Healthcare startup NightWare, Inc reported on Tuesday the receipt of the US Food and Drug Administration (FDA) breakthrough status designation for its lead product NightWare that measures and treats nightmares in people with Post-Traumatic Stress Disorder (PTSD).

Following the US FDA breakthrough status designation, the company said it can expedite its clinical trials and review cycles, shortening the timeline to broad clinical availability of its groundbreaking technology.

Currently, the company is enrolling patients in two Randomized Clinical Trials (RCTs), one of which is being conducted at VA hospitals in Minneapolis and St Cloud, Minnesota. It is enrolling a virtual RCT trial that is much broader in geographic scope.

The company added that the 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, enabling the patient to get better and more restful sleep.

Nightmares and Nightmare Disorder have reportedly been linked to increased suicidality, heightened risk of heart disease, diabetes and contributes to cognitive difficulties including memory loss, anxiety, depression and other physical and mental conditions.