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Darmiyan Executives Call FDA's Accelerated Approval of Aducanumab A Big Step in the Right Direction

FDA Makes History, Shows New Openness to Alzheimer's Disease Detection and Therapeutics
Today Marks Major Milestone for Alzheimer's Patients

San Francisco, CA, June 7, 2021:

"This is a big day in the history of Alzheimer's disease. The past 10 days have seen new openness in the FDA’s approach towards this devastating disease. On May 28 FDA granted Darmiyan's BrainSee (AI-powered early detection and monitoring of Alzheimer's) with breakthrough designation, and today FDA granted accelerated approval for Aduhelm (aducanumab) as a treatment for Alzheimer's disease. Now it's more important than ever to detect the disease early when treatments have the highest chance of being effective. "

- Darmiyan CEO Padideh Kamali-Zare, PhD

"This is a big step in the right direction. It brings hope and energy to patients, their families and the entire Alzheimer’s field. Now the question is, which patients should take the drug? Darmiyan’s BrainSee soon will help identify those patients who are most likely to benefit from this drug and others in the pipeline."

-Darmiyan Chief Medical and Technology Officer Kaveh Vejdani, MD




Based in San Francisco, California, Darmiyan was incorporated in September 2016 and backed by Y-Combinator (YC) in Summer 2017. The Company has won numerous awards and recognitions including the TEDMED Hive Innovator in 2018, CABHI Innovation Award in 2019 and Fortune 40 Under 40 for healthcare in 2020 and in May 2021 an FDA Breakthrough designation for BrainSee. Darmiyan's most recent funding in 2020 was led by the global pharma giant Eisai with participation of YC and IT-Farm. Darmiyan’s proprietary technology using brain MRI is patented in the US; patents are pending in Europe, Japan and China.

Quotes
This is a big day in the history of Alzheimer's disease. Now it's more important than ever to detect the disease early when treatments have the hi...
Padideh Kamali-ZareCEO
This is a big step in the right direction. It brings hope and energy to patients, their families and the entire Alzheimer’s field. Now the questio...
Kaveh VejdaniChief Medical and Technology Officer
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Key Takeaways
  • Today FDA made history and marked a major milestone for Alzheimer's patients.
  • The past 10 days have seen new openness in the FDA’s approach towards this devastating disease.
  • On May 28 FDA granted Darmiyan's BrainSee (AI-powered early detection and monitoring of Alzheimer's) with breakthrough designation, and today FDA granted accelerated approval for Aduhelm (aducanumab) as a treatment for Alzheimer's disease.
Contacts
Ilyse Veron
ILYSE@DARMIYAN.COM
Chief of Communications/Head of US Strategic Partnerships