FDA Clears Prognostic Test for Predicting Progression to Alzheimer Disease

Darmiyan, Inc. announced the FDA's approval of its first-in-class (De Novo) clinical test, BrainSee, the first clinical application of Darmiyan's patented core proprietary technology powered by advanced whole-brain image analysis and medical AI.

BrainSee is a highly-scalable and fully-automated software platform that combines standard clinical brain MRI and cognitive assessments – part of the routine, non-invasive workup of patients concerned with memory loss – and generates an objective score that predicts the likelihood of progression from aMCI to Alzheimer dementia within 5 years. BrainSee addresses a critical unmet need for over 10 million Americans and over 100 million patients worldwide grappling with aMCI. With an aging global population, the socio-economic impact of BrainSee is expected to grow rapidly and exponentially.

"Our vision is to redefine brain health screening and monitoring standards and impact the lives of patients and their family members in a meaningful way. BrainSee is the first product of this vision, backed by our solid technological infrastructure that is capable of driving further transformations and scalable innovations in the brain health landscape," stated Dr Padideh Kamali-Zare, Founder and CEO of Darmiyan.

Early screening and risk stratification by BrainSee enables timely and personalized treatments for those aMCI patients at high risk of progression to Alzheimer dementia, aiming to delay dementia onset, while reassuring those at lower risk of progression, hence reducing the need for costly and invasive tests and the heavy burdens of financial and emotional abuse. This shifts the patient experience from prolonged anxiety to proactive management, which is crucial in an era of emerging Alzheimer treatments where accurate prognosis can help determine suitable treatment candidates. The economic impact of BrainSee will be significant for all stakeholders in healthcare, promising to reduce the billions of dollars annually spent on Alzheimer care, through more effective management and treatment.

BrainSee was previously granted FDA breakthrough designation in 2021. It stands out for its prognostic accuracy, patient convenience, same-day test results and seamless integration into the clinical workflow. Global availability of MRI significantly enhances BrainSee's clinical utility. Most notably, BrainSee shifts the paradigm in aMCI workup from biomarker-based methods that have limited real-world capabilities due to their invasiveness, non-specificity, cost, and inaccessibility, to non-invasive and actionable forecasts of future improvement or progression.