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NightBalance Strengthens Competitive Position in Sleep Apnea Market with Key U.S. Patent
U.S. PTO grants patent for “method and device for sleep posture correction”


NightBalance Strengthens Competitive Position in Sleep Apnea Market with Key U.S. Patent for Innovative Sleep Position Trainer

Delft, the Netherlands, July 1, 2015 - NightBalance BV, a leading innovator of obstructive sleep apnea (OSA) technology, announced today that the U.S. Patent and Trademark Office has granted the company an important patent for “method and device for sleep posture correction.” The intellectual property covered by the patent provides broad protection for NightBalance’s Sleep Position Trainer (SPT). In the burgeoning field of sleep apnea innovation such strong protection is vital. The SPT is CE marked since January 1, 2012, and is the first innovative OSA device in the world to be reimbursed by a major healthcare payer, Achmea in the Netherlands, which covers 5 million lives. NightBalance currently sells the SPT in 11 European countries through a network of specialized distributors.

“This U.S. patent provides us with vital IP protection in the largest and most attractive market for sleep apnea,” said Eline van Beest, co-founder and CEO of NightBalance. “Together with the unique properties of our Sleep Position Trainer, its ease of use and the large clinical data set we have generated, it lays a solid basis for our U.S. strategy – conducting clinical studies and file for U.S. FDA 510k clearance in the near future.”

The SPT is a smart device that gently trains patients not to sleep on their back (supine) to prevent apnea. Alternative treatment modalities such as continuous positive airway pressure (CPAP) or the use of a mandibular advancement devices (MAD) are considered effective, but invasive, uncomfortable, and complex. Among innovators in the sleep apnea market, NightBalance stands out because of the wealth of clinical data the company has already generated, demonstrating the efficacy and ease of use of its sleep position trainer, and a substantial increase in patient compliance.

NightBalance intends to raise a series B financing to support the further international commercial roll-out of the SPT, obtain reimbursement in other markets, and conduct studies to obtain 510(k) clearance from the U.S. FDA.

About Obstructive Sleep Apnea*
Obstructive sleep apnea is a chronic condition characterized by frequent episodes of upper airway collapse during sleep. Its effect on nocturnal sleep quality and ensuing daytime fatigue and sleepiness are widely acknowledged. Increasingly, obstructive sleep apnea is also being recognized as an independent risk factor for several clinical consequences, including systemic hypertension, cardiovascular disease, stroke, and abnormal glucose metabolism. Estimates of disease prevalence are in the range of 3% to 7%, with certain subgroups of the population bearing higher risk. Factors that increase vulnerability for the disorder include age, male sex, obesity, family history, menopause, craniofacial abnormalities, and certain health behaviors such as cigarette smoking and alcohol use. Despite the numerous advancements in our understanding of the pathogenesis and clinical consequences of the disorder, a majority of those affected remain undiagnosed.

About the Sleep Position Trainer
The Sleep Position Trainer has been developed by NightBalance to treat positional obstructive sleep apnea patients. The SPT trains patients not to sleep on their backs (supine) to prevent positional apneas. The SPT is worn on the chest and constantly measures the sleep position of the patient. When the patient lies in a supine position, the SPT gives off a light vibration that nudges the patient to change sleep position. This happens during the light sleep stage, so that the natural sleep pattern is not affected. Since the SPT activates itself after 20 minutes, it allows patients to fall asleep in any position. The smart sensor uses individually adjusted vibration strengths and patterns to assure its long-term effectiveness. The SPT is prescribed by ear, nose and throat specialists or pulmonologists.

About NightBalance
A spin out from Delft University of Technology, NightBalance was founded in 2009 and is based in Delft, the Netherlands. The company has developed the Sleep Position Trainer, a proprietary, highly advanced and easy to use device to prevent obstructive sleep apnea. The SPT is currently sold in 11 European countries. NightBalance has conducted extensive clinical studies demonstrating the SPT’s efficacy, and collaborates with more than 20 hospitals in the Netherlands, Germany, France, Denmark and Belgium for further studies.


Contacts

NightBalance
Eline van Beest
CEO
+31 642 24 14 11
eline@nightbalance.com

Media
Hans Herklots
Capricorn One
+41 79 598 7149
capricorn1@bluewin.ch

*Naresh M. Punjabi 'The Epidemiology of Adult Obstructive Sleep Apnea', Proceedings of the American Thoracic Society, Vol. 5, No. 2 (2008), pp. 136-143.


Publisher Contact Information:

NightBalance
+31 642 24 14 11
eline@nightbalance.com

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