Neurostimulation device GammaSense by Cognito Therapeutics secures FDA Breakthrough Device Designation to explore Alzheimer ’s Disease applications

Credit: The Picower Institute @ MIT Cognito Therapeutics nets FDA breakthrough label for light, sound therapy for Alzheimer’s disease (Fierce Biotech): Using specific frequencies of flashing lights and sounds to stimulate the brain’s electrical activity, Cognito Therapeutics believes it can help treat Alzheimer’s disease by energizing neurons and reactivating the immune system. Described as similar to a strobe light, but much faster, Cognito’s GammaSense stimulation system is built into a pair of opaque glasses worn with a set of headphones. The daily treatment has shown positive effects in mice, with changes in the brain’s hippocampus and auditory cortex including the reduction of amyloid plaques, according to a study published in Cell. Now, with the treatment approach being studied in placebo-controlled human trials, the FDA said it has seen enough early clinical data to label the device as a potential breakthrough therapy—affording the company priority review and additional opportunities to work with agency officials through the project’s clinical and commercial development. The Announcement: Cognito Therapeutics Receives FDA Breakthrough Device Designation for Next-Generation Digital Therapeutic in Alzheimer’s Disease (press release): Cognito Therapeutics, a clinical-stage company leading the development of a new class of disease-modifying digital therapeutics to treat neurodegenerative disorders, announced today its lead product has received Breakthrough...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Technology & Innovation amyloid plaques breakthrough device breakthrough therapy cognitive-symptoms Cognito Therapeutics digital therapeutics FDA GammaSense hippocampus neurodegenerative-diseases neuromodulatio Source Type: blogs