Breakthrough Designation will advance the development of industry’s first predictive diagnostic device for conversion to Alzheimer’s disease, backed by two decades of global clinical studies

Altoida, Inc., a pioneer in brain health and digital biomarker science, announced that their precision neurology device planned for use in Alzheimer’s disease and dementia diagnosis has been awarded Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The non-invasive software device which measures and monitors neurocognitive function is backed by two decades of global research, and is now being evaluated to predict conversion from Mild Cognitive Impairment to Alzheimer’s disease with artificial intelligence.

The Breakthrough Program is designed to accelerate patients’ access to innovative technologies that could provide more effective treatment or diagnosis. Under the program, Altoida will receive priority review and interactive communication regarding product development and clinical trial protocols, through to commercialization decisions.

“We are proud to receive this designation for the Altoida device, which will be a completely digital solution for predictive Alzheimer’s disease diagnosis,” said Travis Bond, CEO of Altoida. “This significant milestone enables Altoida to pioneer a new generation of precision neurology devices which leverage artificial intelligence for prediction of neurodegenerative disorders before onset, rather than rely on analysis of symptoms after onset. We look forward to working with the FDA to continue development of our device and to make highly accurate, non-invasive, and cost effective diagnosis of neurodegenerative disorders universally accessible, beginning with Alzheimer’s disease.”

“We have devoted more than twenty years of research to reinventing traditional approaches in dementia diagnosis,” said Ioannis Tarnanas, Ph.D., Chief Scientific Officer of Altoida. “This designation is recognition of the strong clinical need to accurately and reliably predict conversion to Alzheimer’s disease before irreversible damage can occur. Altoida’s device could enable predictive diagnosis of neurodegenerative disorders at the population level, which can in turn enable preventative and therapeutic intervention in the earliest stages to delay onset and improve clinical outcomes.”

Altoida’s device collects personalized brain data by asking users to complete a 10 minute set of augmented reality and motor activities on their smartphone or tablet. With this data, the device will use artificial intelligence to predict if an individual aged 55+ with Mild Cognitive Impairment will or will not convert to Alzheimer’s disease within 12 months.

Altoida recently secured funding and a partnership with Eisai Innovation, Inc., a strategic investment subsidiary of Eisai, Inc., to accelerate their predictive dementia diagnostics work. According to the recent press release, the funding will contribute to new scientific research, product development, and global commercialization efforts.

Altoida’s device is a Computerized Cognitive Assessment Aid that is classified as Class II, 510(k) exempt.