FDA Breakthrough Designation for Altoida's medtech neurology device

Established in 2016 in Luzern, Altoida is a pioneer in brain health and digital biomarker science. The medtech startup developing a non-invasive software device that measures and monitors neurocognitive function is backed by two decades of global research. It is now being evaluated to predict conversion from Mild Cognitive Impairment to Alzheimer’s disease with artificial intelligence.

The 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.

The US Food and Drug Administration has awarded Altoida Breakthrough Designation. This will  advance the development of the industry’s first predictive diagnostic device for conversion to Alzheimer’s disease, backed by two decades of global clinical studies

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 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.”

Backed by Eisai Innovation
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.

(Press release/RAN)