Sleep specialists in attendance at SLEEP 2017, the 31st annual meeting of the Associated Professional Sleep Societies in Boston, will be among the fi rst to experience the novel technology behind EbbTM Insomnia Therapy. The device is a safe and drug-free treatment for insomnia. Cleared by the FDA, Ebb Insomnia Therapy reduces latency to Stage 1 and Stage 2 sleep.
Later this year, Ebb Therapeutics (formerly Cerêve) will begin off ering Ebb Insomnia Therapy to select sleep centers as manufacturing is scaled, with national availability planned for 2018. Protected by nine issued and 23 pending patents, Ebb Insomnia Therapy is a so ware-controlled bedside device that cools and pumps fl uid to a forehead pad that is worn through the night.
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. Three independent clinical studies conducted over 3,800 research nights demonstrated the safety and efficacy of this novel device.
“Patients with insomnia often describe ‘racing minds’ that prevent them from sleeping soundly,” said Dr. Nofzinger. “My 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".
"Our clinical studies have demonstrated that by gently cooling the forehead within a precise therapeutic range, Ebb Insomnia Therapy allows insomnia patients to fall sleep faster.” On the evening of June 4, Dr. Nofzinger will give a poster presentation for conference attendees titled, A Novel Forehead Temperature Regulating Device for Insomnia: A Randomised Clinical Trial.
The presentation will summarise a pivotal clinical study of Ebb Insomnia Therapy, conducted at seven clinical sites across the U.S. The study included a randomised, placebo-controlled trial collecting polysomnographic sleep measurements in 106 adults with primary insomnia.
Results of the study showed a statistically signifi cant reduction in latency to Stage 1 sleep, the time it takes to get into the fi rst stage of sleep, as well as latency to Stage 2 sleep, a deeper stage of sleep that typically represents over half the night.
Authors of the study included Thomas Roth, Ph.D.; David Mayleben, Ph.D.; Neil Feldman, M.D.; Alan Lankford, Ph.D.; Timothy Grant, M.D.; and Dr. Nofzinger. Additionally, patients who tried Ebb Insomnia Therapy reported improved quality of sleep a er 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. “Knowing 55 million Americans are living with insomnia, Ebb Therapeutics is working diligently to bring our new technology to market to relieve the suff ering experienced by so many,” said Don Spence, CEO at Ebb Therapeutics.
“Sleep is a vital pillar of health, along with diet and exercise, yet the current therapeutic options available to physicians and insomnia patients are limited, many leading to unwanted side effects".
"Ebb Insomnia Therapy is safe, free of signifi cant side eff ects and will address an important clinical need by quieting the racing minds of insomnia patients, helping them fall asleep faster and get the rest they need to take on tomorrow.”
Ebb Therapeutics announced in January that it closed a $38 million Series B round of financing led by KKR, a leading global investment fi rm. Well capitalised into the future, Ebb is initially deploying this funding to build out its infrastructure in preparation for product launch.