Healthcare innovation startup NightWare Inc, a privately-held digital therapeutics for mental health company, has received breakthrough status designation from the US Food and Drug Administration (FDA).

Nightware’s lead product, NightWare, measures and treats nightmares in people with post-traumatic stress disorder (PTSD). Nightmares and nightmare disorder have been linked to increased suicidality, heightened risk of heart disease, diabetes, and contributes to cognitive difficulties such as memory loss, anxiety, depression, and other physical and mental conditions.

The FDA designation recognizes a therapeutic solution for a life-threatening condition for which no currently approved treatment offers similar benefits to those of the proposed therapy. The designation allows the FDA to grant priority review when preliminary clinical trials indicate that a given therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.

Daniel Karlin, MD, chief medical officer for NightWare, says in a release, “We’ve seen a markedly large effect size for improved sleep quality in NightWare open label trials. We are excited to get folks enrolled in these randomized trials to further verify the observed efficacy.”

NightWare is a smart watch application that runs on the Apple Watch platform. The device collects biometric data through integrated sensors and uses machine learning algorithms to create a profile of an individual’s sleep patterns. At the point the onset of a nightmare is detected, the device intervenes using vibrotactile feedback to arouse the sleeper out of sleep without waking them. The result is that the nightmare is interrupted without interrupting the circadian sleep pattern, enabling the patient to get better and more restful sleep.

“This is truly a watershed moment for our company,” says NightWare CEO and founder Grady Hannah. “In our initial studies, NightWare has demonstrated substantial and significant efficacy. The FDA’s breakthrough status designation will enable us to complete our randomized clinical trials ahead of schedule and give us the opportunity to help improve the lives of veterans and others suffering from PTSD sooner than we anticipated.”

NightWare is currently enrolling patients in two randomized clinical trials, one of which is being conducted at VA hospitals in Minneapolis and St Cloud, Minn. The company is also enrolling a virtual randomized clinical trial that is much broader in geographic scope.