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Cervella FDA-Cleared Cranial Electrotherapy Stimulator

About

Innovative Neurological Devices

INNOVATIVE NEUROLOGICAL DEVICES LLC, the maker of the Cervella CES system, is a medical device company located in Carmel, Indiana.

COMPANY AND PRODUCT HISTORY

  • The mission of our company is to provide innovative and affordable neurological medical devices that have a significant impact on improving patient’s lives.
  • Our flagship product, Cervella, features several innovative and patented features that allow a patient to integrate the treatment into his or her lifestyle. Cervella's electrodes are seamlessly incorporated into a pair of high-end Bluetooth-enabled stereo headphones allowing the patient to receive the treatment during work, study, or play. Cervella is also the first and only CES device which is controlled via user's smartphone which allows patient to automatically record his or her treatment data for easy sharing with patient's healthcare professional. In sum, Cervella is designed to be integrated into patient's life, not the other way around.
  • Our company was founded in 2017 by Bart Waclawik. The genesis for starting the company was rooted in Bart's experience with a family member who was suffering from a Generalized Anxiety Disorder and for whom drug-based therapies were not effective. Through research for non-drug treatment of anxiety and depression disorders, Bart came across the Cranial Electrotherapy Stimulators which showed clinically-validated efficacy for treatment anxiety, depression, and comorbid insomnia. Bart obtained a CES device for his family member and within few weeks patient's conditions improved markedly. However, the patient soon discontinued using the device as he complained about the device being cumbersome to use (electrodes had to be clipped to ear-lobes during treatment) and also conspicuous prohibiting the patient from using the device outside of the home environment. Bart, who is an experienced medical device entrepreneur and an inventor (Bart is a recipient of several patents) began the work on making a modern version of a CES device which would not only be comfortable to use but also conspicuous allowing patient to use it anywhere. After two years of design, development, testing, and the FDA approval process, the Cervella was born!