Redmond, WA. USA–Cerevast Medical, Inc. announced today that the CE (Conformité Européenne) Certificate for the Neuros pulsed transdermal electrical stimulation system has been received. This certification allows sales and marketing of Neuros as a class IIa medical device, as defined by the Medical Device Directive (93/42/EEC) for the treatment of anxiety and insomnia. CE certification or “CE Mark” allows Neuros to be marketed directly within the European Union. Approximately 15-25% of the adult European population suffers from insomnia. Lack of sleep is associated with a broad range of negative health factors including increased mortality. The financial impact of insomnia through lost productivity and increased health care costs are conservatively estimated to be 1-3% of GDP. In the UK alone, it has been suggested that increasing nightly sleep from under six hours to between six and seven hours could add £24 billion to the UK economy. (RAND 2016) “Europe is the primary geography for our launch of Neuros sales,” said Bradford Zakes, President and CEO of Cerevast Medical, Inc. “Today we are focused on making Neuros available to all patients in Europe who desire an alternative to prescription medications, non-prescription remedies and psychotherapy for the treatment of insomnia and anxiety. Now that we have CE Certification, we will accelerate partnership and distribution discussions. We are pleased to have gained certification making Neuros available in Europe.”
Neuros is designed for the millions of people suffering from chronic insomnia and anxiety. Available, by prescription, the advanced neurostimulation device will be worn prior to bedtime. A Neuros session lasts 15 minutes and users can start, stop, and adjust electrical intensity via the Neuros app. Neuros applies ultra-low levels of pulsed electricity to modulate the trigeminal and C2/C3 cervical nerves. Stimulation of these nerves improves sleep quality by reducing sympathetic nervous system activity in the ascending RAS (which regulates sleep/wake cycles, arousal and alertness, attention and sensorimotor behaviors). In clinical studies, regular use of Neuros significantly decreased insomnia, reduced overnight wake-ups, and was demonstrated to be safe and effective. Visit www.neurossleep.com for more information.
Cerevast has commercial rights to the Neuros technology for all regions of the world outside North America.
About Cerevast Medical, Inc.
Cerevast is an innovation-driven healthcare company utilizing bioelectrical, ultrasound and microbubble technologies to address health conditions including sleep disorders, stroke, blindness and neurological rehabilitation. Neuros is the company’s first commercial product. The company maintains an active research effort and has several pipeline programs, including a transcranial ultrasound (TUS) for the treatment of stroke. The company is located in Redmond, Washington, USA and was founded in 2015. For more information, please visit www.cerevast.com.