Neurophet’s AI-backed degenerative brain disease software scores FDA 510k
Neurophet said on Thursday that it obtained FDA 510k clearance for its AI-based degenerative brain disease diagnosis assistant software, Neurophet AQUA.
Neurophet AQUA uses AI algorithms to analyze brain atrophy observed in neurodegenerative diseases such as Alzheimer's disease. It can segment and analyze brain images in five minutes for people of all races, ages, and genders.
Particularly, Neurophet AQUA is expected to play an important role in the diagnosis of Alzheimer's disease and prognostic monitoring for prescribing therapies, the company said.
Neurophet said it is in advanced discussions with several imaging medical AI solution platform companies to supply Neurophet AQUA in the U.S. market.
Abnormal brain atrophy is detected in MRIs of the brains of most Alzheimer's disease patients, and patients treated with antibody therapies that remove beta-amyloid protein deposits in the cortex of the brain often experience brain atrophy. Although the cause of brain atrophy stemming from Alzheimer's disease drug administration is unclear, it is important to continuously monitor brain atrophy during treatment.
According to Grand View Research, the global dementia drug market is expected to grow at a compound annual growth rate (CAGR) of 16.2 percent from $4.2 billion in 2022 to reach $15.6 billion by 2030.
In August 2022, the company received FDA 510k clearance for its positron emission tomography (PET) image automated analysis software, Neurophet SCALE PET.
"As Neurophet AQUA and Neurophet SCALE PET have been certified by the U.S. FDA, we are looking forward to its use in the clinical and prescription fields of Alzheimer's disease treatment,” said Neurophet CEO Been Jun-kil. "We are also positioning ourselves to respond to the expanding market for dementia therapies, as our technology can quantify vascular neuropathologies that can be used to analyze amyloid-related imaging abnormalities (ARIA), a side effect of anti-amyloid therapy.”