Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

Cognito Therapeutics’ lead product has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of cognitive and functional symptoms associated with Alzheimer’s disease.
 
The product, a non-invasive neurostimulation device using gamma frequency technology, is the first in the company’s pipeline of digital therapeutics for neurodegenerative diseases and other chronic indications.
 
The FDA Breakthrough Device Program helps patients receive more timely access to innovative technologies that could provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Cognito with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
 
“We are thrilled to receive this FDA designation for our lead product in Alzheimer’s, based on promising outcomes in multiple clinical studies to date,” said Brent Vaughan, CEO of Cognito Therapeutics. “This marks a significant milestone for Cognito Therapeutics as we advance a new generation of digital therapeutics with drug-like mechanisms of action to effect disease modification. We look forward to working with the agency to develop our product for the millions of patients with neurodegenerative disorders, beginning with Alzheimer’s disease.”
 
“There is an urgent need to develop new therapies for patients with Alzheimer’s,” said Tom Megerian, M.D., Ph.D., chief medical officer at Cognito Therapeutics. “The Breakthrough Designation is recognition of the strength of clinical evidence for our lead product, which demonstrated that Alzheimer’s patients in the treatment arm exhibited improved cognitive and functional outcomes compared to placebo. It is exciting to see the results of a novel approach to treating AD that attacks the disease on three fronts, by addressing both the pathological accumulation of tau and beta amyloid while also using non-invasive neuromodulation to effect the restoration of neurological function.”
 
“I am encouraged by Cognito’s innovative approach,” said Allan Levey, M.D., Ph.D., professor and chairman of the Department of Neurology at Emory University and director of the Emory Goizueta Alzheimer’s Disease Research Center. “This strategy translating recent advances in non-invasive modulation of brain activity with sensory stimulation with light and sound has the potential to be an urgently needed safe, non-invasive, and effective treatment for millions of individuals with Alzheimer’s disease.”