FDA Approves the First Prognostic Test for Alzheimer’s Progression

Darmiyan, Inc., a leader in brain health innovation, announces a groundbreaking achievement: FDA's De Novo approval of BrainSee, the world's first prognostic test for predicting the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia. This approval is a significant leap forward in Alzheimer's diagnostics, showcasing the potential for proactive brain health management on a global scale.

BrainSee is the clinical application of Darmiyan's patented core proprietary technology. It leverages over 40 years of cutting-edge brain science, incorporating advanced whole-brain image analysis and medical artificial intelligence (AI). It is a highly-scalable and fully-automated software platform that utilizes standard clinical brain MRI and cognitive assessments to generate an objective score predicting the likelihood of progression to Alzheimer's dementia within five years. Over 10 million Americans and more than 100 million global patients face aMCI, meaning BrainSee addresses a critical unmet need in the field.

Dr. Padideh Kamali-Zare, Founder and CEO of Darmiyan, said that, "BrainSee is the first product of this vision, backed by our solid technological infrastructure capable of driving further transformations and scalable innovations in the brain health landscape."

The test's early screening capabilities and risk stratification empower timely and personalized treatments for high-risk aMCI patients, potentially delaying dementia onset. Through taking away the need for expensive and invasive tests, BrainSee shifts the patient experience from prolonged anxiety to proactive management, aligning with emerging Alzheimer's treatments where accurate prognosis is crucial for determining suitable candidates.

BrainSee's impact extends beyond patient care, offering significant economic benefits to healthcare stakeholders. By potentially reducing the billions of dollars spent annually on Alzheimer's care through effective management and treatment, the test promises a transformative impact on the industry.

Previously granted FDA breakthrough designation in 2021, BrainSee stands out for its prognostic accuracy, patient convenience, same-day results, and seamless integration into clinical workflows. The global availability of MRI enhances its clinical utility, providing a paradigm shift in aMCI workup from invasive, non-specific, and costly biomarker-based methods to non-invasive and actionable forecasts of future improvement or progression.

The FDA approval coincided with the JP Morgan HealthCare conference in San Francisco, and BrainSee is now accessible to physicians through a secure and HIPAA-compliant web portal. For more information, visit brainsee.ai.

About Darmiyan:

Darmiyan is a pioneering brain technology company based in San Francisco, California, their mission is to “leverage 40 years of cutting edge neuroscience research combined with advanced medical image processing and advanced ML/AI to address the biggest healthcare challenge of our time: detecting neurodegenerative disease at early stages when treatments matter.”