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Study Shows Drug-Free Insomnia Treatment to be Clinically Effective

Placebo-controlled trial of Ebb Insomnia Therapy publishes today in the official journal of the Sleep Research Society

 

PITTSBURGH, PA, April 10, 2018 – A clinical study of a new, drug-free insomnia treatment is publishing today in SLEEP, the official publication of the Sleep Research Society, an organization for scientific investigators who educate and research sleep and sleep disorders. Results of the study, which tested Ebb® Insomnia Therapy, 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, a deeper stage of sleep that typically represents over half the night.

Conducted at seven clinical sites across the U.S., the SLEEP study included a randomized, placebo-controlled trial collecting polysomnographic sleep measurements in 106 adults with primary insomnia. Authors of the study include Thomas Roth, Ph.D.; David Mayleben, Ph.D.; Neil Feldman, M.D.; Alan Lankford, Ph.D.; Timothy Grant, M.D.; and Eric Nofzinger, M.D.

Protected by nine issued and 25 pending patents, Ebb Insomnia Therapy is a software-controlled bedside device that cools and pumps fluid to a forehead pad worn through the night. The device is also the only drug-free insomnia treatment cleared by the FDA that reduces the time it takes to both fall asleep and enter deep, restorative sleep.* The inspiration behind Ebb Insomnia Therapy came from pioneering functional brain imaging studies conducted at the University of Pittsburgh by Eric Nofzinger, M.D., Founder and Chief Medical Officer at Ebb Therapeutics.

In total, three independent clinical studies conducted over 3,800 research nights demonstrated the safety and efficacy of this novel device, with an extremely low incidence of adverse events.** Ebb Insomnia Therapy’s safety profile compares favorably to that observed for approved prescription drugs for insomnia, which have the potential for dependence, memory loss, confusional arousals, sleep-walking and problems with coordination that increase the risk of middle-of-the-night falls and fractures for the elderly.

Patients who used Ebb Insomnia Therapy reported improved quality of sleep after 30 days of in-home use and found it was easy to use and wear, creating a calming and comfortable experience. Ebb Insomnia Therapy has also been found to be safe over six months of in-home use.

“With our pivotal clinical study now publishing in SLEEP, it is wonderful to see the strong data to authenticate our hard work and support Ebb Insomnia Therapy’s clinical effectiveness,” said Dr. Nofzinger. “This device is truly ground-breaking and can impact the lives of so many, helping them fall asleep faster and enter deeper sleep, all in a safe way that can reduce dependency on other drugs.”

Currently, Ebb Insomnia Therapy is available by prescription at 17 sleep centers and sleep specialist offices across the country, in Delaware, Georgia, Kansas, Maryland, Missouri, North Carolina, North Dakota, Ohio, Pennsylvania and Texas. Availability is expanding rapidly, with complete national availability of the treatment expected by early 2019.

 

About Ebb Therapeutics

Headquartered in Pittsburgh, Pa., Ebb Therapeutics is a privately held company founded in 2008 by Eric Nofzinger, M.D. The company’s technology was inspired by Dr. Nofzinger’s pioneering brain imaging studies on patients with insomnia at the University of Pittsburgh. With more than a century of collective experience in the sleep space, the Ebb Therapeutics team is on a mission to help everyone get the deep, refreshing sleep needed to take on tomorrow. Ebb was funded in part by a grant from the National Institutes of Health, as well as by private equity and venture capital firms KKR, Arboretum Ventures, Versant Ventures and Partner Ventures.

*The Food and Drug Administration cleared Ebb Insomnia Therapy as a class II medical device indicated to reduce sleep latency to Stage 1 and Stage 2 sleep in patients with primary insomnia based on a de novo clearance request. Ebb is a prescription device.

**Most common adverse event was headache in both therapy and placebo group and all were resolved without intervention.

Ebb Therapeutics in the News

Cerêve Raises $38 Million to Fuel Launch of Insomnia Device in New Financing Led by KKR

Investment Will Fund Launch of FDA-cleared Device to Safely Treat Insomnia

OAKMONT, Pa.–(BUSINESS WIRE)–Jan. 5, 2017– Cerêve Inc., a privately-held health care company preparing to launch its FDA-cleared insomnia device, announced today the closing of a $38 million Series B round of financing led by KKR, a leading global investment firm. Also participating in the financing are existing shareholders Versant Ventures, Arboretum Ventures, and Partner Ventures.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170105005480/en/

Fifty-five million Americans have insomnia, not only experiencing problems getting to sleep but also serious impairment in their daytime activities. Currently, sleeping pills are the most common medical treatment for insomnia. According to the National Center for Health Statistics…


FDA Clears Sleep Device for Insomnia – System cools hyperactive frontal cortex

The FDA has granted commercial clearance for the Cerêve Sleep System, a prescription device that reduces latency to stage-1 and stage-2 sleep for people with insomnia.

Functional brain-imaging studies have shown that the frontal cortex, or executive brain, remains active in people with insomnia during sleep, preventing them from getting deeper, more-restorative sleep. The Cerêve Sleep System consists of a software-controlled bedside device that cools and pumps fluid to a forehead pad that is worn through the night. The pad cools the forehead within a clinically proven therapeutic range to reduce hyperactivity in the frontal cortex…


Ebb sleep in Pittsburgh Business TimesPitt spinoff on insomnia: Cooler heads do prevail

Studies at the University of Pittsburgh found that the brains of patients with insomnia were overactive. Pitt had a patent for a technique to reduce brain metabolic activity using cooling, and Dr. Eric Nofzinger saw the potential.

The burgeoning business of sleep is awakening.

Nationally, the global sleep services market is expected to reach $8.4 billion by the end of 2021, according to Persistence Market Research. And as more people are seeking new ways to bolster the quality of their shut-eye, local companies are developing products to address everything from insomnia and sleep apnea to keeping special needs kids from getting injured at night. Here are their stories…


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Press Contact

Elaine Lesnak

Director of Marketing Communications

412-517-6731

elesnak@ebbsleep.com