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Cognito Therapeutics announced Tuesday that its non-invasive neurostimulation device which uses gamma frequency technology has received breakthrough status by the FDA to treat cognitive and functional symptoms associated with Alzheimer's disease. The company said the device is the first in its pipeline of digital therapeutics for neurodegenerative diseases and other chronic indications.
Brent Vaughan, who was appointed CEO last month, stated that the designation "marks a significant milestone for Cognito as we advance a new generation of digital therapeutics with drug-like mechanisms of action to effect disease modification."
According to Cognito, the therapy uses visual and auditory stimulation to treat neurodegenerative diseases. The company indicated that the breakthrough designation was based on positive outcomes from clinical trials.
Chief medical officer Tom Megerian said clinical evidence for the product "demonstrated that Alzheimer's patients in the treatment arm exhibited improved cognitive and functional outcomes compared to placebo." Megerian added that the novel approach addresses "both the pathological accumulation of tau and beta amyloid, while also using non-invasive neuromodulation to effect the restoration of neurological function."
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