Darmiyan, Inc. announced that the U.S. Food and Drug Administration has approved the company's post-market surveillance study for BrainSee, its AI-powered clinical prognostic tool for Alzheimer's disease. The 7-year study aims to further validate the safety and effectiveness of BrainSee in a socio-demographically diverse patient population across the United States, while supporting pharmaceutical companies and contract research organizations in identifying optimal candidates for next-generation Alzheimer's clinical trials.
First-in-Class Prognostic Technology
BrainSee represents a significant advancement in Alzheimer's disease assessment as the first and only FDA-approved, non-invasive technology that offers clinicians actionable insight into disease progression. The AI-powered tool combines standard brain MRI, basic cognitive assessments, age, and biological sex to generate a prognostic score for patients over the age of 55 with amnestic mild cognitive impairment (aMCI). The FDA granted BrainSee marketing authorization in January 2024 via the De Novo pathway.
The technology addresses a critical clinical gap in Alzheimer's care. Unlike traditional tests that detect non-specific biomarkers like amyloid beta plaques, BrainSee predicts disease progression. According to the company, roughly 40% of amyloid-positive aMCI patients remain stable for at least five years or return to normal cognition. These individuals are unlikely to benefit from anti-amyloid drugs and may face unnecessary side effects.
Broad Clinical Accessibility
A key differentiator of BrainSee is its accessibility across medical specialties. Any licensed physician, not just neurologists, can prescribe the test, including primary care providers such as internists and family medicine doctors, as well as specialists in psychiatry, geriatrics, and preventive medicine. This broad accessibility enables early cognitive risk assessment at the point of first contact—often in primary care settings—without the need for specialist referral.
Comprehensive Post-Market Study Design
The post-market study will collect, curate, and analyze large-scale data from patients of diverse ethnic and socioeconomic backgrounds via community clinics and hospitals. The research will highlight BrainSee's clinical utility in underrepresented populations, addressing health equity concerns in dementia care.
Darmiyan is collaborating with leading Alzheimer's Disease Research Centers and nationally recognized datasets, including the National Alzheimer's Coordinating Center (NACC), the Health & Aging Brain Study – Health Disparities (HABS-HD), the Alzheimer's Disease Neuroimaging Initiative (ADNI), the University of Alabama at Birmingham (UAB) ADRC, UC Davis ADRC, and the Open Access Series of Imaging Studies (OASIS) of Washington University.
Clinical Impact and Future Applications
"With FDA approval of our post-market study, we aim to demonstrate BrainSee's value in addressing one of the most pressing challenges in medicine: equitable access to high-quality, predictive care that guides dementia prevention, improves outcomes, and reduces costs," said Dr. Kaveh Vejdani, Chief Medical and Technology Officer of Darmiyan. "We're proud to work with these national leaders to ensure no community is left behind in the fight against Alzheimer's disease."
The insights gained from the study will support pharmaceutical companies and CROs in advancing both precision and equity in patient selection for clinical trials. By identifying patients most likely to progress to clinical Alzheimer's disease, BrainSee aims to guide individuals through next steps to prevent or delay the onset of dementia symptoms.
Based in San Francisco, Darmiyan is a neuroscience and AI company that leverages proprietary Virtual Microscope technology and advanced AI to provide non-invasive, highly accurate prognosis for patients at risk of Alzheimer's disease.
