials with the VA will offer their company a clear initial path toward commercialization.

Hannah, 46, is a Silicon Valley veteran who grew up in St. Paul and went to Macalaster College.

Investment banker J.P. Morgan this year ranked NightWare one of the 20 most-promising health care tech firms found in "flyover country" between the east and west coasts.