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Devices Neurology FDA

 News Release - March 27, 2019

FDA Clears the Cervella Cranial Electrotherapy Stimulator for Treatment of Anxiety, Insomnia, and Depression

CARMEL, Ind., March 27, 2019 -- (Healthcare Sales & Marketing Network) -- Innovative Neurological Devices is pleased to announce receiving the FDA market clearance for the Cervella™ Cranial Electrotherapy Stimulator. The FDA cleared the Cervella medical device for treatment of anxiety, depression, and insomnia. Cervella works by delivering micro pulses of electrical current across patient's brain. According to clinical studies, this electrical stimulation results in reduction in anxiety levels, insomnia, and patient's depressive mood.

Cervella is the world's first Cranial Electrotherapy Stimulator (CES) with proprietary conductive treatment electrodes that have been seamlessly integrated into noise-cancelling Bluetooth-enabled headphones. Patients can use the audio and noise cancelling features of the headphones during treatment, which allows them to use the device during study, work, or play. Furthermore, Cervella is also the first CES device that is managed through an app on a smart device allowing for automated treatment data recording, reminders, and analytics aimed at improving patient treatment outcomes. In sum, Cervella is designed to fit into a patient's lifestyle, not the other way around.

"Anxiety, insomnia, and depression are disorders affecting at least 20% of adult population. Furthermore, recent research brought to light that 70% of teenagers list anxiety and depression as the main problem affecting the younger population. For many years, CES devices have been clinically validated as a safe and effective alternative to drug-based therapies without the side-effects that often exist with the use of antidepressants," commented Mr. Bart Waclawik, President and CEO of Innovative Neurological Devices. "We hope that by incorporating treatment electrodes into a noise-cancelling headset, patient compliance will significantly increase and, consequently, treatment outcomes will improve. Also, by making the Cervella device appear indistinguishable from ordinary over-ear headphones, patients will have the freedom to use the device in anxiety-inducing situations without curious looks from onlookers. Last but not least, the automated data aggregation available through the proprietary Cervella app gives a patient an option to easily share treatment data with his or her health provider in order to better manage the treatment plan," added Mr. Waclawik.

Cervella will be available in the US at the introductory price of $695 and will be launched at the Anxiety and Depression Conference in Chicago, IL on March 28, 2019. A prescription from a licensed healthcare practitioner is required to purchase Cervella.

For more information, please visit www.cervella.us. US and worldwide patents are pending.


Source: Innovative Neurological Devices

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