The device, called the Cognision, has been in development for more than 10 years. It collects data that can be used to evaluate several neurological and cognitive disorders, including Alzheimer's disease and concussions, said Neuronetrix CEO K.C. Fadem. The company believes that the market for widespread Alzheimer's diagnostics is particularly strong.
The Cognision System is a portable device used to record electrical brainwaves from patients with neurological problems. Cognision tests include both standard electroencephalograms (EEG) as well as auditory event-related potentials (ERP). The device is easy-to-use and inexpensive enough to be used by private practice physicians in their office, according to the company.
"Mobile neurodiagnostic devices offer great promise to enhance the objective assessment of a patients' cognitive and neurological status at the point of care. Neural markers closely tied to cognitive status can also accelerate drug development for a variety of brain disorders," said Murali Doraiswamy, M.D.,an expert in neurocognitive disorders at the Duke Institute for Brain Sciences and a scientific advisor to Neuronetrix.
Neuronetrix already has been marketing the Cognision for use in clinical trials and has established a large network of committed users. Austin, Texas-based Onnit Labs, for example, used Cognision in its clinical study on Alpha BRAIN and reported positive results reflected in the Cognision data. Anavex Life Sciences Corp. of New York, N.Y., is using the test to evaluate the effects of a novel therapy on Alzheimer’s patients. The system also is being used in university clinical research such as the HIV-associated Neurocognitive Disorders ((HAND) study being performed at the East Tennessee State University James H. Quillen College of Medicine in Johnson City, Tenn.
“The effects of several drug compounds have already been successfully evaluated in well-controlled clinical studies using COGNISION™. Now physicians will have access to that same technology in their own practices.” said Marco Cecchi, director of Research and Clinical Affairs at Neuronetrix.
Now that the company has the approval, its next step will be to begin selling the device—which it produces in-house—for clinical use. Corporate executives were not sure how many units would be produced during the company's first manufacturing run as they attempt to work out distribution and marketing for the Cognision in the coming months.
Based in Louisville, Ky., Neuronetrix develops advanced neurodiagnostic technology.