Sleep-focused company Cereve said today it won FDA 510(k) clearance for its Cereve Sleep System device designed to reduce latency to stage 1 and stage 2 sleep for patients suffering from insomnia.
The sleep system is designed to cool the forehead within a therapeutic range to reduce activity in the frontal cortex, which the company says stays active in insomnia patients and interferes with deep, restorative sleep. The device consists of a software-controlled bedside device which cools and pumps fluid into a forehead pad worn throughout the night.
“We are thrilled that the FDA has cleared the Cerêve Sleep System for treating people with insomnia. This is the first and only insomnia device cleared to reduce sleep latency to Stage 1, the first stage of sleep, as well as stage 2, a stage of sleep that typically represents over 50% of the sleep period. The Cerêve system offers a clinically-proven and safe alternative to pills, with the potential to help millions of Americans get to sleep fast,” founder Dr. Eric Nofzinger said in a press release.
The company said that the device was designed around functional brain imaging studies performed at the University of Pittsburgh which identified activity in the frontal cortex of patients with insomnia.
A pivotal clinical study of the device indicated that insomnia patients treated with the device showed a statistically significant reduction in latency to reaching the 1st and 2nd stage of sleep. Cereve touted results from another 2 studies of the device which indicated quality of sleep improvements over 30 days.
“We are working hard to bring our new technology to market to relieve the suffering experienced by those with chronic insomnia. The importance of sleep as a vital pillar of health (along with diet and exercise) is ever increasing, and current therapeutic options available to physicians and insomnia patients are limited. The Cerêve Sleep System, which is slated to launch during the second half of 2017, will help to meet an important clinical need,” CEO Craig Reynolds said in a prepared release.