The FDA has cleared the Cerêve Sleep System, a prescription device that reduces the time it takes to fall asleep for those with insomnia. Over 55 million Americans have insomnia, which costs over $100 billion annually in lost productivity and healthcare costs. Current treatments with sleeping pills have safety risks like next-day impairment. The Cerêve System addresses insomnia by gently cooling the forehead to reduce activity in the brain's frontal cortex and help people fall asleep faster, as shown in clinical studies. The company plans to launch the Cerêve System in late 2017 to provide an alternative to pills for treating insomnia.

1. FDAClearsCerêve Device forTreatingInsomniaPatients
By Helping Them Get to Sleep Faster
June 6, 2016
Oakmont, PA -- The U.S. Food and Drug Administration (FDA) has granted commercial clearance for the
CerêveTM
Sleep System, a prescription device that reduces latency to Stage 1 and Stage 2 sleep for
people with insomnia.
A staggering 55 million Americans meet the clinical definition of insomnia, experiencing not only
problems getting to sleep but also serious impairment in their daytime activities. The cost of insomnia in
the U.S. is over $100 billion annually, including poorer workplace performance, increased health care
utilization, and increased accident risk. To date, sleeping pills have been by far the most common
medical treatment with nearly nine million adults having taken prescription sleeping pills in the last 30
days. Unfortunately, these pills come with well-established safety risks, in particular decreased mental
alertness the morning after use, even if users feel fully awake. These medications can cause next-day
impairment of driving and other activities that require full alertness, leading physicians and consumers
alike to seek a drug-free alternative.
“We are thrilled that the FDA has cleared the Cerêve Sleep System for treating people with insomnia,”
states Eric Nofzinger, M.D., a board-certified sleep physician and the company’s founder. “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.”
The inspiration behind the Cerêve System came from pioneering functional brain imaging studies that
Dr. Nofzinger conducted at the University of Pittsburgh. Patients with insomnia often describe “racing
minds” that prevent them from sleeping soundly. The functional brain imaging studies confirmed that
the frontal cortex, or executive brain, stays active in people with insomnia during sleep, preventing
them from getting deeper, more restorative sleep. Dr. Nofzinger’s solution: gently cooling the forehead
within a precise, clinically-proven therapeutic range in order to reduce this activity in the frontal cortex.
Three independent clinical studies conducted on more than 230 patients over 3,800 research nights
demonstrated the safety and efficacy of this novel device. The Company’s pivotal clinical study was a
randomized, placebo-controlled trial of people with primary insomnia at seven clinical sites across the
U.S. Results from polysomnographic sleep measurements of subjects in sleep labs (the gold standard for
evaluating sleep) showed a statistically significant reduction in latency to Stage 1 sleep, the time it takes
to get into the first stage of sleep, as well as latency to Stage 2 sleep. Across two additional studies, self-
reports from patients demonstrate that the quality of their sleep improved over 30 days of in-home use

2. of the Cerêve Sleep System. The FDA evaluated the company’s application under a de novo classification
for novel, low risk devices. Clinical studies over 3,800 nights confirmed this low-risk safety profile.
With seven issued and nineteen pending patents, the Cerêve System is comprised of a software-
controlled bedside device that cools and pumps fluid to a forehead pad that is worn through the night.
Clinical subjects found the device easy to use and to wear, and commented that it was a calming and
comfortable experience.
“We are working hard to bring our new technology to market to relieve the suffering experienced by
those with chronic insomnia,” states Craig Reynolds, President and Chief Executive Officer. “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.”
About Cerêve
Based near Pittsburgh, PA, the privately-held company was formed in 2008 after the company’s
Founder, Eric Nofzinger M.D., performed pioneering brain imaging studies on patients with insomnia at
the University of Pittsburgh. The Cerêve management team includes former executives from
Respironics, a global leader in sleep and respiratory markets that was acquired by Philips in 2008 for $5
billion.
Cerêve was funded in part by a grant from the National Institute of Health as well as by venture capital
firms Arboretum Ventures, Versant Ventures and Partner Ventures.
For more information, or to receive updates as Cerêve becomes available, visit www.cerevesleep.com.
SOURCES:
National Sleep Foundation. Sleep in America Poll - Sleep, Performance and Workplace. Sleep Health:
Journal of the National Sleep Foundation. 2008;1(2):7.
Roth T, Coulouvrat C, Hajak G, et al. Prevalence and perceived health associated with insomnia based on
DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, Tenth
Revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, Second Edition
criteria: results from the America Insomnia Survey. Biol Psychiatry. 2011;69(6):592-600.

3. Wickwire, Shaya and Sharf: Health economics of insomnia treatments: The return on investment
for a good night's sleep Sleep Medicine Reviews, Volume 30, December 2016, Pages 72-82
Chong Y, Fryar CD, Gu Q. Prescription sleep aid use among adults: United States, 2005–2010. NCHS data
brief, no 127. Hyattsville, MD: National Center for Health Statistics. 2013.
http://www.cdc.gov/nchs/products/databriefs/db127.htm
Consumer Reports, February 2016: http://www.consumerreports.org/sleep/why-americans-cant-sleep/
For media inquiries please contact us at:
Damian Rippole
Phone (412) 794-8152
contact@cerevesleep.com