FDA clears novel insomnia device, slated for 2017 launch

Dr. Eric Nofzinger

Former Respironics executives have been quietly working on a startup for the last several years that's now been cleared by the FDA. Startup Cerêve has nabbed a regulatory nod for its sleep system as a prescription device to treat insomnia and is slated to launch it in the second half of next year.

"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," said the company's founder Dr. Eric Nofzinger in a statement. "The Cerêve System offers a clinically proven and safe alternative to pills."

Cerêve was founded in 2008 by Nofzinger, who had performed brain imaging studies on insomnia patients at the University of Pittsburgh. His research that went into the Pennsylvania-based company was supported in part by the National Institutes of Health.

The startup has raised $15 million, which was sufficient to get it through product development and regulatory clearance while also helping it to market launch plans, Cerêve CFO Damian Rippole told FierceMedicalDevices. Its venture capital backers include Arboretum Ventures, Versant Ventures and Partner Ventures.

Nofzinger found in his imaging studies that insomnia patients were unable to fall deeply asleep because their working brain remained too active during sleep. He developed a novel approach to help calm this activity, which the company said alters patient physiology to offer deeper, more restorative forms of sleep.

The solution was to cool the forehead to a precise temperature to reduce the activity in the frontal cortex. The Cerêve System includes a bedside device that cools and pumps fluid to a forehead pad that is worn throughout the night. The device is software-controlled to maintain the specific desired temperature. Cerêve declined to disclose an image of its system just yet.

The system was studied in three clinical trials in more than 230 patients over 3,800 nights. The company conducted a randomized, placebo-controlled trial of people with primary insomnia at 7 U.S. clinical sites.

Polysomnographic sleep measurements of subjects in sleep labs found that the device resulted in a statistically significant reduction in latency to Stage 1 sleep, which is the time it takes to get into the first stage of sleep, as well as latency to Stage 2 sleep.

The Cerêve System was approved via the de novo pathway, which is reserved by the FDA specifically for low risk devices.

The startup's management team includes a trio of execs pulled from sleep and respiratory company Respironics, which was acquired by Royal Philips ($PHG) in 2008 for $5 billion. These include Cerêve President and CEO Craig Reynolds, VP of Engineering Jeff Schirm as well as CFO Damian Rippole.

"We are working hard to bring our new technology to market to relieve the suffering experienced by those with chronic insomnia," said Reynolds. "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 ... will help to meet an important clinical need."

- here is the release