Cognito Therapeutics Receives FDA Breakthrough Device Designation for Next-Generation Digital Therapeutic in Alzheimer’s Disease

– Breakthrough designation is based on positive outcomes from clinical studies, and will advance the industry’s first next-generation digital therapeutic to treat memory and cognition in Alzheimer’s disease

– Company pipeline of digital therapeutics based on proprietary, non-invasive neurostimulation technology developed by MIT scientific founders Professors Li-Huei Tsai and Edward Boyden

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 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.”

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