Zach Malchano’s (SLP Silicon Valley, 2012) Cognito Therapeutics Receives FDA Breakthrough Device Designation for Next-Generation Digital Therapeutic in Alzheimer’s DiseaseMay 14, 2021, 5:27 a.m.
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.
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