NightWare Inc., a Minneapolis-based startup that treats nightmares caused by post-traumatic stress disorder, has received FDA clearance for its device, which uses an Apple Watch to gently shake users out of their nightmares.
NightWare announced the clearance last Tuesday, the day before Veterans Day. That's fitting because the device was designed with veterans and active duty military in mind, CEO Grady Hannah said; for years, the company had Veterans Day in 2020 set as its goal for receiving FDA clearance. The clearance allows NightWare to make medical claims about the device in marketing and will make it much more attractive to doctors, Hannah said.
In May, NightWare received Breakthrough Status from the FDA, putting it on a fast track towards clearance. The device works using software installed on an Apple Watch and an iPhone. The Apple Watch sensors detect heart rate and body movement, which tell it when a user is having a nightmare. The watch vibrates enough to knock the user out of the nightmare, but not enough to wake them up.
"Sleep is an essential part of a person’s daily routine. Today’s authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares," said Carlos Peña, the FDA's director of the office of neurological and physical medicine devices, in a statement.
The firm completed a 30-day trial of 70 patients with PTDS which showed that its device improved sleep quality and that its benefits outweighed its risks. A larger second trial, with an enrollment of 240 patients, is ongoing and is expected to deliver results in the second half of 2020.
The firm, which has five employees, is now working on shipping 100 sample kits to customers ahead of a larger planned rollout. NightWare is raising funds to aide in its commercialization, Hannah said. The firm hopes to raise about $7 million by the end of the year. It raised $2.8 million last year to complete the trials that led to its FDA clearance.
